rucaparib
Trade name: rubraca
Small moleculeapprovedOrphan Drug FDABreakthrough Therapy FDA
Approved
Dec 19, 2016
Rucaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for the treatment of advanced mutant BRCA ovarian cancer. Rucaparib is being investigated in clinical trials against prostate cancer, breast cancer and other neoplasms. — NCATS
Clinical trial activity
58 trials · 63 clinical orgs · 3 marketing orgs
Phase 1
26
Phase 2
43
Phase 3
7
Phase 4
0
Earliest trial started Jun 1, 2007 (NCT00457470)
Timeline
2000s
- Jan 1, 2007
Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2010
Clovis Oncology — Earliest Phase 1 Sponsor(trial)
- Jul 31, 2012
Orphan Drug Designation
- Jan 1, 2014
Clovis Oncology — Earliest Phase 3 Sponsor(trial)
- Dec 19, 2016
Clovis Oncology — Earliest FDA Approval
- Dec 19, 2016
pharmaand — Marketing Organization
- Dec 19, 2016
Clovis Oncology — NDA Secondary Org
- Dec 19, 2016
Clovis Oncology — NDA Organization
- Dec 19, 2016
zr pharma — Marketing Organization
- Dec 19, 2016
zr pharma — NDA Secondary Org
Indications
Approved for
Studied for
- Adenocarcinoma, Clear Cell · Phase 3
- Biliary Tract Neoplasms · Phase 2
- Biomarkers · Phase 1
- Brain Neoplasms · Early Phase 1
- BRCA1 Protein · Phase 2
- Breast Neoplasms · Phase 2
- Carcinoma · Phase 1/Phase 2
- Carcinoma, Endometrioid · Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Carcinoma, Ovarian Epithelial · Phase 3
- Carcinoma, Transitional Cell · Phase 2
- Castration · Phase 2
- Colorectal Neoplasms · Phase 1/Phase 2
- Diabetes Mellitus · Phase 2
- Diabetic Retinopathy · Phase 2
- Endometrial Neoplasms · Phase 2
- Esophageal Neoplasms · Phase 1/Phase 2
- Fallopian Tube Neoplasms · Phase 3
- Genital Neoplasms, Female · Phase 1
- Hamartoma · Phase 3
- Head and Neck Neoplasms · Phase 1
- Healthy Volunteers · Phase 1
- Homologous Recombination · Phase 2
- Leiomyosarcoma · Phase 2
- Loss of Heterozygosity · Phase 2
- Lung Neoplasms · Phase 2
- Melanoma · Phase 2
- Mesothelioma, Malignant · Phase 2
- Mutation · Phase 2
- Neoplasm Metastasis · Phase 1/Phase 2
- Ovarian Neoplasms · Phase 3
- Pancreatic Neoplasms · Phase 2
- Peritoneal Cavity · Phase 3
- Prostatic Neoplasms · Phase 3
- Prostatic Neoplasms, Castration-Resistant · Phase 3
- Small Cell Lung Carcinoma · Phase 2
- Stomach Neoplasms · Phase 1/Phase 2
- Triple Negative Breast Neoplasms · Phase 1/Phase 2
- Ureteral Neoplasms · Phase 2
- Urethral Neoplasms · Phase 2
- Urinary Bladder Neoplasms · Phase 2
- Uterine Cervical Neoplasms · Phase 2
- Uterine Neoplasms · Phase 2
Mechanism of action
Approval history
- approvedPriority reviewAcceleratedBreakthroughDec 19, 2016
Chemistry & pharmacology
Loading structure…
SMILES
CNCC1=CC=C(C=C1)C2=C3CCNC(=O)C4=CC(F)=CC(N2)=C34- Mol. weight
- 323.3641 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Prescription Only
Oral
Yes
Parenteral
No
Topical
No
Sources
- WikipediaRucaparib ↗
- NCATS8237F3U7EH ↗
- ChEMBLCHEMBL3833368 ↗
- ChEMBLCHEMBL2105733 ↗
- ChEMBLCHEMBL1173055 ↗
Also known as
- ag014699
- ag 014699
- ag-014699
- ag-014699
- ag-014699
- ag-014699
- ag-14447
- ag-14447
- ag-14699
- ag-14699
- pf-01367338
- pf-01367338
- pf-01367338
- pf-01367338
- rubraca
- rubraca
- rucaparib
- rucaparib
- rucaparib
- rucaparib
- rucaparib
- rucaparib
- rucaparib
- rucaparib camsylate
- rucaparib camsylate
- rucaparib camsylate
- rucaparib phosphate
- rucaparib phosphate
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06923839 | Phase 1 | Jul 28, 2025 | University of Copenhagen |
