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Chemistry

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Also known as: 864953-29-7, Bms-663068, Bms-663068 free acid, Bms 663068, Fostemsavir [usan], Rukobia
Molecular Formula
C25H26N7O8P
Molecular Weight
583.5  g/mol
InChI Key
SWMDAPWAQQTBOG-UHFFFAOYSA-N
FDA UNII
97IQ273H4L

Fostemsavir
Fostemsavir is the phosphonooxymethyl prodrug of temsavir, a novel HIV-1 attachment inhibitor. It binds to and inhibits the activity of gp120, a subunit within the HIV-1 gp160 envelope glycoprotein that facilitates the attachment of HIV-1 to host cell CD4 receptors - in doing so, temsavir prevents the first step in the HIV-1 viral lifecycle. The discovery of gp120 as a potential target of interest in the treatment of HIV-1 infection is relatively recent, and was born out of a desire to find alternative target proteins (i.e. mechanistically orthogonal therapies) for the treatment of HIV-1 patients with resistant infections. Fostemavir is the first attachment inhibitor to receive FDA approval, granted in July 2020 for use in combination with other antiretrovirals in highly treatment-experienced patients with multidrug-resistant HIV-1 infection whom are failing their current therapy. Targeting gp120 subunits is a new and novel therapeutic approach to HIV-1 infection, and the addition of attachment inhibitors, like temsavir, to the armament of therapies targeted against HIV-1 fills a necessary niche for therapeutic options in patients left with few, if any, viable treatments.
1 2D Structure

Fostemsavir

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
[3-[2-(4-benzoylpiperazin-1-yl)-2-oxoacetyl]-4-methoxy-7-(3-methyl-1,2,4-triazol-1-yl)pyrrolo[2,3-c]pyridin-1-yl]methyl dihydrogen phosphate
2.1.2 InChI
InChI=1S/C25H26N7O8P/c1-16-27-14-32(28-16)23-21-20(19(39-2)12-26-23)18(13-31(21)15-40-41(36,37)38)22(33)25(35)30-10-8-29(9-11-30)24(34)17-6-4-3-5-7-17/h3-7,12-14H,8-11,15H2,1-2H3,(H2,36,37,38)
2.1.3 InChI Key
SWMDAPWAQQTBOG-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CC1=NN(C=N1)C2=NC=C(C3=C2N(C=C3C(=O)C(=O)N4CCN(CC4)C(=O)C5=CC=CC=C5)COP(=O)(O)O)OC
2.2 Other Identifiers
2.2.1 UNII
97IQ273H4L
2.3 Synonyms
2.3.1 MeSH Synonyms

1. (3-((4-benzoyl-1-piperazinyl)(oxo)acetyl)-4-methoxy-7-(3-methyl-1h-1,2,4-triazol-1-yl)-1h-pyrrolo(2,3-c)pyridin-1-yl)methyl Dihydrogen Phosphate

2. 1,2-ethanedione, 1-(4-benzoyl-1-piperazinyl)-2-(4-methoxy-7-(3-methyl-1h-1,2,4-triazol-1-yl)-1-((phosphonooxy)methyl)-1h-pyrrolo(2,3-c)pyridin-3-yl)-

3. Bms-663068

2.3.2 Depositor-Supplied Synonyms

1. 864953-29-7

2. Bms-663068

3. Bms-663068 Free Acid

4. Bms 663068

5. Fostemsavir [usan]

6. Rukobia

7. Fostemsavir(bms-663068)

8. 97iq273h4l

9. 864953-29-7(free Base)

10. Fostemsavir (usan)

11. [3-[2-(4-benzoylpiperazin-1-yl)-2-oxoacetyl]-4-methoxy-7-(3-methyl-1,2,4-triazol-1-yl)pyrrolo[2,3-c]pyridin-1-yl]methyl Dihydrogen Phosphate

12. Bms663068

13. Piperazine, 1-benzoyl-4-((4-methoxy-7-(3-methyl-1h-1,2,4-triazol-1-yl)-1-((phosphonooxy)methyl)-1h-pyrrolo(2,3-c)pyridin-3-yl)oxoacetyl)-

14. (3-(2-(4-benzoylpiperazin-1-yl)-2-oxoacetyl)-4-methoxy-7-(3-methyl-1h-1,2,4-triazol-1-yl)-1h-pyrrolo[2,3-c]pyridin-1-yl)methyl Dihydrogen Phosphate

