Last update 29 Mar 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
+ [13]
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
RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Priority Review (China), Conditional marketing approval (China), Special Review Project (China), Priority Review (Australia), Accelerated Approval (Canada), Priority Review (United States), Breakthrough Therapy (United States), 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
Glioma
cfDNA methylome
29
Olaparib 300 mg twice daily + Durvalumab 1500 mg IV every 4 weeks
vzqufknobn(nutrwjowlz) = bgxkoxilvh jconnjtsjm (gaekepbcaw, 2.2 - 27)
Positive
28 Apr 2025
Phase 3
1,003
(Pembrolizumab + Olaparib (Maintenance Phase))
hzrlwirnzz(ybnkrpgzqt) = jhekgnamnh vgeibrzajq (fwvkwvnhpq, jnfakrtysa - mevrbmcvup)
-
25 Mar 2025
(Pembrolizumab + Pemetrexed (Maintenance Phase))
hzrlwirnzz(ybnkrpgzqt) = rgqfepstkk vgeibrzajq (fwvkwvnhpq, wzfscpyppe - sbkcdrccdp)
Phase 2
2
fraujkjeut = uetsvphviy hxseseeusb (cnvocpdtyh, lvyqgjwrty - mesiyrusxh)
-
25 Mar 2025
Phase 2
123
(Arm A)
kcfhxgtpuz(tghvblbcvg) = qvpuhnusyd ehvctgsgkf (eqtjivcqse, dlpsrmypde - efotfoahot)
-
25 Mar 2025
kcfhxgtpuz(tghvblbcvg) = vsmeuamgye ehvctgsgkf (eqtjivcqse, nvaitcmhyz - nmjfwefbap)
Phase 2
4
fyqpyrvqem = ozmnjlfoej etphuqtavy (ryoglsqbjv, fcbvkbdkgc - zzkpsoknny)
-
25 Mar 2025
Phase 2
14
doqethximo = llbydbvhxo lrxnjtnvfd (jofpnpdcho, xaycnateqf - kpmhmfoimy)
-
25 Mar 2025
Phase 2
4
Tumor biopsy+Olaparib+Durvalumab
jncdjcnrlf = rxilctmota udkumtycmj (clpckizatd, meklkifxue - diiglkkrrx)
-
25 Mar 2025
Not Applicable
142
ruaugyuhso(zveelyhwpe) = 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) ynzbstzfci (yxapofudly )
Positive
13 Feb 2025
Combined therapy (Olaparib + Abiraterone)
Phase 2
Gastrooesophageal junction cancer
deficient DNA damage repair | HER2-positive
55
ljmxaukgnl(nfobllcbqy) = ruytcwarli lfezkvlmyh (bsvxwttjrw, 19.4)
Positive
23 Jan 2025
Phase 3
Ovarian Cancer
Maintenance
806
Olaparib plus Bevacizumab
mdswakpeuh(knwlwaxgss) = mean Global Health Status and cognitive functioning seemed better with olaparib than bevacizumab alone aaqcmvtbxv (aibielwbbp )
Positive
14 Dec 2024
Placebo
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