TheraRadar
Data updated: May 26, 2026

LYNPARZA (olaparib)

Poly(ADP-Ribose) Polymerase Inhibitors Genetic Support Trial Activity: Growth 145 active trials
Oncology Approved 2014-12-19

LYNPARZA is indicated for the treatment of Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer; Breast Cancer.

Source: FDA Label • AstraZeneca • Poly(ADP-Ribose) Polymerase Inhibitor
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How LYNPARZA Works

Olaparib inhibits PARP enzymes, including PARP1, PARP2, and PARP3, which are involved in normal cellular functions such as DNA transcription and repair. The drug blocks PARP enzymatic activity and increases the formation of PARP-DNA complexes, resulting in DNA damage and cancer cell death. This cytotoxic activity is most effective in tumor cells with deficiencies in homologous recombination repair genes, such as BRCA1/2 or ATM. In certain models, the drug also contributes to the regulation of androgen receptor activity.

Source: FDA Label

Development Insights

National Cancer Institute (NCI) conducting 44 trials (16%)
610 indications explored (Broad Platform)
→ ovarian cancer (27 trials)
→ breast cancer (22 trials)
→ prostate cancer (12 trials)
16
Indications
--
Phase 3 Trials
11
Priority Reviews
11
Years on Market

Details

Status
Prescription
First Approved
2014-12-19
Patent Cliff
2041
Revenue
$878M (Q4-2025)

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
TABLET, CAPSULE

Companies

AstraZeneca
Active Ingredient: OLAPARIB

LYNPARZA Approval History

2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
51 FDA actions from 2014 to 2025 · 14 indication expansions
Jul 2025 SUPPL
Label · Labeling
FDA Letter Label
Nov 2023 SUPPL
Efficacy
FDA Letter Label
Sep 2023 SUPPL
Label · Labeling
FDA Letter Label

What LYNPARZA Treats

4 indications

LYNPARZA is approved for 4 conditions since its original approval in 2014. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Breast Cancer
Source: FDA Label

LYNPARZA Target & Pathway

Pro

Target

PARP (Poly ADP-Ribose Polymerase) DNA Repair Enzyme

LYNPARZA Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

1

Same target(s) AND same indication — head-to-head.

TALZENNA
Pfizer
2018 2 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

BONCRESA
AMNEAL PHARMS
2025 3 indic.
CONJUGATED ESTROGENS
NOVAST LABS
2025 6 indic.
Unlock 8 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in LYNPARZA's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications LYNPARZA treats. First-in-class if their pivotal trials read out positive.

Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials
Tiragolumab MTIG7192A / RG6058 ~ Mixed — Ph3 readout
Hoffmann-La Roche
TIGIT · monoclonal antibody (anti-TIGIT) · 10 Phase 3 trials

Drugs Similar to LYNPARZA

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Shared indications:
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Shared indications:
Ovarian CancerFallopian Tube CancerPrimary Peritoneal Cancer
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Shared indications:
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📋

