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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
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)
Molecular Weight | 489.6 g/mol |
---|---|
Molecular Formula | C27H41F2N5O |
XLogP3 | 4.8 |
Hydrogen Bond Donor Count | 3 |
Hydrogen Bond Acceptor Count | 6 |
Rotatable Bond Count | 11 |
Exact Mass | 489.32791727 g/mol |
Monoisotopic Mass | 489.32791727 g/mol |
Topological Polar Surface Area | 71 Ų |
Heavy Atom Count | 35 |
Formal Charge | 0 |
Complexity | 685 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 2 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
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.)
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Date of Issue : 2025-08-05
Valid Till : 2028-07-14
Written Confirmation Number : WC-0130
Address of the Firm :
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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...
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...
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
Lead Product(s) : Nirogacestat Hydrobromide,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)
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
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
Lead Product(s) : Nirogacestat Hydrobromide,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of Nirogacestat in Japanese Adults With Desmoid Tumors/Aggressive Fibromatosis (DT/AF)
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
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
Lead Product(s) : Nirogacestat Hydrobromide,Famotidine,Rabeprazole Sodium
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Evaluate the Effects of Famotidine or Rabeprazole on the PK of Nirogacestat
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
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
Lead Product(s) : Belantamab Mafodotin,Nirogacestat Hydrobromide
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Belantamab Mafodotin + Nirogacestat in Participants with Relapsed/Refractory Myeloma
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
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
Lead Product(s) : Nirogacestat Hydrobromide,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Merck Group
Deal Size : $3,900.0 million
Deal Type : Acquisition
Merck Completes Acquisition of SpringWorks Therapeutics
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
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
Lead Product(s) : Nirogacestat Hydrobromide,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Merck Group
Deal Size : $3,900.0 million
Deal Type : Acquisition
Merck KGaA in $3.9 Billion Deal to Buy US bIotech Firm SpringWorks
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
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
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
SpringWorks Announces EMA Validation for Nirogacestat in Adults with Desmoid Tumors
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
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
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
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
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
SpringWorks Therapeutics Announces Pricing of Upsized Public Offering of Common Stock
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
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
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
SpringWorks Therapeutics Announces Proposed Public Offering of Common Stock
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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09 May 2025
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Patents & EXCLUSIVITIES
ABOUT THIS PAGE
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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.
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.
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.
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 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.
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).