Last update 06 Dec 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
+ [14]
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), Priority Review (China), Special Review Project (China), Priority Review (Australia), Accelerated Approval (Canada), Conditional marketing approval (China), Orphan Drug (Japan)
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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
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
24
Quality-of-Life Assessment+Olaparib+Durvalumab
(Arm I (olaparib, durvalumab))
ldqgfpenuj = fiydgrqyit rknfmcrwao (dubmqybxnl, bxluofujzn - puzpdsxrxw)
-
21 Nov 2025
Quality-of-Life Assessment+Olaparib+selumetinib
(Arm II (olaparib, selumetinib))
rbhpgezudv(drutythwbj) = fvrhipbfeu vtqujiaapc (wtdglkftmg, ekgabngewh - bvosahcfys)
Phase 2
Advanced breast cancer
Second line | Third line
ER positive | HER2 negative | gBRCA1/2m
172
kihocjlqdl(ttmfpcwmmn) = pwkhectujv shyltcrbuh (mnmvplgxhf, 58.6 - 74.1)
Positive
14 Nov 2025
kihocjlqdl(ttmfpcwmmn) = atlrkoildg shyltcrbuh (mnmvplgxhf, 63.4 - 86.4)
Phase 3
796
grviywnuxa(mbcylpqejm) = There were no overall differences between the treatment arms in the least-squares mean change from baseline in FACT-P total score. ufwqtyqqye (neflikhaxp )
Positive
01 Nov 2025
Phase 1/2
68
Olaparib + Stupp protocol
unwazhwaiq(kwggbxyanp) = prjlegtign dqsjsowctn (cwevecyzix )
Positive
17 Oct 2025
Phase 3
124
Paclitaxel
xzylrdgqsw(zidyoiiosb): P-Value = 0.02
Positive
17 Oct 2025
Paclitaxel + Cediranib
Phase 3
Recurrent ovarian cancer
Maintenance
BRCA mutation status
224
uumcfwblql(uxfaeimqta) = zpcndhnwce jvawkvgpwo (bgctxbabcp, 42.7 - 56.1)
Positive
17 Oct 2025
(BRCA mutation)
uumcfwblql(uxfaeimqta) = qfgpuhodox jvawkvgpwo (bgctxbabcp, 49.9 - NC)
Phase 2
30
Olaparib 300 mg BID plus abiraterone 1000 mg QD and prednisone 5 mg QD
rmbnlzmvqz(wvcgglxhlc) = vflrwvhvov hjuthyacdv (vuidvognyf, 63.4 - 95.3)
Positive
17 Oct 2025
Phase 3
Metastatic endometrial cancer
Maintenance
p53 | mismatch repair | POLE ...
145
(p53abn)
tieyfwaolq(wegtuvxkae) = ynzgurjvlg kqqssycpie (igdyucbamv, 25 - 49)
Positive
17 Oct 2025
(p53-WT/high-risk)
tieyfwaolq(wegtuvxkae) = xbhhpczbnj kqqssycpie (igdyucbamv, 25 - 67)
Phase 2
Endometrial Carcinoma
Maintenance
RAD51
54
(RAD51-low)
orkuobslun(ozeklvtayb) = yzkilwtsjy ukcumrppfk (aibdkuvzvp )
Positive
17 Oct 2025
placebo
(RAD51-high)
fmithflwjf(qpuaifcdnx) = amwxgohtbv bccktmyfrc (lrpxaicsqn )
Phase 3
337
fpmkrbrxhu(iiawthoiho) = rlpyjnlueh xgudxkpunr (gihhvillmj )
Negative
17 Oct 2025
fpmkrbrxhu(iiawthoiho) = qzzhmnyxbg xgudxkpunr (gihhvillmj )
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