15. Unii-97iq273h4l

16. Fostemsavir & N6

17. [3-[2-(4-benzoylpiperazin-1-yl)-2-oxo-acetyl]-4-methoxy-7-(3-methyl-1,2,4-triazol-1-yl)pyrrolo[2,3-c]pyridin-1-yl]methyl Dihydrogen Phosphate

18. 1,2-ethanedione, 1-(4-benzoyl-1-piperazinyl)-2-(4-methoxy-7-(3-methyl-1h-1,2,4-triazol-1-yl)-1-((phosphonooxy)methyl)-1h-pyrrolo(2,3-c)pyridin-3-yl)-

19. 1,2-ethanedione, 1-(4-benzoyl-1-piperazinyl)-2-[4-methoxy-7-(3-methyl-1h-1,2,4-triazol-1-yl)-1-[(phosphonooxy)methyl]-1h-pyrrolo[2,3-c]pyridin-3-yl]-

20. Gsk3684934

21. Fostemsavir & Pg16

22. Fostemsavir & 4dm2m

23. Fostemsavir & Vrc03

24. Fostemsavir & Ch106

25. Fostemsavir & 35o22

26. Fostemsavir & Pgt128

27. Fostemsavir [mi]

28. Fostemsavir [inn]

29. Fostemsavir & 3bnc117

30. Fostemsavir & Pg16-imab

31. Fostemsavir [who-dd]

32. Fostemsavir & Pgt128-imab

33. Fostemsavir & Vrc07-523

34. Schembl754395

35. Fostemsavir; Bms-663068

36. Chembl3301594

37. Gtpl11100

38. Dtxsid40235596

39. Fostemsavir & Nih45-46g54w

40. Bcp13226

41. Ex-a1973

42. Bms-626529 & 4dm2m

43. Hy-15440a

44. S7220

45. Zinc14210883

46. Bms-626529 & Pg16-imab

47. Bms-663038

48. Cs-1059

49. Db11796

50. Sb11250

51. Bms-626529 & Pgt128-imab

52. Bms626-529 & Vrc03

53. Gsk-3684934

54. Bms-626529 & N6

55. Bms-626529 & Pg16

56. Compound 35 [pmid: 29271653]

57. Ncgc00510187-01

58. Ac-30663

59. Bms-626529 & Pgt128

60. Bms-626529 & Ch106

61. Bms-626529 & 3bnc117

62. Bms-626529 & 35o22

63. Bms-626529 & Vrc07-523

64. Bms626-529 & Nih45-46g54w

65. D10707

66. A863152

67. Q17001240

68. ({3-[2-(4-benzoylpiperazin-1-yl)-2-oxoacetyl]-4-methoxy-7-(3-methyl-1h-1,2,4-triazol-1-yl)-1h-pyrrolo[2,3-c]pyridin-1-yl}methoxy)phosphonic Acid

69. (3-((4-benzoyl-1-piperazinyl)(oxo)acetyl)-4-methoxy-7-(3-methyl-1h-1,2,4-triazol-1-yl)-1h-pyrrolo(2,3-c)pyridin-1-yl)methyl Dihydrogen Phosphate

70. (3-((4-benzoylpiperazin-1-yl)-oxoacetyl)-4-methoxy- 7-(3-methyl-1h-1,2,4-triazol-1-yl)-1h-pyrrolo(2,3-c)pyridin- 1-yl)methyl Dihydrogen Phosphate

71. 1-(4-benzoyl-1-piperazinyl)-2-[4-methoxy-7-(3-methyl-1h-1,2,4-triazol-1-yl)-1-[(phosphonooxy)methyl]-1h-pyrrolo[2,3-c]pyridin-3-yl]-1,2-ethanedione

2.4 Create Date
2006-10-26
3 Chemical and Physical Properties
Molecular Weight 583.5 g/mol
Molecular Formula C25H26N7O8P
XLogP3-0.1
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count11
Rotatable Bond Count8
Exact Mass583.15804781 g/mol
Monoisotopic Mass583.15804781 g/mol
Topological Polar Surface Area182 Ų
Heavy Atom Count41
Formal Charge0
Complexity1020
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Indication

Fostemsavir is indicated, in combination with other antiretrovirals, for the treatment of multidrug-resistant HIV-1 infection in heavily treatment-experienced adults failing their current antiretroviral therapy due to resistance, intolerance, or safety concerns.


