Product Description
Olaparib (Lynparza [AstraZeneca, Cambridge, UK], formerly referred to as AZD2281 or KU0059436) is an oral poly(ADP-ribose) polymerase (PARP) inhibitor. It is rationally designed to act as a competitive inhibitor of NAD+ at the catalytic site of PARP1 and PARP2, both members of the PARP family of enzymes that are central to the repair of DNA single-strand breaks (SSBs) mediated via the base excision repair (BER) pathway. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/30069770/)
Mechanisms of Action: PARP Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Orphan Drug - Oncology Solid Tumor Unspecified|Pancreatic Cancer *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: AstraZeneca
Company Location: CAMBRIDGE X0 CB2 0AA
Company CEO: Pascal Soriot
Additional Commercial Interests: Merck
Clinical Description
Countries in Clinic: Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location, Vietnam
Active Clinical Trial Count: 174
Recent & Upcoming Milestones
- Clinical Outcomes Reported - AstraZeneca presented P3 Breast Cancer results on 2024-12-11 for Olaparib
Highest Development Phases
Phase 3: Breast Cancer|Colorectal Cancer|Endometrial Cancer|Endometrioid Carcinoma|Fallopian Tube Cancer|Lung Cancer|Non-Small-Cell Lung Cancer|Nose Cancer|Ovarian Cancer|Pancreatic Cancer|Peritoneal Cancer|Prostate Cancer|Serous Cystadenocarcinoma|Small Cell Lung Cancer|Squamous Cell Carcinoma|Triple Negative Breast Cancer
Phase 2: Abnormalities, Multiple|Adenocarcinoma|Bladder Cancer|Brain Cancer|Carcinosarcoma|Cervical Cancer|Cholangiocarcinoma|Clear Cell Adenocarcinoma|Clear Cell Sarcoma|DNA Repair-Deficiency Disorders|Esophageal Cancer|Gastrointestinal Cancer|Glioblastoma|Glioma|Head and Neck Cancer|Hodgkin Lymphoma|Kidney Cancer|Leiomyosarcoma|Liposarcoma|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Mesothelioma|Mixed Tumor, Mullerian|Mucinous Adenocarcinoma|Mucinous Cystadenocarcinoma|Multiple Myeloma|Oncology Solid Tumor Unspecified|Oncology Unspecified|Osteosarcoma|Pancreatic Ductal Carcinoma|Renal Cell Carcinoma|Sarcoma|Sarcoma, Experimental|Soft Tissue Cancer|T-Cell Peripheral Lymphoma|Transitional Cell Carcinoma|Uterine Cancer|Uveal Melanoma|Vision, Low
Phase 1: Medulloblastoma|Neuroblastoma|Neuroendocrine Tumors|Rhabdomyosarcoma|Sarcoma, Ewing|Thymoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| 2010-022278-15 | P2 |
Completed |
Oncology Unspecified |
2024-08-12 |
12% |
2025-07-07 |
Treatments |
| MONO_OLA1 | P3 |
Completed |
Ovarian Cancer |
2026-06-24 |
58% |
2025-07-09 |
Treatments |
| NeoSarc | P2 |
Recruiting |
Soft Tissue Cancer|Sarcoma, Experimental|Liposarcoma |
2027-07-01 |
64% |
2025-07-09 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
| PaxPlus-ABC | P1 |
Recruiting |
Breast Cancer |
2026-08-10 |
2025-07-07 |
Patient Enrollment|Primary Completion Date|Start Date|Treatments|Trial Status |
|
| ELEMENT | P2 |
Recruiting |
Breast Cancer |
2028-12-31 |
12% |
2024-10-16 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
| GBG 114 | P2 |
Recruiting |
Breast Cancer |
2028-12-15 |
2025-05-02 |
Treatments |
|
| NCI-2022-06841 | P2 |
Recruiting |
Endometrial Cancer|Ovarian Cancer|Peritoneal Cancer |
2028-10-01 |
2024-06-28 |
||
| J19135 | P2 |
Active, not recruiting |
Gastrointestinal Cancer|Adenocarcinoma |
2028-09-01 |
12% |
2025-05-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
| WJOG14020B/OPERETTA | P2 |
Recruiting |
Triple Negative Breast Cancer |
2028-06-30 |
12% |
2025-03-21 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
| WO42178 | P2 |
Active, not recruiting |
Oncology Unspecified |
2028-05-30 |
2025-05-02 |
Treatments |
|
| IRB20-0117 | P2 |
Recruiting |
Mesothelioma |
2028-04-15 |
12% |
2025-05-07 |
|
| BOUQUET | P2 |
Active, not recruiting |
Ovarian Cancer |
2028-02-28 |
12% |
2024-09-20 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
| OlympiaN | P2 |
Active, not recruiting |
Breast Cancer |
2028-01-29 |
12% |
2025-05-06 |
Treatments |
| WoO | P2 |
Recruiting |
Ovarian Cancer |
2028-01-01 |
12% |
2025-02-05 |
Primary Endpoints|Treatments |
| NRG-GY036 | P3 |
Recruiting |
Peritoneal Cancer|Endometrioid Carcinoma|Serous Cystadenocarcinoma|Ovarian Cancer|Fallopian Tube Cancer |
2034-12-31 |
2025-05-21 |
Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
|
| D0817C00098 | P3 |
Recruiting |
Pancreatic Cancer|Prostate Cancer|Breast Cancer|Ovarian Cancer |
2030-12-30 |
2025-05-02 |
Treatments |
|
| RAINBO-RED | P3 |
Recruiting |
Endometrial Cancer |
2030-06-01 |
32% |
2024-12-03 |
Primary Endpoints|Treatments |
| SOLO 1-D0818C00001 | P3 |
Active, not recruiting |
Ovarian Cancer |
2029-09-30 |
2025-05-02 |
Treatments |
|
| S67130 | P3 |
Recruiting |
Prostate Cancer |
2029-07-15 |
2025-05-02 |
Treatments |
|
| D081CC00006 | P3 |
Active, not recruiting |
Breast Cancer |
2029-05-28 |
30% |
2025-05-02 |
Treatments |
| DUoENDE | P3 |
Recruiting |
Endometrial Cancer |
2028-11-30 |
51% |
2025-01-22 |
Primary Endpoints|Start Date|Treatments|Trial Status |
| MK-7339-013 | P3 |
Active, not recruiting |
Small Cell Lung Cancer |
2028-02-20 |
2025-05-02 |
Treatments |
|
| NCI-2023-09685 | P1 |
Recruiting |
Non-Small-Cell Lung Cancer |
2028-08-25 |
23% |
2025-04-23 |
Primary Completion Date|Primary Endpoints |
| 2019-JEK-DIA-001 | P2 |
Active, not recruiting |
Cervical Cancer|Uterine Cancer |
2030-11-01 |
28% |
2024-04-06 |
|
| FPI-2265-203 | P2 |
Recruiting |
Prostate Cancer |
2030-01-29 |
12% |
2025-04-05 |
Primary Endpoints|Treatments |