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Synopsis

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Chemistry

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Also known as: Pf-03084014, 1290543-63-3, Pf-3084014, 865773-15-5, Pf 3084014, Nirogacestat [usan]
Molecular Formula
C27H41F2N5O
Molecular Weight
489.6  g/mol
InChI Key
VFCRKLWBYMDAED-REWPJTCUSA-N
FDA UNII
QZ62892OFJ

Nirogacestat Hydrobromide
Nirogacestat is a selective gamma secretase (GS) inhibitor with potential antitumor activity. Nirogacestat binds to GS, blocking proteolytic activation of Notch receptors; Notch signaling pathway inhibition may follow, which may result in the induction of apoptosis in tumor cells that overexpress Notch. The integral membrane protein GS is a multi-subunit protease complex that cleaves single-pass transmembrane proteins, such as Notch receptors, at residues within their transmembrane domains. Overexpression of the Notch signaling pathway has been correlated with increased tumor cell growth and survival.
1 2D Structure

Nirogacestat Hydrobromide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
(2S)-2-[[(2S)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl]amino]-N-[1-[1-(2,2-dimethylpropylamino)-2-methylpropan-2-yl]imidazol-4-yl]pentanamide
2.1.2 InChI
InChI=1S/C27H41F2N5O/c1-7-8-23(32-20-10-9-18-11-19(28)12-22(29)21(18)13-20)25(35)33-24-14-34(17-31-24)27(5,6)16-30-15-26(2,3)4/h11-12,14,17,20,23,30,32H,7-10,13,15-16H2,1-6H3,(H,33,35)/t20-,23-/m0/s1
2.1.3 InChI Key
VFCRKLWBYMDAED-REWPJTCUSA-N
2.1.4 Canonical SMILES
CCCC(C(=O)NC1=CN(C=N1)C(C)(C)CNCC(C)(C)C)NC2CCC3=C(C2)C(=CC(=C3)F)F
2.1.5 Isomeric SMILES
CCC[C@@H](C(=O)NC1=CN(C=N1)C(C)(C)CNCC(C)(C)C)N[C@H]2CCC3=C(C2)C(=CC(=C3)F)F
2.2 Other Identifiers
2.2.1 UNII
QZ62892OFJ
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2-(5,7-difluoro-1,2,3,4-tetrahydronaphthalen-3-ylamino)-n-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1h-imidazol-4-yl)pentanamide

2. Pf 03084014

3. Pf 3084014

4. Pf-03084014

5. Pf-3084014

6. Pf03084014

7. Pf3084014

2.3.2 Depositor-Supplied Synonyms

1. Pf-03084014

2. 1290543-63-3

3. Pf-3084014

4. 865773-15-5

5. Pf 3084014

6. Nirogacestat [usan]

7. Pf 03084014

8. Pf3084014

9. Qz62892ofj

10. (s)-2-(((s)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl)amino)-n-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1h-imidazol-4-yl)pentanamide

11. (2s)-2-[[(2s)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl]amino]-n-[1-[1-(2,2-dimethylpropylamino)-2-methylpropan-2-yl]imidazol-4-yl]pentanamide

12. Pf-03084014 (pf-3084014)

13. (s)-2-((s)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-ylamino)-n-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1h-imidazol-4-yl)pentanamide

14. Unii-qz62892ofj

15. Nirogacestat (usan/inn)

16. Nirogacestat [inn]

17. Z-3181

18. Nirogacestat [who-dd]

19. Gtpl7746

20. Chembl1770916

21. Schembl13184754

22. Dtxsid60235679

23. Ex-a855

24. Pf-3084014 (y-secratase)

25. Hms3886p21

26. Bdbm50458159

27. Mfcd19980705

28. Nsc754348

29. S8018

30. Zinc38217837

31. Akos030526383

32. Ccg-269609

33. Cs-1689

34. Db12005

35. Nsc-754348

36. Ncgc00378713-01

37. 2-(5,7-difluoro-1,2,3,4-tetrahydronaphthalen-3-ylamino)-n-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1h-imidazol-4-yl)pentanamide

