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Chemistry

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Also known as: 84371-65-3, Mifegyne, Mifeprex, Ru-486, Korlym, Ru486
Molecular Formula
C29H35NO2
Molecular Weight
429.6  g/mol
InChI Key
VKHAHZOOUSRJNA-GCNJZUOMSA-N
FDA UNII
320T6RNW1F

Mifepristone
A progestational and glucocorticoid hormone antagonist. Its inhibition of progesterone induces bleeding during the luteal phase and in early pregnancy by releasing endogenous prostaglandins from the endometrium or decidua. As a glucocorticoid receptor antagonist, the drug has been used to treat hypercortisolism in patients with nonpituitary CUSHING SYNDROME.
Mifepristone is a Progestin Antagonist. The mechanism of action of mifepristone is as a Progestational Hormone Receptor Antagonist.
1 2D Structure

Mifepristone

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(8S,11R,13S,14S,17S)-11-[4-(dimethylamino)phenyl]-17-hydroxy-13-methyl-17-prop-1-ynyl-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-3-one
2.1.2 InChI
InChI=1S/C29H35NO2/c1-5-15-29(32)16-14-26-24-12-8-20-17-22(31)11-13-23(20)27(24)25(18-28(26,29)2)19-6-9-21(10-7-19)30(3)4/h6-7,9-10,17,24-26,32H,8,11-14,16,18H2,1-4H3/t24-,25+,26-,28-,29-/m0/s1
2.1.3 InChI Key
VKHAHZOOUSRJNA-GCNJZUOMSA-N
2.1.4 Canonical SMILES
CC#CC1(CCC2C1(CC(C3=C4CCC(=O)C=C4CCC23)C5=CC=C(C=C5)N(C)C)C)O
2.1.5 Isomeric SMILES
CC#C[C@@]1(CC[C@@H]2[C@@]1(C[C@@H](C3=C4CCC(=O)C=C4CC[C@@H]23)C5=CC=C(C=C5)N(C)C)C)O
2.2 Other Identifiers
2.2.1 UNII
320T6RNW1F
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Mifgyne

2. Mifegyne

3. Mifeprex

4. R 38486

5. R-38486

6. R38486

7. Ru 38486

8. Ru 486

9. Ru-38486

10. Ru-486

11. Ru38486

12. Ru486

13. Zk 98296

14. Zk-98296

15. Zk98296

2.3.2 Depositor-Supplied Synonyms

1. 84371-65-3

2. Mifegyne

3. Mifeprex

4. Ru-486

5. Korlym

6. Ru486

7. Ru 486

8. Mifepriston

9. Corlux

10. Ru 38486

11. Ru-38486

12. Mls000069785

13. 320t6rnw1f

14. Vgx-410c

15. Chebi:50692

16. Vgx-410

17. Nsc-759862

18. Ncgc00025179-05

19. Smr000058481

20. Mifepristonum [latin]

21. Mifepristona [spanish]

22. Dsstox_cid_3322

23. C-1073

24. Dsstox_rid_76976

25. Dsstox_gsid_23322

26. (11beta,17beta)-11-[4-(dimethylamino)phenyl]-17-hydroxy-17-(1-propyn-1-yl)estra-4,9-dien-3-one

27. (8s,11r,13s,14s,17s)-11-(4-(dimethylamino)phenyl)-17-hydroxy-13-methyl-17-(prop-1-yn-1-yl)-1,2,6,7,8,11,12,13,14,15,16,17-dodecahydro-3h-cyclopenta[a]phenanthren-3-one

28. (8s,11r,13s,14s,17s)-11-(4-dimethylaminophenyl)-17-hydroxy-13-methyl-17-prop-1-ynyl-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-3-one

29. (8s,11r,13s,14s,17s)-11-[4-(dimethylamino)phenyl]-17-hydroxy-13-methyl-17-prop-1-ynyl-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-3-one

30. 11-(4-dimethylamino-phenyl)-17-hydroxy-13-methyl-17-prop-1-ynyl-1,2,6,7,8,11,12,13,14,15,16,17-dodec Ahydro-cyclopenta[a]phenanthren-3-one

31. Mifepristona

32. Mifepristonum

33. (11beta,17beta)-11-[4-(dimethylamino)phenyl]-17-hydroxy-17-prop-1-yn-1-ylestra-4,9-dien-3-one

34. Ru486 (tetramethyl-rhodamine Conjugated)

35. Mifepristone [usan:inn:ban]

36. Hsdb 6841

37. Sr-01000076011

38. R 38486

39. Brn 5779404

40. Unii-320t6rnw1f

41. Pictovir

42. Ru 486-6

43. Ccris 9332

44. 1nhz

45. 11beta-(p-(dimethylamino)phenyl)-17beta-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one

46. Mifeprex (tn)

47. Pictovir (tm)

48. Prestwick_570

49. Cas-84371-65-3

50. Korlym (tn)

51. 2w8y

52. Mifepristone (mifeprex)

53. Opera_id_562

54. Mifepristone, >=98%

55. Prestwick0_000299

56. Prestwick1_000299

57. Prestwick2_000299

58. Prestwick3_000299

59. Spectrum5_002045

60. Mifepristone [mi]

61. Mifepristone [inn]

62. Mifepristone [jan]

63. Mifepristone [hsdb]

64. Mifepristone [usan]

65. 11beta-(4-(dimethylamino)phenyl)-17beta-hydroxy-17-(1-propynyl)estra-4,9-dien-3-on