Rukobia, in combination with other antiretrovirals, is indicated for the treatment of adults with multidrug resistant HIV-1 infection for whom it is otherwise not possible to construct a suppressive anti-viral regimen.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Temsavir inhibits the first stage in the HIV-1 viral lifecycle: attachment. It has a moderate duration of action necessitating twice-daily dosing. Fostemsavir, administered at roughly 4x the recommended human dose, has been observed to significantly prolong the QTc-interval. Patients with a history of QTc-prolongation, those receiving other QTc-prolonging medications, and/or those with pre-existing cardiac disease should use fostemsavir with caution, and should be monitored at baseline and throughout therapy for signs or symptoms suggestive of QTc-prolongation. Fostemsavir should also be used with caution in patients with hepatitis B or C co-infection as elevations in hepatic transaminases were observed in greater proportions in these populations in clinical trials.


5.2 MeSH Pharmacological Classification

Anti-HIV Agents

Agents used to treat AIDS and/or stop the spread of the HIV infection. These do not include drugs used to treat symptoms or opportunistic infections associated with AIDS. (See all compounds classified as Anti-HIV Agents.)


HIV Fusion Inhibitors

Inhibitors of the fusion of HIV to host cells, preventing viral entry. This includes compounds that block attachment of HIV ENVELOPE PROTEIN GP120 to CD4 RECEPTORS. (See all compounds classified as HIV Fusion Inhibitors.)


5.3 ATC Code

J05AX


J - Antiinfectives for systemic use

J05 - Antivirals for systemic use

J05A - Direct acting antivirals

J05AX - Other antivirals

J05AX29 - Fostemsavir


5.4 Absorption, Distribution and Excretion

Absorption

The absorption of temsavir is significantly limited by suboptimal dissolution and solubility following oral administration. Fostemsavir, a phosphonooxymethyl prodrug of temsavir, has improved aqueous solubility and stability under acidic conditions as compared to its parent drug - following oral administration of fostemsavir, the absolute bioavailability is approximately 26.9%. The Cmax and AUCtau following oral administration of fostemsavir 600mg twice daily was 1770 ng/mL and 12,900 ng.h/L, respectively, with a Tmax of approximately 2 hours. Co-administration of fostemsavir with a standard meal increases its AUC by approximately 10%, while co-administration with a high-fat meal increases its AUC by approximately 81%.


Route of Elimination

Temsavir is highly metabolized, after which it is excreted in the urine and feces as inactive metabolites. Approximately 51% of a given dose is excreted in the urine, with <2% comprising unchanged parent drug, and 33% is excreted in the feces, of which 1.1% is unchanged parent drug.


Volume of Distribution

The steady-state volume of distribution of temsavir following intravenous administration is approximately 29.5 L.


Clearance

The mean clearance and apparent clearance of temsavir, the active metabolite of fostemsavir, are 17.9 L/h and 66.4 L/h, respectively.


5.5 Metabolism/Metabolites

Fostemsavir is rapidly hydrolyzed to temsavir, its active metabolite, by alkaline phosphatase(s) present at the brush border membrane of the intestinal lumen. Temsavir undergoes further biotransformation to two predominant inactive metabolites: BMS-646915, a product of hydrolysis by esterases, and BMS-930644, an N-dealkylated metabolite generated via oxidation by CYP3A4. Approximately 36.1% of an administered oral dose is metabolized by esterases, 21.2% is metabolized by CYP3A4, and <1% is conjugated by UDP-glucuronosyltransferases (UGT) prior to elimination. Both temsavir and its two predominant metabolites are known to inhibit BCRP.


5.6 Biological Half-Life

The half-life of temsavir is approximately 11 hours. Fostemsavir is generally undetectable in plasma following oral administration.


5.7 Mechanism of Action

The gp120 subunit within the gp160 envelope glycoprotein of HIV-1 is a new and novel target in the treatment of HIV-1 infection. These subunits are responsible for facilitating the first step in the viral life cycle, attachment, by mediating the interaction between the virus and host cell CD4 receptors. Following attachment, HIV-1 undergoes assembly, budding, and maturation within the host cell, after which mature viral particles are released to continue the viral life cycle. Fostemsavir's active metabolite, temsavir, is an HIV-1 attachment inhibitor. It binds directly to the gp120 subunit to inhibit viral interaction with host CD4 receptors, thereby preventing the initial attachment required for viral replication. It has also been shown to inhibit other gp120-dependent post-attachment steps required for viral entry.