38. Ac-36191

39. As-56178

40. Hy-15185

41. Pf-03084014-pf-3084014

42. A11993

43. D10960

44. F17429

45. A910640

46. Nirogacestat (pf-03084014, Pf-3084014)

47. Q27088329

48. Pf-03084014;pf-3084014;865773-15-5;

49. (2s)-2-(((2s)-6,8-difluoro-1,2,3,4-tetrahydro-2-naphthalenyl)amino)-n-(1-(2-((2,2-dimethylpropyl)amino)-1,1-dimethylethyl)-1h-imidazol-4-yl)pentanamide

50. (2s)-2-{[(2s)-6,8-difluoro-1,2,3,4-tetrahydronaphthalen-2-yl]amino}-n-(1-{1-[(2,2-dimethylpropyl)amino]-2-methylpropan-2-yl}-1h-imidazol-4-yl)pentanamide

51. Pentanamide, 2-(((2s)-6,8-difluoro-1,2,3,4-tetrahydro-2-naphthalenyl)amino)-n-(1-(2-((2,2-dimethylpropyl)amino)-1,1-dimethylethyl)-1h-imidazol-4-yl)-, (2s)-

52. Pentanamide, 2-((6,8-difluoro-1,2,3,4-tetrahydro-2-naphthalenyl)amino)-n-(1-(2-((2,2-dimethylpropyl)amino)-1,1-dimethylethyl)-1h-imidazol-4-yl)-, (2s)-

53. Pentanamide, 2-[(6,8-difluoro-1,2,3,4-tetrahydro-2-naphthalenyl)amino]-n-[1-[2-[(2,2-dimethylpropyl)amino]-1,1-dimethylethyl]-1h-imidazol-4-yl]-, (2s)

2.4 Create Date
2010-07-06
3 Chemical and Physical Properties
Molecular Weight 489.6 g/mol
Molecular Formula C27H41F2N5O
XLogP34.8
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count6
Rotatable Bond Count11
Exact Mass489.32791727 g/mol
Monoisotopic Mass489.32791727 g/mol
Topological Polar Surface Area71 Ų
Heavy Atom Count35
Formal Charge0
Complexity685
Isotope Atom Count0
Defined Atom Stereocenter Count2
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Pharmacology and Biochemistry
4.1 MeSH Pharmacological Classification

Gamma Secretase Inhibitors and Modulators

Agents that suppress GAMMA-SECRETASE by inhibiting or modulating its activities. Targeted enzymatic activities include its involvement in accumulation of toxic AMYLOID BETA-PEPTIDES (e.g., Aβ42) in ALZHEIMER DISEASE and activation of NOTCH RECEPTOR mediated SIGNAL PATHWAYS in certain cancer types. (See all compounds classified as Gamma Secretase Inhibitors and Modulators.)


API SUPPLIERS

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01

TAPI Technology & API Services

Israel

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

  • fda
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  • WHO-GMP

Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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Sichuan Taienkang Pharmaceutical

China

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

OPRD
Not Confirmed
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03

Sai Life Sciences Limited

India

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

OPRD
Not Confirmed
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Sai Life Sciences Limited

India

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

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OPRD
Not Confirmed
USDMF CEP/COS JDMF EU-WCarrow-down NDC KDMF VMF Others AUDIT
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Listed Suppliers

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  • fda
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Virtual BoothTAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.

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Nirogacestat Hydrobromide

About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...

Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, driving progress in the pharmaceutical industry. Leveraging our extensive experience and world-class expertise, we deliver one of the most comprehensive API portfolios in the industry with over 350 Products portfolio. Additionally, we provide tailored CDMO services, harnessing our proficiency in diverse technologies to meet our partners' unique needs, ensuring flexibility and excellence in every project.
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02

OTS 2025
Not Confirmed
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OTS 2025
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Nirogacestat Hydrobromide

About the Company : Sichuan Taienkang Pharmaceutical Co., Ltd., established in 2020, is a subsidiary of Guangdong Taienkang Pharmaceutical Co., Ltd. The company specializes in the R&D, production, and...

Sichuan Taienkang Pharmaceutical Co., Ltd., established in 2020, is a subsidiary of Guangdong Taienkang Pharmaceutical Co., Ltd. The company specializes in the R&D, production, and sales of generic APIs and intermediates, focusing on high-value APIs such as Dapoxetine Hydrochloride, Tadalafil, and others to meet diverse market needs. Located in the Yuechi Economic Development Zone, Sichuan Province, the manufacturing site spans 100 acres within a provincial-level chemical industry park. Phase one includes 4 independent production lines and a Class D GMP workshop, equipped with 500L to 5000L multifunctional reactors.
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Drugs in Development

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Details:

Nirogacestat HBr is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Desmoid Tumors.


