Drug Profile

Olaparib - AstraZeneca

Alternative Names: AZD 221; AZD-2281; KU-0059436; KU-59436; Lynparza; MK 7339

Latest Information Update: 26 Feb 2025

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At a glance

Originator KuDOS Pharmaceuticals; University of Pennsylvania
Developer AstraZeneca; Cancer Research UK; Dana-Farber Cancer Institute; European Network of Gynaecological Oncological Trial Groups; German Breast Group; Hospices Civils de Lyon; M. D. Anderson Cancer Center; Mario Negri Institute for Pharmacological Research; Massachusetts General Hospital; Merck & Co; Merck Sharp & Dohme; Myriad Genetic Laboratories; Myriad Genetics; National Cancer Institute (USA); National Institute of Oncology; Netherlands Cancer Institute; NHS Greater Glasgow and Clyde; Nordic Society of Gynaecological - Clinical Trial Unit; Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins; Spanish Oncology Genito-Urinary Group; University Health Network; University of Manchester; University of Oxford; University of Sydney; University of Texas M. D. Anderson Cancer Center
Class Amides; Antineoplastics; Cyclopropanes; Fluorobenzenes; Ketones; Phthalazines; Piperazines; Small molecules
Mechanism of Action Poly(ADP-ribose) polymerase inhibitors

Orphan Drug Status

Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

Yes - Ovarian cancer; Fallopian tube cancer; Breast cancer; Pancreatic cancer; Peritoneal cancer
New Molecular Entity Yes

Marketed Fallopian tube cancer; HER2 negative breast cancer; Ovarian cancer; Pancreatic cancer; Peritoneal cancer; Prostate cancer
Registered Endometrial cancer
Phase III Breast cancer; Colorectal cancer; Non-small cell lung cancer; Small cell lung cancer; Squamous cell cancer
Phase II/III Triple negative breast cancer
Phase II Bladder cancer; Cervical cancer; Gastric cancer; Glioblastoma; Head and neck cancer; HER2 positive breast cancer; Osteosarcoma; Renal cell carcinoma; Solid tumours; Urogenital cancer

06 Feb 2025 AstraZeneca completes a phase-II clinical trials in Solid tumours (Inoperable/Unresectable, Late-stage disease, Metastatic disease, Second-line therapy or greater) in USA, Argentina, Australia, Canada, Colombia, Denmark, France, Guatemala, Ireland, Israel, Italy, Japan, South Korea, Mexico, Peru, Romania, Russia, Spain, Switzerland, Turkey and the UK before February 2025 (NCT03742895) (JAPIC-CTI194694) (EudraCT 2018-003007-19) (AstraZeneca pipeline, February 2025)
19 Dec 2024 Updated efficacy and adverse events data from a phase III trial in HER2-negative-breast-cancer released by AstraZeneca
12 Dec 2024 Updated efficacy data from a phase III trial in HER2-negative-breast-cancer released by AstraZeneca

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