Product Description
Rucaparib (Rubraca®) is a small molecule poly(ADP-ribose) polymerase (PARP) inhibitor with potent activity against PARP-1, -2 and -3. It is approved in the USA and the EU for the treatment of adult patients with BRCA-mutated ovarian cancer who have been treated with two or more lines of chemotherapy. Rucaparib is also approved in the USA and the EU for use as maintenance therapy in adult patients with recurrent or relapsed ovarian cancer who are in a complete or partial response to platinum-based chemotherapy. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/30830551/)
Mechanisms of Action: PARP Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Argentina | Austria | Bangladesh | Belgium | Croatia | Czech | Estonia | European Medicines Agency | Finland | France | Germany | Hungary | Iceland | Ireland | Israel | Italy | Latvia | Lithuania | Netherlands | Poland | Portugal | Slovakia | Spain | Sweden | Switzerland | United Kingdom | United States
Approved Indications: Ovarian Cancer | Oncology Unspecified
Known Adverse Events: Abdominal Pain | Dysgeusia | Labor Pain | Pain Unspecified | Anemia | Thrombocytopenia | Dyspnea | Asthenia | Constipation | Diarrhea
Company: Clovis Oncology
Company Location: BOULDER CO 80301
Company CEO: Patrick J. Mahaffy
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Argentina, Australia, Belgium, Brazil, Canada, Chile, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Korea, Mexico, New Zealand, Poland, Romania, Russia, Singapore, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Active Clinical Trial Count: 21
Highest Development Phases
Phase 3: Adenomyoepithelioma|Clear Cell Adenocarcinoma|Endometrioid Carcinoma|Fallopian Tube Cancer|Nose Cancer|Oncology Solid Tumor Unspecified|Ovarian Cancer|Peritoneal Cancer|Prostate Cancer
Phase 2: Adenocarcinoma|Bladder Cancer|Breast Cancer|Carcinosarcoma|Endometrial Cancer|Esophageal Cancer|Gastrointestinal Cancer|Kidney Diseases|Leiomyosarcoma|Mixed Tumor, Mullerian|Non-Small-Cell Lung Cancer|Renal Cell Carcinoma|Small Cell Lung Cancer|Transitional Cell Carcinoma|Uterine Cancer
Phase 1: Serous Cystadenocarcinoma|Triple Negative Breast Cancer
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| CO-338-087 | P3 |
Unknown Status |
Ovarian Cancer|Peritoneal Cancer|Fallopian Tube Cancer |
2027-06-30 |
|
| BrUOG 360 | P2 |
Active, not recruiting |
Prostate Cancer |
2027-01-01 |
|
| jRCT2080224597 | P3 |
Completed |
Ovarian Cancer |
2025-12-30 |
|
| NCT04624178 | P2 |
Active, not recruiting |
Leiomyosarcoma |
2025-11-05 |