Lynparza

(Olaparib)

ApprovedSmall molecule

Olaparib is used to treat certain types of cancer, particularly ovarian and breast cancers that have a specific genetic mutation (BRCA mutation). It works by stopping cancer cells from repairing their DNA, causing them to die.[2] Lynparza is currently approved and in use across 114 indications[4].[1]

Lynparza is one of 1405 small molecule programs targeting Glioma. It is currently in Approved.

114

Indications

372

Total Trials

Active Trials

1,404

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

GliomaCompleted

Biliary Tract CancerRecruiting

Malignant MesotheliomaRecruiting

Ovarian CarcinomaCompleted

TreatmentRecruiting

PARP InhibitorTerminated

HypertensionApproved

Breast CarcinomaApproved

Prostate CarcinomaApproved

Malignant GliomaApproved

GliomaPhase 2

Completed

Biliary Tract CancerPhase 2

Recruiting

Malignant MesotheliomaPhase 2

Recruiting

Ovarian CarcinomaPhase 3

Completed

TreatmentPhase 2

Recruiting

PARP InhibitorPhase 2

Terminated

HypertensionApproved

Approved

Breast CarcinomaApproved

Approved

Prostate CarcinomaApproved

Approved

Malignant GliomaApproved

Approved

Showing 10 of 114 indications

Competition

Competitive Landscape

744 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Lynparza

AstraZeneca

Approved

39 2

Zolymbus

AbbVie

Preclinical

1 3

Cortef

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 4

Acupan

YYonsei University

Preclinical

1 5

Chantix

PPrism Pharmaceuticals

Preclinical

1 6

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 7

Vfend

PPrism Pharmaceuticals

Rilvegostomig

1 9

Paracetamol

GSK

Preclinical

1 10

Systemic Therapy

Bristol-Myers Squibb

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q3 2026

Phase 1Active, not recruiting

Patients With Advanced Solid Tumors

NCT04197713

Q4 2026

Phase 1Active, not recruiting

Breast Cancer

NCT03641755

Phase 1Active, not recruiting

Small Cell Lung Cancer

NCT03923270

Phase 1Active, not recruiting

Breast Cancer

NCT03742245

Phase 2Recruiting

Biliary Tract Cancer

NCT05222971

Recruiting

Prostate Cancer

NCT06783127

Clinical

Trials by Indication[1]

Ovarian Cancer26 trials

NEoadjuvant Olaparib Combination OvArian Cancer Targeted Study

Not yet recruiting·BBritish Columbia Cancer Agency·Phase 2·NCT06650709·40 enrolled

Resistant Ovarian Cancer, Olaparib and Liposomal Doxorubicin

Completed·GGrupo Español de Investigación en Cáncer de Ovario·Phase 2·NCT03161132·32 enrolled

Study Evaluating the Efficacy of Maintenance Olaparib and Cediranib or Olaparib Alone in Ovarian Cancer Patients

Unknown status·UUniversity College, London·Phase 3·NCT03278717·330 enrolled

Show 23 more trials

Olaparib Treatment in Relapsed Germline Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT02282020·266 enrolled

Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected

Terminated· Novartis logo

Novartis·Phase 3·NCT04729387·358 enrolled

Delayed Initiation of Olaparib Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer

Terminated·SSarah E Taylor·Phase 2·NCT04377087·3 enrolled

An uMbrella Study of BIomarker-driven Targeted Therapy In Patients With Platinum-resistant Recurrent OvariaN Cancer(AMBITION)

Unknown status·YYonsei University·Phase 2·NCT03699449·104 enrolled

Combination ATR and PARP Inhibitor (CAPRI) Trial With AZD6738 and Olaparib in Recurrent Ovarian Cancer

Completed·UUniversity of Pennsylvania·Phase 2·NCT03462342·123 enrolled

Olaparib, Durvalumab and UV1 in Relapsed Ovarian Cancer

Active, not recruiting·NNordic Society of Gynaecological Oncology - Clinical Trials Unit·Phase 2·NCT04742075·188 enrolled

Olaparib Maintenance With Pembrolizumab & Bevacizumab in BRCA Non-mutated Patients With Platinum-sensitive Recurrent Ovarian Cancer

Enrolling by invitation·YYonsei University·Phase 2·NCT04361370·44 enrolled

Olaparib for Patients With Recurrent BRCA Deficient Ovarian Cancer

Withdrawn·—·Phase 2·NCT01661868

Circulating Tumor DNA Guiding (Olaparib) Lynparza® Treatment in Ovarian Cancer

Unknown status·UUniversitaire Ziekenhuizen KU Leuven·Phase 2·NCT02822157·160 enrolled

Olaparib Tablets as a Treatment for Ovarian Cancer Subjects With Different HRD Tumor Status

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT02983799·272 enrolled

A Study of Cediranib and Olaparib at the Time Ovarian Cancer Worsens on Olaparib

Completed·UUniversity Health Network, Toronto·Phase 2·NCT02340611·4 enrolled

Olaparib Expanded Access Program for BRCA Mutated Platinum Sensitive Relapsed High Grade Epithelial Ovarian Cancer Patients in Japan

No longer available· AstraZeneca logo

AstraZeneca··NCT03063710

Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT03402841·279 enrolled

A Study to Evaluate the Effectiveness and Tolerability of a Second Maintenance Treatment in Participants With Ovarian Cancer, Who Have Previously Received Polyadenosine 5'Diphosphoribose [Poly (ADP Ribose)] Polymerase Inhibitor (PARPi) Treatment.

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 2·NCT04239014

Olaparib Maintenance Treatment Versus Placebo in Patients With PSR Ovarian Cancer Who Are in CR or PR to Platinum-based Chemotherapy and Whose Tumours Carry sBRCAm or HRR-associated Genes Mutations

Withdrawn· AstraZeneca logo

AstraZeneca·Phase 3·NCT02392676

Olaparib +/- Cediranib or Chemotherapy in Patients With Platinum-resistant Ovarian Cancer

Completed·UUniversity of Oxford·Phase 2·NCT03117933·139 enrolled

MITO 35B: Olaparib Beyond Progression Compared to Platinum Chemotherapy After Secondary Cytoreductive Surgery in Recurrent Ovarian Cancer Patients.

