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abiraterone

Trade name: zytiga

Small moleculeapproved

Approved

Apr 28, 2011

Abiraterone acetate (trade name Zytiga) is a prodrug to the abiraterone, steroidal compound with antiandrogen activity and a 17 α-hydroxylase/C17,20-lyase (CYP17) inhibitor. It is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer. Abiraterone acetate is converted in vivo to abiraterone which inhibits CYP17, enzyme expressed in testicular, adrenal, and prostatic tumor tissues and required for androgen biosynthesis. Administration of this agent may suppress testosterone production by both the testes and the adrenals to castrate-range levels. Androgen sensitive prostatic carcinoma responds to treatment that decreases androgen levels. Androgen deprivation therapies, such as treatment with GnRH agonists or orchiectomy, decrease androgen production in the testes but do not affect androgen production by the adrenals or in the tumor. — NCATS

Clinical trial activity

315 trials · 214 clinical orgs · 17 marketing orgs

Phase 1
96
Phase 2
231
Phase 3
54
Phase 4
7

Earliest trial started Sep 1, 2005 (NCT00268476)

Timeline

1990s

  1. Jun 1, 1993

    BTG — IND Organization

  2. Jun 1, 1993

    BTG — IND Organization

2000s

  1. Jan 1, 2005

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2008

    Earliest Phase 3 Sponsor(trial)

2010s

  1. Apr 28, 2011

    Johnson and Johnson — Earliest FDA Approval

  2. Apr 28, 2011

    Johnson and Johnson — NDA Secondary Org

  3. Apr 28, 2011

    Johnson and Johnson — NDA Organization

  4. May 22, 2018

    Sun Pharmaceuticals — Marketing Organization

  5. May 22, 2018

    Sun Pharmaceuticals — NDA Secondary Org

  6. Oct 31, 2018

    Apotex — Marketing Organization

  7. Oct 31, 2018

    Hikma — Marketing Organization

  8. Oct 31, 2018

    Mylan — Marketing Organization

  9. Oct 31, 2018

    Teva — Marketing Organization

  10. Jan 7, 2019

    Amneal Pharmaceuticals — Marketing Organization

  11. Jan 22, 2019

    Glenmark Pharmaceuticals — Marketing Organization

  12. Feb 25, 2019

    Rising Pharmaceuticals — Marketing Organization

  13. Feb 27, 2019

    Wockhardt — Marketing Organization

  14. Jul 10, 2019

    MSN Laboratories — Marketing Organization

  15. Sep 27, 2019

    Qilu Pharmaceutical Co., Ltd. — Marketing Organization

2020s

  1. May 18, 2020

    Dr. Reddy's Laboratories — Marketing Organization

  2. Jan 5, 2022

    oncogen — Marketing Organization

  3. Jan 5, 2022

    SciTech Development, LLC — Marketing Organization

  4. Mar 23, 2023

    Lachman Consultants — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewApr 28, 2011

Chemistry & pharmacology

Loading structure…

SMILES

C[C@]12CC[C@H]3[C@@H](CC=C4C[C@@H](O)CC[C@]34C)[C@@H]1CC=C2C5=CC=CN=C5
Mol. weight
349.509 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • 17-(3-pyridyl)androsta-5,16-dien-3beta-ol
  • 17-(3-pyridyl)androsta-5,16-dien-3beta-ol
  • 17-(3-pyridyl)androsta-5,16-dien-3beta-ol
  • (3β)-17-(pyridin-3-yl)androsta-5,16-dien-3-ol
  • (3β)-17-(pyridin-3-yl)androsta-5,16-dien-3-ol
  • abiraterone
  • abiraterone
  • abiraterone
  • abiraterone
  • abiraterone
  • abiraterone
  • abiraterone
  • abiraterone acetate
  • abiraterone acetate
  • abiraterone acetate
  • abiraterone acetate
  • abiraterone acetate
  • abiraterone acetate
  • abiraterone acetate
  • abiraterone acetate
  • abiraterone acetate
  • abiraterone acetate
  • androsta-5,16-dien-3-ol, 17-(3-pyridinyl)-, (3beta)-
  • cb7598
  • cb 7598
  • cb-7598
  • cb7630
  • cb-7630
  • cb-7630
  • cb-7630
  • jnj-212082
  • jnj-212082
  • zytiga
  • zytiga
  • zytiga
  • zytiga