Lead Product(s): Nirogacestat Hydrobromide,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IVProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 16, 2025

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01

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Details : Nirogacestat HBr is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Desmoid Tumors.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 16, 2025

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Details:

Nirogacestat is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Desmoid Tumors.


Lead Product(s): Nirogacestat Hydrobromide,Inapplicable

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase IIProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 12, 2025

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02

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Details : Nirogacestat is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase II clinical studies for the treatment of Desmoid Tumors.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 12, 2025

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Details:

Nirogacestat HBr is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of undefined medical condition.


Lead Product(s): Nirogacestat Hydrobromide,Famotidine,Rabeprazole Sodium

Therapeutic Area: Undisclosed Brand Name: Undisclosed

Study Phase: Phase IProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable September 12, 2025

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03

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Details : Nirogacestat HBr is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of undefined medical condition.

Product Name : Undisclosed

Product Type : Miscellaneous

Upfront Cash : Inapplicable

September 12, 2025

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  • Development Update

Details:

Belantamab Mafodotin is a Antibody-drug Conjugate drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Multiple Myeloma.


Lead Product(s): Belantamab Mafodotin,Nirogacestat Hydrobromide

Therapeutic Area: Oncology Brand Name: Undisclosed

Study Phase: Phase I/ Phase IIProduct Type: Antibody-drug Conjugate

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable July 25, 2025

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04

GSK

United Kingdom
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Aus. Peptide Conference
Not Confirmed

GSK

United Kingdom
arrow
Aus. Peptide Conference
Not Confirmed

Details : Belantamab Mafodotin is a Antibody-drug Conjugate drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Multiple Myeloma.

Product Name : Undisclosed

Product Type : Antibody-drug Conjugate

Upfront Cash : Inapplicable

July 25, 2025

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Details:

Through the acquisition, Merck will leverage SpringWorks’ oncology portfolio, including Ogsiveo (Nirogacestat HBr). It is being indicated for adult patients with progressing desmoid tumors.


Lead Product(s): Nirogacestat Hydrobromide,Inapplicable

Therapeutic Area: Oncology Brand Name: Ogsiveo

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Merck Group

Deal Size: $3,900.0 million Upfront Cash: $3,900.0 million

Deal Type: Acquisition July 01, 2025

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05

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Details : Through the acquisition, Merck will leverage SpringWorks’ oncology portfolio, including Ogsiveo (Nirogacestat HBr). It is being indicated for adult patients with progressing desmoid tumors.

Product Name : Ogsiveo

Product Type : Miscellaneous

Upfront Cash : $3,900.0 million

July 01, 2025

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Details:

Through the acquisition, Merck will leverage SpringWorks’ oncology portfolio, including Ogsiveo (Nirogacestat HBr). It is being indicated for adult patients with progressing desmoid tumors.


Lead Product(s): Nirogacestat Hydrobromide,Inapplicable

Therapeutic Area: Oncology Brand Name: Ogsiveo

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Merck Group

Deal Size: $3,900.0 million Upfront Cash: $3900 million

Deal Type: Acquisition April 28, 2025

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06

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Details : Through the acquisition, Merck will leverage SpringWorks’ oncology portfolio, including Ogsiveo (Nirogacestat HBr). It is being indicated for adult patients with progressing desmoid tumors.

Product Name : Ogsiveo

Product Type : Miscellaneous

Upfront Cash : $3900 million

April 28, 2025

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Details:

Ogsiveo (nirogacestat) is a USFDA approved oral, selective, small molecule gamma secretase inhibitor. It is being evaluated for the treatment of adults with desmoid tumors.


Lead Product(s): Nirogacestat Hydrobromide,Nirogacestat HBr,Inapplicable

Therapeutic Area: Oncology Brand Name: Ogsiveo

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Undisclosed

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 29, 2024

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07

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Lead Product(s) : Nirogacestat Hydrobromide,Nirogacestat HBr,Inapplicable

Therapeutic Area : Oncology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Undisclosed

Deal Size : Inapplicable

Deal Type : Inapplicable

Details : Ogsiveo (nirogacestat) is a USFDA approved oral, selective, small molecule gamma secretase inhibitor. It is being evaluated for the treatment of adults with desmoid tumors.

