TheraRadar
Data updated: May 26, 2026

RUBRACA (rucaparib camsylate)

Genetic Support Trial Activity: Declining 10 active trials
First-in-Class Orphan Drug Breakthrough Therapy Priority Review Fast Track
Oncology Approved 2016-12-19

Rubraca helps patients with recurrent ovarian, fallopian tube, or primary peritoneal cancer that involves a BRCA mutation. It is used as a maintenance therapy for adults who have already shown a partial or complete response to platinum-based chemotherapy. This medication also treats metastatic castration-resistant prostate cancer in patients with BRCA mutations who have previously received androgen receptor-directed therapy. Healthcare providers use a specific diagnostic test to confirm the presence of these genetic mutations before starting therapy.

Source: FDA Label • PHARMAAND
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How RUBRACA Works

Rubraca works by blocking PARP enzymes, which are responsible for repairing damaged DNA within cells. By inhibiting these enzymes and creating stable PARP-DNA complexes, the drug triggers DNA damage that leads to cancer cell death. This effect is especially strong in tumor cells with BRCA mutations, as they already have a limited ability to repair DNA.

Source: FDA Label

Development Insights

pharmaand GmbH conducting 18 trials (33%)
98 indications explored (Broad Platform)
→ ovarian cancer (9 trials)
→ fallopian tube cancer (8 trials)
→ peritoneal cancer (5 trials)
7
Indications
--
Phase 3 Trials
6
Priority Reviews
9
Years on Market

Details

Status
Prescription
First Approved
2016-12-19
Patent Cliff
2035

Pro Metrics

Patent cliff and revenue data

Unlock with Pro
Routes
ORAL
Dosage Forms
TABLET

Companies

PHARMAAND
Active Ingredient: RUCAPARIB CAMSYLATE

RUBRACA Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
27 FDA actions from 2016 to 2025 · 6 indication expansions
Dec 2025 SUPPL
Efficacy
FDA Letter Label
Dec 2022 SUPPL Priority
Efficacy
FDA Letter Label
Jun 2022 SUPPL Priority
Efficacy
FDA Letter Label

What RUBRACA Treats

2 indications

RUBRACA is approved for 2 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Ovarian Cancer
  • Prostate Cancer
Source: FDA Label

RUBRACA Target & Pathway

Pro

Target

PARP (Poly ADP-Ribose Polymerase) DNA Repair Enzyme

RUBRACA Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Direct competitors

2

Same target(s) AND same indication — head-to-head.

AKEEGA
Johnson &
2023 1 indic.
ZEJULA
GSK
2017 3 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

CONJUGATED ESTROGENS
NOVAST LABS
2025 6 indic.
BILDYOS
SHANGHAI HENLIUS
2025 4 indic.
Unlock 8 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in RUBRACA's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications RUBRACA treats. First-in-class if their pivotal trials read out positive.

Ceralasertib AZD6738 ~ Mixed — Ph3 readout
AstraZeneca
ATR · small-molecule ATR kinase inhibitor · 2 Phase 3 trials

Drugs Similar to RUBRACA

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

AKEEGA
ABIRATERONE ACETATE
1 shared
Johnson & Johnson
Shared indications:
Prostate Cancer
AMICAR
AMINOCAPROIC ACID
1 shared
EPIC PHARMA LLC
Shared indications:
Prostate Cancer
AMINOCAPROIC ACID
AMINOCAPROIC ACID
1 shared
AJENAT PHARMS
Shared indications:
Prostate Cancer
View all 20 similar drugs Pro
📋

