TheraRadar
Data updated: May 30, 2026

OLAPARIB

Oncology
Jump to: Indications Approvals Trials Competitors Safety Patents

Details

Status
None (Tentative Approval)
First Approved
N/A
Routes
N/A
Dosage Forms
TABLET

Companies

ZYDUS PHARMS USA Novartis Cipla
Active Ingredient: OLAPARIB

OLAPARIB Approval History

No approval records found
📋

Clinical Trial Registry

265 trials
Trial Sponsor ID Phase Status Title
NCT04858334 NCI-2020-05659 NCI-2020-05659, EA2192 Ph 2 recruiting APOLLO: A Randomized Phase II Double-Blind Study of Olaparib Versus Placebo Following Curative Intent Therapy in Patients With Resected Pancreatic Cancer and a Pathogenic BRCA1, BRCA2 or PALB2 Mutation
NCT03732820 results posted D081SC00001 2018-002011-10 Ph 3 active not recruiting Study on Olaparib Plus Abiraterone as First-line Therapy in Men With Metastatic Castration-resistant Prostate Cancer
NCT03660826 results posted NCI-2017-01672 NCI-2017-01672, NRG-GY012 Ph 2 active not recruiting Testing the Combination of Olaparib and Durvalumab, Cediranib and Durvalumab, Olaparib and Capivasertib, and Cediranib Alone in Recurrent or Refractory Endometrial Cancer Following the Earlier Phase of the Study That Tested Olaparib and Cediranib in Comparison to Cediranib Alone, and Olaparib Alone
NCT07024784 M25-219 GOG-3124 Ph 2 recruiting A Study to Assess Change in Disease Activity and Adverse Events in Adult Participants With Gynecologic Cancers Receiving Intravenous Infusion of IMGN151 as Monotherapy or in Combination With Other Therapies
NCT05564377 NCI-2022-06842 NCI-2022-06842, EAY191 Ph 2 recruiting Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial
NCT03880019 results posted NCI-2019-01500 NCI-2019-01500, #AAAS4040 Ph 2 active not recruiting A Phase II Clinical Trial Evaluating the Combination of Olaparib and Temozolomide for the Treatment of Advanced Uterine Leiomyosarcoma
NCT06915025 OVATION-3 201-24-301 Ph 3 recruiting Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemotherapy in Newly Diagnosed Patients w/ Advanced EOC, Fallopian Tube or Primary Peritoneal Cancer
NCT05432791 results posted NCI-2022-05065 NCI-2022-05065, A092104 Ph 2, Ph 3 active not recruiting Testing Olaparib and Temozolomide Versus the Usual Treatment for Uterine Leiomyosarcoma After Chemotherapy Has Stopped Working
NCT03878095 results posted NCI-2019-01461 NCI-2019-01461, 2000027026 Ph 2 active not recruiting Testing Olaparib and AZD6738 in IDH1 and IDH2 Mutant Tumors
NCT03155620 results posted NCI-2017-01251 NCI-2017-01251, APEC1621SC Ph 2 active not recruiting Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)
NCT03012321 NU_16U05 STU00203960, NCI-2016-01834 Ph 2 active not recruiting Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects
NCT06966700 2870-032 U1111-1316-7898, 2024-520190-12-00 Ph 3 recruiting A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032)
NCT04269200 DUO-E results posted D9311C00001 GOG-3041, ENGOT-EN10 Ph 3 active not recruiting Durvalumab With or Without Olaparib as Maintenance Therapy After First-Line Treatment of Advanced and Recurrent Endometrial Cancer
NCT03953898 results posted NCI-2019-03057 NCI-2019-03057, 2000027686 Ph 2 active not recruiting Using the Anticancer Drug Olaparib to Treat Relapsed/Refractory Acute Myeloid Leukemia or Myelodysplastic Syndrome With an Isocitrate Dehydrogenase (IDH) Mutation
NCT04753879 J2112 IRB00267980 Ph 2 active not recruiting Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer.