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07287150Phase 2Mar 31, 2026Roche
NCT07311694Phase 3Jan 31, 2026Hengrui Therapeutics, Inc.
NCT07226986Phase 1/Phase 2 (Phase 2)Dec 16, 2025Novartis
NCT07299292Phase 2Dec 1, 2025SMED Clinical Research
NCT07230106Phase 2Nov 30, 2025Hengrui Therapeutics, Inc.
NCT07190300Phase 1/Phase 2 (Phase 2)Nov 24, 2025Novartis
NCT07213674Phase 3Nov 1, 2025Amgen
NCT07198633Phase 1/Phase 2 (Phase 2)Oct 31, 2025Qilu Pharmaceutical Co., Ltd.
NCT07104110Phase 1/Phase 2 (Phase 2)Oct 31, 2025Qilu Pharmaceutical Co., Ltd.
NCT07140900Phase 1Oct 7, 2025Amgen
NCT06894511Phase 2Sep 11, 2025Novartis
NCT06952803Phase 3Aug 6, 2025AstraZeneca, Parexel
NCT07093866Phase 2Jul 20, 2025Nanjing University
NCT06991556Phase 2Jul 7, 2025Novartis
NCT07005154Phase 2Jun 19, 2025Astellas
NCT06863272Phase 1/Phase 2 (Phase 2)Jun 17, 2025Daiichi Sankyo, Merck
NCT06832774Phase 2Apr 1, 2025Jiao Tong University
NCT06764485Phase 3Mar 13, 2025Bristol-Myers Squibb, Celgene
NCT06785636Phase 1/Phase 2 (Phase 2)Feb 7, 2025Duke University, Pathos AI, Inc.
NCT06691984Phase 3Jan 31, 2025Amgen
Showing 20 of 315 trials
Page 1 / 16

Organizations

Research & Development (214)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Johnson and JohnsonFor profit413452006
Janssen Pharmaceutica NVFor profit36342010
National Cancer Institute (NCI)Government29532010
AstraZenecaFor profit141142013
Cougar BiotechnologyFor profit121132005
University of Texas at HoustonAcademic/Hospital111012009
Hengrui Therapeutics, Inc.For profit10932019
Harvard UniversityAcademic/Hospital9842011
MerckFor profit7432018
NovartisFor profit7422013
SanofiFor profit7322012
BayerFor profit6332013
Nanjing UniversityAcademic/Hospital6612019
University of MichiganAcademic/Hospital6322016
University of WashingtonAcademic/Hospital6612010
AstellasFor profit5332012
Cornell UniversityAcademic/Hospital5432012
Duke UniversityAcademic/Hospital5312012
MedivationFor profit5132012
University of California, San FranciscoAcademic/Hospital5422010
214 organizations
Page 1 / 11

Marketing (28)

OrganizationOrg typeRelationshipDate
Amneal PharmaceuticalsFor profitMKTGJan 7, 2019
ApotexFor profitSYNOct 31, 2018
ApotexFor profitMKTGOct 31, 2018
BTGFor profitINDJun 1, 1993
Dr. Reddy's LaboratoriesFor profitSYNMay 18, 2020
Dr. Reddy's LaboratoriesFor profitMKTGMay 18, 2020
Glenmark PharmaceuticalsFor profitMKTGJan 22, 2019
Glenmark PharmaceuticalsFor profitSYNOct 16, 2019
Glenmark PharmaceuticalsFor profitSYNOct 16, 2019
HikmaFor profitMKTGOct 31, 2018
HikmaFor profitSYNOct 31, 2018
Johnson and JohnsonFor profitNDA2Apr 28, 2011
Johnson and JohnsonFor profitNDAApr 28, 2011
Lachman ConsultantsFor profitMKTGMar 23, 2023
MSN LaboratoriesFor profitSYNJul 10, 2019
MSN LaboratoriesFor profitMKTGJul 10, 2019
MylanFor profitSYNOct 31, 2018
MylanFor profitMKTGOct 31, 2018
Qilu Pharmaceutical Co., Ltd.For profitMKTGSep 27, 2019
Qilu Pharmaceutical Co., Ltd.For profitSYNSep 27, 2019
Rising PharmaceuticalsFor profitMKTGFeb 25, 2019
Rising PharmaceuticalsFor profitSYNFeb 25, 2019
SciTech Development, LLCFor profitMKTGJan 5, 2022
Sun PharmaceuticalsFor profitMKTGMay 22, 2018
Sun PharmaceuticalsFor profitNDA2May 22, 2018
TevaFor profitMKTGOct 31, 2018
WockhardtFor profitMKTGFeb 27, 2019
oncogenFor profitMKTGJan 5, 2022