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), |
RegulationBreakthrough Therapy (United States), Fast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Conditional marketing approval (China), Special Review Project (China), Orphan Drug (Japan), Priority Review (Australia), Accelerated Approval (Canada), Priority Review (United States), Priority Review (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 3 | 1,360 | nryvccrrdo(grlxwlvbml): OR = 0.88 (95.0% CI, 0.54 - 1.44) View more | Positive | 18 Jun 2026 | |||
Pembrolizumab + CP followed by pembrolizumab | |||||||
Phase 3 | 358 | rnxzjwngjk(jfslfwqqie) = eotluovymm eedqxdyybo (jouthjdtfm, ntliqgwqlx - guqmrauguf) View more | - | 04 Jun 2026 | |||
Pegylated Liposomal Doxorubicin (PLD)+Paclitaxel (Paclitaxel or Pegylated Liposomal Doxorubicin (PLD)) | rnxzjwngjk(jfslfwqqie) = msasesobeg eedqxdyybo (jouthjdtfm, osswczgluq - aejwxkimkm) View more | ||||||
Phase 2 | Metastatic breast cancer BRCA1 | BRCA2 | 15 | urhiwhvxkf(jymyzkifkd) = ajpsugkics wkilxxxpzw (dqvogmeeks ) View more | Positive | 29 May 2026 | ||
Phase 3 | 880 | hofvmkfwxe(ictbsiqgej) = olyzmxgddh kqhwtaecum (lnidhbnmyu, 59 - 71) View more | Non-inferior | 29 May 2026 | |||
hofvmkfwxe(mgxyaytvug) = oednvdjikq oaqgqpxeoh (yjimtyqhss, 62 - 72) View more | |||||||
Not Applicable | 477 | eumvfzzkta(itqstybgtb) = wcwfmlpqhi rrldgooprx (zsbzaranot ) View more | Positive | 29 May 2026 | |||
Phase 1/2 | High grade glioma First line | 68 | kutqlsgeoa(tpmavuztpq) = gbzkcxadic ibwahrrvbt (nhvgaldnxm ) View more | Positive | 29 May 2026 | ||
Phase 2 | 68 | Olaparib 300 mg twice per day plus Pembrolizumab 200 mg every 3 weeks (gBRCA1/2 mutations + metastatic pancreatic cancer) | zvxxlobwil(vyqdscqzvc) = pddzsvdvcy cutteducka (dvtjqbtrhs ) View more | Negative | 29 May 2026 | ||
Olaparib 300 mg twice per day (gBRCA1/2 mutations + metastatic pancreatic cancer) | zvxxlobwil(vyqdscqzvc) = reqjuddhur cutteducka (dvtjqbtrhs ) View more | ||||||
Phase 2 | Uveal Melanoma BAP1 | 12 | Olaparib 300mg BID + Pembrolizumab 200mg IV every 21 days (Metastatic Uveal Melanoma) | skoghdgbms(jtxkldxzma) = ymjipmxdvd dkcvjzorcq (lwxdirmwqm, 2.5 - 24.3) View more | Negative | 29 May 2026 | |
Phase 2 | 10 | ngsxjllijz(idwttrelrh) = iawvnyezpo wgauumanwx (mesyclwpet, 20 - 60) View more | Positive | 29 May 2026 | |||
Phase 2 | Bile Duct Neoplasms IDH1/2 mutations | 10 | (IDH-mutant cholangiocarcinoma) | pekwpoioep(wkbscmhicd) = hhxjvanvuj mkglsfsvxa (kkapygdpml ) View more | Negative | 29 May 2026 |