| NCT04455750 | Phase 3 | Jan 31, 2021 | Baylor University, National Cancer Institute (NCI) |
| NCT04676334 | Phase 3 | Dec 22, 2020 | Clovis Oncology |
| NCT04624178 | Phase 2 | Nov 5, 2020 | Bristol-Myers Squibb, Clovis Oncology, Memorial Sloan-Kettering Cancer Center |
| NCT04826198 | Phase 1/Phase 2 (Phase 2) | Oct 5, 2020 | Institut Gustave Roussy |
| NCT04253262 | Phase 1/Phase 2 (Phase 2) | Apr 30, 2020 | Bayer, Brown University, Clovis Oncology, Rhode Island Hospital |
| NCT04227522 | Phase 3 | Jan 31, 2020 | Charité University, Berlin, Germany, Clovis Oncology, J. W. Goethe University, North Eastern Germany Society of Gynaecologic Oncology |
| NCT04179396 | Phase 1 | Dec 31, 2019 | Clovis Oncology |
| NCT04209595 | Phase 1/Phase 2 (Phase 2) | Dec 27, 2019 | National Cancer Institute (NCI) |
| NCT04171700 | Phase 2 | Nov 30, 2019 | Clovis Oncology, University of Pennsylvania |
| NCT04173104 | Early Phase 1 (Phase 1) | Nov 1, 2019 | Memorial Sloan-Kettering Cancer Center |
| NCT03995017 | Phase 1/Phase 2 (Phase 2) | Jul 31, 2019 | Bristol-Myers Squibb, Clovis Oncology, University of Kansas |
| NCT03958045 | Phase 2 | Jul 31, 2019 | University of Kentucky |
| NCT03992131 | Phase 1/Phase 2 (Phase 2) | Jun 30, 2019 | Clovis Oncology, Immunomedics |
| NCT03694262 | Phase 2 | Jun 15, 2019 | Clovis Oncology, Genentech, Medical College of Wisconsin |
| NCT03840200 | Phase 1/Phase 2 (Phase 2) | Jun 11, 2019 | Roche |
| NCT03824704 | Phase 2 | May 15, 2019 | Bristol-Myers Squibb, Foundation Medicine, pharmaand, University of Oklahoma |
| NCT03954366 | Phase 1 | May 8, 2019 | Clovis Oncology |
| NCT03911453 | Early Phase 1 (Phase 1) | Apr 19, 2019 | University of Arizona |
| NCT04276376 | Phase 2 | Apr 12, 2019 | Institut Gustave Roussy |
Showing 20 of 58 trials
Page 1 / 3
Organizations
Research & Development (63)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Clovis Oncology | For profit | 36 | 18 | 3 | 2010 |
| Foundation Medicine | For profit | 10 | 0 | 2 | 2011 |
| Bristol-Myers Squibb | For profit | 6 | 1 | 2 | 2017 |
| Memorial Sloan-Kettering Cancer Center | Academic/Hospital | 4 | 4 | 2 | 2018 |
| National Cancer Institute (NCI) | Government | 4 | 2 | 2 | 2018 |
| Institut Gustave Roussy | Academic/Hospital | 3 | 2 | 1 | 2016 |
| Roche | For profit | 3 | 2 | 2 | 2017 |
| Merck | For profit | 2 | 0 | 1 | 2018 |
| North Eastern Germany Society of Gynaecologic Oncology | Academic/Hospital | 2 | 1 | 2 | 2019 |
| pharmaand | For profit | 2 | 2 | 2 | 2018 |
| University of Michigan | Academic/Hospital | 2 | 2 | 1 | 2018 |
| University of Oklahoma | Academic/Hospital | 2 | 1 | 1 | 2018 |
| University of Pennsylvania | Academic/Hospital | 2 | 1 | 1 | 2017 |
| Academic and Community Cancer Research United | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Astellas | For profit | 1 | 0 | 1 | 2017 |
| Bayer | For profit | 1 | 0 | 1 | 2020 |
| Baylor University | Academic/Hospital | 1 | 0 | 1 | 2021 |
| BerGenBio ASA | For profit | 1 | 0 | 1 | 2018 |
| British Lung Foundation | Academic/Hospital | 1 | 0 | 1 | 2018 |
| Brown University | Academic/Hospital | 1 | 1 | 1 | 2020 |
63 organizations
Page 1 / 4
Marketing (5)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Clovis Oncology | For profit | NDA2 | Dec 19, 2016 |
| Clovis Oncology | For profit | NDA | Dec 19, 2016 |
| pharmaand | For profit | MKTG | Dec 19, 2016 |
| zr pharma | For profit | MKTG | Dec 19, 2016 |
| zr pharma | For profit | NDA2 | Dec 19, 2016 |