Find Nirogacestat Hydrobromide manufacturers, exporters & distributors on PharmaCompass

PharmaCompass

Synopsis

Synopsis

ACTIVE PHARMA INGREDIENTS

0

USDMF

US DMFs Filed

0

CEP/COS

CEP/COS Certifications

0

JDMF

JDMFs Filed

0

KDMF

KDMF

0

NDC API

NDC API

0

VMF

NDC API

0INTERMEDIATES

REF. STANDARDS OR IMPURITIES

0

EDQM

0

USP

0

JP

0

Others

FINISHED DOSAGE FORMULATIONS

0

Europe

Europe

0

Canada

Canada

0

Australia

Australia

0

South Africa

South Africa

0

Listed Dossiers

Listed Dossiers

FDF Dossiers

DRUG PRODUCT COMPOSITIONS

0RELATED EXCIPIENT COMPANIES

0EXCIPIENTS BY APPLICATIONS

PATENTS & EXCLUSIVITIES

0

Health Canada Patents

API REF. PRICE (USD/KG)

GLOBAL SALES INFORMATION

US Medicaid

NA

Annual Reports

NA

Regulatory FDF Prices

NA

API/FDF Prices: Book a Demo to
explore the features and consider
upgrading later

MARKET PLACE

0

FDF

DIGITAL CONTENT

0

Stock Recap #PipelineProspector

0

Weekly News Recap #Phispers

Chemistry

Click the arrow to open the dropdown
read-moreClick the button for full data set
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

read-more
read-more

01

TAPI Technology & API Services

Israel

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

  • fda
  • EDQM
  • WHO-GMP

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

Flag Israel
Digital Content Digital Content
USDMF CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
TAPI Company Banner

02

Sai Life Sciences Limited

India

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

IOPC
Not Confirmed
arrow

Sai Life Sciences Limited

India

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

arrow
IOPC
Not Confirmed
USDMF CEP/COS JDMF EU-WCarrow-down NDC KDMF VMF Others AUDIT
blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

EU WC

read-more
read-moreread-more

01

IOPC
Not Confirmed
arrow
arrow
IOPC
Not Confirmed

Nirogacestat Hydrobromide IH

Date of Issue : 2022-06-24

Valid Till : 2025-07-14

Written Confirmation Number : WC-0130

Address of the Firm : Plot No. 79B, 80A, 80B, 81A, & 82, Kolhar Industrial Area, Bidar, Karnataka -585...

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Listed Suppliers

read-more
read-more

01

  • fda
  • EDQM
  • WHO-GMP

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

Flag Israel
Digital Content Digital Content

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.
TAPI Company Banner
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Drugs in Development

read-more
read-more

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

Therapeutic Area: Oncology Brand Name: Ogsiveo

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 29, 2024

blank

01

IOPC
Not Confirmed
IOPC
Not Confirmed

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 : Other Small Molecule

Upfront Cash : Inapplicable

February 29, 2024

blank

Details:

Ogsiveo (nirogacestat) is an investigational gamma secretase inhibitor which is approved by USFDA as the first and only treatment for adults with desmoid tumors.


Lead Product(s): Nirogacestat Hydrobromide

Therapeutic Area: Oncology Brand Name: Ogsiveo

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 27, 2023

blank

02

IOPC
Not Confirmed
IOPC
Not Confirmed

Details : Ogsiveo (nirogacestat) is an investigational gamma secretase inhibitor which is approved by USFDA as the first and only treatment for adults with desmoid tumors.

Product Name : Ogsiveo

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 27, 2023

blank

Details:

Ogsiveo (nirogacestat) is an investigational gamma secretase inhibitor which is approved by USFDA as the first and only treatment for adults with desmoid tumors.


Lead Product(s): Nirogacestat Hydrobromide

Therapeutic Area: Oncology Brand Name: Ogsiveo

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable November 27, 2023

blank

03

IOPC
Not Confirmed
IOPC
Not Confirmed

Details : Ogsiveo (nirogacestat) is an investigational gamma secretase inhibitor which is approved by USFDA as the first and only treatment for adults with desmoid tumors.

Product Name : Ogsiveo

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

November 27, 2023

blank

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

Therapeutic Area: Oncology Brand Name: Ogsiveo

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Goldman Sachs & Co

Deal Size: $316.2 million Upfront Cash: Undisclosed

Deal Type: Public Offering August 12, 2023

blank

04

IOPC
Not Confirmed
IOPC
Not Confirmed

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 : Other Small Molecule

Upfront Cash : Undisclosed

August 12, 2023

blank

Details:

PF-03084014 (nirogacestat) is an investigational gamma secretase inhibitor being develop in patients with recurrent ovarian granulosa cell tumors (OvGCT).


Lead Product(s): Nirogacestat Hydrobromide

Therapeutic Area: Oncology Brand Name: Ogsiveo

Study Phase: Phase IIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 30, 2023

blank

05

IOPC
Not Confirmed
IOPC
Not Confirmed

Details : PF-03084014 (nirogacestat) is an investigational gamma secretase inhibitor being develop in patients with recurrent ovarian granulosa cell tumors (OvGCT).