API SUPPLIERS

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Piramal Enterprises Limited

India

USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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Piramal Enterprises Limited

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NDC API

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FOSTEMSAVIR TROMETHAMINE

NDC Package Code : 24584-1113

Start Marketing Date : 2020-07-02

End Marketing Date : 2026-12-31

Dosage Form (Strength) : POWDER (15kg/15kg)

Marketing Category : BULK INGREDIENT

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Drugs in Development

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Details:

VH3810109 is a Antibody drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of HIV Infections.


Lead Product(s): VH3810109,Fostemsavir

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Antibody, Unconjugated

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 08, 2025

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ViiV Healthcare

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ViiV Healthcare

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Details : VH3810109 is a Antibody drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of HIV Infections.

Product Name : Undisclosed

Product Type : Antibody, Unconjugated

Upfront Cash : Inapplicable

July 08, 2025

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Details:

MGN1703 (lefitolimod) is synthetic TLR9 agonist of the double-stem loop immunomodulators or dSLIM family where multiple CG-motifs are embedded into a stable, covalently closed double stem-loop DNA molecule harboring only natural phosphodiester bonds between nucleotides.


Lead Product(s): Lefitolimod,10-1074,Fostemsavir

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Oligonucleotide

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 21, 2023

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Details : MGN1703 (lefitolimod) is synthetic TLR9 agonist of the double-stem loop immunomodulators or dSLIM family where multiple CG-motifs are embedded into a stable, covalently closed double stem-loop DNA molecule harboring only natural phosphodiester bonds betw...

Product Name : Undisclosed

Product Type : Oligonucleotide

Upfront Cash : Inapplicable

February 21, 2023

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Details:

Study findings showed that people living with multidrug-resistant HIV-1 treated for approximately five years with Rukobia (fostemsavir)-based regimens experienced durable virologic response and continued clinically meaningful improvement in CD4+ cell count and CD4+/CD8+ ratio.


Lead Product(s): Fostemsavir,Inapplicable

Therapeutic Area: Infections and Infectious Diseases Brand Name: Rukobia

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: GSK

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 29, 2022

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ViiV Healthcare

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Details : Study findings showed that people living with multidrug-resistant HIV-1 treated for approximately five years with Rukobia (fostemsavir)-based regimens experienced durable virologic response and continued clinically meaningful improvement in CD4+ cell cou...

Product Name : Rukobia

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 29, 2022

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Details:

Fostemsavir is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of HIV Infections.


Lead Product(s): Fostemsavir,Inapplicable

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: ViiV Healthcare

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 02, 2022

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Orlando Immunology Center

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Orlando Immunology Center

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Details : Fostemsavir is a Other Small Molecule drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of HIV Infections.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 02, 2022

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Albuvirtide is a Peptide drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of HIV Infections.


Lead Product(s): Albuvirtide,Fostemsavir

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Peptide, Unconjugated

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable March 26, 2021

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Details : Albuvirtide is a Peptide drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of HIV Infections.

Product Name : Undisclosed

Product Type : Peptide, Unconjugated

Upfront Cash : Inapplicable

March 26, 2021

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Details:

Fostemsavir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of HIV Infections.


Lead Product(s): Fostemsavir,Inapplicable

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 17, 2021

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ViiV Healthcare

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ViiV Healthcare

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Details : Fostemsavir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I clinical studies for the treatment of HIV Infections.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 17, 2021

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  • Development Update

Details:

Fostemsavir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of HIV Infections.


Lead Product(s): Fostemsavir,Inapplicable

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous

Sponsor: ViiV Healthcare | PHPT Foundation | Hospital Universitario 12 de Octubre | Cromsource

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 01, 2020

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PENTA Foundation

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PENTA Foundation

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Lead Product(s) : Fostemsavir,Inapplicable

Therapeutic Area : Infections and Infectious Diseases

Highest Development Status : Phase I/ Phase II

Partner/Sponsor/Collaborator : ViiV Healthcare | PHPT Foundation | Hospital Universitario 12 de Octubre | Cromsource

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Fostemsavir is a Other Small Molecule drug candidate, which is currently being evaluated in phase I/ phase II clinical studies for the treatment of HIV Infections.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

December 01, 2020

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Details:

Albuvirtide is a Peptide drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of HIV Infections.


Lead Product(s): Albuvirtide,Fostemsavir

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Peptide, Unconjugated

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 23, 2020

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AIChE Annual Meeting
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Details : Albuvirtide is a Peptide drug candidate, which is currently being evaluated in phase II clinical studies for the treatment of HIV Infections.

