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    Also known as: 120287-85-6, Cetrotide, Cetrorelixum, Sb 75, Cetrorelixum [inn-latin], Cetrorelix (inn)
    Molecular Formula
    C70H92ClN17O14
    Molecular Weight
    1431.0  g/mol
    InChI Key
    SBNPWPIBESPSIF-MHWMIDJBSA-N
    FDA UNII
    OON1HFZ4BA
    Cetrorelix Acetate
    Cetrorelix is cetrorelix is a synthetic decapeptide which is structurally related to gonadotrophin-releasing hormone (luteinising-hormone releasing hormone). It acts as an LHRH antagonist. (from ASTA Medica)
    Cetrorelix is a Gonadotropin Releasing Hormone Receptor Antagonist. The mechanism of action of cetrorelix is as a Gonadotropin Releasing Hormone Receptor Antagonist. The physiologic effect of cetrorelix is by means of Decreased GnRH Secretion.
    1 2D Structure

    Cetrorelix Acetate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2S)-1-[(2S)-2-[[(2S)-2-[[(2R)-2-[[(2S)-2-[[(2S)-2-[[(2R)-2-[[(2R)-2-[[(2R)-2-acetamido-3-naphthalen-2-ylpropanoyl]amino]-3-(4-chlorophenyl)propanoyl]amino]-3-pyridin-3-ylpropanoyl]amino]-3-hydroxypropanoyl]amino]-3-(4-hydroxyphenyl)propanoyl]amino]-5-(carbamoylamino)pentanoyl]amino]-4-methylpentanoyl]amino]-5-(diaminomethylideneamino)pentanoyl]-N-[(2R)-1-amino-1-oxopropan-2-yl]pyrrolidine-2-carboxamide
    2.1.2 InChI
    InChI=1S/C70H92ClN17O14/c1-39(2)31-52(61(94)82-51(15-9-28-77-69(73)74)68(101)88-30-10-16-58(88)67(100)79-40(3)59(72)92)83-60(93)50(14-8-29-78-70(75)102)81-63(96)54(34-43-20-25-49(91)26-21-43)86-66(99)57(38-89)87-65(98)56(36-45-11-7-27-76-37-45)85-64(97)55(33-42-18-23-48(71)24-19-42)84-62(95)53(80-41(4)90)35-44-17-22-46-12-5-6-13-47(46)32-44/h5-7,11-13,17-27,32,37,39-40,50-58,89,91H,8-10,14-16,28-31,33-36,38H2,1-4H3,(H2,72,92)(H,79,100)(H,80,90)(H,81,96)(H,82,94)(H,83,93)(H,84,95)(H,85,97)(H,86,99)(H,87,98)(H4,73,74,77)(H3,75,78,102)/t40-,50-,51+,52+,53-,54+,55-,56-,57+,58+/m1/s1
    2.1.3 InChI Key
    SBNPWPIBESPSIF-MHWMIDJBSA-N
    2.1.4 Canonical SMILES
    CC(C)CC(C(=O)NC(CCCN=C(N)N)C(=O)N1CCCC1C(=O)NC(C)C(=O)N)NC(=O)C(CCCNC(=O)N)NC(=O)C(CC2=CC=C(C=C2)O)NC(=O)C(CO)NC(=O)C(CC3=CN=CC=C3)NC(=O)C(CC4=CC=C(C=C4)Cl)NC(=O)C(CC5=CC6=CC=CC=C6C=C5)NC(=O)C
    2.1.5 Isomeric SMILES
    C[C@H](C(=O)N)NC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCN=C(N)N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CCCNC(=O)N)NC(=O)[C@H](CC2=CC=C(C=C2)O)NC(=O)[C@H](CO)NC(=O)[C@@H](CC3=CN=CC=C3)NC(=O)[C@@H](CC4=CC=C(C=C4)Cl)NC(=O)[C@@H](CC5=CC6=CC=CC=C6C=C5)NC(=O)C
    2.2 Other Identifiers
    2.2.1 UNII
    OON1HFZ4BA
    2.3 Synonyms
    2.3.1 MeSH Synonyms