Clinical Trial Registry

53 trials
Trial Sponsor ID Phase Status Title
NCT03768063 IMbrella B BO40729 2023-506184-34-00 Ph 3 active not recruiting A Study in Patients Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Atezolizumab Study
NCT03694262 EndoBARR results posted EndoBARR Ph 2 completed The EndoBARR Trial (Endometrial Bevacizumab, Atezolizumab, Rucaparib)
NCT02873962 results posted 16-263 Ph 2 active not recruiting A Phase II Study Of Nivolumab/ Bevacizumab/Rucaparib
NCT03899155 CA209-8TT 2018-004362-34 Ph 2 recruiting Pan Tumor Rollover Study
NCT03617679 results posted 18-0567.cc P30CA046934 Ph 2 completed Rucaparib vs Placebo Maintenance Therapy in Metastatic and Recurrent Endometrial Cancer
NCT03559049 results posted UMCC 2018.033 HUM00142973 Ph 1, Ph 2 terminated Rucaparib and Pembrolizumab for Maintenance Therapy in Stage IV Non-Squamous Non-Small Cell Lung Cancer
NCT04455750 CASPAR A031902 NCI-2020-02360, U10CA180821 Ph 3 active not recruiting A Clinical Study Evaluating The Benefit of Adding Rucaparib to Enzalutamide for Men With Metastatic Prostate Cancer That Has Become Resistant To Testosterone-Deprivation Therapy
NCT03338790 CheckMate 9KD results posted CA209-9KD Ph 2 completed An Investigational Immunotherapy Study of Nivolumab in Combination With Rucaparib, Docetaxel, or Enzalutamide in Metastatic Castration-resistant Prostate Cancer
NCT03542175 results posted 18-002 P50CA247749 Ph 1 completed A Study of Rucaparib Administered With Radiation in Patients With Triple Negative Breast Cancer With an Incomplete Response Following Chemotherapy
NCT04276376 ARIANES 2018-001744-62 2018/2727 Ph 2 terminated Efficacy and Safety of the Combination of Rucaparib (PARP Inhibitor) and Atezolizumab (Anti-PD-L1 Antibody) in Patients With DNA Repair-deficient or Platinum-sensitive Solid Tumors
NCT04624178 20-358 Ph 2 active not recruiting A Study of Rucaparib and Nivolumab in People With Leiomyosarcoma
NCT02711137 results posted INCB 57643-101 2017-002641-29 Ph 1, Ph 2 terminated Open-Label Safety and Tolerability Study of INCB057643 in Subjects With Advanced Malignancies
NCT02975934 TRITON3 results posted CO-338-063 2016-003163-20 Ph 3 completed A Study of Rucaparib Versus Physician's Choice of Therapy in Participants With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
NCT03522246 ATHENA results posted CO-338-087/GOG-3020/ENGOT-ov45 2017-004557-17, 2024-516662-11-00 Ph 3 active not recruiting A Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy
NCT03442556 9841 NCI-2018-00016, 9841 Ph 2 terminated Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency
NCT02678182 PLATFORM 3804 Ph 2 active not recruiting Planning Treatment for Oesophago-gastric Cancer: a Maintenance Therapy Trial
NCT03639935 results posted UMCC 2018.044 HUM00142974 Ph 2 completed Rucaparib in Combination With Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy
NCT03845296 results posted S1900A NCI-2018-02129, S1900A Ph 2 completed Rucaparib in Treating Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial)
NCT04253262 BrUOG 360 Ph 1, Ph 2 active not recruiting A Study of Copanlisib Combined With Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer
NCT04209595 results posted 200013 20-C-0013 Ph 1, Ph 2 completed PLX038 (PEGylated SN38) and Rucaparib in Solid Tumors and Small Cell Cancers
NCT03552471 OSU-18007 NCI-2018-00438 Ph 1 completed Mirvetuximab Soravtansine and Rucaparib Camsylate in Treating Participants With Recurrent Endometrial, Ovarian, Fallopian Tube or Primary Peritoneal Cancer
NCT04826198 REVOCAN 2020-000825-18 2020-3047 Ph 1, Ph 2 terminated Safety and Efficacy of AsiDNATM, a DNA Repair Inhibitor, Administered Intravenously in Addition to PARP Inhibitors in Patients With Relapsed Platinum Sensitive Ovarian Cancer Already Treated With PARP Inhibitors Since at Least 6 Months