NCT03486873 3475-587 MK-3475-587, KEYNOTE-587 Ph 3 recruiting Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587)
NCT03842228 COD results posted NCI-2019-00601 NCI-2019-00601, NCI10217 Ph 1 active not recruiting Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations
NCT04739800 results posted NCI-2021-00615 NCI-2021-00615, NRG-GY023 Ph 2 active not recruiting Comparison of Standard of Care Treatment With a Triplet Combination of Targeted Immunotherapeutic Agents
NCT05411094 NCI-2022-04526 NCI-2022-04526, UMCC 2021.037 Ph 1 suspended Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer
NCT05203445 results posted 21-018 Ph 2 active not recruiting A Study of Olaparib and Pembrolizumab in People With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer
NCT02693535 TAPUR Pro00014171 Ph 2 recruiting TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer
NCT04548752 NCI-2020-06838 NCI-2020-06838, S2001 Ph 2 active not recruiting Testing the Addition of Pembrolizumab, an Immunotherapy Cancer Drug to Olaparib Alone as Therapy for Patients With Pancreatic Cancer That Has Spread With Inherited BRCA Mutations
NCT02446600 results posted NCI-2015-00606 NCI-2015-00606, s16-01480 Ph 3 active not recruiting Testing the Use of A Single Drug (Olaparib) or the Combination of Two Drugs (Cediranib and Olaparib) Compared to the Usual Chemotherapy for Women With Platinum Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
NCT02345265 results posted NCI-2015-00051 NCI-2015-00051, 16-700 Ph 2 active not recruiting Testing the Combination of the Study Drugs Cediranib and Olaparib in Recurrent Ovarian Cancer
NCT01116648 results posted NCI-2012-02938 NCI-2012-02938, NCI-2010-01329 Ph 1, Ph 2 active not recruiting Cediranib Maleate and Olaparib in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Peritoneal Cancer or Recurrent Triple-Negative Breast Cancer
NCT04034927 results posted NCI-2019-04829 NCI-2019-04829, NRG-GY021 Ph 2 active not recruiting Testing the Addition of an Immunotherapy Drug, Tremelimumab, to the PARP Inhibition Drug, Olaparib, for Recurrent Ovarian, Fallopian Tube or Peritoneal Cancer
NCT02893917 results posted NCI-2016-01346 NCI-2016-01346, 2000020461 Ph 2 active not recruiting Testing Two Oral Drugs Combination (Cediranib and Olaparib) Compared to a Single Drug (Olaparib) for Men With Advanced Prostate Cancer
NCT02755844 ENDOLA 69HCL15_0321 2015-004364-11 Ph 1, Ph 2 completed Safety and Efficacy of Metronomic Cyclophosphamide, Metformin and Olaparib in Endometrial Cancer Patients
NCT06177171 23992 5R01CA255613-02, NCI-2023-10542 Ph 1 recruiting Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors
NCT05554328 NCI-2022-06841 NCI-2022-06841, EAY191-N4 Ph 2 recruiting Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial
NCT06353386 5684-01A MK-5684-01A, 2023-506288-33-00 Ph 1, Ph 2 recruiting Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A)
NCT02308072 ORCA-2 UCL/13/0696 2014-002525-35 Ph 1 completed Phase I Study of Olaparib Combined With Cisplatin-based Chemoradiotherapy to Treat Locally Advanced Head and Neck Cancer
NCT02849496 NCI-2016-01130 NCI-2016-01130, 1608018258 Ph 2 active not recruiting Testing Olaparib Either Alone or in Combination With Atezolizumab in BRCA Mutant Non-HER2-positive Breast Cancer
NCT04086485 190138 19-C-0138 Ph 1, Ph 2 recruiting Lu-177-DOTATATE (Lutathera) in Combination With Olaparib in Inoperable Gastroenteropancreatico Neuroendocrine Tumors (GEP-NET)