Clinical Trial Registry

266 trials
Trial Sponsor ID Phase Status Title
NCT04633239 NCI-2020-10084 NCI-2020-10084, 10422 Ph 1 recruiting Testing the Addition of Abemaciclib to Olaparib for Women With Recurrent Ovarian 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
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
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
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
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
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
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
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
NCT05411094 NCI-2022-04526 NCI-2022-04526, UMCC 2021.037 Ph 1 recruiting Testing the Safety of the Anti-Cancer Drugs Durvalumab and Olaparib During Radiation Therapy for Locally Advanced Unresectable Pancreatic Cancer
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
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)
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
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
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)
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)
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)
NCT02484404 150145 15-C-0145 Ph 1, Ph 2 active not recruiting Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
NCT06441747 BIL-PPP Ph 2 recruiting 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)
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
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
NCT06217757 SCS-Lung01 Ph 1, Ph 2 recruiting Safety and Tolerability of LDRT+Sugemalimab+Chemotherapy+Olaparib for First-Line Treatment of SLFN-11 Positive ES-SCLC
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)
NCT03740165 results posted 7339-001 ENGOT-ov43, MK-7339-001 Ph 3 completed Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036)
NCT05379972 results posted 21-4129.cc MK3475-A53 Ph 2 active not recruiting Study of SBRT/Olaparib Followed by Pembrolizumab/Olaparib in Gastric Cancers
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
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
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
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
NCT05933265 LTRN184-1AST23-1 Ph 1, Ph 2 active not recruiting Study of LP-184 in Patients With Advanced Solid Tumors
NCT02498613 results posted NCI-2015-01097 NCI-2015-01097, 1604017576 Ph 2 active not recruiting A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors
NCT03775486 ORION results posted D9102C00001 2018-003460-30 Ph 2 active not recruiting Study of Durvalumab+Olaparib or Durvalumab After Treatment With Durvalumab and Chemotherapy in Patients With Lung Cancer (ORION)
NCT05898399 ART6043C001 Ph 1, Ph 2 recruiting Study of ART6043 in Advanced/Metastatic Solid Tumors Patients (POLKA)
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
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
NCT02502266 results posted NCI-2015-00651 NCI-2015-00651, NRG-GY005 Ph 2, Ph 3 active not recruiting Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer
NCT04197713 results posted NCI-2019-08262 NCI-2019-08262, 10329 Ph 1 active not recruiting 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
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
NCT05156268 21-447 Ph 2 completed A Study of Pembrolizumab and Olaparib in People With Endometrial Cancer or Endometrial Carcinosarcoma
NCT03682289 189510 NCI-2018-01648 Ph 2 active not recruiting Ceralasertib (AZD6738) Alone and in Combination With Olaparib or Durvalumab in Patients With Solid Tumors
NCT04123366 7339-007 MK-7339-007, KEYLYNK-007 Ph 2 active not recruiting Study of Olaparib (MK-7339) in Combination With Pembrolizumab (MK-3475) in the Treatment of Homologous Recombination Repair Mutation (HRRm) and/or Homologous Recombination Deficiency (HRD)-Positive Advanced Cancer (MK-7339-007/KEYLYNK-007)
NCT05457257 results posted D081LC00002 Ph 4 active not recruiting 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
NCT02734004 MEDIOLA results posted D081KC00001 2015-004005-16 Ph 1, Ph 2 active not recruiting A Phase I/II Study of MEDI4736 in Combination With Olaparib in Patients With Advanced Solid Tumors.
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)
NCT06545942 MOMA-313-001 Ph 1 active not recruiting Study of Orally Administered MOMA-313 in Participants With Advanced or Metastatic Solid Tumors
NCT04421963 ROSY-O D0817C00098 2019-003777-26 Ph 3 active not recruiting Roll Over StudY for Patients Who Have Completed a Previous Oncology Study With Olaparib
NCT03162627 2016-1129 NCI-2018-01205 Ph 1 active not recruiting Selumetinib and Olaparib in Solid Tumors
NCT05238922 INCB 123667-101 2021-005357-91 Ph 1 recruiting Study of INCB123667 in Subjects With Advanced Solid Tumors
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

Showing 50 of 266 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

LYNPARZA FDA Label Details

Indications & Usage

FDA Label (PDF)

LYNPARZA is indicated for the treatment of Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer; Breast Cancer.

View full patent landscape →
12 OB patents · 6 families · 268 international docs across 47 countries

LYNPARZA Patents & Exclusivity

Latest Patent: Oct 2041
Exclusivity: May 2027

Patents (12 active)

US11970530 Expires Oct 25, 2041
US8859562 Expires Aug 4, 2031
US8475842 Expires Dec 31, 2029
US11975001 Expires Oct 7, 2029
US11633396 Expires Oct 7, 2029
US12048695 Expires Oct 7, 2029
US12178816 Expires Oct 7, 2029
US12144810 Expires Oct 7, 2029
US8247416 Expires Sep 24, 2028
US7449464 Expires Sep 8, 2027
US8143241 Expires Aug 12, 2027
US8071579 Expires Aug 12, 2027

Exclusivity

I-914 Until May 2026
ODE-283 Until Dec 2026
ODE-306 Until May 2027
I-914 Until May 2026
ODE-283 Until Dec 2026
ODE-306 Until May 2027
I-914 Until May 2026
ODE-283 Until Dec 2026
ODE-306 Until May 2027
I-914 Until May 2026
ODE-283 Until Dec 2026
ODE-306 Until May 2027
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for LYNPARZA

Revenue Insights

  • • Q4-2025: $878M
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2041
  • • 231 active patents

Trial Analysis

  • • 270 total trials
  • • Stage: Growth

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA208558 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment