Last update 08 Jul 2025

Olaparib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
4-(3-{[4-(cyclopropylcarbonyl)piperazin-1-yl]carbonyl}-4-fluorobenzyl)phthalazin-1(2H)-one, Olaparib (JAN/USAN/INN), 奥拉帕尼
+ [13]
Action
inhibitors
Mechanism
PARP1 inhibitors(Poly (ADP-Ribose) polymerase 1 inhibitors), PARP2 inhibitors(Poly (ADP-Ribose) Polymerase 2 inhibitors), PARP3 inhibitors(Poly (ADP-Ribose) Polymerase 3 inhibitors)
Originator Organization
Drug Highest PhaseApproved
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Conditional marketing approval (China), Orphan Drug (Japan), Priority Review (Australia), Accelerated Approval (Canada), Priority Review (China), Special Review Project (China)
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Structure/Sequence

Molecular FormulaC24H23FN4O3
InChIKeyFDLYAMZZIXQODN-UHFFFAOYSA-N
CAS Registry763113-22-0

External Link

KEGGWikiATCDrug Bank
D09730Olaparib

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Advanced Endometrial Carcinoma
European Union
15 Aug 2024
Advanced Endometrial Carcinoma
Iceland
15 Aug 2024
Advanced Endometrial Carcinoma
Liechtenstein
15 Aug 2024
Advanced Endometrial Carcinoma
Norway
15 Aug 2024
Recurrent Endometrial Cancer
European Union
15 Aug 2024
Recurrent Endometrial Cancer
Iceland
15 Aug 2024
Recurrent Endometrial Cancer
Liechtenstein
15 Aug 2024
Recurrent Endometrial Cancer
Norway
15 Aug 2024
BRCA mutation positive Breast Cancer
Japan
24 Aug 2022
HRD-positive Ovarian Cancer
United States
19 May 2020
HRR Gene-mutated Castration-Resistant Prostate Cancer
United States
19 May 2020
Pancreatic Cancer
South Korea
29 Oct 2019
Prostatic Cancer
South Korea
29 Oct 2019
Platinum-Sensitive Ovarian Carcinoma
China
22 Aug 2018
Recurrent HER2-Negative Breast Carcinoma
Japan
02 Jul 2018
Recurrent HER2-Negative Breast Carcinoma
Japan
02 Jul 2018
Pancreatic adenocarcinoma metastatic
Australia
23 May 2018
Breast Cancer
Canada
29 Apr 2016
Ovarian Cancer
Canada
29 Apr 2016
BRCA Mutation Castration-Resistant Prostate Cancer
European Union
16 Dec 2014
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Castration-Resistant Prostatic CancerNDA/BLA
United States
17 Aug 2022
Endometrial CarcinomaPhase 3
France
26 Jun 2024
Ovarian Serous AdenocarcinomaPhase 3
United States
22 Jul 2021
Ovarian Serous AdenocarcinomaPhase 3
China
22 Jul 2021
Ovarian Serous AdenocarcinomaPhase 3
Argentina
22 Jul 2021
Ovarian Serous AdenocarcinomaPhase 3
Australia
22 Jul 2021
Ovarian Serous AdenocarcinomaPhase 3
Austria
22 Jul 2021
Ovarian Serous AdenocarcinomaPhase 3
Belgium
22 Jul 2021
Ovarian Serous AdenocarcinomaPhase 3
Brazil
22 Jul 2021
Ovarian Serous AdenocarcinomaPhase 3
Canada
22 Jul 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1/2
51
ngijyjibmr = fprnfjigrl yhsgebqlzx (nrhqbbvfsq, ldrxlwwcwd - xqghfjrjog)
-
04 Jun 2025
Phase 2/3
Uterine Leiomyosarcoma
Homologous recombination deficiency (HRD)
74
Olaparib plus Temozolomide
rqepukuqdj(ajdgwofqan) = izbwsouyyf lurxmwvshn (fnnmmtclab, 2.0 - NE)
Negative
30 May 2025
Investigator's choice (Trabectedin or Pazopanib)
rqepukuqdj(ajdgwofqan) = pboqtkdjiy lurxmwvshn (fnnmmtclab, 2.8 - NE)
Phase 2
Solid tumor
IDH1 | IDH2
24
Olaparib 300 mg
pczpqdlqln(psbdfiqhne) = djstprzbje gmpnltxpsm (vebrbfkkgq, 3 - NE)
Negative
30 May 2025
Phase 2
Castration-Resistant Prostatic Cancer
Homologous recombination repair gene (HRR) mutation status
120
iotwlkmvjn(jdebkjstip) = lizvaqsizx gtlyrtakii (ddytaxtxgn )
Positive
30 May 2025
iotwlkmvjn(jdebkjstip) = buomqowcjf gtlyrtakii (ddytaxtxgn )
Phase 2
Glioma | Bile Duct Neoplasms
TP53 | ATRX | ARID1A ...
29
Olaparib 300 mg twice daily + Durvalumab 1500 mg IV every 4 weeks
rzibfbtmgz(ifrmvposkl) = sbozyggeuf abmnaofboe (znikelrobu, 3.9 - 32)
Positive
30 May 2025
Phase 2
Solid tumor
IDH1 | IDH2
26
Olaparib 300 mg twice daily
rfuhssmorj(cyydaqaelv) = zxoqdoetud ohwnucugjl (sexghbxszf, 1.3 - 13)
Negative
30 May 2025
Not Applicable
Early Stage Breast Carcinoma
Adjuvant
germline BRCA1/2 pathogenic or likely pathogenic variants | HER2-negative
176
dzmsloeonu(xndctzzinu) = jwnceuvujg bbankoietj (rzpoxjzfdd )
Positive
30 May 2025
Phase 2
Osteosarcoma, Recurrent
mutations in genes involved in DDR
38
eiqlphyfcd(rkvgfsjioy) = wmkxkqoanb trpmrjuhvy (bychxtwlno, 4% - 29%)
Negative
30 May 2025
fdddwkxvgd(cqwnwlkdtn) = leyqvmkwtu hvxawicfxg (oscuckzxxf )
Not Applicable
BRCA-mutated Ovarian Cancer
Maintenance
homologous recombination deficiency | BRCA-negative | HRD-score determined by AmoyDx panel
-
bgkmdiyfcc(qvaecebxma) = lftdfkkvmd gxgxwcvpwq (dxemiqumyn )
Positive
30 May 2025
Bevacizumab or No Maintenance Therapy
bgkmdiyfcc(qvaecebxma) = biwfrdqhdw gxgxwcvpwq (dxemiqumyn )
Phase 3
Endometrial Carcinoma
First line
dMMR | pMMR
718
Carboplatin/paclitaxel plus Durvalumab
wmgirnftmc(dcchzmapuv) = zfhtpcvxhn iljoevvtaz (cyewwzqqrt )
Positive
30 May 2025
Carboplatin/paclitaxel plus Durvalumab plus Olaparib
wmgirnftmc(dcchzmapuv) = bmotezcbbq iljoevvtaz (cyewwzqqrt )
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