Synopsis
Synopsis
0
CEP/COS
0
JDMF
0
EU WC
0
KDMF
0
NDC API
0
VMF
0
EDQM
0
USP
0
JP
0
Others
0
South Africa
0
Listed Dossiers
DRUG PRODUCT COMPOSITIONS
Regulatory FDF Prices
NA
0
API
0
FDF
0
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1. 4-amino-n-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)piperidine-4-carboxamide
2. Azd5363
1. Azd5363
2. 1143532-39-1
3. Azd-5363
4. Azd 5363
5. (s)-4-amino-n-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)piperidine-4-carboxamide
6. 4-amino-n-[(1s)-1-(4-chlorophenyl)-3-hydroxypropyl]-1-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)piperidine-4-carboxamide
7. Wfr23m21ie
8. 4-piperidinecarboxamide, 4-amino-n-[(1s)-1-(4-chlorophenyl)-3-hydroxypropyl]-1-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-
9. 4-amino-n-[(1s)-1-(4-chlorophenyl)-3-hydroxypropyl]-1-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)-4-piperidinecarboxamide
10. Unii-wfr23m21ie
11. Chembl2325741
12. Cc-638
13. Capivasertib?
14. 4-amino-n-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)piperidine-4-carboxamide
15. 4-piperidinecarboxamide, 4-amino-n-((1s)-1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo(2,3-d)pyrimidin-4-yl)-
16. Capivasertib (jan/usan)
17. Capivasertib [inn]
18. Capivasertib [jan]
19. Capivasertib [usan]
20. Capivasertib (azd5363)
21. Mls006011179
22. Capivasertib [who-dd]
23. Schembl390243
24. Gtpl7709
25. Azc5363
26. Dtxsid40150710
27. Ex-a285
28. Us10654855, Example 9
29. Bdbm443385
30. Mfcd22628785
31. Nsc764039
32. Nsc782347
33. Nsc799347
34. S8019
35. Zinc43204023
36. Akos027323693
37. Bcp9000365
38. Ccg-268989
39. Cs-1284
40. Db12218
41. Nsc-764039
42. Nsc-782347
43. Nsc-799347
44. Ncgc00345795-01
45. Ncgc00345795-04
46. Ac-32685
47. Hy-15431
48. Smr004702948
49. Bcp0726000111
50. A1387
51. Sw220158-1
52. D11371
53. J-514447
54. Q27074756
55. 0xz
56. 4-amino-n-((1s)-1-(4-chlorophenyl)-3-hydroxypropyl)-1- (1h-pyrrolo(2,3-d)pyrimidin-4-yl)piperidine-4-carboxamide
57. Alternative Route 1: (s)-4-amino-n-(1-(4-chlorophenyl)-3-hydroxypropyl)-1-(7h-pyrrolo[2,3-d]pyrimidin-4-yl)piperidine-4-carboxamide
| Molecular Weight | 428.9 g/mol |
|---|---|
| Molecular Formula | C21H25ClN6O2 |
| XLogP3 | 1.7 |
| Hydrogen Bond Donor Count | 4 |
| Hydrogen Bond Acceptor Count | 6 |
| Rotatable Bond Count | 6 |
| Exact Mass | 428.1727518 g/mol |
| Monoisotopic Mass | 428.1727518 g/mol |
| Topological Polar Surface Area | 120 Ų |
| Heavy Atom Count | 30 |
| Formal Charge | 0 |
| Complexity | 580 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 1 |
| Undefined Atom Stereocenter Count | 0 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 1 |
Treatment of breast cancer , Treatment of prostate cancer
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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 43325
Submission : 2026-01-12
Status : Active
Type : II

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Details:
Capivasertib is a small molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of breast neoplasms.
Lead Product(s): Capivasertib,Loperamide Hydrochloride,Fulvestrant,Cetirizine
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIProduct Type: Miscellaneous
Sponsor: AstraZeneca
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 23, 2026

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Lead Product(s) : Capivasertib,Loperamide Hydrochloride,Fulvestrant,Cetirizine
Therapeutic Area : Oncology
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : AstraZeneca
Deal Size : Inapplicable
Deal Type : Inapplicable
Rash & Diarrhea Prophylaxis With Capivasertib
Details : Capivasertib is a small molecule drug, which is currently being evaluated in Phase II clinical studies for the treatment of breast neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
February 23, 2026