    1. Cetrorelix Acetate

    2. Cetrorelix Pamoate

    3. Cetrotide

    4. Lhrh, N-ac-1-nal(2)-2-phe(pcl)-3-pal(3)-6-cit-10-ala-

    5. Lhrh, N-acetyl-1-(3-(2-naphthyl)alanyl)-2-(4-chlorophenylalanyl)-3-(3-(3-pyridyl)alanyl)-6-citrulline-10-alanine-

    6. N-acetyl-1-(3-(2-naphthyl)alanine)-2-(4-chlorophenylalanine)-3-(3-(3-pyridyl)alanine)-6-citrulline-10-alanine-lhrh

    7. Sb 75

    8. Sb-75

    2.3.2 Depositor-Supplied Synonyms

    1. 120287-85-6

    2. Cetrotide

    3. Cetrorelixum

    4. Sb 75

    5. Cetrorelixum [inn-latin]

    6. Cetrorelix (inn)

    7. Cetrorelix [inn]

    8. Sb-75

    9. Oon1hfz4ba

    10. Cetrotide (tn)

    11. Chebi:59224

    12. 130143-01-0

    13. D-alaninamide,n-acetyl-3-(2-naphthalenyl)-d-alanyl-4-chloro-d-phenylalanyl-3-(3-pyridinyl)-d-alanyl-l-seryl-l-tyrosyl-n5-(aminocarbonyl)-d-ornithyl-l-leucyl-l-arginyl-l-prolyl-

    14. Ac-(d-ala[3-(2-naphthyl)])-[d-phe(4-cl)]-(d-ala[3-(3-pyridyl)])-ser-tyr-(d-cit)-leu-arg-pro-d-ala-oh

    15. N-acetyl-3-(2-naphthyl)-d-alanyl-p-chloro-d-phenylalanyl-3-(3-pyridyl)-d-alanyl-l-seryl-l-tyrosyl-n(sup 5)-carbamoyl-d-ornithyl-l-leucyl-l-arginyl-l-prolyl-d-alaninamide

    16. Sb-075

    17. Cetrorelix [inn:ban]

    18. Unii-oon1hfz4ba

    19. Hsdb 7696

    20. Hs-2008

    21. Cetrorelix [mi]

    22. Cetrorelix [hsdb]

    23. Cetrorelix [vandf]

    24. Cetrorelix [who-dd]

    25. Schembl61331

    26. Cetrorelix [ema Epar]

    27. Gtpl1190

    28. Cetrorelix [orange Book]

    29. Chembl1200490

    30. Dtxsid7040996

    31. Schembl19712202

    32. Hy-p0009

    33. Vea28785

    34. Bdbm50369965

    35. Ac-d-nal(2)-d-phe(pcl)-d-pal(3)-ser-tyr-d-cit-leu-arg-pro-d-ala-nh2

    36. Akos015994648

    37. Db00050

    38. Ncgc00481544-01

    39. Ncgc00485296-01

    40. Ac-28734

    41. N-acetyl-3-(2-naphthyl)-d-alanyl-4-chloro-d-phenylalanyl-3-(3-pyridyl)-d-alanyl-l-seryl-l-tyrosyl-n5-carbomoyl-d-ornithyl-l-leucyl-l-prolyl-d-alaninamide

    42. N-acetyl-3-(naphthalen-2-yl)-d-alanyl-4-chloro-d-phenylalanyl-3-(pyridin-3-yl)-d-alanyl-l-seryl-l-tyrosyl-n(5)-carbamoyl-d-ornithyl-l-leucyl-l-arginyl-l-prolyl-d-alaninamide

    43. Cs-0012400

    44. D07665

    45. 287c856

    46. Q5065704

    47. Y-100040

    48. N-acetyl-3-(2-naphthalenyl)-d-alanyl-4-chloro-d-phenylalanyl-3-(3-pyridinyl)-d-alanyl-l-seryl-l-tyrosyl-n5-(aminocarbonyl)-d-ornithyl-l-leucyl-l-arginyl-l-prolyl-d-alaninamide