66. 17-beta-hydroxy-11-beta-(4-dimethylaminophenyl-1)-17-alpha-(prop-1-ynyl)oestra-4,9-dien-3-one

67. Mifepristone [vandf]

68. Bidd:pxr0123

69. Lopac0_000801

70. Schembl16087

71. Bspbio_000238

72. Mifepristone [mart.]

73. 11beta-(4-(dimethylamino)phenyl)-17-hydroxy-21-methyl-19-nor-17alpha-pregna-4,9-dien-20-m-3-on

74. 11beta-(4-(n,n-dimethylamino)phenyl)-17alpha-(prop-1-ynyl)-delta4,9-estradiene-17beta-ol-3-one

75. Mls001074115

76. Mls001424271

77. (non-labelled)mifepristone-d3

78. Mifepristone [usp-rs]

79. Mifepristone [who-dd]

80. Spbio_002457

81. Ru-486; Mifepristone

82. Bpbio1_000262

83. Chembl438575

84. Gtpl2805

85. Mifepristone (jan/usan/inn)

86. Chembl1276308

87. Dtxsid5023322

88. Bdbm18627

89. Hms1568l20

90. Hms2052l05

91. Hms2090l22

92. Hms2095l20

93. Hms2230p21

94. Hms3262b03

95. Hms3412d17

96. Hms3649j08

97. Hms3676d17

98. Hms3712l20

99. Hms3884d12

100. Mifepristone [orange Book]

101. 11.beta.-(p-(dimethylamino)phenyl)-17.beta.-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one

102. Act02598

103. Bcp02145

104. Zinc3831128

105. Tox21_110952

106. Tox21_301841

107. Tox21_500801

108. Bdbm50072024

109. Hsci1_000369

110. S2606

111. Vx-410

112. Akos015895416

113. Tox21_110952_1

114. Ccg-101164

115. Ci-1073

116. Cs-1435

117. Db00834

118. Lp00801

119. Nc00414

120. Nsc 759862

121. Sdccgsbi-0050778.p002

122. Mifepristone 1.0 Mg/ml In Acetonitrile

123. Ncgc00025179-06

124. Ncgc00025179-07

125. Ncgc00025179-08

126. Ncgc00025179-09

127. Ncgc00025179-12

128. Ncgc00025179-13

129. Ncgc00025179-23

130. Ncgc00179632-01

131. Ncgc00255152-01

132. Ncgc00261486-01

133. (11beta,17beta)-11-(4-(dimethylamino)phenyl)-17-hydroxy-17-(1-propynyl)-estra-4,9-dien-3-one

134. As-13938

135. Cpd000058481

136. Estra-4,9-dien-3-one, 11-(4-(dimethylamino)phenyl)-17-hydroxy-17-(1-propynyl)-, (11-beta,17-beta)-

137. Hy-13683

138. Ru486;c-1073

139. Eu-0100801

140. C07652

141. D00585

142. M 8046

143. 371m653

144. A840767

145. Q411240

146. Sr-01000721888

147. Q-201405

148. Sr-01000076011-1

149. Sr-01000076011-3

150. Sr-01000076011-5

151. Sr-01000076011-9

152. Sr-01000721888-4

153. Brd-k37270826-001-04-5

154. Brd-k37270826-001-31-8

155. Mifepristone, United States Pharmacopeia (usp) Reference Standard

156. (11?,17?)-11-[4-(dimethylamino)phenyl]-17-hydroxy-17-(1-propynyl)-estra-4,9-dien-3-one

157. 11.beta.-[4-(dimethylamino)phenyl]-17.beta.-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one

158. 11beta-(4-dimethylamino)phenyl-17beta-hydroxy-17-(1-propynyl)estra-4,9-dien-3-one

159. 11ss-[p-(dimethylamino)fenyl]-17ss-hydroxy- 17-(1-propynyl)estra-4,9-dien-3-on

160. (10s,11s,14s,15s,17r)-17-[4-(dimethylamino)phenyl]-14-hydroxy-15-methyl-14-(prop-1-yn-1-yl)tetracyclo[8.7.0.0;{2,7}.0;{11,15}]heptadeca-1,6-dien-5-one

161. (10s,11s,14s,15s,17r)-17-[4-(dimethylamino)phenyl]-14-hydroxy-15-methyl-14-(prop-1-yn-1-yl)tetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-1,6-dien-5-one

162. (11.beta.,17.beta.)-11-(4-(dimethylamino)phenyl)-17-hydroxy-17-(1-propynyl)-estra-4,9-dien-3-one

163. (11r,13s,14s,17s)-11-(4-dimethylamino-phenyl)-17-hydroxy-13-methyl-17-prop-1-ynyl-1,2,6,7,8,11,12,13,14,15,16,17-dodecahydro-cyclopenta[a]phenanthren-3-one

164. (8s,11r,13s,14s,17s)-11-[4-(dimethylamino)phenyl]-13-methyl-17-oxidanyl-17-prop-1-ynyl-1,2,6,7,8,11,12,14,15,16-decahydrocyclopenta[a]phenanthren-3-one

