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olaparib

Trade name: lynparza

Small moleculeapprovedOrphan Drug FDA

Approved

Dec 19, 2014

Olaparib is an oral inhibitor of poly (ADP-ribose) polymerase enzymes, including PARP1, PARP2, and PARP3 which are involved in normal cellular homeostasis, such as DNA transcription, cell cycle regulation, and DNA repair. Olaparib has shown activity in ovarian and breast tumors with known BRCA mutations and was the first FDA approved drug in this class. Lynparza (olaparib) is indicated for treatment of gBRCA-mutated advanced ovarian cancer. Its use together with other chemotherapy medicines can lead to increased effects on the blood resulting in reduction in the numbers of white blood cells and platelets, and anaemia. — NCATS

Clinical trial activity

404 trials · 283 clinical orgs · 4 marketing orgs

Phase 1
144
Phase 2
285
Phase 3
45
Phase 4
6

Earliest trial started Jul 4, 2005 (NCT00516373)

Timeline

2000s

  1. Jan 1, 2005

    AstraZeneca — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2007

    AstraZeneca — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2013

    AstraZeneca — Earliest Phase 3 Sponsor(trial)

  2. Oct 16, 2013

    Orphan Drug Designation

  3. Dec 19, 2014

    AstraZeneca — Earliest FDA Approval

  4. Dec 19, 2014

    AstraZeneca — Marketing Organization

  5. Dec 19, 2014

    AstraZeneca — NDA Organization

2020s

  1. May 22, 2025

    Sandoz — Marketing Organization

  2. Jun 2, 2025

    Cipla — Marketing Organization

  3. Nov 6, 2025

    Zydus Discovery DMCC — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedDec 19, 2014

Chemistry & pharmacology

Loading structure…

SMILES

FC1=CC=C(CC2=NNC(=O)C3=C2C=CC=C3)C=C1C(=O)N4CCN(CC4)C(=O)C5CC5
Mol. weight
434.4628 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

First in class

Sources

Also known as

  • 4-(3-{[4-(cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorobenzyl)phthalazin-1(2h)-one
  • 4-(3-{[4-(cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorobenzyl)phthalazin-1(2h)-one
  • az2281
  • az2281
  • azd221
  • azd2281
  • azd2281
  • azd2281
  • azd2281
  • azd2281
  • azd 2281
  • azd 2281
  • azd 2281
  • azd-2281
  • azd-2281
  • azd-2281
  • ku-0059436
  • ku-0059436
  • lymparza
  • lymparza
  • lynparza
  • lynparza
  • lynparza
  • olaparib
  • olaparib
  • olaparib
  • olaparib
  • olaparib
  • olaparib
  • olaparib
  • olaparib
  • olaparib
  • olaparib
  • olaparib
  • olaparib

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06856499Phase 1Dec 31, 2025National Cancer Institute (NCI), National Institutes of Health (NIH), University of Colorado, Denver
NCT07187674N/ADec 30, 2025Harbin Medical University
NCT07090369Phase 1Nov 1, 2025Peter MacCallum Cancer Centre
NCT07113964Phase 2Aug 30, 2025Nanjing Medical University
NCT07156253Phase 1Aug 26, 2025Government of China
NCT07024784Phase 2Jul 30, 2025AbbVie
NCT06858865Phase 1Jul 12, 2025Addpharma Inc.
NCT06915025Phase 3Jul 9, 2025Celsion, Washington University in St. Louis
NCT07005583Phase 2Jun 30, 2025Tianjin Medical University
NCT06966700Phase 3Jun 30, 2025Merck
NCT07069335Phase 1Jun 17, 2025Boryung Pharmaceutical Company
NCT06829199Phase 2Mar 26, 2025Merck
NCT06797635Phase 2Mar 3, 2025Daiichi Sankyo, Merck
NCT06909825Phase 2Feb 26, 2025Fusion Pharma LLC
NCT06785636Phase 1/Phase 2 (Phase 2)Feb 7, 2025Duke University, Pathos AI, Inc.
NCT06580314Phase 3Jan 16, 2025National Cancer Institute (NCI), NRG Oncology
NCT06630325Phase 2Jan 1, 2025AstraZeneca, Eli Lilly, OHSU Knight Cancer Institute, Oregon Health and Science University
NCT06746116Phase 3Dec 31, 2024Apices Soluciones S.L., AstraZeneca
NCT06686030Phase 2Dec 31, 2024Akeso Pharmaceuticals, Inc.
NCT06747936Phase 3Dec 31, 2024Addpharma Inc.
Showing 20 of 404 trials
Page 1 / 21

Organizations

Research & Development (283)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AstraZenecaFor profit1687552005
National Cancer Institute (NCI)Government604532008
MerckFor profit431542016
Harvard UniversityAcademic/Hospital221132008
University of Texas at HoustonAcademic/Hospital171132014
University of LondonAcademic/Hospital13632007
University of TorontoAcademic/Hospital12642007
Yale UniversityAcademic/Hospital12322015
Myrexis Inc.For profit11032013
Johns Hopkins UniversityAcademic/Hospital9822011
NRG OncologyAcademic/Hospital9122014
Royal Marsden Hospital NHS TrustAcademic/Hospital9222005
Cancer Research UKAcademic/Hospital8132007
Institut Gustave RoussyAcademic/Hospital8632014
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital8722018
Netherlands Cancer InstituteAcademic/Hospital8532007
KuDOSFor profit7022007
Seoul National UniversityAcademic/Hospital7422010
OHSU Knight Cancer InstituteAcademic/Hospital6622018
The Christie NHS Foundation TrustAcademic/Hospital6222008
283 organizations
Page 1 / 15

Marketing (5)

OrganizationOrg typeRelationshipDate
AstraZenecaFor profitMKTGDec 19, 2014
AstraZenecaFor profitNDADec 19, 2014
CiplaFor profitMKTGJun 2, 2025
SandozFor profitMKTGMay 22, 2025
Zydus Discovery DMCCFor profitMKTGNov 6, 2025