    2.4 Create Date
    2008-12-10
    3 Chemical and Physical Properties
    Molecular Weight 1431.0 g/mol
    Molecular Formula C70H92ClN17O14
    XLogP31.9
    Hydrogen Bond Donor Count16
    Hydrogen Bond Acceptor Count16
    Rotatable Bond Count38
    Exact Mass1429.6698184 g/mol
    Monoisotopic Mass1429.6698184 g/mol
    Topological Polar Surface Area498 Ų
    Heavy Atom Count102
    Formal Charge0
    Complexity2840
    Isotope Atom Count0
    Defined Atom Stereocenter Count10
    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 2  
    Drug NameCetrotide
    PubMed HealthCetrorelix (Injection)
    Drug ClassesEndocrine-Metabolic Agent
    Active IngredientCetrorelix
    Dosage FormInjectable
    RouteInjection
    Strengtheq 0.25mg base/ml
    Market StatusPrescription
    CompanyEmd Serono

    2 of 2  
    Drug NameCetrotide
    PubMed HealthCetrorelix (Injection)
    Drug ClassesEndocrine-Metabolic Agent
    Active IngredientCetrorelix
    Dosage FormInjectable
    RouteInjection
    Strengtheq 0.25mg base/ml
    Market StatusPrescription
    CompanyEmd Serono

    4.2 Therapeutic Uses

    Cetrorelix is indicated for the inhibition of premature luteinizing hormone (LH) surges in women undergoing controlled ovarian stimulation.

    Novak, K.M. (ed.). Drug Facts and Comparisons2008 Edition. Wolters Kluwer Health. St. Louis, Missouri 2008., p. 353

    /EXPL THER/ This randomized, placebo-controlled, single-blind, experimental study was performed on 45 Wistar adult female rats ... . After the peritoneal implantation of endometrial tissue, rats were randomized to three equal intervention groups: (i) control group, (ii) leuprolide group, and (iii) cetrorelix group. Six weeks later, following implant volume measurements (volume-1) by performing a second laparotomy, saline (0.1 mL/rat) was administered subcutaneously to the control group once a week, leuprolide (0.075 mg/kg) subcutaneously to the leuprolide group twice at 4-week intervals and cetrorelix (0.001 mg/rat/day) subcutaneously to the cetrorelix group for 8 weeks. At the end of the treatment, by performing a third laparotomy, implant volumes were remeasured (volume-2) and implants were totally excised for histopathological examination. The volume-1 and volume-2 values within the groups, and stromal and glandular tissue scores between the groups were compared. In both the leuprolide group and the cetrorelix group, volume-2 as compared to volume-1 had significantly reduced (P < 0.01, P < 0.01 respectively), while there was no significant volume change in the control group (P > 0.05). In this group, when compared with the control group, glandular and stromal tissues had significantly lessened (P < 0.01, P < 0.01 respectively). Leuprolide and cetrorelix were found to have similar efficacy in the regression of both the size and the histological structure of experimental endometriotic implants.

    PMID:19012701 Altintas D et al; J Obstet Gynaecol Res 34 (6): 1014-9 (2008)

    4.3 Drug Warning

    Cetrorelix should be prescribed by health care providers who are experienced in fertility treatment. Before starting treatment with cetrorelix acetate, pregnancy must be excluded.

    Novak, K.M. (ed.). Drug Facts and Comparisons2008 Edition. Wolters Kluwer Health. St. Louis, Missouri 2008., p. 354

    Elevations in liver function test results including ALT (SGPT), AST (SGOT), gamma-glutamyltransferase (GGT, gamma-glutamyl transpeptidase, GGTP), and alkaline phosphatase up to 3 times the upper limit of normal were reported in 1-2% of patients receiving cetrorelix during controlled ovarian stimulation.

