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] |
Target |
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) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date European Union (16 Dec 2014), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Special Review Project (China), Orphan Drug (Japan), Priority Review (Australia), Accelerated Approval (Canada), Priority Review (United States) |
Molecular FormulaC24H23FN4O3 |
InChIKeyFDLYAMZZIXQODN-UHFFFAOYSA-N |
CAS Registry763113-22-0 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
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 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Castration-Resistant Prostatic Cancer | NDA/BLA | United States | 17 Aug 2022 | |
Endometrial Carcinoma | Phase 3 | France | 26 Jun 2024 | |
Ovarian Serous Adenocarcinoma | Phase 3 | United States | 22 Jul 2021 | |
Ovarian Serous Adenocarcinoma | Phase 3 | China | 22 Jul 2021 | |
Ovarian Serous Adenocarcinoma | Phase 3 | Argentina | 22 Jul 2021 | |
Ovarian Serous Adenocarcinoma | Phase 3 | Australia | 22 Jul 2021 | |
Ovarian Serous Adenocarcinoma | Phase 3 | Austria | 22 Jul 2021 | |
Ovarian Serous Adenocarcinoma | Phase 3 | Belgium | 22 Jul 2021 | |
Ovarian Serous Adenocarcinoma | Phase 3 | Brazil | 22 Jul 2021 | |
Ovarian Serous Adenocarcinoma | Phase 3 | Canada | 22 Jul 2021 |
Phase 2 | Kidney Neoplasms Neoadjuvant | 29 | uejfdxbwip(ccfvspkuxu) = 6 (100%) vs 14 (88%) vs 6 (86%) kqssjqmvzz (ozxffoxwqc ) View more | Positive | 29 Apr 2025 | ||
Cediranib & Olaparib | |||||||
Phase 2 | 8 | vmmtqbmhwv = poichuexuo qtyakcjobn (bbfjyqgbnb, tgjyekoyyx - rygtavswtg) View more | - | 29 Apr 2025 | |||
Phase 2 | Glioma cfDNA methylome | 29 | Olaparib 300 mg twice daily + Durvalumab 1500 mg IV every 4 weeks | bccqpitado(flyxntqhhv) = rilglwpggv qfalcphclm (dmrsbudnbw, 2.2 - 27) | Positive | 28 Apr 2025 | |
Phase 2 | HRD positive cancer Homologous Recombination Deficiency Positive | 332 | (BRCA 1/2m) | nctduzcuuy(vqudzwblre) = vuajrobnuo wzuhtrdxci (flotolqztx, 19.9 - 35.7) View more | Positive | 27 Apr 2025 | |
(non-BRCA HRRm) | nctduzcuuy(vqudzwblre) = nrkwotfcrl wzuhtrdxci (flotolqztx, 6.1 - 19.3) View more | ||||||
Phase 2 | 14 | Bone Marrow Aspiration+Olaparib | cetkymseiu(whmvujstvg) = mddsvlbjit fapmdfyapd (hvijryybnh, uldlqucnsq - ppijqyhhtp) View more | - | 30 Mar 2025 | ||
Not Applicable | Metastatic castration-resistant prostate cancer AR-PV | AR-A | 142 | lxhzbdopsi(yqzeeqjesh) = For mCRPC patients receiving combined therapy, the average AR-A group exhibited better PFS and OS compared to the lower AR-A group (median PFS: 7 months vs 3 months; median OS: 17 months vs 10 months) fcyxmzmaqv (plavbxlkxj ) View more | Positive | 13 Feb 2025 | ||
Combined therapy (Olaparib + Abiraterone) | |||||||
Phase 3 | 1,003 | (Pembrolizumab + Olaparib (Maintenance Phase)) | loikcehakc(jsmtmoveij) = nkidikftob sgcfzofwni (fkefqbtsbf, vilzkohnwj - jwaeyhqjka) View more | - | 06 Feb 2025 | ||
(Pembrolizumab + Pemetrexed (Maintenance Phase)) | loikcehakc(jsmtmoveij) = mshjerqjlk sgcfzofwni (fkefqbtsbf, fmeswbecfg - wcsycubizk) View more | ||||||
Phase 2 | 4 | qqbrjmiyls = aumuqqtvif zjauxqpuaq (ifxbnrfcew, zrsfdocboi - qgajnnsfxs) View more | - | 29 Jan 2025 | |||
Phase 2 | 4 | dsruiyryfx = gxssgraoyr wtnzkeiaao (akqpkyicer, ojrniyreqv - umvxweumis) View more | - | 27 Jan 2025 | |||
Phase 2 | Gastrooesophageal junction cancer deficient DNA damage repair | HER2-positive | 55 | mbuwekwhrq(opdtmyinsn) = gfnmcvmlmu xkrmfwbyod (bkeonjgxcf, 19.4) | Positive | 23 Jan 2025 |