165. 122742-25-0

166. 83203-42-3

167. Estra-4,9-dien-3-one, 11-[4-(dimethylamino)phenyl]-17-hydroxy-17-(1-propyn-1-yl)-, (11.beta.,17.beta.)-

168. Estra-4,9-dien-3-one, 11-[4-(dimethylamino)phenyl]-17-hydroxy-17-(1-propynyl)-, (11b,17b)-

2.4 Create Date
2005-06-24
3 Chemical and Physical Properties
Molecular Weight 429.6 g/mol
Molecular Formula C29H35NO2
XLogP33.8
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count3
Rotatable Bond Count3
Exact Mass429.266779359 g/mol
Monoisotopic Mass429.266779359 g/mol
Topological Polar Surface Area40.5 Ų
Heavy Atom Count32
Formal Charge0
Complexity921
Isotope Atom Count0
Defined Atom Stereocenter Count5
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 4  
Drug NameKorlym
PubMed HealthMifepristone (By mouth)
Drug ClassesAntiglucocorticoid, Antiprogesterone
Drug LabelKorlym (mifepristone) is a cortisol receptor blocker for oral administration. The chemical name of mifepristone is 11-(4-dimethylaminophenyl)-17-hydroxy-17-(1-propynyl)-estra-4, 9-dien-3-one. The chemical formula is C29H35NO2; the molecular wei...
Active IngredientMifepristone
Dosage FormTablet
RouteOral
Strength300mg
Market StatusPrescription
CompanyCorcept Therap

2 of 4  
Drug NameMifeprex
Active IngredientMifepristone
Dosage FormTablet
RouteOral
Strength200mg
Market StatusPrescription
CompanyDanco Labs

3 of 4  
Drug NameKorlym
PubMed HealthMifepristone (By mouth)
Drug ClassesAntiglucocorticoid, Antiprogesterone
Drug LabelKorlym (mifepristone) is a cortisol receptor blocker for oral administration. The chemical name of mifepristone is 11-(4-dimethylaminophenyl)-17-hydroxy-17-(1-propynyl)-estra-4, 9-dien-3-one. The chemical formula is C29H35NO2; the molecular wei...
Active IngredientMifepristone
Dosage FormTablet
RouteOral
Strength300mg
Market StatusPrescription
CompanyCorcept Therap

4 of 4  
Drug NameMifeprex
Active IngredientMifepristone
Dosage FormTablet
RouteOral
Strength200mg
Market StatusPrescription
CompanyDanco Labs

4.2 Therapeutic Uses

Abortifacient Agents, Steroidal; Contraceptives, Oral, Synthetic; Contraceptives, Postcoital, Synthetic; Hormone Antagonists; Luteolytic Agents; Menstruation-Inducing Agents

National Library of Medicine's Medical Subject Headings online file (MeSH, 1999)


Mifepristone is indicated in combination with misoprostol for the medical termination of intrauterine pregnancy of 49 days duration or less. /Included in US product labeling/

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


4.3 Drug Warning

Confirmed or suspected ectopic pregnancy, undiagnosed adnexal mass, or IUD currently in place. Chronic adrenal failure or concurrent long-term corticosteroid therapy. Known hypersensitivity to mifepristone, misoprostol, or other prostaglandins. Hemorrhagic disorders, inherited porphyrias, or concurrent anticoagulant therapy.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3148


Vaginal bleeding that is heavier than associated with a normal menses occurs in almost all women receiving mifepristone and misoprostol. Based on clinical studies, bleeding or spotting should be expected for an average of 9-16 days. ... Excessive bleeding may require treatment with vasoconstrictors, saline infusions, and/or blood transfusions or curettage.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3148


Severe vaginal bleeding may occur following spontaneous, surgical, or medical abortion (including following mifepristone administration). Prolonged heavy vaginal bleeding (i.e. soaking through 2 thick full-size sanitary pads per hour for 2 consecutive hours) may be a sign of incomplete abortion or other complications, and prompt medical or surgical intervention maybe required to prevent the development of hypovolemic shock. Patients should be advised to seek immediate medical attention if prolonged heavy vaginal bleeding or syncope occurs following mifepristone administration.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3148


Serious bacterial infections (including very rare cases of fatal septic shock) have been reported following mifepristone administration; a causal relationship to the mifepristone-misoprostol regimen has not been established. Clinicians should consider the possibility of infection if sustained fever (temperature of 38 degrees C or higher persisting for more than 4 hours), severe abdominal pain, or pelvic tenderness occurs within several days of medical abortion. Atypical presentations of serious infection and sepsis (i.e., presence of significant leukocytosis, tachycardia, or hemoconcentration without fever, severe abdominal pain, pelvic tenderness) may also occur.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3148


For more Drug Warnings (Complete) data for MIFEPRISTONE (14 total), please visit the HSDB record page.


4.4 Drug Indication

For the medical termination of intrauterine pregnancy through 49 days' pregnancy. Also indicated to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have type 2 diabetes mellitus or glucose intolerance and are not candidates for surgery or have had unsuccessful surgery.


FDA Label


Treatment of endometriosis


Treatment of hypercortisolism (Cushing's syndrome) of endogenous origin


Treatment of leiomyoma of uterus


5 Pharmacology and Biochemistry
5.1 Pharmacology

Mifepristone is a synthetic steroid with antiprogestational effects indicated for the medical termination of intrauterine pregnancy through 49 days' pregnancy. Doses of 1 mg/kg or greater of mifepristone have been shown to antagonize the endometrial and myometrial effects of progesterone in women. During pregnancy, the compound sensitizes the myometrium to the contraction-inducing activity of prostaglandins. Mifepristone also exhibits antiglucocorticoid and weak antiandrogenic activity. The activity of the glucocorticoid dexamethasone in rats was inhibited following doses of 10 to 25 mg/kg of mifepristone. Doses of 4.5 mg/kg or greater in human beings resulted in a compensatory elevation of adrenocorticotropic hormone (ACTH) and cortisol.


