Drugs / Rucaparib
last change Mar 2026 re-read 2 minutes ago

Rucaparib

Small molecule targets PARP1 via inhibition

Developed for
fallopian tube cancer · cancer · neoplasm · ovarian cancer · breast cancer · castration-resistant prostate carcinoma · peritoneum cancer · malignant epithelial tumor of ovary
+42 more · primary peritoneal carcinoma · prostate cancer · endometrial cancer · fallopian tube carcinoma · biliary tract cancer · cervical cancer · esophageal adenocarcinoma · gastric adenocarcinoma · gastroesophageal junction adenocarcinoma · metastatic prostate carcinoma · ovarian carcinoma · prostate adenocarcinoma · small cell lung carcinoma · urothelial carcinoma · carcinosarcoma of the corpus uteri · colorectal carcinoma · diabetes mellitus · diabetic retinopathy · endometrial serous adenocarcinoma · endometrioid adenocarcinoma · female reproductive organ cancer · female reproductive system neoplasm · gastric cancer · leiomyosarcoma · lung adenocarcinoma · lung large cell carcinoma · malignant mesothelioma · malignant pancreatic neoplasm · non-small cell lung carcinoma · non-small cell squamous lung carcinoma · ovarian neoplasm · pancreatic adenocarcinoma · pancreatic ductal adenocarcinoma · peritoneal carcinoma · prostate carcinoma · renal pelvis carcinoma · serous adenocarcinoma · triple-negative breast carcinoma · ureter carcinoma · urethra cancer · urinary bladder carcinoma · uterine carcinosarcoma
Investigated by
Clovis Oncology, Inc. · pharmaand GmbH · Bristol-Myers Squibb · Foundation Medicine · National Cancer Institute (NCI) · Eli Lilly and Company
+72 more · Hoffmann-La Roche · Merck Sharp & Dohme LLC · AstraZeneca · Bayer · Dana-Farber Cancer Institute · GlaxoSmithKline · Memorial Sloan Kettering Cancer Center · Myriad Genetics, Inc. · North Eastern German Society of Gynaecological Oncology · Novartis · Pfizer · Roche Pharma AG · University of Michigan Rogel Cancer Center · Abramson Cancer Center at Penn Medicine · Academic and Community Cancer Research United · Alliance for Clinical Trials in Oncology · Amgen · Astellas Pharma Inc · Belgian Gynaecological Oncology Group · BerGenBio ASA · Boehringer Ingelheim · British Lung Foundation · Brown University · Cancer Research UK · Central and Eastern European Oncology Group · Clovis Oncology - Pharma and · Dutch Cancer Society · Eisai Inc. · European Network of Gynaecological Oncological Trial Groups (ENGOT) · Exelixis · Fondation ARC · Fondazione Policlinico Universitario Agostino Gemelli IRCCS · GCP-enhederne · GSO Global Clinical Research BV · Genentech, Inc. · Gilead Sciences · Gustave Roussy, Cancer Campus, Grand Paris · Gynecologic Oncology Group · ImmunoGen, Inc. · Incyte Corporation · Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest · Institute of Cancer Research, United Kingdom · Ipsen · Istituto Di Ricerche Farmacologiche Mario Negri · Janssen Pharmaceuticals · Janssen, LP · MedImmune LLC · Medical College of Wisconsin · Nordic Society of Gynaecological Oncology - Clinical Trials Unit · Ohio State University Comprehensive Cancer Center · PGOG (Polish Gynaecologic Oncology Group) · Pamela Munster · Princess Margaret Hospital, Canada · Rhode Island Hospital · Royal Marsden NHS Foundation Trust · SWOG Cancer Research Network · Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Stelvio for Life · The Christie NHS Foundation Trust · The Miriam Hospital · The Netherlands Cancer Institute · UNICANCER · University Hospitals, Leicester · University of Arizona · University of Chicago · University of Kansas Medical Center · University of Leicester · University of Oklahoma · University of Utah · University of Washington · Vanderbilt University Medical Center · Zhonglin Hao

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Rubraca 2018-05-23 europa.eu

Trials 58 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03911453 Apr 2019 → Jul 2021 breast cancer University of Arizona Completed No outcome recorded
Phase 112 trials
Phase 1 NCT04179396 Dec 2019 → Nov 2021 castration-resistant prostate carcinoma pharmaand GmbH Completed No outcome recorded
Phase 1 NCT03840200 Jun 2019 → Dec 2021 breast cancer, ovarian cancer, prostate cancer Hoffmann-La Roche Completed No outcome recorded
Phase 1 NCT03954366 Apr → Dec 2019 neoplasm pharmaand GmbH Completed No outcome recorded
Phase 1 NCT03552471 Jul 2018 → Jun 2022 BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, carcinosarcoma of the corpus uteri, endometrial serous adenocarcinoma +3 Ohio State University Comprehensive Cancer Center Completed No outcome recorded
Phase 1 NCT03542175 May 2018 → Jul 2024 breast cancer Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1 NCT03521037 Feb 2018 → Sep 2019 neoplasm pharmaand GmbH Completed No outcome recorded
Phase 1 NCT03499444 Feb 2018 → Jun 2019 neoplasm pharmaand GmbH Completed No outcome recorded
Phase 1 NCT03318445 Jan 2018 → Mar 2021 cancer Pamela Munster Completed No outcome recorded
Phase 1 NCT03101280 Apr 2017 → Aug 2020 female reproductive system neoplasm Hoffmann-La Roche Completed No outcome recorded
Phase 1 NCT02986100 Nov 2016 → Dec 2017 neoplasm pharmaand GmbH Completed No outcome recorded
Phase 1/29 trials
Phase 1/2 NCT03462212 Mar 2021 → Mar 2025 female reproductive organ cancer Fondazione Policlinico Universitario Agostino Gemelli IRCCS Unknown No outcome recorded
Phase 1/2 NCT04209595 Apr 2020 → Aug 2021 small cell lung carcinoma National Cancer Institute (NCI) Completed No outcome recorded
Phase 1/2 NCT04253262 Apr 2020 → Jan 2027 expected prostate carcinoma Brown University Active not recruiting No outcome recorded
Phase 1/2 NCT03995017 Jan 2020 → Oct 2022 esophageal adenocarcinoma, gastric adenocarcinoma University of Kansas Medical Center Unknown No outcome recorded
Phase 1/2 NCT03992131 Jun 2019 → Mar 2022 ovarian cancer, triple-negative breast carcinoma, urothelial carcinoma pharmaand GmbH Terminated No outcome recorded
Phase 1/2 NCT03559049 Dec 2018 → May 2025 non-small cell lung carcinoma University of Michigan Rogel Cancer Center Terminated No outcome recorded
Phase 1/2 NCT03337087 Nov 2018 → Mar 2021 biliary tract cancer, colorectal carcinoma, gastroesophageal junction adenocarcinoma, pancreatic adenocarcinoma Academic and Community Cancer Research United Unknown No outcome recorded
Phase 1/2 NCT03572478 Aug 2018 → Feb 2020 endometrial cancer, prostate cancer University of Chicago Terminated No outcome recorded
Phase 1/2 NCT01482715 Nov 2011 → Mar 2019 fallopian tube cancer, ovarian cancer, peritoneum cancer pharmaand GmbH Completed No outcome recorded
Phase 228 trials
Phase 2 NCT04624178 Nov 2020 → Nov 2025 overdue leiomyosarcoma Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 2 NCT04171700 Jan 2020 → Jun 2022 neoplasm pharmaand GmbH Terminated No outcome recorded
Phase 2 NCT03795272 Oct 2019 cervical cancer Nordic Society of Gynaecological Oncology - Clinical Trials Unit Withdrawn No outcome recorded
Phase 2 NCT03958045 Sep 2019 → Nov 2022 small cell lung carcinoma Zhonglin Hao Completed No outcome recorded
Phase 2 NCT03824704 Aug 2019 → Aug 2020 endometrioid adenocarcinoma, fallopian tube carcinoma, ovarian neoplasm, primary peritoneal carcinoma +1 pharmaand GmbH Terminated No outcome recorded
Phase 2 NCT03899155 Aug 2019 → Aug 2029 expected cancer Bristol-Myers Squibb Recruiting No outcome recorded
Phase 2 NCT03694262 Jul 2019 → Mar 2023 endometrial cancer, uterine carcinosarcoma Medical College of Wisconsin Completed No outcome recorded
Phase 2 NCT03533946 May 2019 → Jan 2023 prostate cancer University of Utah Terminated No outcome recorded
Phase 2 NCT03845296 Apr 2019 → Jan 2022 BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, lung adenocarcinoma, lung large cell carcinoma +1 SWOG Cancer Research Network Completed No outcome recorded
Phase 2 NCT04276376 Apr 2019 → Jan 2023 cancer Gustave Roussy, Cancer Campus, Grand Paris Terminated No outcome recorded
Phase 38 trials
Phase 3 NCT04455750 Oct 2021 → Mar 2027 expected castration-resistant prostate carcinoma, prostate adenocarcinoma Alliance for Clinical Trials in Oncology Active not recruiting No outcome recorded
Phase 3 NCT04676334 Mar 2021 → Mar 2023 castration-resistant prostate carcinoma, fallopian tube cancer, malignant epithelial tumor of ovary, peritoneum cancer pharmaand GmbH Completed No outcome recorded
Phase 3 NCT04227522 Jun 2020 → Dec 2023 fallopian tube cancer, ovarian cancer, primary peritoneal carcinoma North Eastern German Society of Gynaecological Oncology Completed No outcome recorded
Phase 3 NCT03768063 Feb 2019 → Jul 2028 expected cancer Hoffmann-La Roche Active not recruiting No outcome recorded
Phase 3 NCT03522246 May 2018 → May 2024 overdue fallopian tube cancer, malignant epithelial tumor of ovary, primary peritoneal carcinoma pharmaand GmbH Active not recruiting No outcome recorded
Phase 3 NCT02975934 Jun 2017 → Aug 2022 castration-resistant prostate carcinoma pharmaand GmbH Completed No outcome recorded
Phase 3 NCT02855944 Mar 2017 → Dec 2020 fallopian tube cancer, malignant epithelial tumor of ovary, peritoneum cancer pharmaand GmbH Completed No outcome recorded
Phase 3 NCT01968213 Apr 2014 → Apr 2017 fallopian tube cancer, ovarian cancer, peritoneum cancer pharmaand GmbH Completed No outcome recorded
Also used as a comparator or background therapy in 4 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/22 trials
Phase 1/2 NCT04826198 Background Oct 2020 → Apr 2024 ovarian cancer Gustave Roussy, Cancer Campus, Grand Paris Terminated No outcome recorded
Phase 1/2 NCT02711137 Background May 2016 → Feb 2019 cancer Incyte Corporation Terminated No outcome recorded
Phase 22 trials
Phase 2 NCT03617679 Comparator Mar 2019 → Oct 2023 endometrial cancer University of Colorado, Denver Completed No outcome recorded
Phase 2 NCT01074970 Comparator Feb 2010 → Dec 2018 breast cancer Hoosier Cancer Research Network Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2011-06-02 Pfizer Clovis Oncology, Inc. Receives License for Worldwide Development and Commercialization Rights to Pfizer’s Oral and IV PARP Inhibitor PF-01367338 pfizer.com