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Capivasertib is a small molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of liver diseases.
Lead Product(s): Capivasertib,Inapplicable
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: PAREXEL International Corporation
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 15, 2026

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Lead Product(s) : Capivasertib,Inapplicable
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : PAREXEL International Corporation
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Capivasertib is a small molecule drug, which is currently being evaluated in Phase I clinical studies for the treatment of liver diseases.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 15, 2026

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AMXT 1501 Dicaprate is a small molecule drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Melanoma.
Lead Product(s): AMXT-1501 dicaprate,Eflornithine Hydrochloride,Fulvestrant,Capivasertib,Pembrolizumab
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 17, 2025

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Lead Product(s) : AMXT-1501 dicaprate,Eflornithine Hydrochloride,Fulvestrant,Capivasertib,Pembrolizumab
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors
Details : AMXT 1501 Dicaprate is a small molecule drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Melanoma.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 17, 2025

Details:
Capivasertib is a small molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Breast Neoplasms.
Lead Product(s): Capivasertib,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: AstraZeneca
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 15, 2025

Lead Product(s) : Capivasertib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : AstraZeneca
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Capivasertib is a small molecule drug candidate, which is currently being evaluated in Phase III clinical studies for the treatment of Breast Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
December 15, 2025

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Details:
Dextromethorphan is a small molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of undefined medical condition.
Lead Product(s): Dextromethorphan,Capivasertib
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: PAREXEL International Corporation
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 21, 2025

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Lead Product(s) : Dextromethorphan,Capivasertib
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : PAREXEL International Corporation
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Dextromethorphan is a small molecule 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
November 21, 2025

Details:
Capivasertib is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Leukemia, Lymphoid.
Lead Product(s): Capivasertib,Venetoclax,Dexamethasone,Methotrexate,Prednisone,Hydrocortisone,Cytarabine
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Miscellaneous
Sponsor: AstraZeneca | AbbVie Inc
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 16, 2025

Lead Product(s) : Capivasertib, Venetoclax, Dexamethasone, Methotrexate, Prednisone
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : AstraZeneca | AbbVie Inc
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Capivasertib is a Small Molecule drug candidate drug candidate, which is currently being evaluated in Phase I/ Phase II clinical studies for the treatment of Leukemia, Lymphoid.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
September 16, 2025

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Capivasertib is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.
Lead Product(s): Capivasertib,Rosuvastatin Calcium
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Miscellaneous
Sponsor: Parexel
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 28, 2025

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Lead Product(s) : Capivasertib,Rosuvastatin Calcium
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Parexel
Deal Size : Inapplicable
Deal Type : Inapplicable
Study of Capivasertib Effect on Oral Rosuvastatin Pharmacokinetics in Healthy Adults
Details : Capivasertib is a Other Small Molecule drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of unspecified medical condition.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
July 28, 2025

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Truqap (capivasertib) is a first-in-class, potent, adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms. Currently, it is being evaluated for treatment of mCRPC.
Lead Product(s): Capivasertib,Docetaxel
Therapeutic Area: Oncology Brand Name: Truqap
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 29, 2025

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Lead Product(s) : Capivasertib,Docetaxel
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
AstraZeneca's Truqap Falls Short in Another Phase 3 Trial
Details : Truqap (capivasertib) is a first-in-class, potent, adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms. Currently, it is being evaluated for treatment of mCRPC.
Product Name : Truqap
Product Type : Miscellaneous
Upfront Cash : Inapplicable
April 29, 2025

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Fulvestrant is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Breast Neoplasms.
Lead Product(s): Fulvestrant,Capivasertib
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Apices Soluciones | SOLTI Breast Cancer Research Group
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable January 08, 2025

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Lead Product(s) : Fulvestrant,Capivasertib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Apices Soluciones | SOLTI Breast Cancer Research Group
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Fulvestrant is a Other Small Molecule drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Breast Neoplasms.
Product Name : Undisclosed
Product Type : Miscellaneous
Upfront Cash : Inapplicable
January 08, 2025