5.2 MeSH Pharmacological Classification

Contraceptives, Oral, Synthetic

Oral contraceptives which owe their effectiveness to synthetic preparations. (See all compounds classified as Contraceptives, Oral, Synthetic.)


Luteolytic Agents

Chemical compounds that cause LUTEOLYSIS or degeneration of the CORPUS LUTEUM. (See all compounds classified as Luteolytic Agents.)


Contraceptives, Postcoital, Synthetic

Postcoital contraceptives which owe their effectiveness to synthetic preparations. (See all compounds classified as Contraceptives, Postcoital, Synthetic.)


Abortifacient Agents, Steroidal

Steroidal compounds with abortifacient activity. (See all compounds classified as Abortifacient Agents, Steroidal.)


Menstruation-Inducing Agents

Chemical compounds that induce menstruation either through direct action on the reproductive organs or through indirect action by relieving another condition of which amenorrhea is a secondary result. (From Dorland, 27th ed) (See all compounds classified as Menstruation-Inducing Agents.)


Hormone Antagonists

Chemical substances which inhibit the function of the endocrine glands, the biosynthesis of their secreted hormones, or the action of hormones upon their specific sites. (See all compounds classified as Hormone Antagonists.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
MIFEPRISTONE
5.3.2 FDA UNII
320T6RNW1F
5.3.3 Pharmacological Classes
Progestin Antagonist [EPC]; Progestational Hormone Receptor Antagonists [MoA]
5.4 ATC Code

G03XB01

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


G - Genito urinary system and sex hormones

G03 - Sex hormones and modulators of the genital system

G03X - Other sex hormones and modulators of the genital system

G03XB - Progesterone receptor modulators

G03XB01 - Mifepristone


5.5 Absorption, Distribution and Excretion

Absorption

The absolute bioavailability of a 20 mg oral dose is 69%


Route of Elimination

Fecal: 83%; Renal: 9%.


The absolute bioavailability of oral mifepristone is 69%.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


Protein binding: Very high (98%); predominantly to albumin and alpha1- acid glycoprotein.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


Time to peak concentration: 90 minutes after a 600 mg oral dose.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


Peak plasma concentration: 1.98 mg/L following a single 600 mg oral dose.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


Fecal; 83% of a 600 mg dose over 11 days. Renal; 9% of a 600 mg dose over 11 days.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


5.6 Metabolism/Metabolites

Hepatic. Hepatic, by Cytochrome P450 3A4 isoenzyme to the N-monodemethylated metabolite (RU 42 633); RU 42 698, which results from the loss of two methyl groups from position 11 beta; and RU 42 698, which results from terminal hydroxylation of the 17–propynyl chain.


Hepatic, by Cytochrome P450 3A4 isoenzyme to the N-monodemethylated metabolite (RU 42 633); RU 42 698, which results from terminal hydroxylation of the 17-propynyl chain.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


Mifepristone has known human metabolites that include 17alpha-hydroxymifepristone and Monodemethylated mifepristone.

S73 | METXBIODB | Metabolite Reaction Database from BioTransformer | DOI:10.5281/zenodo.4056560


5.7 Biological Half-Life

18 hours


Terminal: 18 hours; begins slowly and becomes more rapid with time.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


5.8 Mechanism of Action

The anti-progestational activity of mifepristone results from competitive interaction with progesterone at progesterone-receptor sites. Based on studies with various oral doses in several animal species (mouse, rat, rabbit and monkey), the compound inhibits the activity of endogenous or exogenous progesterone. The termination of pregnancy results. In the treatment of Cushing's syndrome, Mifepristone blocks the binding of cortisol to its receptor. It does not decrease cortisol production but reduces the effects of excess cortisol, such as high blood sugar levels.


Mifepristone competitively inhibits the actions of progesterone at progesterone-receptor sites, resulting in termination of pregnancy.The combination of mifepristone and misoprostol causes expulsion of the products of conception through decidual necrosis, myometrial contractions, and cervical softening.

Thomson.Micromedex. Drug Information for the Health Care Professional. 24th ed. Volume 1. Plus Updates. Content Reviewed by the United States Pharmacopeial Convention, Inc. Greenwood Village, CO. 2004., p. 1971


When administered in the early stages of pregnancy, mifepristone causes decidual breakdown by blockade of uterine progesterone receptors. This leads to detachment of the blastocyte, which decreases hCG production. This in turn causes a decrease in progesterone secretion from the corpus luteum, which further accentuates decidual breakdown. Decreased endogenous progesterone coupled with blockade of progesterone receptors in the uterus increases prostaglandin levels and sensitizes the myometrium to the contractile actions of prostaglandins.

Hardman, J.G., L.E. Limbird, P.B., A.G. Gilman. Goodman and Gilman's The Pharmacological Basis of Therapeutics. 10th ed. New York, NY: McGraw-Hill, 2001., p. 1622


In addition, mifepristone promotes uterine contractions and softening of the cervix and sensitizes the myometrium to effects of prostaglandins (e.g., misoprostol) that stimulate uterine contraction and expulsion of the products of conception. In the absence of progesterone, mifepristone acts as a partial progestin agonist. At dosages higher than those used for termination of pregnancy, mifepristone also exhibits antiglucocorticoid activity. The drug also has been shown to have weak antiandrogenic activity.