Recruiting·NNational Cancer Institute, Naples·Phase 3·NCT05255471·200 enrolled

The PROOV Study: Exploiting the Synergistic Effect of PARP Inhibition With Cisplatin and Hyperthermia During Interval Cytoreductive Surgery and HIPEC in Ovarian Cancer

Recruiting·TThe Netherlands Cancer Institute·Phase 1/2·NCT07460180·55 enrolled

Real-life Data of Olaparib in Relapsed Ovarian Cancers Patients

Completed·AARCAGY/ GINECO GROUP··NCT04152941·130 enrolled

Safety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously in Addition to PARP Inhibitors in Patients With Relapsed Platinum Sensitive Ovarian Cancer Already Treated With PARP Inhibitors Since at Least 6 Months

Terminated·GGustave Roussy, Cancer Campus, Grand Paris·Phase 1/2·NCT04826198·13 enrolled

Phase Ib Study of Olaparib Plus Weekly Carboplatin and Paclitaxel in Relapsed Ovarian Cancer

Unknown status·SSwedish Medical Center·Phase 1/2·NCT01650376·52 enrolled

A Study of Cediranib and Olaparib at Disease Worsening in Ovarian Cancer

Completed·UUniversity Health Network, Toronto·N/A·NCT02681237·34 enrolled

Anlotinib Combined With Dose-reduced Olaparib in Patients With Platinum-Sensitive Recurrent Ovarian Cancer

Unknown status·XXiaoxiang Chen·Phase 2·NCT04566952·68 enrolled

Breast Cancer24 trials

A Study of Olaparib and Pembrolizumab in People With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05203445·23 enrolled

Olaparib + Sapacitabine in BRCA Mutant Breast Cancer

Active, not recruiting·—·Phase 1·NCT03641755·10 enrolled

Predicting Olaparib Sensitivity in Patients With Unresectable Locally Advanced/Metastatic HER2-negative Breast Cancer.

Completed·SSOLTI Breast Cancer Research Group·Phase 2·NCT05340413·65 enrolled

Show 21 more trials

Estradiol Plus Olaparib for Breast Cancer (PHOEBE)

Recruiting·MMary D Chamberlin·Phase 1·NCT05900895·6 enrolled

Analysis of Olaparib Response in Patients With BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast Cancer

Completed·SSpanish Breast Cancer Research Group·Phase 2·NCT03205761·11 enrolled

Olaparib+Trastuzumab in HER2[+],Breast Cancer Susceptibility Gene (BRCA) Mutated Advanced Breast Cancer

Terminated·MMedSIR·Phase 2·NCT03931551·5 enrolled

Olaparib and Radiotherapy in Inoperable Breast Cancer

Completed·TThe Netherlands Cancer Institute·Phase 1·NCT02227082·7 enrolled

Platinum and Polyadenosine 5'Diphosphoribose Polymerisation Inhibitor for Neoadjuvant Treatment of Triple Negative Breast Cancer and/or Germline BRCA Positive Breast Cancer

Recruiting·—·Phase 2/3·NCT03150576·780 enrolled

Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer

Recruiting·OOkayama University·Phase 2·NCT05485766·23 enrolled

To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients.

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT03286842·256 enrolled

HOPE: Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer

Completed·—·Phase 1·NCT03685331·9 enrolled

Olaparib in Combination With Vorinostat in Patients With Relapsed/Refractory and/or Metastatic Breast Cancer

Active, not recruiting·TThe Methodist Hospital Research Institute·Phase 1·NCT03742245·28 enrolled

Window of Opportunity Trial of Neoadjuvant Olaparib and Durvalumab for Triple Negative or Low ER+ Breast Cancer

Active, not recruiting·SSeoul National University Hospital·Phase 1/2·NCT03594396·54 enrolled

A Study of Radiation Therapy With Pembrolizumab and Olaparib or Other Radiosensitizers in Women Who Have Triple-Negative or Hormone-Receptor Positive/Her2 Negative Breast Cancer

Recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04683679·34 enrolled

Breast Cancer Treatment Based on Organ-like Culture

Unknown status·XXijing Hospital··NCT03925233·300 enrolled

Hyperthermia and Olaparib in Treating Breast Cancer Patients With Chest Wall Recurrences

Terminated·TThomas Jefferson University·Phase 1·NCT03955640·3 enrolled

SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer

Active, not recruiting·UUNICANCER·Phase 2·NCT02299999·1,460 enrolled

Prospective Multicentre Phase-IV Clinical Trial of Olaparib in Indian Patients With Ovarian and Metastatic Breast Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT04330040·202 enrolled

Olaparib & Radiation Therapy for Patients Triple Negative Breast Cancer (TNBC)

Completed·IInstitut Curie·Phase 1·NCT03109080·24 enrolled

PHOENIX DDR/Anti-PD-L1 Trial: A Pre-surgical Window of Opportunity and Post-surgical Adjuvant Biomarker Study of DNA Damage Response Inhibition With or Without Anti-PD-L1 Immunotherapy in Patients With Neoadjuvant Treatment Resistant Residual Triple Negative Breast Cancer

Recruiting·IInstitute of Cancer Research, United Kingdom·Phase 2·NCT03740893·119 enrolled

Olaparib In Metastatic Breast Cancer

Active, not recruiting·—·Phase 2·NCT03344965·114 enrolled

Olaparib Maintenance Therapy in Metastatic Breast Cancer

Unknown status·NNational Taiwan University Hospital·Phase 2·NCT05629429·300 enrolled

Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC)

Not yet recruiting·AAHS Cancer Control Alberta·Phase 2·NCT05128734·40 enrolled

Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer

Completed·YYuan Yuan·Phase 2·NCT03025035·14 enrolled

Prostate Cancer15 trials

A Study of Olaparib and Durvalumab in Prostate Cancer

Terminated·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT03810105·5 enrolled