NCT04633239 NCI-2020-10084 NCI-2020-10084, 10422 Ph 1 recruiting Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian Cancer
NCT06797635 1022-010 MK-1022-010, 2024-514376-40-00 Ph 2 recruiting Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
NCT04585958 NCI-2020-07841 NCI-2020-07841, 10355 Ph 1 recruiting Testing the Combination of DS-8201a and Olaparib in HER2-Expressing Cancers With Expansion in Patients With Platinum Resistant Ovarian Cancer
NCT03317392 results posted NCI-2017-01920 NCI-2017-01920, 10096 Ph 1, Ph 2 active not recruiting Testing the Safety of Different Doses of Olaparib Given Radium-223 for Men With Advanced Prostate Cancer With Bone Metastasis
NCT03742895 7339-002 MK-7339-002, LYNK-002 Ph 2 active not recruiting Efficacy and Safety of Olaparib (MK-7339) in Participants With Previously Treated, Homologous Recombination Repair Mutation (HRRm) or Homologous Recombination Deficiency (HRD) Positive Advanced Cancer (MK-7339-002 / LYNK-002)
NCT05255653 RAINBO RAINBO ENGOT-en14-1,2,3,4, CCTG EN.10 TAPER arm A POLE Ph 2, Ph 3 recruiting Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features
NCT04380636 7339-012 MK-7339-012, KEYLYNK-012 Ph 3 active not recruiting Study of Pembrolizumab With Concurrent Chemoradiation Therapy Followed by Pembrolizumab With or Without Olaparib in Stage III Non-Small Cell Lung Cancer (NSCLC) (MK-7339-012/KEYLYNK-012)
NCT04042831 results posted ACCRU-ICRN-1702 NCI-2019-04434, ACCRU-ICRN-1702 Ph 2 active not recruiting Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations
NCT03375307 NCI-2017-02296 NCI-2017-02296, P162941 Ph 2 suspended Testing Olaparib in Patients With Advanced or Metastatic (Cancer That Has Spread) Bladder Cancer and Other Genitourinary Tumors With DNA-Repair Genetic Changes
NCT01081951 results posted D0810C00041 2009-015970-36 Ph 2 active not recruiting Study to Compare the Efficacy and Safety of Olaparib When Given in Combination With Carboplatin and Paclitaxel, Compared With Carboplatin and Paclitaxel in Patients With Advanced Ovarian Cancer
NCT04394858 NCI-2020-03379 NCI-2020-03379, A021804 Ph 2 active not recruiting Testing the Addition of an Anticancer Drug, Olaparib, to the Usual Chemotherapy (Temozolomide) for Advanced Neuroendocrine Cancer
NCT03598257 NCI-2018-01519 NCI-2018-01519, S1706 Ph 2 active not recruiting Radiation Therapy With or Without Olaparib in Treating Patients With Inflammatory Breast Cancer
NCT03047135 results posted J16163 IRB00114635 Ph 2 active not recruiting Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis
NCT03459846 BAYOU results posted D933IC00003 2017-004556-27 Ph 2 active not recruiting A Study of Durvalumab Alone and Durvalumab+Olaparib in Advanced, Platinum-Ineligible Bladder Cancer (BAYOU)
NCT02032823 OlympiA results posted D081CC00006 NSABP B-55, BIG 6-13 Ph 3 active not recruiting Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer
NCT06909825 FPI-2265-203 CT-2024-CTN-00137-1 Ph 2 active not recruiting FPI-2265 (225Ac-PSMA-I&T) and Olaparib for Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Showing 50 of 265 trials

🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

OLAPARIB FDA Label Details

Looking for the branded version?

LYNPARZA

Full clinical data, patents, trials, and competitive landscape for olaparib.

See LYNPARZA

Data Sources

FDA Approval: ANDA219893 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.