    Caution is advised in patients with hypersensitivity to GnRH. Carefully monitor these patients after the first injection. A severe anaphylactic reaction associated with cough, rash, and hypotension was observed in 1 patient after 7 months of treatment with 10 mg/day cetrorelix in a study for an indication unrelated to infertility.

    Novak, K.M. (ed.). Drug Facts and Comparisons2008 Edition. Wolters Kluwer Health. St. Louis, Missouri 2008., p. 353

    Local site reactions (e.g. redness, erythema, bruising, itching, swelling and pruritus) were reported. Usually, they were of a transient nature, mild intensity and short duration.

    US Natl Inst Health; DailyMed. Current Medication Information for Cetrotide (Cetrorelix acetate) (April 2008). Available from, as of February 9, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=7634

    For more Drug Warnings (Complete) data for CETRORELIX (8 total), please visit the HSDB record page.

    4.4 Drug Indication

    For the inhibition of premature LH surges in women undergoing controlled ovarian stimulation

    FDA Label

    Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte-pick-up and assisted-reproductive techniques.

    In clinical trials, Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicule-stimulating hormone (FSH) suggested similar efficacy.

    5 Pharmacology and Biochemistry
    5.1 Pharmacology

    Cetrorelix is a synthetic decapeptide with gonadotropin-releasing hormone (GnRH) antagonistic activity. GnRH induces the production and release of luteinizing hormone (LH) and follicle stimulating hormone (FSH) from the gonadotrophic cells of the anterior pituitary. Due to a positive estradiol (E2) feedback at midcycle, GnRH liberation is enhanced resulting in an LH-surge. This LH-surge induces the ovulation of the dominant follicle, resumption of oocyte meiosis and subsequently luteinization as indicated by rising progesterone levels. Cetrorelix competes with natural GnRH for binding to membrane receptors on pituitary cells and thus controls the release of LH and FSH in a dose-dependent manner.

    5.2 MeSH Pharmacological Classification

    Fertility Agents, Female

    Compounds which increase the capacity to conceive in females. (See all compounds classified as Fertility Agents, Female.)

    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
    CETRORELIX
    5.3.2 FDA UNII
    OON1HFZ4BA
    5.3.3 Pharmacological Classes
    Mechanisms of Action [MoA] - Gonadotropin Releasing Hormone Receptor Antagonists
    5.4 ATC Code

    H01CC02

    H01CC02

    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

    H - Systemic hormonal preparations, excl. sex hormones and insulins

    H01 - Pituitary and hypothalamic hormones and analogues

    H01C - Hypothalamic hormones

    H01CC - Anti-gonadotropin-releasing hormones

    H01CC02 - Cetrorelix

    5.5 Absorption, Distribution and Excretion

    Absorption

    Rapidly absorbed following subcutaneous injection. The mean absolute bioavailability following subcutaneous administration to healthy female subjects is 85%.

    Route of Elimination

    Following subcutaneous administration of 10 mg cetrorelix to males and females, only unchanged cetrorelix was detected in urine.

    Volume of Distribution

    1.16 L/kg

    Clearance

    1.28 ml/minkg [adult healthy female with 3 mg single SC administration]

    Following subcutaneous administration of 10 mg cetrorelix to males and females, only unchanged cetrorelix was detected in urine. In 24 hours, cetrorelix and small amounts of the (1-9), (1-7), (1-6), and (1-4) peptides were found in bile samples. 2-4% of the dose was eliminated in the urine as unchanged cetrorelix, while 5-10% was eliminated as cetrorelix and the four metabolites in bile. Therefore, only 7-14% of the total dose was recovered as unchanged cetrorelix and metabolites in urine and bile up to 24 hours. The remaining portion of the dose may not have been recovered since bile and urine were not collected for a longer period of time.

    US Natl Inst Health; DailyMed. Current Medication Information for Cetrotide (Cetrorelix acetate) (April 2008). Available from, as of February 9, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=7634

    The volume of distribution of Cetrotide following a single intravenous dose of 3 mg is about 1 L/kg. In vitro protein binding to human plasma is 86%. Cetrotide concentrations in follicular fluid and plasma were similar on the day of oocyte pick-up in patients undergoing controlled ovarian stimulation. Following subcutaneous administration of Cetrotide 0.25 mg and 3 mg, plasma concentrations of cetrorelix were below or in the range of the lower limit of quantitation on the day of oocyte pick-up and embryo transfer.