McEvoy, G.K. (ed.). American Hospital Formulary Service- Drug Information 2005. Bethesda, MD: American Society of Health-System Pharmacists, Inc. 2005 (Plus Supplements)., p. 3148


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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37121

Submission : 2022-05-12

Status : Active

Type : II

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05

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05

06

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06

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GDUFA

DMF Review : Complete

Rev. Date : 2017-11-16

Pay. Date : 2017-08-21

DMF Number : 31873

Submission : 2017-07-20

Status : Active

Type : II

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JDMF

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01

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Mifepristone micronized

Registration Number : 302MF10146

Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain

Initial Date of Registration : 2020-12-15

Latest Date of Registration : 2020-12-15

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EU WC

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Mifepristone IH

Date of Issue : 2022-08-08

Valid Till : 2025-07-14

Written Confirmation Number : WC-0168

Address of the Firm : Plot No. 24/2, & 25, Phase -IV, GIDC Industrial Zone, At & Post - Panoli, Dist.-...

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NDC API

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01

PCAS

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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MIFEPRISTONE

NDC Package Code : 68925-0007

Start Marketing Date : 2011-01-28

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

Seqens Company Banner

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MIFEPRISTONE

NDC Package Code : 69989-0003

Start Marketing Date : 2008-09-01

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/1)

Marketing Category : DRUG FOR FURTHER PROCESSING

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MIFEPRISTONE

NDC Package Code : 65089-0043

Start Marketing Date : 2000-09-28

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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MIFEPRISTONE

NDC Package Code : 66499-0056

Start Marketing Date : 2013-08-23

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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MIFEPRISTONE

NDC Package Code : 51508-011

Start Marketing Date : 2022-03-04

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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MIFEPRISTONE

NDC Package Code : 83914-003

Start Marketing Date : 2025-02-01

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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MIFEPRISTONE

NDC Package Code : 44132-005

Start Marketing Date : 2012-06-08

End Marketing Date : 2027-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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MIFEPRISTONE

NDC Package Code : 44132-013

Start Marketing Date : 2014-06-17

End Marketing Date : 2027-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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MIFEPRISTONE

NDC Package Code : 60722-3002

Start Marketing Date : 2020-10-23

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (1kg/kg)

Marketing Category : BULK INGREDIENT

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Listed Suppliers

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01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothGonane has API manufacturing expertise in new-age Corticosteroids, Hormones and other pharma raw materials.

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Mifepristone

About the Company : Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology p...

Gonane Pharma is a contract pharmaceutical company based in Gujarat, India, specializing in the manufacturing and marketing of corticosteroids, hormones, antivirals, and oncology products. The company is supported by a dedicated team and promoters with over 25 years of experience in manufacturing, product promotion, and regulatory audits across markets including the EU, Mexico, China, Korea, and Russia. Gonane Pharma is also engaged with Japanese customers and continues to expand into new markets. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
Gonane Pharma

02

LGM Pharma

U.S.A
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothLGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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Mifepristone

About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulat...

LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for pharmaceutical and biotech industries. LGM also operates as a full-service CDMO, offering formulation, analytical method development and testing, custom API synthesis, regulatory support, and commercial manufacturing. Supported by a network of over 300 accredited cGMP manufacturing partners and more than 100,000 sq. ft. of FDA-inspected cGMP manufacturing and warehouse space, LGM delivers secure, end-to-end solutions across multiple dosage forms. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
LGM Pharma CB

03

Seqens

France
  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.

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Mifepristone

About the Company : Founded in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. The company supports customers in the development, scale-up, and man...

Founded in 2003, Seqens has evolved into a global leader in pharmaceutical solutions and specialty ingredients. The company supports customers in the development, scale-up, and manufacturing of drug substances from pre-clinical to commercial stages. Seqens offers a broad portfolio of APIs and proprietary products, along with custom solutions for healthcare, electronics, and cosmetics. With 16 industrial plants and 9 R&D centers worldwide, Seqens produces complex molecules across small- and large-scale requirements. Note: Product(s) under patent(s) are offered only for R&D purposes as per the Patent Act & not for commercial sale.
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Mifepristone

About the Company : Arudavis Labs is in the business of manufacturing and trading of Active Pharmaceutical Ingredients and Formulations. We have been serving the Pharmaceutical and Biotechnology Indus...

Arudavis Labs is in the business of manufacturing and trading of Active Pharmaceutical Ingredients and Formulations. We have been serving the Pharmaceutical and Biotechnology Industries all over the world for the past 10 years with good track regard of keeping our customers happy. We are specialized in the area of Vitamins, Nutraceuticals and Excipients. Our main products are N-Acetyl-L-Cysteine, Pyridoxine Hydrochloride, Thiamine Hydrochloride and Benfotiamine. The company growth is mainly driven by technology based research and development to meet customer demands.
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ASG Biochem

India
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ASG Biochem

India
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Mifepristone

About the Company : ASG Biochem Private Limited at Ganganagar near Kolkata, West Bengal, India, is a bulk API manufacturing company of the New Delhi based diversified APEEJAY STYA GROUP. The unit acqu...

