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
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 |
|---|---|---|---|---|---|
| 2019-JEK-DIA-001 | P2 |
Active, not recruiting |
Cervical Cancer|Uterine Cancer |
2030-11-01 |
28% |
| WO42178 | P2 |
Active, not recruiting |
Oncology Unspecified |
2028-05-30 |
|
| IRB20-0117 | P2 |
Recruiting |
Mesothelioma |
2028-04-15 |
12% |
| POLAR | P2 |
Recruiting |
T-Cell Peripheral Lymphoma |
2028-01-01 |
44% |
| DRUP | P2 |
Recruiting |
Hodgkin Lymphoma|Abnormalities, Multiple|Multiple Myeloma|Lymphoma, B-Cell|Vision, Low|Lymphoma, Non-Hodgkin |
2027-09-01 |
12% |
| ORCHID | P2 |
Recruiting |
Renal Cell Carcinoma|Kidney Cancer |
2027-03-01 |
12% |
| MCC-21731 | P2 |
Recruiting |
Uveal Melanoma |
2026-12-01 |
12% |
| NeoSarc | P2 |
Not yet recruiting |
Liposarcoma|Sarcoma, Experimental|Soft Tissue Cancer |
2026-09-01 |
64% |
| GUIDANCE | P2 |
Enrolling by invitation |
Small Cell Lung Cancer |
2026-09-01 |
12% |
| BIL-PPP | P2 |
Recruiting |
Cholangiocarcinoma |
2026-08-01 |
12% |
| MK-7339-002 / LYNK-002 | P2 |
Active, not recruiting |
Oncology Solid Tumor Unspecified |
2026-06-30 |
12% |
| 22-0384.cc | P2 |
Recruiting |
Ovarian Cancer|Fallopian Tube Cancer|Peritoneal Cancer |
2026-04-15 |
12% |
| ATARI | P2 |
Recruiting |
Clear Cell Sarcoma|Endometrial Cancer|Carcinosarcoma|Endometrioid Carcinoma|Ovarian Cancer|Cervical Cancer |
2026-04-01 |
45% |
| DUO-O/D081RC00001 | P3 |
Active, not recruiting |
Peritoneal Cancer|Ovarian Cancer|Nose Cancer |
2026-03-17 |
|
| DAPPER | P2 |
Active, not recruiting |
Leiomyosarcoma|Colorectal Cancer|Pancreatic Cancer|Adenocarcinoma |
2026-01-01 |
68% |
| NCT04666740 | P2 |
Active, not recruiting |
Pancreatic Cancer|Adenocarcinoma|Pancreatic Ductal Carcinoma |
2026-01-01 |
12% |
| MK-7339-006 | P3 |
Active, not recruiting |
Lung Cancer |
2025-12-31 |
|
| J2112 | P2 |
Recruiting |
Pancreatic Cancer |
2025-12-01 |
38% |
| SOLARA | P2 |
Recruiting |
Brain Cancer|Breast Cancer |
2025-11-01 |
12% |
| LCCC2047 | P2 |
Recruiting |
Head and Neck Cancer|Squamous Cell Carcinoma |
2025-10-31 |
12% |
| UR1909 | P2 |
Recruiting |
Renal Cell Carcinoma |
2025-09-05 |
|
| MISP 60154 | P2 |
Recruiting |
Glioblastoma |
2025-08-01 |
12% |
| Olaparib Expanded | P2 |
Active, not recruiting |
Breast Cancer |
2025-07-30 |
12% |
| MK-7339-007 | P2 |
Active, not recruiting |
Prostate Cancer |
2025-07-24 |
|
| NCT04417062 | P2 |
Active, not recruiting |
Osteosarcoma |
2025-06-01 |
12% |