Phase II Study of PARP Inhibitor Olaparib and IV Ascorbate in Castration Resistant Prostate Cancer

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT05501548·4 enrolled

Durvalumab and Olaparib for the Treatment of Prostate Cancer in Men Predicted to Have a High Neoantigen Load

Terminated·UUniversity of Washington·Phase 2·NCT04336943·6 enrolled

Show 12 more trials

BrUOG 337: Olaparib Prior to Radical Prostatectomy For Advanced Prostate Cancer Defects in DNA Repair Genes

Terminated·—·Phase 2·NCT03432897·1 enrolled

Abiraterone/Prednisone, Olaparib, or Abiraterone/Prednisone + Olaparib in Patients With Metastatic Castration-Resistant Prostate Cancer With DNA Repair Defects

Active, not recruiting·NNorthwestern University·Phase 2·NCT03012321·70 enrolled

Clinical Outcomes of Use of Olaparib in Castration Resistant Prostate Cancer

Recruiting·SSanta Chiara Hospital··NCT06783127·3,000 enrolled

Ph II Study to Evaluate Olaparib With Abiraterone in Treating Metastatic Castration Resistant Prostate Cancer.

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01972217·158 enrolled

Study of Pembrolizumab (MK-3475) Plus Olaparib Versus Abiraterone Acetate or Enzalutamide in Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-7339-010/KEYLYNK-010)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT03834519·793 enrolled

Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis

Active, not recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT03047135·51 enrolled

Study of Olaparib (± Degarelix) Given to Men With Intermediate/High Risk Prostate Cancer Before Prostatectomy

Completed·—·Phase 1·NCT02324998·20 enrolled

TOPARP: A Phase II Trial of Olaparib in Patients With Advanced Castration Resistant Prostate Cancer

Unknown status·IInstitute of Cancer Research, United Kingdom·Phase 2·NCT01682772·148 enrolled

Targeting Resistant Prostate Cancer With ATR and PARP Inhibition (TRAP Trial)

Active, not recruiting·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT03787680·49 enrolled

Testosterone and Olaparib in Treating Patients With Castration-Resistant Prostate Cancer

Completed·UUniversity of Washington·Phase 2·NCT03516812·36 enrolled

Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer

Terminated·UUniversity of Washington·Phase 2·NCT03570476·2 enrolled

Clinical Study to Assess the Efficacy and Safety of Olaparib in Chinese Patients With Metastatic Castration-Resistant Prostate Cancer Who Have Failed Prior Treatment With a New Hormonal Agent and Have BRCA1/2 Mutations

Completed· AstraZeneca logo

AstraZeneca·Phase 4·NCT05457257·43 enrolled

Gastric Cancer5 trials

Efficacy and Safety Study of Olaparib in Combination With Paclitaxel to Treat Advanced Gastric Cancer.

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT01924533·525 enrolled

Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers

Active, not recruiting·UUniversity of Colorado, Denver·Phase 2·NCT05379972·9 enrolled

A Translational Study of Single Agent Olaparib in the Treatment of Advanced Oesophagogastric Cancer

Unknown status·RRoyal Marsden NHS Foundation Trust·Phase 2·NCT03829345·54 enrolled

Show 2 more trials

Biomarker-oriented Study of Durvalumab (MEDI4736) in Combination With Olaparib and Paclitaxel in Gastric Cancer

Active, not recruiting·DDo-Youn Oh·Phase 2·NCT03579784·40 enrolled

Efficacy Study of Olaparib With Paclitaxel Versus Paclitaxel in Gastric Cancer Patients

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01063517·124 enrolled

Trial5 trials

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR)

Recruiting·CCanadian Cancer Trials Group·Phase 2·NCT03297606·720 enrolled

NUVOLA TRIAL Open-label Multicentre Study

Unknown status·FFondazione Policlinico Universitario Agostino Gemelli IRCCS·Phase 2·NCT04261465·35 enrolled

Show 2 more trials

Trial of Olaparib in Combination with AZD5363 (ComPAKT)

Completed·RRoyal Marsden NHS Foundation Trust·Phase 1·NCT02338622·60 enrolled

Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial

Terminated·OOHSU Knight Cancer Institute·Phase 1·NCT03878524·2 enrolled

86 more indications

Small Cell Lung Cancer5 trials

Olaparib and Bevacizumab in Relapsed Small Cell Lung Cancer Subjects

Completed·SSe-Hoon Lee·Phase 2·NCT04939662·25 enrolled

Radiotherapy and Durvalumab/Durvalumab Combo (Tremelimumab/Olaparid) for Small Cell Lung Cancer

Active, not recruiting·HH. Lee Moffitt Cancer Center and Research Institute·Phase 1·NCT03923270·25 enrolled

A Study of Olaparib and Low Dose Radiotherapy for Small Cell Lung Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT03532880·26 enrolled

Show 2 more trials

Study of Olaparib and Temozolomide in Patients With Recurrent Small Cell Lung Cancer Following Failure of Prior Chemotherapy

Unknown status·ZZofia Piotrowska·Phase 1/2·NCT02446704·66 enrolled

Study of AZD6738 and Olaparib Combination Therapy in Relapsed Small Cell Lung Cancer Patients [SUKSES-N2]

Completed·SSamsung Medical Center·Phase 2·NCT03428607·26 enrolled

Advanced Solid Tumours5 trials

Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal or Impaired Kidney Function

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01894256·56 enrolled

A Study Using Olaparib Tablets for Subjects With Advanced Solid Tumours.