ASG Biochem Private Limited at Ganganagar near Kolkata, West Bengal, India, is a bulk API manufacturing company of the New Delhi based diversified APEEJAY STYA GROUP. The unit acquired from AKZO NOBEL N.V., the Netherlands in 2004 is engaged in the synthesis of specialized APIs, in particular, hormones and intermediates.The unit has global exports including intermediates / penultimates to the European Union apart from supply to internal Group companies. In addition, the plant also holds ISO 9001-2008 and ISO 14001:2004 certification from DNV, the Netherlands.The unit has Japan accreditation for manufacturing APIs.
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Mifepristone

About the Company : Balaji corporation was established in 2006, the group have two branch in india.To play a key role as innovative and delenadable service provided.The company was quick to envisage t...

Balaji corporation was established in 2006, the group have two branch in india.To play a key role as innovative and delenadable service provided.The company was quick to envisage the challenges which the repidly growing pharmaceuticals industry in india . To meet high qulity requirement means for high calliber of expertise to understand cutting edge technology and provide suitable products Today balaji corporation is a name well-known with pharamceuticals player in healthcare idustries .Our principal have undoubtedly played a key role in our success. We strive to provide best quality pharmaceutical products.
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Curia

U.S.A
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Curia

U.S.A
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Mifepristone

About the Company : Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners tur...

Curia is a global contract research, development and manufacturing organization (CDMO), offering products and services across the drug development spectrum to help our partners turn their ideas into real-world impact. We partner closely with pharmaceutical and biotechnology companies to boost business performance and improve patients’ lives. From early discovery and development through manufacturing and commercialization, our suite of custom solutions allows us to tailor every engagement to your precise needs, whether that’s an independent project or an opportunity that cuts across the drug continuum.
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Mifepristone

About the Company : Formosa Laboratories Inc. founded in Taiwan since 1995 started with API business and has been serving customers worldwide. As an established API manufacturer receiving GMP inspecti...

Formosa Laboratories Inc. founded in Taiwan since 1995 started with API business and has been serving customers worldwide. As an established API manufacturer receiving GMP inspections from regulatory authorities around the world, Formosa now provides CDMO service extending from APIs and ADCs (Antibody Drug Conjugates) to cytotoxic and non-cytotoxic injectables of aseptic liquid filling and lyophilization. Formosa Laboratories is able to offer full-service GMP manufacturing for drug substance, ADCs and drug product with its API and injectable facilities that accommodates small molecules, biologics and ADCs etc.
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Mifepristone

About the Company : Hanways Chempharm Co., Limited, the former one is Hubei Hanways Pharchem CO.,Limited, set up in 2009 in Wuhan, China. We are engaged in supplying APIs, pharmaceutical intermediate...

Hanways Chempharm Co., Limited, the former one is Hubei Hanways Pharchem CO.,Limited, set up in 2009 in Wuhan, China. We are engaged in supplying APIs, pharmaceutical intermediates, and fine chemicals for worldwide markets. With decades of development, now we grow to a leading and outstanding company. We are not just a trading company, but a comprehensive solutions supplier. With our sound knowledge of pharmaceutical business, our advantage is to integrate resources and adapt to all different demands of markets. We are a young but dynamic and energetic company with high efficient and high flexible decision making system.
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Naari

India
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Naari

India
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Mifepristone

About the Company : NAARI, meaning woman in Sanskrit, embodies the philosophy and objectives of our Organization. NAARI is a Swiss Pharmaceuticals company focused on female health with an emphasis on...

NAARI, meaning woman in Sanskrit, embodies the philosophy and objectives of our Organization. NAARI is a Swiss Pharmaceuticals company focused on female health with an emphasis on hormones and complex generics. We are an integrated player producing Biotech intermediates, Active Pharmaceutical Ingredients and Finished Dosage Forms supported by in house R&D in each domain. The company's current portfolio consists of generics and a robust innovative pipeline.
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API Reference Price

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Grade","supplierPort":"BEIJING","supplierAddress":"1209,1210,1211,CABIN A,12TH FLOOR, UNIVERSAL MAJESTIC, P L LOKHANDE MA RG CH CHEMBUR,MAHARASHT , MAHARASHT INDIA","customerAddress":"218\/219, 2ND FLOOR,KAILASH PLAZA,"}]
08-Jan-2022
24-Dec-2025
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Drugs in Development

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Details:

Korlym (mifepristone) is a selective antagonist of the progesterone receptor at low doses and blocks the GR-II at higher doses. It is being evaluated for the treatment of cushing syndrome.


Lead Product(s): Mifepristone,Inapplicable

Therapeutic Area: Endocrinology Brand Name: Korlym

Study Phase: Phase IVProduct Type: Hormone

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 12, 2024

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SCOPE Summit
Not Confirmed
SCOPE Summit
Not Confirmed

Details : Korlym (mifepristone) is a selective antagonist of the progesterone receptor at low doses and blocks the GR-II at higher doses. It is being evaluated for the treatment of cushing syndrome.

Product Name : Korlym

Product Type : Hormone

Upfront Cash : Inapplicable

December 12, 2024

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Details:

Mifepristone is a Hormone drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Stress Disorders, Post-Traumatic.


Lead Product(s): Mifepristone,Inapplicable

Therapeutic Area: Psychiatry/Psychology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Hormone

Sponsor: Christiaan Vinkers

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 14, 2024

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02

SCOPE Summit
Not Confirmed
SCOPE Summit
Not Confirmed

Details : Mifepristone is a Hormone drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of Stress Disorders, Post-Traumatic.

Product Name : Undisclosed

Product Type : Hormone

Upfront Cash : Inapplicable

November 14, 2024

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  • Development Update

Details:

Progesterone is a Hormone drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Progesterone Supplementation After Mifepristone.


