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: Ovarian Cancer | Oncology Unspecified | Hypopituitarism | Adenocarcinoma | Breast Cancer | Fallopian Tube Cancer | Oncology Solid Tumor Unspecified | Ovarian Cancer | Pancreatic Cancer | Prostate Cancer | Oncology Unspecified | Peritoneal Cancer
Known Adverse Events: Dysgeusia | Headache | Stomatitis | Nasopharyngitis | Pharyngitis | Anemia | Respiratory Tract Infections | Arthralgia | Myalgia | Asthenia | Constipation | Diarrhea | Dyspepsia | Influenza, Human | Dizziness | Leukopenia | Lymphopenia | Thrombocytopenia | Neutropenia | Dyspnea
Company: AstraZeneca
Company Location: CAMBRIDGE X0 CB2 0AA
Company CEO: Pascal Soriot
Additonal Commercial Interests: None
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: 219
Highest Development Phases
Phase 3: Breast Cancer|Colorectal Cancer|Endometrial Cancer|Fallopian Tube Cancer|Lung Cancer|Non-Small-Cell Lung Cancer|Nose Cancer|Ovarian Cancer|Pancreatic Cancer|Peritoneal Cancer|Prostate Cancer|Sarcoma|Small Cell Lung Cancer|Squamous Cell Carcinoma|Triple Negative Breast Cancer
Phase 2: Abnormalities, Multiple|Adenocarcinoma|Bladder Cancer|Brain Cancer|Carcinosarcoma|Cervical Cancer|Cholangiocarcinoma|Chronic Lymphoid Leukemia|Clear Cell Adenocarcinoma|Clear Cell Sarcoma|DNA Repair-Deficiency Disorders|Endometrioid Carcinoma|Esophageal Cancer|Familial Primary Pulmonary Hypertension|Gastrointestinal Cancer|Glioblastoma|Glioma|Head and Neck Cancer|Hodgkin Lymphoma|Hypertension, Pulmonary|Kidney Cancer|Leiomyosarcoma|Liposarcoma|Lymphocytic Chronic B-Cell Leukemia|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, Experimental|Serous Cystadenocarcinoma|Soft Tissue Cancer|T-Cell Peripheral Lymphoma|Transitional Cell Carcinoma|Uterine Cancer|Uveal Melanoma|Vision, Low
Phase 1: Healthy Volunteers|Medulloblastoma|Neuroblastoma|Neuroendocrine Tumors|Other|Rhabdomyosarcoma|Sarcoma, Ewing|Thymoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| 2019-JEK-DIA-001 | P2 |
Active, not recruiting |
Uterine Cancer|Cervical Cancer |
2030-11-01 |
|
| ROSY-O | P3 |
Active, not recruiting |
Breast Cancer|Ovarian Cancer|Pancreatic Cancer |
2030-08-08 |
|
| NOBLE | P2 |
Active, not recruiting |
Triple Negative Breast Cancer |
2030-03-03 |
|
| SOLO 1-D0818C00001 | P3 |
Active, not recruiting |
Ovarian Cancer |
2029-09-30 |