Drug Profile

Olaparib - AstraZeneca

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

Latest Information Update: 23 Feb 2026

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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; Drug conjugates; 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

11 Feb 2026 AstraZeneca discontinues its Phase-III DUO-O clinical trials in Ovarian cancer (First-line therapy, Combination therapy, Late-stage disease) in Belgium, Bulgaria, Brazil, China, Denmark, France, Germany, Italy, Poland, Italy, Peru, Romania, Spain, Turkey, South Korea, Finland, Hungary, Japan due to regulatory reasons (PO) (NCT03737643)
23 Dec 2025 AstraZeneca completes the phase III OlympiAD trial in Breast cancer (Metastatic disease, Monotherapy) in Bulgaria, China, Czech Republic, France, Hungary, Italy, Japan, Mexico, Peru, Poland, Romania, Russia, South Korea, Spain, Switzerland, Taiwan, Turkey, United Kingdom, USA (PO) (NCT02000622)
17 Oct 2025 Adverse events and efficacy data from a phase II trial in Endometrial cancer presented at the 50^th European Society for Medical Oncology Congress (ESMO-2025)

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