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT03553108·18 enrolled

Study to Assess the Effect of Rifampicin (CYP Inducer) on Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01929603·32 enrolled

Show 2 more trials

To Assess the Effect of Itraconazole (a CYP3A4 Inhibitor) on the Pharmacokinetics of Olaparib, and the Effect of Olaparib on QT Interval Following Oral Dosing of a Tablet Formulation to Patients With Advanced Solid Tumours

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01900028·85 enrolled

Study to Assess the Blood Levels and Safety of Olaparib in Patients With Advanced Solid Tumours and Normal Liver Function or Mild or Moderate Liver Impairment

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01894243·31 enrolled

Pancreatic Cancer5 trials

Olaparib and Durvalumab (MEDI4736) in Patients with Metastatic Pancreatic Cancer and DNA Damage Repair Genes Alterations

Active, not recruiting·SSpanish Cooperative Group for the Treatment of Digestive Tumours (TTD)·Phase 2·NCT05659914·40 enrolled

Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy

Completed· AstraZeneca logo

AstraZeneca·Phase 3·NCT02184195·154 enrolled

Pembrolizumab With Olaparib as Combined Therapy in Metastatic Pancreatic Cancer

Recruiting·—·Phase 2·NCT05093231·20 enrolled

Show 2 more trials

Efficacy and Safety of PARPi to Treat Pancreatic Cancer

Completed·SSheba Medical Center·Phase 2·NCT02511223·24 enrolled

A Precision Medicine Approach (SMMART-ACT) for the Treatment of Patients With Advanced Sarcoma, Prostate, Breast, Ovarian or Pancreatic Cancer

Active, not recruiting·OOHSU Knight Cancer Institute·Phase 2·NCT06630325·30 enrolled

Non-Small Cell Lung Cancer4 trials

Trial Evaluating Maintenance Olaparib in Patients With Platinum-sensitive Advanced Non-small Cell Lung Cancer

Unknown status·GGustave Roussy, Cancer Campus, Grand Paris·Phase 2·NCT02679963·600 enrolled

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)

Active, not recruiting· Merck & Co. logo

Merck & Co.·Phase 3·NCT04380636·870 enrolled

Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mutated Advanced Solid Tumors, With a Focus on Gynecological, Breast, Pancreatic and KEAP1 Mutated Non-small Cell Lung Cancers

Recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT06130254·52 enrolled

Show 1 more trial

A Study of Pembrolizumab (MK-3475) With or Without Maintenance Olaparib in First-line Metastatic Squamous Non-small Cell Lung Cancer (NSCLC, MK-7339-008/KEYLYNK-008)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT03976362·851 enrolled

Endometrial Cancer4 trials

A Study of Pembrolizumab and Olaparib in People With Endometrial Cancer or Endometrial Carcinosarcoma

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT05156268·26 enrolled

Does Cediranib With Paclitaxel, or Cediranib and Olaparib, Treat Advanced Endometrial Cancer Better Than Paclitaxel?

Unknown status·UUniversity of Manchester·Phase 2·NCT03570437·124 enrolled

Safety and Efficacy of Metronomic Cyclophosphamide, Metformin and Olaparib in Endometrial Cancer Patients

Completed·HHospices Civils de Lyon·Phase 1/2·NCT02755844·35 enrolled

Show 1 more trial

Refining Adjuvant Treatment in Endometrial Cancer Based on Molecular Features

Recruiting·LLeiden University Medical Center·Phase 2/3·NCT05255653·1,615 enrolled

Patients With Advanced Solid Tumors4 trials

Testing the Sequential Combination of the Anti-cancer Drugs Olaparib Followed by Adavosertib (AZD1775) in Patients With Advanced Solid Tumors With Selected Mutations and PARP Resistance, STAR Study

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04197713·13 enrolled

Combination Study of Prexasertib and Olaparib in Patients With Advanced Solid Tumors

Completed·—·Phase 1·NCT03057145·29 enrolled

Study of LP-184 in Patients With Advanced Solid Tumors

Recruiting·LLantern Pharma Inc.·Phase 1/2·NCT05933265·175 enrolled

Show 1 more trial

A Phase 1 Study of RO7623066 Alone and in Combination in Patients With Advanced Solid Tumors

Completed· Roche logo

Roche·Phase 1·NCT05240898·116 enrolled

PARP Inhibitor4 trials

Study in Children and Adolescents of 177Lu-DOTATATE (Lutathera®) Combined with the PARP Inhibitor Olaparib for the Treatment of Recurrent or Relapsed Solid Tumours Expressing Somatostatin Receptor (SSTR) (LuPARPed).

Recruiting·FFundación de investigación HM·Phase 2·NCT06607692·25 enrolled

Study to Evaluate TNG348 Alone and With a PARP Inhibitor in Patients With BRCA 1/2 Mutant or HRD+ Solid Tumors

Terminated·TTango Therapeutics, Inc.·Phase 1/2·NCT06065059·7 enrolled

Improving Peptide Receptor Radionuclide Therapy With PARP Inhibitors

Recruiting·EErasmus Medical Center·Phase 1·NCT05870423·24 enrolled

Show 1 more trial

Pharmacodynamic Study to Assess the Anti-proliferative Activity of the PARP Inhibitor Olaparib in Patients With HPV Positive and HPV Negative HNSCC

Withdrawn·YYale University·Phase 1·NCT02686008

Advanced Solid Tumors3 trials

A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors

Recruiting·EExelixis·Phase 1·NCT05932862·429 enrolled

Phase 1 Trial of RP-3467 Alone and in Combination With Olaparib in Participants With Advanced Solid Tumors

Terminated·RRepare Therapeutics·Phase 1·NCT06560632·26 enrolled

A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02498613·122 enrolled

Solid Tumors3 trials

Study of Olaparib/Trabectedin vs. Doctor's Choice in Solid Tumors

Completed·NNational Center for Tumor Diseases, Heidelberg·Phase 2·NCT03127215·102 enrolled

EIS-12656 as Single Agent and in Combination in Patients With Specified Solid Tumors

Recruiting·EEisbach Bio GmbH·Phase 1/2·NCT06525298·144 enrolled

Selumetinib and Olaparib in Solid Tumors

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT03162627·90 enrolled

Colorectal Cancer2 trials

Pembrolizumab and Olaparib in Homologous-recombination Deficient (HRD) Advanced Colorectal Cancer (CRC).

