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Alternative Names: olaparib, azd2281, azd 2281, ku-0059436, az2281, lynparza, azd-2281
Latest Update: 2024-05-16
Latest Update Note: Clinical Trial Update

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

Map of Global Clinical Trials for Olaparib

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, India, Ireland, Israel, Italy, Japan, Kazakhstan, Korea, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Peru, Poland, Portugal, Puerto Rico, Romania, Russia, 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: 197

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|Small Cell Lung Cancer|Squamous Cell Carcinoma|Triple Negative Breast Cancer

Phase 2: Adenocarcinoma|Bladder Cancer|Brain Cancer|Carcinosarcoma|Cervical Cancer|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|Hypertension, Pulmonary|Kidney Cancer|Liposarcoma|Lymphocytic Chronic B-Cell Leukemia|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|Serous Cystadenocarcinoma|Soft Tissue Cancer|T-Cell Peripheral Lymphoma|Transitional Cell Carcinoma|Uterine Cancer|Uveal Melanoma

Phase 1: Healthy Volunteers|Medulloblastoma|Neuroblastoma|Neuroendocrine Tumors|Other|Rhabdomyosarcoma|Sarcoma, Ewing|Thymoma



Trial Status


Primary Completion Date

Probability of Success



Active, not recruiting

Cervical Cancer|Uterine Cancer




Active, not recruiting

Breast Cancer|Pancreatic Cancer|Ovarian Cancer




Active, not recruiting

Triple Negative Breast Cancer




Not yet recruiting

Prostate Cancer


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