Drug · Small Molecule

Olaparib

CI-DRUG-00000416Explore in graph →NCIt C71721 CHEMBL521686 CIViC Approved

Regulatory

Approvals (26)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

openfdaRegulatory22 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2023-11-06 (see label)	approved	Nov 6, 2023	openfda
US FDA	—	Efficacy supplement 2023-05-31 (see label)	approved	May 31, 2023	openfda
US FDA	—	Efficacy supplement 2022-08-26 (see label)	approved	Aug 26, 2022	openfda
US FDA	—	Efficacy supplement 2022-03-11 (see label)	approved	Mar 11, 2022	openfda
US FDA	—

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 4	155	59	41	343	26	CA, EU, US	Dec 16, 2014	Jun 15, 2007
Malignant Breast Neoplasm	Approved	Phase 4	34	16	5	66	2	US	Aug 17, 2017	Jul 8, 2008
Malignant Prostate Neoplasm	Approved	Phase 4	16	2	4	39	2	US	Aug 17, 2017	2012-07
Malignant Pancreatic Neoplasm	Approved	Phase 3	11	4	1	22

Curated evidence

Clinical evidence (119)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–50 of 119 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
FLT3 ITD + KDM6A LossKDM6A FLT31

Clinical trials

Trials with this intervention (351)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 351 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT03976323	Study of Pembrolizumab With Maintenance Olaparib or Maintenance Pemetrexed in First-line (1L) Metastatic Nonsquamous Non-Small-Cell Lung Cancer (NSCLC) (MK-7339-006, KEYLYNK-006)	completed	Phase 3	1,003	Merck Sharp & Dohme LLCINDUSTRY	20	Sep 28, 2026	clinicaltrials
NCT04086485	Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)

Molecule

Record

Kind: Small Molecule
Mechanism: PARP 1, 2 and 3 inhibitor
Targets: 3 genes
UNII: WOH1JD9AR8
Aliases: AZ-2281, AZ2281, AZD 2281, AZD-2281, AZD2281, KU 0059436, KU-0059436, KU0059436, KU-59436, Lynparza, LYNPARZA, NSC-747856, Olanib, Olaparib, OLAPARIB (AZD2281), OLAPARIBAZD-2281AZD 2281KU 59436KU-59436LYNPARZAAZD2281KU59436O-9201, OLAPARIB COMPONENT OF KEYLYNK-010, Olaparix, PARP Inhibitor AZD2281

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (8)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01XK01	OLAPARIB
DIN (Health Canada)	02454408	LYNPARZA

KDM6A Loss2
Olaparib	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	submitted	EID11034 An array of KDM6 deficient AMP cells showed increased sensitivity to PARP inhibition. In a mouse model xenotransplant with a KDM6A loss of function AMP cell line increased susceptibility to PARP block… (full text at CIViC) Open in CIViC	civic
Olaparib + VenetoclaxCombination	Acute Myeloid LeukemiaCURATED_BROADER	Predictive	D	Supports Sensitivity Response	3	submitted	EID11037 Dual targeting of PARP (olipartinib) and BCL2 (venetoclax) was reported to be superior to either PARP or BCL2 inhibition alone in inducing primary AML cell apoptosis, and loss of KDM6A further enhance… (full text at CIViC) Open in CIViC	civic

