Drug · Small Molecule

Rucaparib

CI-DRUG-00000528Explore in graph →NCIt C137800 CHEMBL1173055 CIViC Approved

Regulatory

Approvals (10)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

emaRegulatory10 approval records from 2 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
EU EMA	Malignant Peritoneal Neoplasm	Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.	approved	May 23, 2018	ema
US FDA	—	Efficacy supplement 2025-12-17 (see label)	approved	Dec 17, 2025	openfda
US FDA	—	Efficacy supplement 2025-12-17 (see label)	approved	Dec 17, 2025	openfda
US FDA

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	9	2	8	59	10	EU, US	Dec 19, 2016	2007-12
Malignant Prostate Neoplasm	Approved	Phase 3	2	0	3	11	1	US	Dec 19, 2016	Feb 15, 2017
Malignant Ovarian Neoplasm	Phase3	Phase 3	2	0	5	14	0	—	—	2007-12
Malignant Gastric Neoplasm	Phase2	Phase 2	1	0	0	3	0

Curated evidence

Clinical evidence (32)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–32 of 32 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
ATM Mutation1
Rucaparib	Castration-Resistant Prostate Carcinoma

Clinical trials

Trials with this intervention (60)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–50 of 60 studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT03899155	Pan Tumor Rollover Study	recruiting	Phase 2	1,500	Bristol-Myers SquibbINDUSTRY	38	Sep 23, 2026	clinicaltrials
NCT03442556	Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency	terminated	Phase 2

Molecule

Record

Kind: Small Molecule
Mechanism: PARP 1, 2 and 3 inhibitor
Targets: 3 genes
UNII: 41AX9SJ8KO
Aliases: 6H-Pyrrolo(4,3,2-ef)(2)benzazepin-6-one, 8-Fluoro-1,3,4,5-tetrahydro-2-(4-((methylamino)methyl)phenyl)-, 8-Fluoro-2-(4-((methylamino)methyl)phenyl)-1,3,4,5-tetrahydro-6H-azepino(5,4,3-cd)indol-6-one, AG 14447, AG-14447, AG14447, RUBRACA, Rucaparib

Data updated 22 hours agoSource updated unknown

Identifiers

Codes (2)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01XX	Antineoplastic agents
EMA product	EMEA/H/C/004272	Rubraca

Regulatory status is jurisdiction-specific and time-bound. Nothing on this page is a treatment recommendation.

BRCA1 Mutation7
Rucaparib	Castration-Resistant Prostate Carcinoma	Predictive	B	Does Not Support Sensitivity Response	3	submitted	EID13266 In a prespecified subgroup analysis of the randomized phase III TRITON3 trial, patients with metastatic castration-resistant prostate cancer harboring germline or somatic deleterious BRCA1 alterations… (full text at CIViC) PMID 36795891 · Fizazi et al., 2023 · Open in CIViC	civic
〃	Malignant Ovarian Neoplasm	Predictive	A	Supports Sensitivity Response	5	accepted	EID11136 Combined meta-analysis of Study 10 (NCT01482715, phase I/II) and ARIEL2 (NCT01891344, phase II), both multi-centre, open-label, single-arm trials evaluating rucaparib in ovarian cancer with BRCA1 or B… (full text at CIViC) PMID 28882436 · Oza et al., 2017 · Open in CIViC	civic
〃	Malignant Ovarian Neoplasm	Predictive	A	Supports Sensitivity Response	5	accepted	EID11138 Combined meta-analysis of Study 10 (NCT01482715, phase I/II) and ARIEL2 (NCT01891344, phase II), both multi-centre, open-label, single-arm trials evaluating rucaparib in ovarian cancer with BRCA1 or B… (full text at CIViC) PMID 28882436 · Oza et al., 2017 · Open in CIViC	civic
〃	Malignant Ovarian Neoplasm	Predictive	B	Supports Sensitivity Response	3	accepted	EID1897 A phase 2 trial on patients with relapsed, platinum-sensitive high grade ovarian, fallopian tube or primary peritoneal carcinoma (ARIEL2 Part1, NCT01891344) was held to assess PARP inhibitor rucaparib… (full text at CIViC) PMID 27908594 · Swisher et al., 2017 · Open in CIViC	civic
〃	Malignant Ovarian Neoplasm	Predictive	B	Supports Sensitivity Response	3	accepted	EID6341 A phase 2 trial on patients with relapsed, platinum-sensitive high grade ovarian, fallopian tube or primary peritoneal carcinoma (ARIEL2 Part1, NCT01891344) was held to assess PARP inhibitor rucaparib… (full text at CIViC) PMID 27908594 · Swisher et al., 2017 · Open in CIViC	civic
〃	Malignant Pancreatic Neoplasm	Predictive	B	Does Not Support Sensitivity Response	2	submitted	EID9291 For this single-arm phase II trial, patients with locally advanced or metastatic pancreatic cancer (neuroendocrine excluded); and had a confirmed pathogenic or likely pathogenic germline (g) or somati… (full text at CIViC) PMID 33970687 · Reiss et al., 2021 · Open in CIViC	civic
〃	Malignant Pancreatic Neoplasm	Predictive	C	Does Not Support Sensitivity Response	3	submitted	EID7435 In a phase 2 trial, patients with advanced pancreatic cancer harboring germline or somatic BRCA1/2 mutation were treated with PARP inhibitor Rucaparib. In this trial, none of four patients with germli… (full text at CIViC) PMID 30051098 · Shroff et al., 2018 · Open in CIViC	civic

BRCA1 Mutation7

Rucaparib

Castration-Resistant Prostate Carcinoma

Predictive

Does Not Support Sensitivity Response

submitted

EID13266

In a prespecified subgroup analysis of the randomized phase III TRITON3 trial, patients with metastatic castration-resistant prostate cancer harboring germline or somatic deleterious BRCA1 alterations… (full text at CIViC)

PMID 36795891 · Fizazi et al., 2023 · Open in CIViC

PALB2 Mutation2
Rucaparib	Malignant Breast Neoplasm	Predictive	B	Supports Sensitivity Response	3	submitted	EID7460 In a phase2 trial, patients with breast cancer harboring mutations in homologous recombination pathway genes other than BRCA1/2 were treated with olaparib. Among 6 patients with breast cancer harbori… (full text at CIViC) Open in CIViC	civic
〃	Malignant Pancreatic Neoplasm	Predictive	B	Supports Sensitivity Response	2	submitted	EID9294 For this single-arm phase II trial patients with locally advanced or metastatic pancreatic cancer (neuroendocrine excluded); and had a confirmed pathogenic or likely pathogenic germline (g) or somatic… (full text at CIViC) PMID 33970687 · Reiss et al., 2021 · Open in CIViC	civic