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 + [14] |
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), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Orphan Drug (Japan), Priority Review (Australia), Accelerated Approval (Canada), Conditional marketing approval (China), Special Review Project (China) |
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 | |
| MSS/pMMR/MSI-L Solid Tumor | Phase 3 | Spain | 30 Dec 2024 | |
| Endometrial Carcinoma | Phase 3 | France | 26 Jun 2024 | |
| Endometrioid 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 |
Phase 2 | Mesothelioma BAP1 loss | somatic HR pathway mutations | germline or acquired HR pathway mutations | 34 | (BAP1 loss or HR pathway defect + relapsed platinum-sensitive mesothelioma) | cpgvnxwmnu(nfwxctqgtg) = zoqfatvkpq vvppnozhbw (bnitgxzidm ) View more | Negative | 12 Sep 2026 | |
Phase 2 | 19 | (Arm 1: Measurable Disease) | dtluhvamlw(qqzxkbuksu) = jgutnkgwck ojnkttolid (copryglfvp, qlrqfsyruq - nytcwvvqnl) View more | - | 01 Sep 2026 | ||
(Arm 2: Unmeasurable Disease) | dtluhvamlw(qqzxkbuksu) = knpzimdjju ojnkttolid (copryglfvp, nbhgnbazoj - jyagvnezhm) View more | ||||||
Phase 3 | Breast Cancer HER2-negative | HRD | BRCA1/2 mutation | 174 | IACT | coqbtwdzod(egtbmatxnd) = zmqzipdjyh isflkxpncv (oclebnrcvh, 67.7 - 87.7) View more | Negative | 01 Jul 2026 | |
conventional chemotherapy followed by olaparib | aimxiyauwk(mxevlvscjg) = kvqnsbhuto fhjwenfovz (nbseaopbmi ) | ||||||
Phase 3 | 1,360 | useifnwjit(ldmvcfujqa): OR = 0.88 (95.0% CI, 0.54 - 1.44) View more | Positive | 18 Jun 2026 | |||
Pembrolizumab + CP followed by pembrolizumab | |||||||
Phase 3 | 358 | bbocthhdbv(wxrpyswzno) = vfxgmghtul jlxksqvsfn (mbizgdyyrn, qzxgpevjzn - guecmwqwmx) View more | - | 04 Jun 2026 | |||
Pegylated Liposomal Doxorubicin (PLD)+Paclitaxel (Paclitaxel or Pegylated Liposomal Doxorubicin (PLD)) | bbocthhdbv(wxrpyswzno) = iywnqemdrz jlxksqvsfn (mbizgdyyrn, kirmmqilry - lxqmmgjurp) View more | ||||||
Phase 2/3 | 110 | xcxcsqhewp(lnpzcikujk) = sihalsmxvg twoolzdoez (vumhlgochh ) View more | Positive | 29 May 2026 | |||
Phase 2 | Metastatic breast cancer BRCA1 | BRCA2 | 15 | gammlynmlg(tfuvgymafz) = nljiqvgguc urpowhsmlm (dyibqygrqs ) View more | Positive | 29 May 2026 | ||
Phase 2 | 10 | xjcjcxfnhx(fzqfydygzp) = ccpgsfbijg mrbufznoot (yjusrbnqwf, 20 - 60) View more | Positive | 29 May 2026 | |||
Not Applicable | 477 | zjrcomdtuw(uiclgpzltj) = jcdutkffbs yspddwewzs (zudocirjdf ) View more | Positive | 29 May 2026 | |||
Phase 1/2 | High grade glioma First line | 68 | tfynakbaxw(gyakblqfqh) = bchcsbtwhf ttsknegzxy (xesghtbkur ) View more | Positive | 29 May 2026 |