    US Natl Inst Health; DailyMed. Current Medication Information for Cetrotide (Cetrorelix acetate) (April 2008). Available from, as of February 9, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=7634

    Cetrotide is rapidly absorbed following subcutaneous injection, maximal plasma concentrations being achieved approximately one to two hours after administration. The mean absolute bioavailability of Cetrotide following subcutaneous administration to healthy female subjects is 85%.

    US Natl Inst Health; DailyMed. Current Medication Information for Cetrotide (Cetrorelix acetate) (April 2008). Available from, as of February 9, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=7634

    Pharmacokinetic studies were performed predominantly in rats and dogs. Absorption from the sc injection site was rapid and complete and there were no differences in absorption with regard to sex or species. A linear relationship between dose and plasma AUC was evident. Distribution of cetrorelix was rapid. Main target organs were the kidney, liver, small intestine and organs containing the luteinising hormone releasing hormone (LHRH) receptor (pituitary gland, ovaries). Plasma protein binding amounted to 86%. Elimination from most tissues was rapid and occurred predominantly within 48 hr. ... Cetrorelix crosses the placenta only to a low extent. The distribution of cetrorelix or its metabolites into milk was not investigated. Cetrorelix is excreted unchanged into urine and after metabolism by peptidases into bile. ... Studies in healthy volunteers indicate that cetrorelix is excreted in a similar manner in humans, rats and dogs.

    European Medicines Agency (EMEA), The European Agency for the Evaluation of Medicinal Products, European Public Assessment Report (EPAR) for Authorized Medicinal Products for Human Use; Cetrotide, Scientific Discussion (2003). Available from, as of February 15, 2009: https://www.emea.europa.eu/humandocs/PDFs/EPAR/Cetrotide/297998en6.pdf

    Following subcutaneous injection, the absolute bioavailability of cetrorelix was approximately 85% in both males and females. The apparent volume of distribution was 1.16 + or - 0.29 L/kg in females and 1.02 + or - 0.33 L/kg in males. The terminal half-life was about 10 hours after iv and 30 hours after subcutaneous injection with a trend towards lower values in female. Protein binding in human plasma was around 85%. Linear pharmacokinetics were observed following both single (0.25, 0.5 and 1.00 mg) and multiple dose administration (0.25 to 1.00 mg). The pharmacokinetics were linear up to a 3 mg dose.

    European Medicines Agency (EMEA), The European Agency for the Evaluation of Medicinal Products, European Public Assessment Report (EPAR) for Authorized Medicinal Products for Human Use; Cetrotide, Scientific Discussion (2003). Available from, as of February 15, 2009: https://www.emea.europa.eu/humandocs/PDFs/EPAR/Cetrotide/297998en6.pdf

    5.6 Metabolism/Metabolites

    In in vitro studies, cetrorelix was stable against phase I- and phase II-metabolism. Cetrorelix was transformed by peptidases, and the (1-4) peptide was the predominant metabolite.

    The main metabolite of cetrorelix in the rat bile was identified as being the heptapeptide (1-7). The metabolite was pharmacologically inactive in rats, in terms of testosterone suppression.

    European Medicines Agency (EMEA), The European Agency for the Evaluation of Medicinal Products, European Public Assessment Report (EPAR) for Authorized Medicinal Products for Human Use; Cetrotide, Scientific Discussion (2003). Available from, as of February 15, 2009: https://www.emea.europa.eu/humandocs/PDFs/EPAR/Cetrotide/297998en6.pdf

    After subcutaneous administration of 10 mg Cetrotide to females and males, Cetrotide and small amounts of (1-9), (1-7), (1-6), and (1-4) peptides were found in bile samples over 24 hours. In in vitro studies, Cetrotide was stable against phase I- and phase II-metabolism. Cetrotide was transformed by peptidases, and the (1-4) peptide was the predominant metabolite.