Product Name : Undisclosed

Product Type : Peptide, Unconjugated

Upfront Cash : Inapplicable

September 23, 2020

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Details:

In a phase III study, a majority (60%) of heavily treatment-experienced adults randomized to receive Rukobia with an optimized background therapy achieved and maintained viral suppression through 96 weeks, addressing a critical unmet need.


Lead Product(s): Fostemsavir,Undisclosed

Therapeutic Area: Infections and Infectious Diseases Brand Name: Rukobia

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 02, 2020

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ViiV Healthcare

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Details : In a phase III study, a majority (60%) of heavily treatment-experienced adults randomized to receive Rukobia with an optimized background therapy achieved and maintained viral suppression through 96 weeks, addressing a critical unmet need.

Product Name : Rukobia

Product Type : Miscellaneous

Upfront Cash : Inapplicable

July 02, 2020

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Details:

Celldex utilized their internal capabilities in production cell line development, process development and GMP manufacturing to support clinical development of 3BNC117 and 10-1074.


Lead Product(s): Fostemsavir,10-1074

Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Rockefeller University

Deal Size: Undisclosed Upfront Cash: $1.7 million

Deal Type: Collaboration March 03, 2020

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Details : Celldex utilized their internal capabilities in production cell line development, process development and GMP manufacturing to support clinical development of 3BNC117 and 10-1074.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : $1.7 million

March 03, 2020

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INTERMEDIATE SUPPLIERS

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ChemExpress

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Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

CAS Number : 619331-35-0

End Use API : Fostemsavir

About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...

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ChemExpress

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Virtual BoothChemExpress delivers end-to-end CRO & CDMO solutions for small molecules, biologics & new modalities with ICH-grade quality.

CAS Number : 446284-32-8

End Use API : Fostemsavir

About The Company : Founded in 2006, ChemExpress specializes in offering CRO & CDMO services for pharmaceutical and biotech companies, focusing on small molecules, biologics and ne...

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VIIV HLTHCARE

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VIIV HLTHCARE

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FOSTEMSAVIR TROMETHAMINE

Brand Name : RUKOBIA

Dosage Form : TABLET, EXTENDED RELEASE;ORAL

Dosage Strength : EQ 600MG BASE

Approval Date : 2020-07-02

Application Number : 212950

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

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Viiv Healthcare Bv

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Fostemsavirtrometamol

Brand Name : Rukobia

Dosage Form : Tablet

Dosage Strength : 600mg

Packaging :

Approval Date : 04/02/2021

Application Number : 20200113000032

Regulatory Info : Approved

Registration Country : Sweden

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Viiv Healthcare Gmbh

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Viiv Healthcare Gmbh

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You Are A Savage

Brand Name : Rukobia

Dosage Form : Modified Release Tablet

Dosage Strength : 600mg

Packaging :

Approval Date : 28/09/2021

Application Number : 67854

Regulatory Info : Allowed

Registration Country : Switzerland

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US Medicaid Prescriptions

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01

Brand Name : Rukobia

United Kingdom
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Brand Name : Rukobia

United Kingdom
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Company : Viiv Healthcare

Fostemsavir Tromethamine

Drug Cost (USD) : 91,208,742

Year : 2023

Prescribers : 1227

Prescriptions : 9968

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02

Brand Name : Rukobia

United Kingdom
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AIChE Annual Meeting
Not Confirmed

Brand Name : Rukobia

United Kingdom
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AIChE Annual Meeting
Not Confirmed

Company : Viiv Healthcare

Fostemsavir Tromethamine

Drug Cost (USD) : 63,858,997

Year : 2022

Prescribers : 934

Prescriptions : 7433

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03

Brand Name : Rukobia

United Kingdom
arrow
AIChE Annual Meeting
Not Confirmed

Brand Name : Rukobia

United Kingdom
arrow
AIChE Annual Meeting
Not Confirmed

Company : Viiv Healthcare

Fostemsavir Tromethamine

Drug Cost (USD) : 38,947,235

Year : 2021

Prescribers : 672

Prescriptions : 4800

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04

Brand Name : Rukobia

United Kingdom
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AIChE Annual Meeting
Not Confirmed

Brand Name : Rukobia

United Kingdom
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AIChE Annual Meeting
Not Confirmed