Unknown status·GGrupo Espanol Multidisciplinario del Cancer Digestivo·Phase 2·NCT05201612·40 enrolled

Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00912743·33 enrolled

Bladder Cancer2 trials

Open-Label, Randomised, Multi-Drug, Biomarker-Directed, Phase 1b Study in Pts w/ Muscle Invasive Bladder Cancer

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 1·NCT02546661·117 enrolled

Durvalumab Plus Olaparib Administered Prior to Surgery of Resectable Urothelial Bladder Cancer (NEODURVARIB)

Completed·SSpanish Oncology Genito-Urinary Group·Phase 2·NCT03534492·29 enrolled

Biliary Tract Cancer2 trials

Olaparib With or Without Durvalumab for DDR Gene Mutated Biliary Tract Cancer Following Platinum-based Chemotherapy

Recruiting·—·Phase 2·NCT05222971·62 enrolled

Olaparib in Treating Patients With Metastatic Biliary Tract Cancer With Aberrant DNA Repair Gene Mutations

Unknown status·—·Phase 2·NCT04042831·36 enrolled

Pembrolizumab2 trials

Pembrolizumab Plus Olaparib in LA-HNSCC

Active, not recruiting·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT05366166·45 enrolled

Pembrolizumab, Olaparib, Recurrent/Advanced Gastric and Gastro-esophageal Junction(GEJ) Cancer

Recruiting·YYonsei University·Phase 1/2·NCT04592211·71 enrolled

Treatment2 trials

SMMART Adaptive Clinical Treatment (ACT) Trial

Withdrawn·OOHSU Knight Cancer Institute·Phase 1·NCT05238831

Olaparib Maintenance in Patients With MCRPC After Docetaxel Treatment Reaching Partial or Stable Response (IMANOL)

Completed·SSpanish Oncology Genito-Urinary Group·Phase 2·NCT03434158·16 enrolled

Maintenance Therapy2 trials

First-line Olaparib Combined With Bevacizumab Maintenance Therapy

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University··NCT05440578·50 enrolled

Outcomes of First-line Olaparib Mono-maintenance therapy-a Multicenter, Retrospective Study Using Data From Real-world Clinical Setting

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University··NCT05153603·50 enrolled

Metastatic Colorectal Cancer2 trials

AZD2281 and Irinotecan in Treating Patients With Locally Advanced or Metastatic Colorectal Cancer

Completed·NNCIC Clinical Trials Group·Phase 1·NCT00535353·26 enrolled

Efficacy and Safety of Olaparib (MK-7339) With or Without Bevacizumab Compared to Bevacizumab With a Fluoropyrimidine in Unresectable or Metastatic Colorectal Cancer (CRC) (MK-7339-003/LYNK-003)

Completed· Merck & Co. logo

Merck & Co.·Phase 3·NCT04456699·335 enrolled

Efficacy and Safety2 trials

Open Label Study to Assess Efficacy and Safety of Olaparib in Confirmed Genetic BRCA1 or BRCA2 Mutation Pats

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT01078662·298 enrolled

Evaluating the Efficacy and Safety of Fulvestrant Plus DNA Damage Repair Inhibitors After a CDK4/6 Inhibitor

Recruiting·SSeoul National University Hospital·Phase 2·NCT05536128·64 enrolled

Ewing's Sarcoma2 trials

Phase I Study of Olaparib and Temozolomide for Ewings Sarcoma or Rhabdoomyosarcoma

Completed·MMassachusetts General Hospital·Phase 1·NCT01858168·49 enrolled

Olaparib in Adults With Recurrent/Metastatic Ewing's Sarcoma

Completed·MMassachusetts General Hospital·Phase 2·NCT01583543·12 enrolled

Fallopian Tube Cancer2 trials

Olaparib and Entinostat in Patients With Recurrent, Platinum-Refractory, Resistant Ovarian, Primary Peritoneal, Fallopian Tube Cancers

Terminated·VVanderbilt-Ingram Cancer Center·Phase 1·NCT03924245·3 enrolled

Dose-Escalation Study of Intraperitoneal (IP) Cisplatin, IV/IP Paclitaxel, IV Bevacizumab, and Oral Olaparib for Newly Diagnosed Ovarian, Primary Peritoneal, and Fallopian Tube Cancer

Completed·MMemorial Sloan Kettering Cancer Center·Phase 1·NCT02121990·17 enrolled

Cervical Cancer2 trials

Pembrolizumab Plus Olaparib in Patients With Recurrent Cervical Cancer

Unknown status·—·Phase 2·NCT04641728·28 enrolled

Pembrolizumab and Olaparib in Cervical Cancer Patients

Terminated·BBaptist Health South Florida·Phase 2·NCT04483544·8 enrolled

Metastatic Sarcoma1 trial

Trabectedin in Combination With Olaparib in Advanced Unresectable or Metastatic Sarcoma

Completed·UUniversity of Michigan Rogel Cancer Center·Phase 2·NCT04076579·29 enrolled

Metastatic NSCLC1 trial

SAFIR02_Lung - Efficacy of Targeted Drugs Guided by Genomic Profiles in Metastatic NSCLC Patients

Completed·UUNICANCER·Phase 2·NCT02117167·999 enrolled

Squamous Cell Carcinoma1 trial

Phase I Study of Olaparib With Cisplatin Based Chemoradiotherapy in Squamous Cell Carcinoma of the Head and Neck

Withdrawn·UUniversity College, London·Phase 1·NCT01491139

Carboplatin1 trial

Olaparib in Combination With Carboplatin for Refractory or Recurrent Women s Cancers

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT01237067·77 enrolled

Pilot Study1 trial

Olaparib for PAH: a Pilot Study

Terminated·LLaval University·Phase 1·NCT03251872·6 enrolled

Head and Neck Squamous Cell Carcinoma1 trial

A Study to Investigate Biomarker Effects of Pre-Surgical Treatment With DNA Damage Repair (DDR) Agents in Patients With Head and Neck Squamous Cell Carcinoma (HNSCC).

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT03022409·21 enrolled

Solid Tumour1 trial

The Pharmacokinetics and Safety of Olaparib Alone and With Paclitaxel in Chinese Patients With Advanced Solid Tumour.

