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 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 101–119 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
PARP1 OVEREXPRESSION1
Olaparib + Trabectedin

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

ATM Mutation1

Olaparib

Solid NeoplasmCURATED_BROADER

Predictive

Supports Sensitivity Response

submitted

EID13081

In this phase II basket trial (TAPUR), response to olaparib treatment was examined in four cohorts with ATM mutations. In the histology pooled cohort (36 evaluable patients) comprised of 19 different … (full text at CIViC)

PMID 41538762 · Carrizosa et al., 2026 · Open in CIViC

BRCA1 Loss-of-function3
Olaparib	Triple-Negative Breast CarcinomaALIAS	Predictive	A	Supports Sensitivity Response	5	accepted	EID11216 Report of OlympiA (NCT02032823), a randomized, double-blind, placebo-controlled study of 1836 patients with HER2-negative breast cancer with germline pathogenic or likely pathogenic mutations in BRCA1… (full text at CIViC) PMID 34081848 · Tutt et al., 2021 · Open in CIViC	civic
〃	HER2 Negative Breast CancerUNRESOLVED	Predictive	A	Supports Sensitivity Response	5	accepted	EID11201 Report of OlympiA (NCT02032823), a randomized, double-blind, placebo-controlled study of 1836 patients with HER2-negative breast cancer with germline pathogenic or likely pathogenic mutations in BRCA1… (full text at CIViC) PMID 34081848 · Tutt et al., 2021 · Open in CIViC	civic
〃	HER2 Negative Breast CancerUNRESOLVED	Predictive	B	Supports Sensitivity Response	5	accepted	EID5815 302 patients (234 with progression events) with HER2-negative metastatic breast cancer and with a confirmed deleterious or suspected deleterious germline BRCA mutation (164 BRCA1, 129 BRCA2) had signi… (full text at CIViC) PMID 28578601 · Robson et al., 2017 · Open in CIViC	civic