Company : Viiv Healthcare

Fostemsavir Tromethamine

Drug Cost (USD) : 6,695,198

Year : 2020

Prescribers : 276

Prescriptions : 831

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Annual Reports

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01

Brand Name : Rukobia

Fostemsavir

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Brand Name : Rukobia

United Kingdom
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Fostemsavir

Main Therapeutic Indication : Infectious Diseases

Currency : USD

2020 Revenue in Millions : 15

2019 Revenue in Millions : 0

Growth (%) : New Launch

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02

Brand Name : Rukobia

Fostemsavir

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Brand Name : Rukobia

United Kingdom
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Fostemsavir

Main Therapeutic Indication : Infectious Diseases

Currency : USD

2021 Revenue in Millions : 61

2020 Revenue in Millions : 15

Growth (%) : 309

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03

Brand Name : Rukobia

Fostemsavir

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AIChE Annual Meeting
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Brand Name : Rukobia

United Kingdom
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AIChE Annual Meeting
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Fostemsavir

Main Therapeutic Indication : Infectious Diseases

Currency : USD

2022 Revenue in Millions : 101

2021 Revenue in Millions : 61

Growth (%) : 66

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04

Brand Name : Rukobia

Fostemsavir

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Brand Name : Rukobia

United Kingdom
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AIChE Annual Meeting
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Fostemsavir

Main Therapeutic Indication : Infectious Diseases

Currency : USD

2023 Revenue in Millions : 126

2022 Revenue in Millions : 101

Growth (%) : 43

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05

Brand Name : Rukobia

Fostemsavir

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AIChE Annual Meeting
Not Confirmed

Brand Name : Rukobia

United Kingdom
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Fostemsavir

Main Therapeutic Indication : Infectious Diseases

Currency : USD

2024 Revenue in Millions : 200

2023 Revenue in Millions : 126

Growth (%) : 59

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Patents & EXCLUSIVITIES

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US Patents

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01

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VIIV HLTHCARE

United Kingdom
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FOSTEMSAVIR TROMETHAMINE

US Patent Number : 8461333

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 212950

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-02-25

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02

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VIIV HLTHCARE

United Kingdom
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FOSTEMSAVIR TROMETHAMINE

US Patent Number : 7745625

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 212950

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2027-11-19

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03

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VIIV HLTHCARE

United Kingdom
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FOSTEMSAVIR TROMETHAMINE

US Patent Number : 8168615

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 212950

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2029-07-13

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ABOUT THIS PAGE

Looking for 864953-29-7 / Fostemsavir API manufacturers, exporters & distributors?

Fostemsavir manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Fostemsavir

Synonyms

864953-29-7, Bms-663068, Bms-663068 free acid, Bms 663068, Fostemsavir [usan], Rukobia

Cas Number

864953-29-7

Unique Ingredient Identifier (UNII)

97IQ273H4L

About Fostemsavir

Fostemsavir is the phosphonooxymethyl prodrug of temsavir, a novel HIV-1 attachment inhibitor. It binds to and inhibits the activity of gp120, a subunit within the HIV-1 gp160 envelope glycoprotein that facilitates the attachment of HIV-1 to host cell CD4 receptors - in doing so, temsavir prevents the first step in the HIV-1 viral lifecycle. The discovery of gp120 as a potential target of interest in the treatment of HIV-1 infection is relatively recent, and was born out of a desire to find alternative target proteins (i.e. mechanistically orthogonal therapies) for the treatment of HIV-1 patients with resistant infections. Fostemavir is the first attachment inhibitor to receive FDA approval, granted in July 2020 for use in combination with other antiretrovirals in highly treatment-experienced patients with multidrug-resistant HIV-1 infection whom are failing their current therapy. Targeting gp120 subunits is a new and novel therapeutic approach to HIV-1 infection, and the addition of attachment inhibitors, like temsavir, to the armament of therapies targeted against HIV-1 fills a necessary niche for therapeutic options in patients left with few, if any, viable treatments.

Fostemsavir Manufacturers

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

Fostemsavir Suppliers

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

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

Fostemsavir 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 Fostemsavir as an active pharmaceutical ingredient (API).

Finished drug products

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

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

Fostemsavir GMP

Fostemsavir 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 Fostemsavir 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 Fostemsavir GMP manufacturer or Fostemsavir GMP API supplier for your needs.

Fostemsavir CoA

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

Fostemsavir CoA mostly includes findings from lab analyses of a specific batch. For each Fostemsavir 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.

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