Lead Product(s): Progesterone,Mifepristone

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Hormone

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 27, 2024

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Reproductive Health Research Insritute, Chile

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SCOPE Summit
Not Confirmed

Reproductive Health Research Insritute, Chile

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SCOPE Summit
Not Confirmed

Details : Progesterone is a Hormone drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of Progesterone Supplementation After Mifepristone.

Product Name : Undisclosed

Product Type : Hormone

Upfront Cash : Inapplicable

September 27, 2024

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  • Development Update

Details:

Levonorgestrel is a Hormone drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Pregnancy, Early.


Lead Product(s): Levonorgestrel,Mifepristone

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase II/ Phase IIIProduct Type: Hormone

Sponsor: Cuidado Integral de la Mujer, Gineclinic, S.C. | Servicios de Salud Medieg, A. C

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 09, 2024

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Gynuity Health Projects

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Gynuity Health Projects

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Not Confirmed

Lead Product(s) : Levonorgestrel,Mifepristone

Therapeutic Area : Undisclosed

Highest Development Status : Phase II/ Phase III

Partner/Sponsor/Collaborator : Cuidado Integral de la Mujer, Gineclinic, S.C. | Servicios de Salud Medieg, A. C

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Levonorgestrel is a Hormone drug candidate, which is currently being evaluated in phase II/ phase III clinical studies for the treatment of Pregnancy, Early.

Product Name : Undisclosed

Product Type : Hormone

Upfront Cash : Inapplicable

July 09, 2024

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Details:

Korlym (mifepristone) is an approved selective antagonist of the progesterone receptor at low doses and blocks the GR-II at higher doses. It is being evaluated in phase 4 for cushing syndrome.


Lead Product(s): Mifepristone,Inapplicable

Therapeutic Area: Endocrinology Brand Name: Korlym

Study Phase: Phase IVProduct Type: Hormone

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable April 29, 2024

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05

SCOPE Summit
Not Confirmed
SCOPE Summit
Not Confirmed

Details : Korlym (mifepristone) is an approved selective antagonist of the progesterone receptor at low doses and blocks the GR-II at higher doses. It is being evaluated in phase 4 for cushing syndrome.

Product Name : Korlym

Product Type : Hormone

Upfront Cash : Inapplicable

April 29, 2024

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Details:

Korlym (mifepristone) blocks cortisol receptors to manage hyperglycemia in adults with Cushing's syndrome who have type 2 diabetes or glucose intolerance.


Lead Product(s): Mifepristone,Inapplicable

Therapeutic Area: Endocrinology Brand Name: Korlym

Study Phase: Phase IVProduct Type: Hormone

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 15, 2024

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06

SCOPE Summit
Not Confirmed
SCOPE Summit
Not Confirmed

Details : Korlym (mifepristone) blocks cortisol receptors to manage hyperglycemia in adults with Cushing's syndrome who have type 2 diabetes or glucose intolerance.

Product Name : Korlym

Product Type : Hormone

Upfront Cash : Inapplicable

February 15, 2024

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Details:

Korlym (mifepristone) is a selective antagonist of the progesterone receptor at low doses and blocks the GR-II at higher doses. It is being evaluated for the treatment of cushing syndrome.


Lead Product(s): Mifepristone,Inapplicable

Therapeutic Area: Endocrinology Brand Name: Korlym

Study Phase: Phase IVProduct Type: Hormone

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 15, 2024

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07

SCOPE Summit
Not Confirmed
SCOPE Summit
Not Confirmed

Details : Korlym (mifepristone) is a selective antagonist of the progesterone receptor at low doses and blocks the GR-II at higher doses. It is being evaluated for the treatment of cushing syndrome.

Product Name : Korlym

Product Type : Hormone

Upfront Cash : Inapplicable

February 15, 2024

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Details:

FloraStilbene (mifepristone and pterostilbene) aims to stimulate the immune system in advanced breast cancer patients, with preclinical data showing efficacy in a triple-negative breast cancer model.


Lead Product(s): Mifepristone,Pterostilbene

Therapeutic Area: Oncology Brand Name: FloraStilbene

Study Phase: Phase IProduct Type: Hormone

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable January 03, 2024

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08

SCOPE Summit
Not Confirmed
SCOPE Summit
Not Confirmed

Details : FloraStilbene (mifepristone and pterostilbene) aims to stimulate the immune system in advanced breast cancer patients, with preclinical data showing efficacy in a triple-negative breast cancer model.

Product Name : FloraStilbene

Product Type : Hormone

Upfront Cash : Inapplicable

January 03, 2024

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Details:

FloraStilbene (RU486 and pterostilbene) to stimulate the immune system in advanced breast cancer patients. Preclinical data demonstrated that FloraStilbene overcame immune suppression induced in the 4T1 mouse model of triple negative breast cancer.


Lead Product(s): Mifepristone,Pterostilbene

Therapeutic Area: Oncology Brand Name: FloraStilbene

Study Phase: Phase IProduct Type: Hormone

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable October 20, 2023

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09

SCOPE Summit
Not Confirmed
SCOPE Summit
Not Confirmed

Details : FloraStilbene (RU486 and pterostilbene) to stimulate the immune system in advanced breast cancer patients. Preclinical data demonstrated that FloraStilbene overcame immune suppression induced in the 4T1 mouse model of triple negative breast cancer.

