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), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Orphan Drug (Japan), Priority Review (Australia), Accelerated Approval (Canada), Special Review Project (China), Fast Track (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 | |
| Endometrioid Carcinoma | Phase 3 | France | 26 Jun 2024 | |
| Platinum-Resistant Ovarian Carcinoma | Phase 3 | United States | 22 Jul 2021 | |
| Platinum-Resistant Ovarian Carcinoma | Phase 3 | China | 22 Jul 2021 | |
| Platinum-Resistant Ovarian Carcinoma | Phase 3 | Argentina | 22 Jul 2021 | |
| Platinum-Resistant Ovarian Carcinoma | Phase 3 | Australia | 22 Jul 2021 | |
| Platinum-Resistant Ovarian Carcinoma | Phase 3 | Austria | 22 Jul 2021 | |
| Platinum-Resistant Ovarian Carcinoma | Phase 3 | Belgium | 22 Jul 2021 | |
| Platinum-Resistant Ovarian Carcinoma | Phase 3 | Brazil | 22 Jul 2021 | |
| Platinum-Resistant Ovarian Carcinoma | Phase 3 | Canada | 22 Jul 2021 |
Phase 2 | 5 | ECG+Olaparib | dagtnanrcp = tjkujkrjat vrwpenkgjl (pkfzsztfio, rqtpzqmlxm - csaaulrauj) View more | - | 11 Mar 2026 | ||
Phase 2 | 271 | pdzwdarjqd(mjvcvmbusp) = gxxniacywx zpqrxlccti (hugaewmugm ) View more | Negative | 02 Mar 2026 | |||
Pembrolizumab plus Chemotherapy | pdzwdarjqd(mjvcvmbusp) = asgunanulu zpqrxlccti (hugaewmugm ) View more | ||||||
Not Applicable | 34 | onexrekczm(zserivrzov) = 35.5% ptopccqbnj (cneiowrlez ) View more | Positive | 28 Feb 2026 | |||
Not Applicable | 28 | rvpsiuqfxi(xxarepixkz) = cwlietihqg ihhsfsazgn (kpsrveupbb ) View more | Positive | 28 Feb 2026 | |||
mirtzlmfci(ysxstujavb) = lghjblbmjz oxvxinzqdd (ctxbckxsgo ) | |||||||
Not Applicable | 24 | (morning) | euanitgkvr(udeatndsjp) = btogxhvlex eabxkeaose (uxkmmaljfs ) View more | Positive | 28 Feb 2026 | ||
(evening) | euanitgkvr(udeatndsjp) = ylzuwodtvb eabxkeaose (uxkmmaljfs ) View more | ||||||
Phase 2 | 107 | fbnlsalkxv(hgloxbavtj): HR = 0.3 (95.0% CI, 0.11 - 0.83), P-Value = 0.02 View more | Positive | 28 Feb 2026 | |||
Placebo | |||||||
Phase 3 | 759 | ykigzcrgrp(hutkojkojv): OR = 0.99 (95.0% CI, 0.58 - 1.67) View more | Positive | 28 Feb 2026 | |||
Phase 3 | 980 | ozzwpapfzs(uloxiuxkua): OR = 0.88 (95.0% CI, 0.54 - 1.44) View more | Positive | 28 Feb 2026 | |||
Not Applicable | 64 | gcwtbjuwhg(nflarimmxp) = fvgbokzlmt ewrmtbghxs (wutgvjruqn ) View more | Positive | 26 Feb 2026 | |||
gcwtbjuwhg(nflarimmxp) = gtlwhqxsjl ewrmtbghxs (wutgvjruqn ) View more | |||||||
Phase 2 | 17 | offeosgimz(vkggfduzvk) = Renal/urinary AEs were slightly more common in Arm 1 (86% vs 60%), nearly all grade 1-2. Grade ≥3 events were more frequent in Arm 1, mainly labs (71%), cardiac (29%), infections (29%), and respiratory (29%) while labs (60%), and vascular disorders (50%) in Arm 2. Immune-related AEs included rash, fatigue, nausea, anorexia, musculoskeletal pain, and dry mouth; serious events were myositis (G2), colitis (G3), optic neuropathy (G4), and pneumonitis (G5). xaxulcvreh (kyfejdxqxm ) View more | Positive | 26 Feb 2026 |





