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.

health-canada-dpdRegulatory26 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as LYNPARZA (DIN 02475200) under ATC L01XK01 OLAPARIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 23, 2018	health-canada-dpd
CA Health Canada	—	Marketed in Canada as LYNPARZA (DIN 02475219) under ATC L01XK01 OLAPARIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	May 23, 2018	health-canada-dpd
CA Health Canada	—	Marketed in Canada as LYNPARZA (DIN 02454408) under ATC L01XK01 OLAPARIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Post Marketsince Jan 11, 2021	May 16, 2016

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 17 hours 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 51–100 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
BRCA1 Mutation8
Olaparib	Malignant Ovarian Neoplasm

Clinical trials

Trials with this intervention (351)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 301–350 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
NCT04579133	Neoadjuvant Durvalumab Alone Versus Durvalumab With Olaparib in Patients Ineligible for Cisplatin With Muscle-Invasive Urothelial Carcinoma of the Bladder Followed by Radical Cystectomy	terminated	Phase 2	140	Latin American Cooperative Oncology GroupOTHER	1	Jun 16, 2021	clinicaltrials
NCT03205176	AZD5153 in Patients With Relapsed or Refractory Solid Tumors, Including Lymphomas

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 20 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

BRCA2 Loss-of-function5
Olaparib	Malignant Ovarian Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID212 The combination of PARP inhibition (Olaparib) with BRCA mutation results in irreparable and lethal DNA damage. Response rates are higher in BRCA2 mutation positive women with high grade serous or undi… (full text at CIViC) PMID 23346317 · Goff, 2013 · Open in CIViC	civic
〃	Malignant Pancreatic Neoplasm	Predictive	B	Supports Sensitivity Response	3	rejected	EID6076 A multicenter phase II study included pancreatic cancer patients with a germline BRCA1/2 mutation after gemcitabine treatment. Olaparib was administered at 400 mg twice per day. Tumor response rate wa… (full text at CIViC) PMID 25366685 · Kaufman et al., 2015 · Open in CIViC	civic
〃	Malignant Prostate Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID650 In a phase 2 trial of patients with metastatic, castration-resistant prostate cancer, treated with olaparib tablets at a dose of 400 mg twice a day, all 7 patients harbouring BRCA2 loss of function al… (full text at CIViC) PMID 26510020 · Mateo et al., 2015 · Open in CIViC	civic
Dasatinib + OlaparibCombination	Malignant Prostate Neoplasm	Predictive	D	Supports Sensitivity Response	4	submitted	EID8979 Transcriptomic analysis of BRCA2-null metastatic castration-resistant prostate cancers revealed activation of the SRC signaling pathway, which may be related to PARP inhibitor resistance. Preclinical … (full text at CIViC) PMID 33334906 · Chakraborty et al., 2021 · Open in CIViC	civic
Olaparib	Pancreatic Adenocarcinoma	Predictive	A	Supports Sensitivity Response	5	accepted	EID7385 In the phase 3 POLO trial patients who had germline BRCA1/2 mutation and metastatic pancreatic adenocarcinoma that had not progressed during first-line platinum-based chemotherapy were allocated to ma… (full text at CIViC) PMID 31157963 · Golan et al., 2019 · Open in CIViC	civic