Evidence & citations 16 cited values

Every value below carries the sentence it was read from. 63 sources stand behind the page.

FieldValueCited text
Known as Rucaparib ClinicalTrials.gov intervention name — accepted as the source's own label NCT02678182
59

NCT03840200

NCT02986100

NCT03318445

NCT03140670

NCT03899155

NCT03954366

NCT03413995

NCT03499444

NCT02042378

NCT04209595

NCT03338790

NCT03522246

NCT03768063

NCT03795272

NCT03694262

NCT04171700

NCT04624178

NCT02505048

NCT03552471

NCT02952534

NCT02975934

NCT03617679

NCT03572478

NCT03639935

NCT04253262

NCT02740712

NCT02935634

NCT01482715

NCT03559049

NCT03337087

NCT03101280

NCT01968213

NCT04455750

NCT03845296

NCT03992131

NCT03462212

NCT03824704

NCT03442556

NCT03521037

NCT00664781

NCT03958045

NCT03654833

NCT04676334

NCT03476798

NCT01891344

NCT02711137

NCT03397394

NCT03995017

NCT03533946

NCT02855944

NCT04276376

NCT01074970

NCT04826198

NCT04179396

NCT03911453

NCT03542175

NCT04227522

NCT02873962

NCT02925234

Known as AG-014699 “A Parallel Arms Phase 1 Safety, Pharmacokinetic And Pharmacodynamic Study Of The Intravenous Poly (ADP-Ribose) Polymerase (PARP) Inhibitor PF-01367338 (AG-014699) In...” NCT01009190
2

“rucaparib (CO-338; formally AG-014699 or PF-01367338)” NCT00664781

NCT00457470

Known as AG-14447 ChEMBL registry synonym — accepted as the source's own label CHEMBL1173055
Known as AG-14699 ChEMBL registry synonym — accepted as the source's own label CHEMBL1173055
Known as C0-338 ChEMBL registry synonym — accepted as the source's own label CHEMBL1173055
Known as CO-338 “The main purpose of this study is to look at the effectiveness, safety, and antitumor activity (preventing growth of the tumor) of the experimental study drug rucaparib (also...” NCT03140670
1

“rucaparib (CO-338; formally AG-014699 or PF-01367338)” NCT00664781

Known as PF-01367338 “rucaparib (CO-338; formally AG-014699 or PF-01367338)” NCT00664781
1

NCT01009190

Known as PF-0136738 “Rucaparib(CO-338;Formally Called AG-014699 or PF-0136738) in Treating Patients With Locally Advanced or Metastatic Breast Cancer or Advanced Ovarian Cancer” NCT00664781
Known as PF-1367338-BW ChEMBL registry synonym — accepted as the source's own label CHEMBL1173055
Known as Rubraca ChEMBL registry synonym — accepted as the source's own label CHEMBL1173055
Known as Rucaparib camsylate “To compare radiographic progression-free survival (rPFS) and overall survival (OS) with enzalutamide and rucaparib camsylate (rucaparib) versus enzalutamide alone for patients...” NCT04455750
2

“This phase I trial studies the side effects and best dose of mirvetuximab soravtansine and rucaparib camsylate in treating participants with endometrial, ovarian, fallopian...” NCT03552471

“Drug: Rucaparib camsylateNCT03521037

Known as RUCAPARIB PHOSPHATE ChEMBL registry synonym — accepted as the source's own label CHEMBL1173055
Action Inhibit “PARP-1 inhibitor” NCT00664781
Modality Small molecule “Rucaparib is an orally available, small molecule inhibitor” NCT01891344
Route Intravenous “The study was originally set up with an IV formulation.” NCT00664781
Target PARP1 “PARP-1 inhibitor” NCT00664781