Product Name : Ogsiveo

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 30, 2023

blank

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

Therapeutic Area: Oncology Brand Name: Ogsiveo

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Goldman Sachs & Co

Deal Size: $275.0 million Upfront Cash: Undisclosed

Deal Type: Public Offering May 12, 2023

blank

06

IOPC
Not Confirmed
IOPC
Not Confirmed

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 : Other Small Molecule

Upfront Cash : Undisclosed

May 12, 2023

blank

Details:

PF-03084014 (nirogacestat) is an investigational gamma secretase inhibitor being develop in patients with treatment of adults with desmoid tumors. PDUFA date has been extended by the standard extension period of three months.


Lead Product(s): Nirogacestat Hydrobromide

Therapeutic Area: Oncology Brand Name: Ogsiveo

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable May 06, 2023

blank

07

IOPC
Not Confirmed
IOPC
Not Confirmed

Details : PF-03084014 (nirogacestat) is an investigational gamma secretase inhibitor being develop in patients with treatment of adults with desmoid tumors. PDUFA date has been extended by the standard extension period of three months.

Product Name : Ogsiveo

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

May 06, 2023

blank

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

Therapeutic Area: Oncology Brand Name: Ogsiveo

Study Phase: Approved FDFProduct Type: Other Small Molecule

Sponsor: Goldman Sachs & Co

Deal Size: $287.5 million Upfront Cash: Undisclosed

Deal Type: Public Offering April 12, 2023

blank

08

IOPC
Not Confirmed
IOPC
Not Confirmed

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 : Other Small Molecule

Upfront Cash : Undisclosed

April 12, 2023

blank

Details:

PF-03084014 (nirogacestat) is an oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors and in Phase 2 clinical development for ovarian granulosa cell tumors.


Lead Product(s): Nirogacestat Hydrobromide

Therapeutic Area: Oncology Brand Name: Ogsiveo

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable February 27, 2023

blank

09

IOPC
Not Confirmed
IOPC
Not Confirmed

Details : PF-03084014 (nirogacestat) is an oral, selective, small molecule gamma secretase inhibitor in Phase 3 clinical development for desmoid tumors and in Phase 2 clinical development for ovarian granulosa cell tumors.

Product Name : Ogsiveo

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

February 27, 2023

blank

Details:

PF-03084014 (nirogacestat) is an oral, selective, small molecule gamma secretase inhibitor in phase 3 clinical development for desmoid tumors and in phase 2 clinical development for ovarian granulosa cell tumors.


Lead Product(s): Nirogacestat Hydrobromide

Therapeutic Area: Oncology Brand Name: Ogsiveo

Study Phase: Phase IIIProduct Type: Other Small Molecule

Sponsor: Inapplicable

Deal Size: Inapplicable Upfront Cash: Inapplicable

Deal Type: Inapplicable December 27, 2022

blank

10

IOPC
Not Confirmed
IOPC
Not Confirmed

Details : PF-03084014 (nirogacestat) is an oral, selective, small molecule gamma secretase inhibitor in phase 3 clinical development for desmoid tumors and in phase 2 clinical development for ovarian granulosa cell tumors.

Product Name : Ogsiveo

Product Type : Other Small Molecule

Upfront Cash : Inapplicable

December 27, 2022

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDF Dossiers

read-more
read-more

01

IOPC
Not Confirmed
arrow
arrow
IOPC
Not Confirmed

NIROGACESTAT HYDROBROMIDE

Brand Name : OGSIVEO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 50MG BASE

Packaging :

Approval Date : 2023-11-27

Application Number : 217677

Regulatory Info : RX

Registration Country : USA

blank

02

IOPC
Not Confirmed
arrow
arrow
IOPC
Not Confirmed

NIROGACESTAT HYDROBROMIDE

Brand Name : OGSIVEO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Packaging :

Approval Date : 2024-04-04

Application Number : 217677

Regulatory Info : RX

Registration Country : USA

blank

03

IOPC
Not Confirmed
arrow
arrow
IOPC
Not Confirmed

NIROGACESTAT HYDROBROMIDE

Brand Name : OGSIVEO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Packaging :

Approval Date : 2024-04-04

Application Number : 217677

Regulatory Info : RX

Registration Country : USA

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

FDA Orange Book

read-more
read-more

01

SPRINGWORKS

U.S.A
IOPC
Not Confirmed
arrow

SPRINGWORKS

U.S.A
arrow
IOPC
Not Confirmed

NIROGACESTAT HYDROBROMIDE

Brand Name : OGSIVEO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 50MG BASE

Approval Date : 2023-11-27

Application Number : 217677

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

02

SPRINGWORKS

U.S.A
IOPC
Not Confirmed
arrow

SPRINGWORKS

U.S.A
arrow
IOPC
Not Confirmed

NIROGACESTAT HYDROBROMIDE

Brand Name : OGSIVEO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 100MG BASE