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02430311·36 enrolled

HRR Gene Mutation1 trial

The Study of Olaparib in Newly Diagnosed mCRPC Patients With HRR Gene Mutation

Unknown status·SSun Yat-Sen Memorial Hospital of Sun Yat-Sen University·Phase 2·NCT05262608·30 enrolled

Newly Diagnosed1 trial

Study of Pamiparib in Newly Diagnosed and rGBM

Active, not recruiting·NNader Sanai·Phase 1·NCT04614909·45 enrolled

Primary Peritoneal Carcinoma1 trial

Study of Tremelimumab Alone or Combined With Olaparib for Patients With Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma)

Terminated·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 1·NCT02485990·24 enrolled

Urothelial Carcinoma1 trial

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·LLatin American Cooperative Oncology Group·Phase 2·NCT04579133·140 enrolled

Metastatic Urothelial Cancer1 trial

Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations

Completed·MMatthew Galsky·Phase 2·NCT03448718·19 enrolled

Gynaecological Cancers1 trial

ATr Inhibitor in Combination With Olaparib/Durvalumab (MEDI4736) in Gynaecological Cancers With ARId1A Loss or no Loss

Active, not recruiting·IInstitute of Cancer Research, United Kingdom·Phase 2·NCT04065269·174 enrolled

Outcome1 trial

Olaparib Real-world Utilization and Clinical Outcomes in France, Italy, and the UK

Completed· AstraZeneca logo

AstraZeneca··NCT04532645·342 enrolled

Hypertension1 trial

Arterial Hypertension Related to PARP Inhibitors (ArteRIB)

Completed·UUniversity Hospital, Caen··NCT04774406·2,336 enrolled

Immunotherapy1 trial

Study Evaluating the Efficacy of a Double Immunotherapy Combined With Olaparib in Patients With Solid Cancers and Carriers of Homologous Recombination Repair Genes After Olaparib Treatment

Active, not recruiting·CCentre Georges Francois Leclerc·Phase 2·NCT04169841·270 enrolled

Fed1 trial

Bioequivalence Study of Olaparib Tablets Under Fasting and Fed Conditions in Healthy Subjects

Completed·CCSPC Ouyi Pharmaceutical Co., Ltd.·Phase 1·NCT06360445·102 enrolled

RCT1 trial

D9319C00001- 1L OC Mono Global RCT

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04884360·366 enrolled

Head and Neck Cancer1 trial

Olaparib and Radiotherapy in Head and Neck Cancer

Unknown status·TThe Netherlands Cancer Institute·Phase 1·NCT02229656·12 enrolled

Cancer1 trial

OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults

Unknown status·UUniversity Medical Center Groningen·Phase 4·NCT05949424·30 enrolled

Advanced Head and Neck Cancer1 trial

Study of Olaparib With Radiation Therapy and Cetuximab in Advanced Head and Neck Cancer With Heavy Smoking History

Completed·UUniversity of Colorado, Denver·Phase 1·NCT01758731·17 enrolled

Melanoma1 trial

Phase II Study of Olaparib and Pembrolizumab in Advanced Melanoma With Homologous Recombination (HR) Mutation

Unknown status·—·Phase 2·NCT04633902·41 enrolled

Metastatic Melanoma1 trial

Olaparib in Unresectable/Metastatic Melanoma With BRCA1/2

Withdrawn·—·Phase 2·NCT05482074

Lymphoma1 trial

AZD5153 in Patients With Relapsed or Refractory Solid Tumors, Including Lymphomas

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT03205176·49 enrolled

Advanced Malignancies1 trial

Phase IB Study to Evaluate the Safety of Selinexor (KPT-330) in Combination With Multiple Standard Chemotherapy or Immunotherapy Agents in Patients With Advanced Malignancies

Terminated·MM.D. Anderson Cancer Center·Phase 1·NCT02419495·221 enrolled

Glioma1 trial

Phase I/IIa Study of Concomitant Radiotherapy With Olaparib and Temozolomide in Unresectable High Grade Gliomas Patients

Active, not recruiting·CCentre Francois Baclesse·Phase 1/2·NCT03212742·91 enrolled

Lung Cancer1 trial

Maintenance Durvalumab (MEDI4736) and Olaparib (AZD2281) After Standard 1st Line Treatment (Carboplatin/Cisplatin, Etoposide, Durvalumab) in HRD Positive Extensive Disease (ED) Small-cell Lung Cancer (SCLC)

Enrolling by invitation·UUniversity of Cologne·Phase 2·NCT06419179·29 enrolled

Advanced Solid Malignancies1 trial

Investigate the Safety and Tolerability of Olaparib Tablet in Japanese Patients With Advanced Solid Malignancies

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01813474·23 enrolled

Gastroesophageal Junction Cancer1 trial

Olaparib and Ramucirumab in Treating Patients With Metastatic or Locally Recurrent Gastric or Gastroesophageal Junction Cancer That Cannot Be Removed by Surgery

Completed·NNational Cancer Institute (NCI)·Phase 1/2·NCT03008278·51 enrolled

Active, not recruiting·UUniversity College, London·Phase 1·NCT02308072·70 enrolled

Solid Tumours1 trial

D081AC00001 Food Interaction With Olaparib Capsule in Patients With Solid Tumours

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT01851265·32 enrolled

Cancer of Unknown Primary Site1 trial

A Phase II Randomized Study Comparing the Efficacy and Safety of Targeted Therapy or Cancer Immunotherapy Versus Platinum-Based Chemotherapy in Patients With Cancer of Unknown Primary Site

Completed· Roche logo

Roche·Phase 2·NCT03498521·529 enrolled

Head and Neck1 trial

Preoperative Administration of Olaparib With Cisplatin or With Durvalumab or Alone or no Tratment in Patients Who Are Candidates for Surgery of Carcinoma of the Head and Neck.