BRCA2 Mutation9
Olaparib	Malignant Ovarian Neoplasm	Predictive	A	Supports Sensitivity Response	5	accepted	EID7276 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	B	Supports Sensitivity Response	3	accepted	EID1773 In a study of 63 patients with ovarian cancer, 17 patients had BRCA1 or BRCA2 mutations and 46 patients had no BRCA mutations. Of the BRCA-positive patients, 7/17(41%; 95%CI 22-64) showed objective r… (full text at CIViC) PMID 21862407 · Gelmon et al., 2011 · Open in CIViC	civic
〃	Malignant Ovarian Neoplasm	Predictive	B	Supports Sensitivity Response	3	submitted	EID11426 The article detailed a phase III trial (SOLO3) of olaparib tablets versus nonplatinum chemotherapy in patients with germline BRCA-mutated platinum-sensitive relapsed ovarian cancer who had received at… (full text at CIViC) PMID 32073956 · Penson et al., 2020 · Open in CIViC	civic
Cediranib + OlaparibCombination	Malignant Ovarian Neoplasm	Predictive	B	Supports Sensitivity Response	3	accepted	EID1678 46 women with platinum-sensitive, high-grade, BRCA1/2+ ovarian cancer received either olaparib monotherapy or olaparib/cediranib combination therapy. Median PFS was increased in combination therapy (… (full text at CIViC) PMID 25218906 · Liu et al., 2014 · Open in CIViC	civic
Olaparib	Malignant Pancreatic Neoplasm	Predictive	B	Supports Sensitivity Response	4	accepted	EID5913 Twenty-three patients with pancreatic cancer havoring BRCA1/2 germline mutations received olaparib. Eighteen (78%) patients had a BRCA2 mutation. In total of patients with BRCA1/2 mutation , all but … (full text at CIViC) PMID 25366685 · Kaufman et al., 2015 · Open in CIViC	civic
〃	Malignant Prostate Neoplasm	Predictive	A	Supports Sensitivity Response	4	submitted	EID12942 In the post hoc exploratory BRCA2-only subgroup (n = 128; olaparib, n = 81; control, n = 47) of the phase III randomized open-label PROfound trial (NCT02987543), olaparib monotherapy supported Sensiti… (full text at CIViC) PMID 37963304 · Mateo et al., 2024 · Open in CIViC	civic
〃	Malignant Prostate Neoplasm	Predictive	B	Supports Sensitivity Response	3	submitted	EID7457 In a retrospective study, 23 consecutive patients with prostate cancer harboring germline BRCA1/2 or ATM mutations were treated with olaparib were reviewed. This study included 2 patients with BRCA1 m… (full text at CIViC) PMID 30797618 · Marshall et al., 2019 · Open in CIViC	civic
〃	Malignant Prostate Neoplasm	Predictive	B	Supports Sensitivity Response	4	submitted	EID7471 In a phase 2 trial, patients with metastatic castration-resistant prostate cancer harboring DNA damage repair (DDR) gene aberrations were treated with olaparib. In gene testing, samples from tumor tis… (full text at CIViC) Open in CIViC	civic
〃	Ovarian Serous AdenocarcinomaALIAS	Predictive	B	Supports Sensitivity Response	4	submitted	EID6334 In patients with platinum-sensitive, recurrent serous ovarian cancer with BRCA mutation, median PFS was significantly longer in patients that received olaparib as compared to placebo (11.2 vs. 4.3 mon… (full text at CIViC) PMID 24882434 · Ledermann et al., 2014 · Open in CIViC	civic

ATM Mutation5
Olaparib	Malignant Pancreatic Neoplasm	Predictive	B	Does Not Support Sensitivity Response	2	submitted	EID13083 In this phase II basket trial (TAPUR), response to olaparib treatment was examined in four cohorts with ATM mutations. In the pancreatic cancer cohort (25 evaluable patients) there was one PR and five… (full text at CIViC) PMID 41538762 · Carrizosa et al., 2026 · Open in CIViC	civic
〃	Malignant Prostate Neoplasm	Predictive	B	Does Not Support Sensitivity Response	3	submitted	EID7458 In a retrospective study, 23 consecutive patients with prostate cancer harboring germline BRCA1/2 or ATM mutations were treated with olaparib were reviewed. This study included 2 patients with BRCA1 m… (full text at CIViC) PMID 30797618 · Marshall et al., 2019 · Open in CIViC	civic
〃	Malignant Prostate Neoplasm	Predictive	B	Supports Sensitivity Response	3	submitted	EID7472 In a phase 2 trial, patients with metastatic castration-resistant prostate cancer harboring DNA damage repair (DDR) gene aberrations were treated with olaparib. In gene testing, samples from tumor tis… (full text at CIViC) Open in CIViC	civic
〃	Malignant Prostate Neoplasm	Predictive	C	Supports Sensitivity Response	3	accepted	EID1960 Response to olaparib was observed in 4 of 5 with prostate cancer patients with ATM aberrations (2 germline). PMID 26510020 · Mateo et al., 2015 · Open in CIViC	civic
〃	Mantle Cell Lymphoma	Predictive	D	Supports Sensitivity Response	3	accepted	EID1907 Two ATM deficient mantle cell lymphoma (MCL) cell lines were more sensitive to PARP-1 inhibition with olaparib or PJ-34 than 4 other MCL cell lines. shRNA mediated ATM knockdown in a cell line increas… (full text at CIViC) PMID 20124459 · Williamson et al., 2010 · Open in CIViC	civic