Approval Date : 2024-04-04

Application Number : 217677

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank

03

SPRINGWORKS

U.S.A
IOPC
Not Confirmed
arrow

SPRINGWORKS

U.S.A
arrow
IOPC
Not Confirmed

NIROGACESTAT HYDROBROMIDE

Brand Name : OGSIVEO

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 150MG BASE

Approval Date : 2024-04-04

Application Number : 217677

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

blank
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

Digital Content read-more

Create Content with PharmaCompass, ask us

DATA COMPILATION #PharmaFlow

read-more
read-more

NEWS #PharmaBuzz

read-more
read-more

Market Place

Do you need sourcing support? Ask us

Patents & EXCLUSIVITIES

Check the patents & exclusivity for this product

US Patents

read-more
read-more

01

arrow
IOPC
Not Confirmed

SPRINGWORKS

U.S.A
arrow
IOPC
Not Confirmed

NIROGACESTAT HYDROBROMIDE

US Patent Number : 7795447

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 217677

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-08-18

blank

02

arrow
IOPC
Not Confirmed

SPRINGWORKS

U.S.A
arrow
IOPC
Not Confirmed

NIROGACESTAT HYDROBROMIDE

US Patent Number : 12011434

Drug Substance Claim :

Drug Product Claim :

Application Number : 217677

Patent Use Code : U-3754

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2043-05-19

blank

03

arrow
IOPC
Not Confirmed

SPRINGWORKS

U.S.A
arrow
IOPC
Not Confirmed

NIROGACESTAT HYDROBROMIDE

US Patent Number : 10941118

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 217677

Patent Use Code : U-3754

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-08-09

blank

04

arrow
IOPC
Not Confirmed

SPRINGWORKS

U.S.A
arrow
IOPC
Not Confirmed

NIROGACESTAT HYDROBROMIDE

US Patent Number : 11845732

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 217677

Patent Use Code : U-3754

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-08-09

blank

05

arrow
IOPC
Not Confirmed

SPRINGWORKS

U.S.A
arrow
IOPC
Not Confirmed

NIROGACESTAT HYDROBROMIDE

US Patent Number : 11845732

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 217677

Patent Use Code : U-3754

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2039-08-09

blank

06

arrow
IOPC
Not Confirmed

SPRINGWORKS

U.S.A
arrow
IOPC
Not Confirmed

NIROGACESTAT HYDROBROMIDE

US Patent Number : 7342118

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 217677

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-08-18

blank

07

arrow
IOPC
Not Confirmed

SPRINGWORKS

U.S.A
arrow
IOPC
Not Confirmed

NIROGACESTAT HYDROBROMIDE

US Patent Number : 11925619

Drug Substance Claim :

Drug Product Claim :

Application Number : 217677

Patent Use Code : U-3754

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2043-05-19

blank

08

arrow
IOPC
Not Confirmed

SPRINGWORKS

U.S.A
arrow
IOPC
Not Confirmed

NIROGACESTAT HYDROBROMIDE

US Patent Number : 11504354

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 217677

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2042-07-08

blank

09

arrow
IOPC
Not Confirmed

SPRINGWORKS

U.S.A
arrow
IOPC
Not Confirmed

NIROGACESTAT HYDROBROMIDE

US Patent Number : 12247012

Drug Substance Claim :

Drug Product Claim : Y

Application Number : 217677

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2042-07-08

blank

10

arrow
IOPC
Not Confirmed

SPRINGWORKS

U.S.A
arrow
IOPC
Not Confirmed

NIROGACESTAT HYDROBROMIDE

US Patent Number : 7342118

Drug Substance Claim : Y

Drug Product Claim :

Application Number : 217677

Patent Use Code :

Delist Requested :

Patent Use Description :

Patent Expiration Date : 2025-08-18

blank
click full view
Full Screen ViewFULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]

ABOUT THIS PAGE

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

Nirogacestat manufacturers, exporters & distributors 1

49

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

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

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

API | Excipient name

Nirogacestat

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

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 Hydrobromide Manufacturers

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

Nirogacestat Hydrobromide Suppliers

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

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

Nirogacestat Hydrobromide WC

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

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

Nirogacestat Hydrobromide GMP

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

Nirogacestat Hydrobromide CoA

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

Nirogacestat Hydrobromide CoA mostly includes findings from lab analyses of a specific batch. For each Nirogacestat Hydrobromide 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 Hydrobromide may be tested according to a variety of international standards, such as European Pharmacopoeia (Nirogacestat Hydrobromide EP), Nirogacestat Hydrobromide JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nirogacestat Hydrobromide 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.
Ask Us for Pharmaceutical Supplier and Partner
Ask Us, Find A Supplier / Partner
No Commissions, No Strings Attached, Get Connected for FREE

What are you looking for?

How can we help you?

The request can't be empty

Please read our Privacy Policy carefully

You must agree to the privacy policy

The name can't be empty
The company can't be empty.
The email can't be empty Please enter a valid email.
The mobile can't be empty