    US Natl Inst Health; DailyMed. Current Medication Information for Cetrotide (Cetrorelix acetate) (April 2008). Available from, as of February 9, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=7634

    5.7 Biological Half-Life

    ~62.8 hours

    In humans, the terminal half-life values after iv and sc administration were 8-9 hr and 24-40 hr, respectively.

    European Medicines Agency (EMEA), The European Agency for the Evaluation of Medicinal Products, European Public Assessment Report (EPAR) for Authorized Medicinal Products for Human Use; Cetrotide, Scientific Discussion (2003). Available from, as of February 15, 2009: https://www.emea.europa.eu/humandocs/PDFs/EPAR/Cetrotide/297998en6.pdf

    The terminal half-lives in rats after iv and sc administration were 1-2 hr and 7-14 hr, respectively ... .

    European Medicines Agency (EMEA), The European Agency for the Evaluation of Medicinal Products, European Public Assessment Report (EPAR) for Authorized Medicinal Products for Human Use; Cetrotide, Scientific Discussion (2003). Available from, as of February 15, 2009: https://www.emea.europa.eu/humandocs/PDFs/EPAR/Cetrotide/297998en6.pdf

    Elimination half life: Single 3 mg dose: 62.8 hr (38.2-108 hr); Single 0.25 mg dose: 5.0 hr (2.4-48.8 hr); 0.25 mg daily for 14 days: dose: 20.6 hr (4.1-179.3 hr) /From table/

    US Natl Inst Health; DailyMed. Current Medication Information for Cetrotide (Cetrorelix acetate) (April 2008). Available from, as of February 9, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=7634

    Half-lives of greater than or equal to 100 hr were observed mainly in organs of elimination (liver, kidney), spleen and in the organs containing LHRH binding sites.

    European Medicines Agency (EMEA), The European Agency for the Evaluation of Medicinal Products, European Public Assessment Report (EPAR) for Authorized Medicinal Products for Human Use; Cetrotide, Scientific Discussion (2003). Available from, as of February 15, 2009: https://www.emea.europa.eu/humandocs/PDFs/EPAR/Cetrotide/297998en6.pdf

    5.8 Mechanism of Action

    Cetrorelix binds to the gonadotropin releasing hormone receptor and acts as a potent inhibitor of gonadotropin secretion. It competes with natural GnRH for binding to membrane receptors on pituitary cells and thus controls the release of LH and FSH in a dose-dependent manner.

    Cetrotide competes with natural GnRH for binding to membrane receptors on pituitary cells and thus controls the release of LH and FSH in a dose-dependent manner. The onset of LH suppression is approximately one hour with the 3 mg dose and two hours with the 0.25 mg dose. This suppression is maintained by continuous treatment and there is a more pronounced effect on LH than on FSH. An initial release of endogenous gonadotropins has not been detected with Cetrotide, which is consistent with an antagonist effect.

    US Natl Inst Health; DailyMed. Current Medication Information for Cetrotide (Cetrorelix acetate) (April 2008). Available from, as of February 9, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=7634

    GnRH induces the production and release of luteinizing hormone (LH) and follicle stimulating hormone (FSH) from the gonadotrophic cells of the anterior pituitary. Due to a positive estradiol (E2) feedback at midcycle, GnRH liberation is enhanced resulting in an LH-surge. This LH-surge induces the ovulation of the dominant follicle, resumption of oocyte meiosis and subsequently luteinization as indicated by rising progesterone levels.

