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: 172
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|Lewy Body Disease|Lung Cancer|Non-Small-Cell Lung Cancer|Nose Cancer|Ovarian Cancer|Pancreatic Cancer|Parkinson's Disease|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|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|T-Cell Peripheral Lymphoma|Transitional Cell Carcinoma|Uterine Cancer|Uveal Melanoma|Vision, Low
Phase 1: Medulloblastoma|Neuroblastoma|Rhabdomyosarcoma|Sarcoma, Ewing|Soft Tissue Cancer
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT04483544 |
2019-JEK-DIA-001 | P2 |
Active, not recruiting |
Cervical Cancer|Uterine Cancer |
2030-11-01 |
28% |
2024-04-06 |
|
NCT04209686 |
J19135 | P2 |
Active, not recruiting |
Adenocarcinoma|Gastrointestinal Cancer |
2028-09-01 |
12% |
2025-05-28 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
2023-508194-89-00 |
WO42178 | P2 |
Active, not recruiting |
Oncology Unspecified |
2028-05-30 |
2025-05-02 |
Treatments |
|
NCT04515836 |
IRB20-0117 | P2 |
Recruiting |
Mesothelioma |
2028-04-15 |
12% |
2025-05-07 |
|
NCT05887609 |
22-0384.cc | P2 |
Recruiting |
Peritoneal Cancer|Ovarian Cancer|Fallopian Tube Cancer |
2028-01-31 |
12% |
2025-10-31 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06630325 |
STUDY00026643 | P2 |
Recruiting |
Ovarian Cancer|Breast Cancer|Prostate Cancer|Pancreatic Cancer|Sarcoma |
2027-12-31 |
12% |
2025-07-01 |
|
NCT06160843 |
POLAR | P2 |
Recruiting |
T-Cell Peripheral Lymphoma |
2028-01-01 |
2% |
2024-07-05 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT02925234 |
DRUP | P2 |
Recruiting |
Abnormalities, Multiple|Hodgkin Lymphoma|Multiple Myeloma|Lymphoma, B-Cell|Lymphoma, Non-Hodgkin|Vision, Low |
2027-09-01 |
12% |
2024-01-25 |
Primary Endpoints |
NCT03786796 |
ORCHID | P2 |
Recruiting |
Kidney Cancer|Renal Cell Carcinoma |
2027-03-01 |
12% |
2025-03-14 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05524935 |
MCC-21731 | P2 |
Recruiting |
Uveal Melanoma |
2026-12-01 |
12% |
2025-03-14 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06441747 |
BIL-PPP | P2 |
Recruiting |
Cholangiocarcinoma |
2026-08-01 |
12% |
2025-01-16 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT03742895 |
MK-7339-002 / LYNK-002 | P2 |
Active, not recruiting |
Oncology Solid Tumor Unspecified |
2026-06-30 |
12% |
2024-12-10 |
Primary Endpoints |
NCT04065269 |
ATARI | P2 |
Recruiting |
Clear Cell Sarcoma|Endometrioid Carcinoma|Endometrial Cancer|Carcinosarcoma|Cervical Cancer|Ovarian Cancer |
2026-04-01 |
45% |
2024-07-12 |
|
2024-512769-16-00 |
D9102C00001 | P2 |
Not yet recruiting |
Non-Small-Cell Lung Cancer |
2026-02-28 |
2025-05-02 |
Treatments |
|
NCT05463848 |
MISP 60154 | P2 |
Recruiting |
Glioblastoma |
2026-02-01 |
12% |
2025-08-26 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05188508 |
NCT05188508 | P2 |
Recruiting |
Glioma |
2026-01-01 |
2% |
2025-08-27 |
Primary Endpoints|Treatments |
NCT03851614 |
DAPPER | P2 |
Active, not recruiting |
Leiomyosarcoma|Pancreatic Cancer|Colorectal Cancer|Adenocarcinoma |
2026-01-01 |
12% |
2025-04-01 |
Primary Endpoints |
NCT04666740 |
NCT04666740 | P2 |
Active, not recruiting |
Adenocarcinoma|Pancreatic Cancer|Pancreatic Ductal Carcinoma |
2026-01-01 |
2% |
2025-03-01 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT05156268 |
NCT05156268 | P2 |
Active, not recruiting |
Mixed Tumor, Mullerian|Carcinosarcoma|Endometrial Cancer |
2026-01-01 |
12% |
2025-02-05 |
Primary Endpoints |
NCT05203445 |
NCT05203445 | P2 |
Active, not recruiting |
Triple Negative Breast Cancer |
2026-01-01 |
12% |
2025-01-14 |
Primary Endpoints|Treatments|Trial Status |
NCT05629429 |
202202045MIPA | P2 |
Recruiting |
Breast Cancer |
2025-12-31 |
82% |
2024-01-18 |
Primary Endpoints|Start Date|Treatments |
NCT06580314 |
NRG-GY036 | P3 |
Recruiting |
Serous Cystadenocarcinoma|Fallopian Tube Cancer|Ovarian Cancer|Peritoneal Cancer|Endometrioid Carcinoma |
2034-12-31 |
2025-05-21 |
Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
|
jRCT2080225256 |
jRCT2080225256 | P3 |
Completed |
Non-Small-Cell Lung Cancer|Small Cell Lung Cancer |
2026-06-06 |
|||
2022-502747-35-00 |
DUO-O/D081RC00001 | P3 |
Active, not recruiting |
Peritoneal Cancer|Ovarian Cancer|Nose Cancer |
2026-03-17 |
2025-05-02 |
Treatments |
|
2023-509774-40-00 |
MK-7339-006 | P3 |
Active, not recruiting |
Lung Cancer |
2025-12-31 |
2025-05-02 |
Treatments |