Completed·HHellenic Cooperative Oncology Group·Phase 2·NCT02882308·41 enrolled

Triple-Negative Breast Cancer1 trial

Olaparib and Onalespib in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery or Recurrent Ovarian, Fallopian Tube, Primary Peritoneal, or Triple-Negative Breast Cancer

Completed·NNational Cancer Institute (NCI)·Phase 1·NCT02898207·28 enrolled

Bevacizumab1 trial

Status of HRD That Lead to a Benefit From Olaparib in Combination With Bevacizumab (STROBE Trial)

Recruiting·VVall d'Hebron Institute of Oncology·Phase 2·NCT06377267·100 enrolled

Recurrent1 trial

Best Approach in Recurrent-Ovarian-Cancer-with Cediranib-Olaparib

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 2·NCT03314740·123 enrolled

Nab-paclitaxel1 trial

Induction of Cisplatin/Nab-paclitaxel/Pembrolizumab Followed by Olaparib/Pembrolizumab Maintenance in mTNBC Patients

Unknown status·FFudan University·Phase 2·NCT05174832·136 enrolled

Oncology1 trial

Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 3·NCT04421963·185 enrolled

Soft Tissue Sarcoma1 trial

A Study of Olaparib With Concomitant Radiotherapy in Locally Advanced/Unresectable Soft-tissue Sarcoma

Completed·IInstitut Bergonié·Phase 1·NCT02787642·41 enrolled

Tic Disorder1 trial

Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial)

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03233204·6 enrolled

Clinical Trial1 trial

Olaparib for PAH: a Multicenter Clinical Trial

Terminated·LLaval University·Phase 1/2·NCT03782818·17 enrolled

Refractory Solid Tumors1 trial

AZD1775 Combined With Olaparib in Patients With Refractory Solid Tumors

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02511795·128 enrolled

Effectiveness1 trial

Pharmacokinetic Boosting of Olaparib to Improve Exposure, Tolerance and Cost-effectiveness

Recruiting·RRadboud University Medical Center·Phase 4·NCT05078671·160 enrolled

Chronic Lymphocytic Leukemia1 trial

RP-3500 and Olaparib in DNA Damage Repair Pathway Deficient Relapsed/Refractory Chronic Lymphocytic Leukemia

Terminated·UUniversity of Utah·Phase 1/2·NCT05405309·5 enrolled

Advanced Cancer1 trial

Study to Assess the Safety and Preliminary Efficacy of AZD0156 at Increasing Doses Alone or in Combination With Other Anti-cancer Treatment in Patients With Advanced Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02588105·84 enrolled

Malignant Mesothelioma1 trial

Olaparib in Patients With HRD Malignant Mesothelioma

Recruiting·UUniversity of Chicago·Phase 2·NCT04515836·56 enrolled

Gynecologic Cancers1 trial

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

Recruiting· AbbVie logo

AbbVie·Phase 2·NCT07024784·377 enrolled

Recurrent or Metastatic1 trial

Olaparib in Combination With Pembrolizumab and Carboplatin as First-Line Treatment of Recurrent or Metastatic Head and Neck Squamous-Cell Carcinoma

Active, not recruiting·WWashington University School of Medicine·Phase 2·NCT04643379·30 enrolled

Phase 21 trial

AMTEC IIT: Phase 2 Multiarm Study in TNBC

Terminated·—·Phase 2·NCT03801369·24 enrolled

Durvalumab1 trial

WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC

Recruiting·AAGO Research GmbH·Phase 2·NCT04644289·60 enrolled

Randomized1 trial

IMPACT: A Randomized WOO Study of Novel Therapeutic Agents in Women Triaged to Primary Surgery for EOC

Completed·HHaukeland University Hospital·Phase 1·NCT03378297·26 enrolled

Safety and Efficacy1 trial

Study to Assess Safety and Efficacy of AsiDNA in Combination with Olaparib in Participants with Recurrent Solid Tumors

Completed·VValerio Therapeutics·Phase 1/2·NCT05700669·3 enrolled

Ovarian Carcinoma1 trial

Olaparib After Response to Trabectedin-pegylated Liposomal Doxorubicin in Recurrent Ovarian Carcinoma

Completed·GGrupo Español de Investigación en Cáncer de Ovario·Phase 2·NCT03470805·9 enrolled

Glioblastoma1 trial

Olaparib and Temozolomide in Treating Patients With Relapsed Glioblastoma

Completed·CCancer Research UK·Phase 1·NCT01390571·34 enrolled

Advanced1 trial

Study to Evaluate CCS1477 in Advanced Tumours

Completed·CCellCentric Ltd.·Phase 1/2·NCT03568656·220 enrolled

Advanced Solid Cancer1 trial

To Assess Safety and Effect of Olaparib on the Pharmacokinetics of Anastrozole, Letrozole & Tamoxifen, and Their Effect on Olaparib, in Patients With Advanced Solid Cancer

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT02093351·79 enrolled

Pancreatic Ductal Adenocarcinoma1 trial

A Study of Pembrolizumab and Olaparib for People With Metastatic Pancreatic Ductal Adenocarcinoma and Homologous Recombination Deficiency or Exceptional Treatment Response to Platinum-Based Therapy

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04666740·63 enrolled

Prostate Adenocarcinoma1 trial

Olaparib for the Treatment of Castration Resistant Prostate Adenocarcinoma

Terminated·UUniversity of Washington·Phase 2·NCT04951492·2 enrolled

Phase II1 trial

Phase II Umbrella Study of Novel Anti-cancer Agents in Participants With NSCLC Who Progressed on an Anti-PD-1/PD-L1 Containing Therapy

Active, not recruiting· AstraZeneca logo

AstraZeneca·Phase 2·NCT03334617·528 enrolled

Cholangiocarcinoma1 trial

Phase II Study of the Combination of Durvalumab (MEDI4736) (PDL1 Inhibitor) and Olaparib (PARP Inhibitor) in Advanced Cholangiocarcinoma After Initial Chemotherapy and Durvalumab (BIL-PPP)

Recruiting·AAustralasian Gastro-Intestinal Trials Group·Phase 2·NCT06441747·40 enrolled

Chemotherapy1 trial

Multi-agent Low Dose Chemotherapy GAX-CI Followed by Olaparib and Pembro in Metastatic Pancreatic Ductal Cancer.