    US Natl Inst Health; DailyMed. Current Medication Information for Cetrotide (Cetrorelix acetate) (April 2008). Available from, as of February 9, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=7634

    The mechanisms through which luteinizing hormone (LH)-releasing hormone (LHRH) antagonists suppress pituitary gonadotroph functions and LHRH-receptor (LHRH-R) expression are incompletely understood. Consequently, we investigated the direct effect of LHRH antagonist cetrorelix in vitro on the expression of the pituitary LHRH-R gene and its ability to counteract the exogenous LHRH and the agonist triptorelin in the regulation of this gene. We also compared the effects of chronic administration of cetrorelix and triptorelin on the LHRH-R mRNA level and gonadotropin secretion in ovariectomized (OVX) and normal female rats. The exposure of pituitary cells in vitro to 3-min pulses of 1 nM LHRH or 0.1 nM triptorelin for 5 hr increased the LHRH-R mRNA level by 77-88%. Continuous perfusion of the cells with 50 nM cetrorelix did not cause any significant changes, but prevented the stimulatory effect of LHRH pulses on the receptor mRNA expression. In OVX rats, 10 days after administration of a depot formulation of cetrorelix, releasing 100 microg of peptide daily, the elevated LHRH-R mRNA level was decreased by 73%, whereas daily injection of 100 microg of triptorelin caused a 41% suppression. In normal female rats, cetrorelix treatment suppressed the LHRH-R mRNA level by 33%, but triptorelin increased it by 150%. The highly elevated serum LH levels in OVX rats and the normal LH concentration of cycling rats were rapidly and completely suppressed by cetrorelix. Triptorelin decreased the serum LH in OVX rats to the precastration level, but had no effect on basal LH in normal rats. Our results confirm that LHRH antagonists, such as cetrorelix, inhibit the gene expression of pituitary LHRH-R indirectly, by counteracting the stimulatory effect of LHRH. A rapid suppression of serum LH by LHRH antagonists would be advantageous in the treatment of sex hormone-dependent tumors and other conditions.

    PMID:11593037 Full text: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC59791 Kovacs M, Schally AV; Proc Natl Acad Sci U S A 98 (21): 12197-202 (2001)

    Cetrorelix binds with high affinity to luteinising hormone releasing hormone (LHRH) receptors, and labelled LHRH was shown to be displaced from the two classes of LHRH receptors by the compound. In vitro, cetrorelix dose-dependently inhibited the LHRH-mediated LH release in perfused rat pituitary cell systems. Further, in a recently established in vitro assay, cetrorelix proved to be a high affinity antagonist at the LHRH-receptor and dose-dependently blocked the signal transduction induced by LHRH.

    European Medicines Agency (EMEA), The European Agency for the Evaluation of Medicinal Products, European Public Assessment Report (EPAR) for Authorized Medicinal Products for Human Use; Cetrotide, Scientific Discussion (2003). Available from, as of February 15, 2009: https://www.emea.europa.eu/humandocs/PDFs/EPAR/Cetrotide/297998en6.pdf

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DEVELOPMENT ZONE, 222000, JIANGSU CN","customerAddress":"6-3-865\/1\/2, FLAT NO.201,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q3","strtotime":1751826600,"product":"CETRORELIX ACETATE CETRORELIX ACETATE","address":"407\/408,SHARDA CHAMBERS,","city":"MUMBAI, MAHARASHTRA.","supplier":"SINOPEP ALLSINO BIOPHARMACEUTICAL COLTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"BDR PHARMACEUTICALS INTERNATIONAL PRIVATE LTD","customerCountry":"INDIA","quantity":"0.06","actualQuantity":"60","unit":"GMS","unitRateFc":"1200","totalValueFC":"72112.2","currency":"USD","unitRateINR":"103440","date":"07-Jul-2025","totalValueINR":"6206400","totalValueInUsd":"72112.2","indian_port":"Bombay Air","hs_no":"29371900","bill_no":"3114615","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.28 LINPU ROAD LIANYUNGANG INDUSTRIAL AREA ECO AND TECH DEVELOPMENT ZONE JIANGSU CN","customerAddress":"407\/408,SHARDA CHAMBERS,"}]
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    USFDA APPLICATION NUMBER - 21197

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    ABOUT THIS PAGE

    Looking for 120287-85-6 / Cetrorelix Acetate API manufacturers, exporters & distributors?