Product Name : FloraStilbene

Product Type : Hormone

Upfront Cash : Inapplicable

October 20, 2023

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Details:

Under the collaboration, Cure Stat Rx will manufacture first in class breast cancer immunotherapy product FloraStilbene™ for a planned 12 patient Phase I/II trial aimed at assessing immunomodulatory activity of the drug candidate in advanced breast cancer patients.


Lead Product(s): Mifepristone,Pterostilbene

Therapeutic Area: Oncology Brand Name: FloraStilbene

Study Phase: PreclinicalProduct Type: Hormone

Sponsor: Cure Stat Rx

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration May 15, 2023

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10

SCOPE Summit
Not Confirmed
SCOPE Summit
Not Confirmed

Details : Under the collaboration, Cure Stat Rx will manufacture first in class breast cancer immunotherapy product FloraStilbene™ for a planned 12 patient Phase I/II trial aimed at assessing immunomodulatory activity of the drug candidate in advanced breast can...

Product Name : FloraStilbene

Product Type : Hormone

Upfront Cash : Undisclosed

May 15, 2023

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INTERMEDIATE SUPPLIERS

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CAS Number : 39416-48-3

End Use API : Mifepristone

About The Company : NINGBO INNO PHARMCHEM CO.,LTD. develop, pilot and commercial produce organic chemicals, pharmaceutical intermediates and nutraceuticals. We also offer custom sy...

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CAS Number : 3962-66-1

End Use API : Mifepristone

About The Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedic...

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CAS Number : 24916-90-3

End Use API : Mifepristone

About The Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedic...

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CAS Number : 84371-57-3

End Use API : Mifepristone

About The Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedic...

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CAS Number : 84371-64-2

End Use API : Mifepristone

About The Company : With the high technology and excellent services, Xianju pharma earned a top worldwide reputation for quality in pharmaceutical industry. Xianju pharma has dedic...

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ABOUT THIS PAGE

Looking for 84371-65-3 / Mifepristone API manufacturers, exporters & distributors?

Mifepristone manufacturers, exporters & distributors 1

13

PharmaCompass offers a list of Mifepristone API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Mifepristone manufacturer or Mifepristone supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Mifepristone manufacturer or Mifepristone supplier.

PharmaCompass also assists you with knowing the Mifepristone API Price utilized in the formulation of products. Mifepristone API Price is not always fixed or binding as the Mifepristone Price is obtained through a variety of data sources. The Mifepristone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Mifepristone

Synonyms

84371-65-3, Mifegyne, Mifeprex, Ru-486, Korlym, Ru486

Cas Number

84371-65-3

Unique Ingredient Identifier (UNII)

320T6RNW1F

About Mifepristone

A progestational and glucocorticoid hormone antagonist. Its inhibition of progesterone induces bleeding during the luteal phase and in early pregnancy by releasing endogenous prostaglandins from the endometrium or decidua. As a glucocorticoid receptor antagonist, the drug has been used to treat hypercortisolism in patients with nonpituitary CUSHING SYNDROME.

Mifepristone Manufacturers

A Mifepristone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mifepristone, including repackagers and relabelers. The FDA regulates Mifepristone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mifepristone API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Mifepristone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Mifepristone Suppliers

A Mifepristone supplier is an individual or a company that provides Mifepristone active pharmaceutical ingredient (API) or Mifepristone finished formulations upon request. The Mifepristone suppliers may include Mifepristone API manufacturers, exporters, distributors and traders.

click here to find a list of Mifepristone suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Mifepristone USDMF

A Mifepristone DMF (Drug Master File) is a document detailing the whole manufacturing process of Mifepristone active pharmaceutical ingredient (API) in detail. Different forms of Mifepristone DMFs exist exist since differing nations have different regulations, such as Mifepristone USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Mifepristone DMF submitted to regulatory agencies in the US is known as a USDMF. Mifepristone USDMF includes data on Mifepristone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mifepristone USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Mifepristone suppliers with USDMF on PharmaCompass.

Mifepristone JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Mifepristone Drug Master File in Japan (Mifepristone JDMF) empowers Mifepristone API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Mifepristone JDMF during the approval evaluation for pharmaceutical products. At the time of Mifepristone JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Mifepristone suppliers with JDMF on PharmaCompass.

Mifepristone WC

A Mifepristone written confirmation (Mifepristone WC) is an official document issued by a regulatory agency to a Mifepristone manufacturer, verifying that the manufacturing facility of a Mifepristone active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Mifepristone APIs or Mifepristone finished pharmaceutical products to another nation, regulatory agencies frequently require a Mifepristone WC (written confirmation) as part of the regulatory process.

click here to find a list of Mifepristone suppliers with Written Confirmation (WC) on PharmaCompass.

Mifepristone NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Mifepristone as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Mifepristone API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Mifepristone as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Mifepristone and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mifepristone NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Mifepristone suppliers with NDC on PharmaCompass.

Mifepristone GMP

Mifepristone Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Mifepristone GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Mifepristone GMP manufacturer or Mifepristone GMP API supplier for your needs.

Mifepristone CoA

A Mifepristone CoA (Certificate of Analysis) is a formal document that attests to Mifepristone's compliance with Mifepristone specifications and serves as a tool for batch-level quality control.

Mifepristone CoA mostly includes findings from lab analyses of a specific batch. For each Mifepristone CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Mifepristone may be tested according to a variety of international standards, such as European Pharmacopoeia (Mifepristone EP), Mifepristone JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mifepristone USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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