BRCA1 Loss-of-function3
Olaparib	Malignant Pancreatic Neoplasm	Predictive	B	Supports Sensitivity Response	3	rejected	EID6075 In multicenter phase II study included individuals with a germline BRCA1/2 mutation and pancreatic cancer after gemcitabine treatment. Olaparib was administered at 400 mg twice per day. Tumor respons… (full text at CIViC) PMID 25366685 · Kaufman et al., 2015 · Open in CIViC	civic
〃	Malignant Prostate Neoplasm	Predictive	C	Supports Sensitivity Response	2	accepted	EID845 1/1 patients with BRCA1 homozygous deletion had a response to olaparib in this phase 2 study. PMID 26510020 · Mateo et al., 2015 · Open in CIViC	civic
〃	Pancreatic Adenocarcinoma	Predictive	A	Supports Sensitivity Response	5	accepted	EID7384 In the phase 3 POLO trial patients who had germline BRCA1/2 mutation and metastatic pancreatic adenocarcinoma that had not progressed during first-line platinum-based chemotherapy were allocated to ma… (full text at CIViC) PMID 31157963 · Golan et al., 2019 · Open in CIViC	civic

BRCA1 Mutation + BRCA2 MutationBRCA2 BRCA13
Olaparib	Malignant Prostate Neoplasm	Predictive	A	Supports Sensitivity Response	4	submitted	EID12941 In the BRCA‑altered cohort (n = 160; BRCA1/2 alterations) of the global, randomized, open‑label phase III PROfound trial (NCT02987543) in metastatic castration‑resistant prostate cancer (mCRPC), patie… (full text at CIViC) PMID 37963304 · Mateo et al., 2024 · Open in CIViC	civic
〃	Malignant Prostate Neoplasm	Predictive	B	Supports Sensitivity Response	3	accepted	EID11666 A clinical study was conducted in 30 patients with Metastatic Prostate Cancer harboring BRCA1/2 mutations treated with olaparib. A disease control rate of 69% (95% CI, 51-81) and an objective response… (full text at CIViC) PMID 36753688 · Yang et al., 2023 · Open in CIViC	civic
〃	Malignant Uterine NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	2	accepted	EID12766 In the uterine carcinoma cohort of the phase II TAPUR trial (NCT02693535), PRs were observed in 3 of 15 evaluable patients with BRCA1 (n = 2) or BRCA2 (n = 1) alterations, with response durations of 8… (full text at CIViC) PMID 41100773 · Al Baghdadi et al., 2025 · Open in CIViC	civic

CDK12 Loss-of-function2
Olaparib + Rucaparib + Talazoparib + VeliparibSubstitutes	Malignant Prostate Neoplasm	Predictive	D	Supports Sensitivity Response	2	submitted	EID12572 In prostate cancer models, CDK12 loss impaired homologous recombination deficiency and sensitized cells to PARP inhibitors (olaparib, rucaparib, talazoparib, veliparib) in a gene dosage-dependent mann… (full text at CIViC) PMID 39321214 · Chou et al., 2024 · Open in CIViC	civic
Olaparib	Ovarian Serous AdenocarcinomaALIAS	Predictive	D	Supports Sensitivity Response	4	accepted	EID623 In models of high-grade serous ovarian cancer (HGS-OVCa), CDK12 attenuation was sufficient to confer sensitivity to PARP1/2 inhibition, suppression of DNA repair via homologous recombination, and redu… (full text at CIViC) PMID 24240700 · Bajrami et al., 2014 · Open in CIViC	civic