    Cetrorelix Acetate manufacturers, exporters & distributors 1

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    PharmaCompass offers a list of Cetrorelix Acetate 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 Cetrorelix Acetate manufacturer or Cetrorelix Acetate supplier for your needs.

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

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

    API | Excipient name

    Cetrorelix Acetate

    Synonyms

    120287-85-6, Cetrotide, Cetrorelixum, Sb 75, Cetrorelixum [inn-latin], Cetrorelix (inn)

    Cas Number

    120287-85-6

    Unique Ingredient Identifier (UNII)

    OON1HFZ4BA

    About Cetrorelix Acetate

    Cetrorelix is cetrorelix is a synthetic decapeptide which is structurally related to gonadotrophin-releasing hormone (luteinising-hormone releasing hormone). It acts as an LHRH antagonist. (from ASTA Medica)

    CETRORELIX (2) Manufacturers

    A CETRORELIX (2) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of CETRORELIX (2), including repackagers and relabelers. The FDA regulates CETRORELIX (2) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. CETRORELIX (2) 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 CETRORELIX (2) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    CETRORELIX (2) Suppliers

    A CETRORELIX (2) supplier is an individual or a company that provides CETRORELIX (2) active pharmaceutical ingredient (API) or CETRORELIX (2) finished formulations upon request. The CETRORELIX (2) suppliers may include CETRORELIX (2) API manufacturers, exporters, distributors and traders.

    click here to find a list of CETRORELIX (2) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    CETRORELIX (2) USDMF

    A CETRORELIX (2) DMF (Drug Master File) is a document detailing the whole manufacturing process of CETRORELIX (2) active pharmaceutical ingredient (API) in detail. Different forms of CETRORELIX (2) DMFs exist exist since differing nations have different regulations, such as CETRORELIX (2) USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A CETRORELIX (2) DMF submitted to regulatory agencies in the US is known as a USDMF. CETRORELIX (2) USDMF includes data on CETRORELIX (2)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The CETRORELIX (2) USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of CETRORELIX (2) suppliers with USDMF on PharmaCompass.

    CETRORELIX (2) 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 CETRORELIX (2) Drug Master File in Japan (CETRORELIX (2) JDMF) empowers CETRORELIX (2) 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 CETRORELIX (2) JDMF during the approval evaluation for pharmaceutical products. At the time of CETRORELIX (2) 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 CETRORELIX (2) suppliers with JDMF on PharmaCompass.

    CETRORELIX (2) WC

    A CETRORELIX (2) written confirmation (CETRORELIX (2) WC) is an official document issued by a regulatory agency to a CETRORELIX (2) manufacturer, verifying that the manufacturing facility of a CETRORELIX (2) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting CETRORELIX (2) APIs or CETRORELIX (2) finished pharmaceutical products to another nation, regulatory agencies frequently require a CETRORELIX (2) WC (written confirmation) as part of the regulatory process.

    click here to find a list of CETRORELIX (2) suppliers with Written Confirmation (WC) on PharmaCompass.

    CETRORELIX (2) 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 CETRORELIX (2) as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for CETRORELIX (2) 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 CETRORELIX (2) 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 CETRORELIX (2) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a CETRORELIX (2) NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of CETRORELIX (2) suppliers with NDC on PharmaCompass.

    CETRORELIX (2) GMP

    CETRORELIX (2) 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 CETRORELIX (2) 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 CETRORELIX (2) GMP manufacturer or CETRORELIX (2) GMP API supplier for your needs.

    CETRORELIX (2) CoA

    A CETRORELIX (2) CoA (Certificate of Analysis) is a formal document that attests to CETRORELIX (2)'s compliance with CETRORELIX (2) specifications and serves as a tool for batch-level quality control.

    CETRORELIX (2) CoA mostly includes findings from lab analyses of a specific batch. For each CETRORELIX (2) 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.

    CETRORELIX (2) may be tested according to a variety of international standards, such as European Pharmacopoeia (CETRORELIX (2) EP), CETRORELIX (2) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (CETRORELIX (2) 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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