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Truqap (capivasertib) is a first-in-class, potent, ATP-competitive inhibitor, is being investigated for PTEN-deficient de novo mHSPC in combination with abiraterone and ADT.
Lead Product(s): Capivasertib,Abiraterone Acetate,Prednisone
Therapeutic Area: Oncology Brand Name: Truqap
Study Phase: Phase IIIProduct Type: Miscellaneous
Sponsor: Undisclosed
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable November 25, 2024

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Lead Product(s) : Capivasertib,Abiraterone Acetate,Prednisone
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Undisclosed
Deal Size : Inapplicable
Deal Type : Inapplicable
TRUQAP® (capivasertib) Phase 3 Shows Radiographic PFS Benefit in Prostate Cancer
Details : Truqap (capivasertib) is a first-in-class, potent, ATP-competitive inhibitor, is being investigated for PTEN-deficient de novo mHSPC in combination with abiraterone and ADT.
Product Name : Truqap
Product Type : Miscellaneous
Upfront Cash : Inapplicable
November 25, 2024

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Global Sales Information
Patents & EXCLUSIVITIES
Patent Expiration Date : 2030-03-10
US Patent Number : 8101623
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 218197
Patent Use Code : U-3762
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2030-03-10

Patent Expiration Date : 2028-10-10
US Patent Number : 12252495
Drug Substance Claim :
Drug Product Claim :
Application Number : 218197
Patent Use Code : U-3762
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-10-10

Patent Expiration Date : 2028-10-10
US Patent Number : 12252495
Drug Substance Claim :
Drug Product Claim :
Application Number : 218197
Patent Use Code : U-3762
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-10-10

Patent Expiration Date : 2028-10-10
US Patent Number : 10059714
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 218197
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-10-10

Patent Expiration Date : 2028-10-10
US Patent Number : 11760760
Drug Substance Claim :
Drug Product Claim :
Application Number : 218197
Patent Use Code : U-3762
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-10-10

Patent Expiration Date : 2028-10-10
US Patent Number : 10059714
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 218197
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-10-10

Patent Expiration Date : 2028-10-10
US Patent Number : 11760760
Drug Substance Claim :
Drug Product Claim :
Application Number : 218197
Patent Use Code : U-3762
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-10-10

Patent Expiration Date : 2033-04-16
US Patent Number : 9487525
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 218197
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-04-16

Patent Expiration Date : 2028-10-10
US Patent Number : 10654855
Drug Substance Claim :
Drug Product Claim :
Application Number : 218197
Patent Use Code : U-3762
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2028-10-10

Patent Expiration Date : 2033-04-16
US Patent Number : 9487525
Drug Substance Claim : Y
Drug Product Claim : Y
Application Number : 218197
Patent Use Code :
Delist Requested :
Patent Use Description :
Patent Expiration Date : 2033-04-16

FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ABOUT THIS PAGE
14
PharmaCompass offers a list of Capivasertib API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Capivasertib manufacturer or Capivasertib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Capivasertib manufacturer or Capivasertib supplier.
A Capivasertib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Capivasertib, including repackagers and relabelers. The FDA regulates Capivasertib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Capivasertib 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 Capivasertib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A Capivasertib supplier is an individual or a company that provides Capivasertib active pharmaceutical ingredient (API) or Capivasertib finished formulations upon request. The Capivasertib suppliers may include Capivasertib API manufacturers, exporters, distributors and traders.
click here to find a list of Capivasertib suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PharmaCompass.
A Capivasertib DMF (Drug Master File) is a document detailing the whole manufacturing process of Capivasertib active pharmaceutical ingredient (API) in detail. Different forms of Capivasertib DMFs exist exist since differing nations have different regulations, such as Capivasertib USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Capivasertib DMF submitted to regulatory agencies in the US is known as a USDMF. Capivasertib USDMF includes data on Capivasertib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Capivasertib USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Capivasertib suppliers with USDMF on PharmaCompass.
Capivasertib 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 Capivasertib GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, and more, enabling you to easily find the right Capivasertib GMP manufacturer or Capivasertib GMP API supplier for your needs.
A Capivasertib CoA (Certificate of Analysis) is a formal document that attests to Capivasertib's compliance with Capivasertib specifications and serves as a tool for batch-level quality control.
Capivasertib CoA mostly includes findings from lab analyses of a specific batch. For each Capivasertib 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.
Capivasertib may be tested according to a variety of international standards, such as European Pharmacopoeia (Capivasertib EP), Capivasertib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Capivasertib USP).