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: Europe
Company Founding Year: 1999
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: 173
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: Headache Disorders|Medulloblastoma|Migraine Disorders|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 |
|---|---|---|---|---|---|---|---|---|
NCT04005690 |
STUDY00019211 | P1 |
Recruiting |
Adenocarcinoma|Pancreatic Cancer|Pancreatic Ductal Carcinoma |
2026-06-01 |
50% |
2025-02-14 |
Primary Endpoints|Treatments |
NCT02813135 |
ESMART | P2 |
Recruiting |
Oncology Unspecified |
2031-02-01 |
2026-01-17 |
||
NCT04483544 |
2019-JEK-DIA-001 | P2 |
Active, not recruiting |
Uterine Cancer|Cervical Cancer |
2030-11-01 |
28% |
2024-04-06 |
|
NCT04209686 |
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 |
NCT04515836 |
IRB20-0117 | P2 |
Recruiting |
Mesothelioma |
2028-04-15 |
12% |
2025-05-07 |
|
NCT05887609 |
22-0384.cc | P2 |
Recruiting |
Fallopian Tube Cancer|Peritoneal Cancer|Ovarian Cancer |
2028-01-31 |
12% |
2025-10-31 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06160843 |
POLAR | P2 |
Recruiting |
T-Cell Peripheral Lymphoma |
2028-01-01 |
2% |
2024-07-05 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT06630325 |
STUDY00026643 | P2 |
Active, not recruiting |
Ovarian Cancer|Breast Cancer|Sarcoma|Pancreatic Cancer|Prostate Cancer |
2027-12-31 |
12% |
2026-01-08 |
|
NCT02925234 |
DRUP | P2 |
Recruiting |
Lymphoma, Non-Hodgkin|Multiple Myeloma|Hodgkin Lymphoma|Vision, Low|Abnormalities, Multiple|Lymphoma, B-Cell |
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 |
NCT03851614 |
DAPPER | P2 |
Active, not recruiting |
Adenocarcinoma|Pancreatic Cancer|Leiomyosarcoma|Colorectal Cancer |
2027-01-01 |
12% |
2026-02-10 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
NCT05188508 |
NCT05188508 | P2 |
Recruiting |
Glioma |
2027-01-01 |
12% |
2026-02-12 |
Primary Completion Date|Primary Endpoints |
NCT05524935 |
MCC-21731 | P2 |
Recruiting |
Uveal Melanoma |
2026-12-01 |
12% |
2025-03-14 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
NCT06419179 |
GUIDANCE | P2 |
Enrolling by invitation |
Small Cell Lung Cancer |
2026-09-01 |
12% |
2024-12-21 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT04065269 |
ATARI | P2 |
Active, not recruiting |
Clear Cell Sarcoma|Endometrioid Carcinoma|Cervical Cancer|Carcinosarcoma|Endometrial Cancer|Ovarian Cancer |
2026-08-01 |
12% |
2026-02-21 |
Primary Endpoints |
NCT05463848 |
MISP 60154 | P2 |
Recruiting |
Glioblastoma |
2026-08-01 |
12% |
2026-03-05 |
|
NCT06441747 |
BIL-PPP | P2 |
Recruiting |
Cholangiocarcinoma |
2026-08-01 |
12% |
2025-01-16 |
Primary Endpoints|Start Date|Treatments|Trial Status |
NCT04123366 |
MK-7339-007/KEYLYNK-007 | P2 |
Active, not recruiting |
Oncology Solid Tumor Unspecified |
2026-07-23 |
12% |
2025-08-27 |
Primary Endpoints |
NCT06650709 |
NEOCATS | P2 |
Not yet recruiting |
Ovarian Cancer |
2026-05-01 |
40% |
2025-08-27 |
Primary Endpoints|Treatments |
NCT05498272 |
NePtune | P2 |
Recruiting |
Prostate Cancer|Adenocarcinoma |
2026-03-01 |
12% |
2026-01-24 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT04711824 |
SOLARA | P2 |
Recruiting |
Brain Cancer|Breast Cancer |
2026-02-01 |
12% |
2025-12-24 |
Primary Completion Date|Primary Endpoints|Treatments |
NCT06580314 |
NRG-GY036 | P3 |
Recruiting |
Peritoneal Cancer|Fallopian Tube Cancer|Ovarian Cancer|Endometrioid Carcinoma|Serous Cystadenocarcinoma |
2034-12-31 |
2025-05-21 |
Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT04380636 |
MK-7339-012/KEYLYNK-012 | P3 |
Active, not recruiting |
Non-Small-Cell Lung Cancer |
2026-07-06 |
52% |
2024-11-27 |
|
2022-502747-35-00 |
DUO-O/D081RC00001 | P3 |
Active, not recruiting |
Nose Cancer|Ovarian Cancer|Peritoneal Cancer |
2026-03-17 |
2025-05-02 |
Treatments |
|
2019-000698-22 |
2019-000698-22 | P3 |
Active, not recruiting |
Colorectal Cancer |
2026-02-26 |
29% |
2022-03-13 |
Treatments |