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT04753879·38 enrolled

Renal Cell Carcinoma1 trial

Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations

Recruiting·SSidney Kimmel Comprehensive Cancer Center at Johns Hopkins·Phase 2·NCT03786796·20 enrolled

Primary Peritoneal Cancer1 trial

Olaparib, Durvalumab, and Tremelimumab in Treating Patients With Recurrent or Refractory Ovarian, Fallopian Tube or Primary Peritoneal Cancer With BRCA1 or BRCA2 Mutation

Completed·RRoswell Park Cancer Institute·Phase 2·NCT02953457·40 enrolled

Unspecified1 trial

Platine, Avastin and OLAparib in 1st Line

Completed·AArcagy Research·Phase 3·NCT02477644·806 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 19, 2014

LYNPARZA

NDA NDA206162

Aug 17, 2017

LYNPARZA

NDA NDA208558

Aug 17, 2017

LYNPARZA

NDA NDA208558

Feb 6, 2018

LYNPARZA

NDA NDA208558

Sep 26, 2018

LYNPARZA

NDA NDA208558

Dec 19, 2018

LYNPARZA

NDA NDA208558

Jul 1, 2019

LYNPARZA

NDA NDA208558

Oct 11, 2019

LYNPARZA

NDA NDA208558

Dec 27, 2019

LYNPARZA

NDA NDA208558

May 8, 2020

LYNPARZA

NDA NDA208558

May 19, 2020

LYNPARZA

NDA NDA208558

Nov 2, 2020

LYNPARZA

NDA NDA208558

Dec 7, 2020

LYNPARZA

NDA NDA208558

Mar 11, 2021

LYNPARZA

NDA NDA208558

Mar 11, 2021

LYNPARZA

NDA NDA208558

Jan 31, 2022

LYNPARZA

NDA NDA208558

Mar 11, 2022

LYNPARZA

NDA NDA208558

Aug 26, 2022

LYNPARZA

NDA NDA208558

Oct 27, 2022

LYNPARZA

NDA NDA208558

May 31, 2023

LYNPARZA

NDA NDA208558

Sep 12, 2023

LYNPARZA

NDA NDA208558

Nov 6, 2023

LYNPARZA

NDA NDA208558

Jul 10, 2025

LYNPARZA

NDA NDA208558

Sources

References

[1]
ClinicalTrials.gov — 372 trial records for Olaparib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Lynparza drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Olaparib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Olaparib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA208558). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Lynparza. U.S. Food & Drug Administration.
[7]
PubMed — 2 publications indexed for Olaparib. U.S. National Library of Medicine.
[8]
SEC EDGAR — AstraZeneca company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: PARP Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: AstraZeneca

Patent Landscape[6]

Patent Cliff

Sep 8, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7449464Sep 8, 2027

8247416Sep 24, 2028

11975001Oct 7, 2029

11633396Oct 7, 2029

12144810Oct 7, 2029

4 more patents

12048695Oct 7, 2029

12178816Oct 7, 2029

8475842Dec 31, 2029

11970530Oct 25, 2041

Key Publications[7]

Adjuvant Olaparib for BRCA-Mutated Breast Cancer: OlympiA Overall Survival

N Engl J MedDec 8, 2022DOI: 10.1056/NEJMoa2208644

Olaparib Plus Abiraterone in Metastatic Castration-Resistant Prostate Cancer

Lancet OncolAug 1, 2022DOI: 10.1016/S1470-2045(22)00432-1

Lynparza

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2026

Trials by Indication[1]

Ovarian Cancer26 trials

Breast Cancer24 trials

Prostate Cancer15 trials

Gastric Cancer5 trials

Trial5 trials

Small Cell Lung Cancer5 trials

Advanced Solid Tumours5 trials

Pancreatic Cancer5 trials

Non-Small Cell Lung Cancer4 trials

Endometrial Cancer4 trials

Patients With Advanced Solid Tumors4 trials

PARP Inhibitor4 trials

Advanced Solid Tumors3 trials

Solid Tumors3 trials

Colorectal Cancer2 trials

Bladder Cancer2 trials

Biliary Tract Cancer2 trials

Pembrolizumab2 trials

Treatment2 trials

Maintenance Therapy2 trials

Metastatic Colorectal Cancer2 trials

Efficacy and Safety2 trials

Ewing's Sarcoma2 trials

Fallopian Tube Cancer2 trials

Cervical Cancer2 trials

Metastatic Sarcoma1 trial

Metastatic NSCLC1 trial

Squamous Cell Carcinoma1 trial

Carboplatin1 trial

Pilot Study1 trial

Head and Neck Squamous Cell Carcinoma1 trial

Solid Tumour1 trial

HRR Gene Mutation1 trial

Newly Diagnosed1 trial

Primary Peritoneal Carcinoma1 trial

Urothelial Carcinoma1 trial

Metastatic Urothelial Cancer1 trial

Gynaecological Cancers1 trial

Outcome1 trial

Hypertension1 trial

Immunotherapy1 trial

Fed1 trial

RCT1 trial

Head and Neck Cancer1 trial

Cancer1 trial

Advanced Head and Neck Cancer1 trial

Melanoma1 trial

Metastatic Melanoma1 trial

Lymphoma1 trial

Advanced Malignancies1 trial

Glioma1 trial

Lung Cancer1 trial

Advanced Solid Malignancies1 trial

Gastroesophageal Junction Cancer1 trial

Neoadjuvant1 trial

Germ Cell Tumor1 trial

Locally Advanced Head and Neck Cancer1 trial

Solid Tumours1 trial

Cancer of Unknown Primary Site1 trial

Head and Neck1 trial

Triple-Negative Breast Cancer1 trial

Bevacizumab1 trial

Recurrent1 trial

Nab-paclitaxel1 trial

Oncology1 trial

Soft Tissue Sarcoma1 trial

Tic Disorder1 trial

Clinical Trial1 trial

Refractory Solid Tumors1 trial

Effectiveness1 trial

Chronic Lymphocytic Leukemia1 trial

Advanced Cancer1 trial

Malignant Mesothelioma1 trial