Product Name : Ogsiveo

Product Type : Miscellaneous

Upfront Cash : Inapplicable

February 29, 2024

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Details:

The net proceeds will be used to support commercialization of Ogsiveo (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment and continued research and development activities.


Lead Product(s): Nirogacestat Hydrobromide,Nirogacestat HBr,Inapplicable

Therapeutic Area: Oncology Brand Name: Ogsiveo

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Goldman Sachs & Co

Deal Size: $316.2 million Upfront Cash: Undisclosed

Deal Type: Public Offering December 08, 2023

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08

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Lead Product(s) : Nirogacestat Hydrobromide,Nirogacestat HBr,Inapplicable

Therapeutic Area : Oncology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Goldman Sachs & Co

Deal Size : $316.2 million

Deal Type : Public Offering

Details : The net proceeds will be used to support commercialization of Ogsiveo (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment and continued research and development ...

Product Name : Ogsiveo

Product Type : Miscellaneous

Upfront Cash : Undisclosed

December 08, 2023

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Details:

The net proceeds will be used to support commercialization of Ogsiveo (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment and continued research and development activities.


Lead Product(s): Nirogacestat Hydrobromide,Nirogacestat HBr,Inapplicable

Therapeutic Area: Oncology Brand Name: Ogsiveo

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Goldman Sachs & Co

Deal Size: $275.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering December 05, 2023

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09

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Lead Product(s) : Nirogacestat Hydrobromide,Nirogacestat HBr,Inapplicable

Therapeutic Area : Oncology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Goldman Sachs & Co

Deal Size : $275.0 million

Deal Type : Public Offering

Details : The net proceeds will be used to support commercialization of Ogsiveo (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment and continued research and development ...

Product Name : Ogsiveo

Product Type : Miscellaneous

Upfront Cash : Undisclosed

December 05, 2023

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Details:

The net proceeds will be used to support commercialization of Ogsiveo (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment and continued research and development activities.


Lead Product(s): Nirogacestat Hydrobromide,Nirogacestat HBr,Inapplicable

Therapeutic Area: Oncology Brand Name: Ogsiveo

Study Phase: Approved FDFProduct Type: Miscellaneous

Sponsor: Goldman Sachs & Co

Deal Size: $287.5 million Upfront Cash: Undisclosed

Deal Type: Public Offering December 04, 2023

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10

Aus. Peptide Conference
Not Confirmed
Aus. Peptide Conference
Not Confirmed

Lead Product(s) : Nirogacestat Hydrobromide,Nirogacestat HBr,Inapplicable

Therapeutic Area : Oncology

Highest Development Status : Approved FDF

Partner/Sponsor/Collaborator : Goldman Sachs & Co

Deal Size : $287.5 million

Deal Type : Public Offering

Details : The net proceeds will be used to support commercialization of Ogsiveo (nirogacestat), approved in the United States for the treatment of adult patients with progressing desmoid tumors who require systemic treatment and continued research and development ...

Product Name : Ogsiveo

Product Type : Miscellaneous

Upfront Cash : Undisclosed

December 04, 2023

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ABOUT THIS PAGE

Looking for 865773-15-5 / Nirogacestat Hydrobromide API manufacturers, exporters & distributors?

Nirogacestat Hydrobromide manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Nirogacestat Hydrobromide

Synonyms

Pf-03084014, 1290543-63-3, Pf-3084014, 865773-15-5, Pf 3084014, Nirogacestat [usan]

Cas Number

865773-15-5

Unique Ingredient Identifier (UNII)

QZ62892OFJ

About Nirogacestat Hydrobromide

Nirogacestat is a selective gamma secretase (GS) inhibitor with potential antitumor activity. Nirogacestat binds to GS, blocking proteolytic activation of Notch receptors; Notch signaling pathway inhibition may follow, which may result in the induction of apoptosis in tumor cells that overexpress Notch. The integral membrane protein GS is a multi-subunit protease complex that cleaves single-pass transmembrane proteins, such as Notch receptors, at residues within their transmembrane domains. Overexpression of the Notch signaling pathway has been correlated with increased tumor cell growth and survival.

Nirogacestat Manufacturers

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

Nirogacestat Suppliers

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

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

Nirogacestat WC

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

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

Nirogacestat GMP

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

Nirogacestat CoA

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

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

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