BRCA1 Mutation + BRCA2 MutationBRCA2 BRCA13
Olaparib	Breast Carcinoma	Predictive	B	Supports Sensitivity Response	4	accepted	EID12763 In the breast carcinoma cohort of the phase II TAPUR trial (NCT02693535), patients with BRCA1/2 alterations treated with olaparib (26 evaluable) had 1 CR (BRCA2 loss), 11 PR (BRCA1 n=5, BRCA2 n=4, BRC… (full text at CIViC) PMID 41100773 · Al Baghdadi et al., 2025 · Open in CIViC	civic
〃	Lung Carcinoma	Predictive	B	Supports Sensitivity Response	2	accepted	EID12765 In the lung carcinoma cohort of the phase II TAPUR trial (NCT02693535), CRs were observed in 2/25 evaluable patients, both with BRCA2 alterations, with DOR of 33 weeks (SCLC, n=1) and 148 weeks (NSCLC… (full text at CIViC) PMID 41100773 · Al Baghdadi et al., 2025 · Open in CIViC	civic
〃	Malignant Biliary Tract NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	4	accepted	EID12764 In the biliary tract carcinoma cohort of the phase II TAPUR trial (NCT02693535), patients with BRCA1/2 alterations treated with olaparib (18 evaluable) had 2 PR (BRCA1 loss n = 1, BRCA2 mutation n = 1… (full text at CIViC) PMID 41100773 · Al Baghdadi et al., 2025 · Open in CIViC	civic

ATM Mutation4
Olaparib	Castration-Resistant Prostate Carcinoma	Predictive	A	Supports Sensitivity Response	4	accepted	EID8505 This study (PMID 32343890) by de Bono et al, is a randomized, open-label, phase 3 trial evaluating the PARP inhibitor olaparib in 387 men with metastatic castration-resistant prostate cancer (mCRPC) w… (full text at CIViC) PMID 32343890 · de Bono et al., 2020 · Open in CIViC	civic
〃	Hematopoietic and Lymphoid Cell NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	5	accepted	EID455 Olaparib was found to inhibit cancer cell growth in ATM mutant cell lines of several blood cancers including Lymphoblastoid Leukemia, Mantle Cell Lymphoma, Chronic Lymphocytic Leukemia, and in a murin… (full text at CIViC) PMID 20739657 · Weston et al., 2010 · Open in CIViC	civic
〃	Malignant Colorectal NeoplasmCURATED_BROADER	Predictive	B	Does Not Support Sensitivity Response	2	submitted	EID13082 In this phase II basket trial (TAPUR), response to olaparib treatment was examined in four cohorts with ATM mutations. In the colorectal cancer cohort (27 evaluable patients) there was one PR and thre… (full text at CIViC) PMID 41538762 · Carrizosa et al., 2026 · Open in CIViC	civic
〃	Malignant Lung Neoplasm	Predictive	B	Supports Sensitivity Response	3	submitted	EID13084 In this phase II basket trial (TAPUR), response to olaparib treatment was examined in four cohorts with ATM mutations. In the lung cancer cohort (20 evaluable patients) there were four PRs and five pa… (full text at CIViC) PMID 41538762 · Carrizosa et al., 2026 · Open in CIViC	civic

BRCA1 Mutation5
Olaparib	Castration-Resistant Prostate Carcinoma	Predictive	A	Supports Sensitivity Response	4	accepted	EID11203 This randomized, open-label, phase 3 trial evaluated the PARP inhibitor olaparib in 387 men with metastatic castration-resistant prostate cancer (mCRPC) who had disease progression while receiving a n… (full text at CIViC) PMID 32343890 · de Bono et al., 2020 · Open in CIViC	civic
〃	Malignant Breast Neoplasm	Predictive	B	Supports Sensitivity Response	3	submitted	EID9019 The non-randomized, sequential phase II ICEBERG trial evaluated the efficacy and safety of olaparib monotherapy in 54 patients (2 cohorts of 27 patients, treated with 400mg or 100 mg twice daily) with… (full text at CIViC) PMID 20609467 · Tutt et al., 2010 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	4	accepted	EID1370 In this phase 1 trial, 60 patients with advanced solid tumors (ovarian, breast, colorectal, melanoma, sarcoma, prostate) were treated with PARP inhibitor olaparib. Durable antitumor activity was only … (full text at CIViC) PMID 19553641 · Fong et al., 2009 · Open in CIViC	civic
〃	Malignant Ovarian Neoplasm	Predictive	A	Supports Sensitivity Response	5	accepted	EID7274 In the phase 3 SOLO1 trial 390 patients with newly diagnosed advanced ovarian cancer with a mutation in BRCA1 or BRCA2 who had complete or partial response after platinum-based chemotherapy were rando… (full text at CIViC) PMID 30345884 · Moore et al., 2018 · Open in CIViC	civic
〃	Malignant Ovarian Neoplasm	Predictive	A	Supports Sensitivity Response	1	accepted	EID7275 In the phase 3 SOLO1 trial 390 patients with newly diagnosed advanced ovarian cancer with a mutation in BRCA1 or BRCA2 who had complete or partial response after platinum-based chemotherapy were rando… (full text at CIViC) PMID 30345884 · Moore et al., 2018 · Open in CIViC	civic

