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Olaparib Oral Product
Olaparib inhibits poly-ADP-ribose polymerase (PARP) enzymes to impair DNA repair in cancer cells with BRCA mutations or homologous recombination deficiency.
Olaparib oral product is a PARP (poly-ADP-ribose polymerase) inhibitor developed by Duke University, currently in discontinued status. The drug works by inhibiting PARP enzymes, which are critical for DNA repair in cancer cells, particularly those with BRCA1/2 mutations or homologous recombination deficiency (HRD). While no FDA-approved indications are listed for the Duke formulation, olaparib has extensive clinical trial activity across 50 trials spanning Phase 1–4, with notable studies in BRCA-mutated breast and ovarian cancers, prostate cancer, and combination therapies with immunotherapies and targeted agents. The clinical pipeline demonstrates broad oncology application, though the discontinued status suggests Duke may have deprioritized development in favor of the commercially available AstraZeneca olaparib (Lynparza®). Competitive positioning is challenged by the established market presence of Lynparza and other PARP inhibitors (rucaparib, niraparib), which have secured multiple regulatory approvals and substantial market penetration in HRD-positive and BRCA-mutated malignancies.
At a glance
| Generic name | Olaparib Oral Product |
|---|---|
| Also known as | Olaparib tablet |
| Sponsor | Duke University |
| Drug class | PARP inhibitor (DNA repair inhibitor) |
| Target | PARP-1 and PARP-2 (poly-ADP-ribose polymerase enzymes) |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | discontinued |
Mechanism of action
Olaparib works by blocking PARP enzymes, which are responsible for repairing single-strand DNA breaks in cells. In normal cells, this repair mechanism is redundant—cells can use homologous recombination (HR) as an alternative pathway. However, cancer cells with BRCA1/2 mutations or other HR deficiencies cannot use this backup pathway. When olaparib blocks PARP, these deficient cancer cells accumulate unrepaired DNA damage, leading to cell death. This creates a synthetic lethal interaction: the drug is selectively toxic to HR-deficient tumors while sparing most normal cells that retain functional HR. The oral formulation allows convenient at-home dosing compared to intravenous alternatives.
Approved indications
Pipeline indications
- BRCA1/2-mutated and HRD-positive advanced solid tumors — Phase 1
- Muscle-invasive bladder cancer — Phase 1
- Advanced prostate adenocarcinoma with neuroendocrine differentiation — Phase 2
- Advanced BRCA-mutated or HDR-deficient breast cancer — Phase 2
- Platinum-resistant/refractory high-grade serous ovarian cancer — Phase 3
Common side effects
Key clinical trials
- A Clinical Study of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) in People With Breast Cancer (MK-2870-032) (PHASE3)
- Testing Two Oral Drugs Combination (Cediranib and Olaparib) Compared to a Single Drug (Olaparib) for Men With Advanced Prostate Cancer (PHASE2)
- Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (PHASE2)
- Substudy 01A: Safety and Efficacy of Opevesostat (MK-5684)-Based Treatment Combinations or Opevesostat Alone in Participants With Metastatic Castration-resistant Prostate Cancer (mCRPC) (MK-5684-01A) (PHASE1, PHASE2)
- Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/KEYNOTE-587) (PHASE3)
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast Cancer (PHASE2)
- Alpelisib Plus Olaparib in Platinum-resistant/Refractory, High-grade Serous Ovarian Cancer, With no Germline BRCA Mutation Detected (PHASE3)
- Testing the Combination of Cediranib and Olaparib in Comparison to Each Drug Alone or Other Chemotherapy in Recurrent Platinum-Resistant Ovarian Cancer (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Olaparib Oral Product CI brief — competitive landscape report
- Olaparib Oral Product updates RSS · CI watch RSS
- Duke University portfolio CI