BRCA2 Mutation3
Olaparib	Castration-Resistant Prostate Carcinoma	Predictive	A	Supports Sensitivity Response	5	accepted	EID8842 In phase 3 trial of 387 patients comparing olaparib and new hormonal agent (enzalutamide or abiraterone) therapy for patients with metastatic castration-resistant prostate cancer harboring homologous … (full text at CIViC) PMID 32343890 · de Bono et al., 2020 · Open in CIViC	civic
〃	Malignant Breast Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID5831 Randomized, open-label, phase 3 trial in which olaparib monotherapy was compared with standard therapy in patients with a germline BRCA mutation HER2–negative metastatic breast cancer. 205 patients we… (full text at CIViC) PMID 28792849 · 2017 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	4	accepted	EID1371 In this phase 1 trial 60 patients with advanced solid tumors (ovarian, breast, colorectal, melanoma, sarcoma, prostate) were treated with PARP inhibitor olaparib. Durable antitumor activity was only o… (full text at CIViC) PMID 19553641 · Fong et al., 2009 · Open in CIViC	civic

ATM Underexpression3
Olaparib	Gastric Adenocarcinoma	Predictive	D	Supports Sensitivity Response	4	accepted	EID878 Low ATM protein expression led to sensitivity to PARP inhibitors in TP53 -ve gastric cancer cell lines (8 lines were used for various aspects of this study). PMID 24841718 · Kubota et al., 2014 · Open in CIViC	civic
Olaparib + PaclitaxelCombination	Malignant Gastric Neoplasm	Predictive	B	Supports Sensitivity Response	1	accepted	EID5215 A randomized phase 2 trial investigating the efficiency of Olaparib plus Paclitaxel vs. Placebo plus Paclitaxel in recurrent or metastatic gastric cancer patients. 123 patients received treatment. Com… (full text at CIViC) PMID 26282658 · Bang et al., 2015 · Open in CIViC	civic
〃	Malignant Gastric Neoplasm	Predictive	B	Does Not Support Sensitivity Response	4	submitted	EID7708 This double-blind, randomized, placebo-controlled, phase 3 study (GOLD) recruited Asian patients with advanced gastric cancer that had progressed after first-line chemotherapy. Patients were randomly … (full text at CIViC) PMID 29103871 · Bang et al., 2017 · Open in CIViC	civic

BAP1 Mutation2
Olaparib	Malignant Mesothelioma	Predictive	B	Supports Sensitivity Response	3	submitted	EID11740 In this study, 23 patients with refractory mesothelioma harbouring germline or somatic BAP1 mutations were treated with olaparib. The median PFS was 3.6 months (95% CI, 2.7-4.2), and the median OS was… (full text at CIViC) PMID 34661178 · Ghafoor et al., 2021 · Open in CIViC	civic
〃	Malignant Mesothelioma	Predictive	B	Supports Sensitivity Response	3	submitted	EID11741 In this study, 23 patients with refractory mesothelioma harbouring germline or somatic BAP1 mutations were treated with olaparib. The median PFS was 3.6 months (95% CI, 2.7-4.2), and the median OS was… (full text at CIViC) PMID 34661178 · Ghafoor et al., 2021 · Open in CIViC	civic