NCT04227522 MAMOC NOGGO ov42 Ph 3 completed Rucaparib MAintenance After Bevacizumab Maintenance Following Carboplatin Based First Line Chemotherapy in Ovarian Cancer Patients
NCT03413995 TRIUMPH results posted J17187 IRB00156514 Ph 2 completed Trial of Rucaparib in Patients With Metastatic Hormone-Sensitive Prostate Cancer Harboring Germline DNA Repair Gene Mutations
NCT01074970 results posted BRE09-146 Ph 2 completed PARP Inhibition for Triple Negative Breast Cancer (ER-/PR-/HER2-)With BRCA1/2 Mutations
NCT03337087 results posted ACCRU-GI-1603 NCI-2017-01976, ACCRU-GI-1603 Ph 1, Ph 2 active not recruiting Liposomal Irinotecan, Fluorouracil, Leucovorin Calcium, and Rucaparib in Treating Patients With Metastatic Pancreatic, Colorectal, Gastroesophageal, or Biliary Cancer
NCT04676334 CATCH-R results posted CO-338-111 2020-001538-37 Ph 3 completed CATCH-R: A Rollover Study to Provide Continued Access to Rucaparib
NCT03533946 ROAR results posted HCI111833 Ph 2 terminated Rucaparib in Nonmetastatic prOstAte With BRCAness
NCT03476798 Clovis-001 results posted OU-SCC-CLOVIS-001 Ph 2 completed Bevacizumab and Rucaparib in Recurrent Carcinoma of the Cervix or Endometrium
NCT02925234 DRUP M15DRU Ph 2 recruiting The Drug Rediscovery Protocol (DRUP Trial)
NCT03992131 results posted CO-338-098 2018-003759-39 Ph 1, Ph 2 terminated A Study to Evaluate Rucaparib in Combination With Other Anticancer Agents in Participants With a Solid Tumor (SEASTAR)
NCT03840200 results posted BO40933 Ph 1 completed A Study Evaluating the Safety, Pharmacokinetics and Efficacy of Ipatasertib Administered in Combination With Rucaparib in Participants With Advanced Breast, Ovarian Cancer, and Prostate Cancer.
NCT04171700 LODESTAR results posted CO-338-100 Ph 2 terminated A Study to Evaluate Rucaparib in Participants With Solid Tumors and With Deleterious Mutations in HRR Genes
NCT03140670 results posted UPCC 05217 Ph 2 terminated Maintenance Rucaparib in BRCA1, BRCA2 or PALB2 Mutated Pancreatic Cancer That Has Not Progressed on Platinum-based Therapy
NCT04179396 RAMP results posted CO-338-107 Ph 1 completed Study of Oral Rucaparib With Other Anticancer Agents in Metastatic Castration Resistant Prostate Cancer Patients (RAMP)
NCT02042378 CO-338-023 Ph 2 completed A Study of Rucaparib in Patients With Pancreatic Cancer and a Known Deleterious BRCA Mutation
NCT03824704 results posted CO-338-097 Ph 2 terminated A Study to Evaluate Rucaparib in Combination With Nivolumab in Patients With Selected Solid Tumors (ARIES)
NCT02740712 DDI CO-338-044 Ph 1 completed Pharmacokinetic Drug-Drug Interaction Study of Rucaparib
NCT02935634 FRACTION-GC results posted CA018-003 2016-002807-24 Ph 2 completed A Study to Test Combination Treatments in Participants With Advanced Gastric Cancer
NCT03499444 CO-338-081 Ph 1 completed A Study of Rucaparib in Japanese Patients With a Previously-treated Solid Tumor
NCT02855944 results posted CO-338-043 2016-000816-14 Ph 3 completed ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients
NCT01968213 ARIEL3 results posted CO-338-014 2013-000518-39 Ph 3 completed Phase 3 Study of Rucaparib as Switch Maintenance After Platinum in Relapsed High Grade Serous or Endometrioid Ovarian Cancer (ARIEL3)
NCT03397394 ATLAS results posted CO-338-085 2017-004166-10 Ph 2 terminated Rucaparib in Patients With Locally Advanced or Metastatic Urothelial Carcinoma
NCT02952534 TRITON2 results posted CO-338-052 2016-003162-13 Ph 2 completed A Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency
NCT01482715 results posted CO-338-010 2011-004250-26 Ph 1, Ph 2 completed A Study of Oral Rucaparib in Patients With a Solid Tumor (Phase I) or With gBRCA Mutation Ovarian Cancer (Phase II)
NCT02986100 AME CO-338-045 2015-004394-32 Ph 1 completed Absorption, Metabolism, and Excretion Following a Single Oral Dose of [14C]-Rucaparib
NCT03521037 CO-338-078 Ph 1 completed Rucaparib Hepatic Impairment Study in Patients With a Solid Tumor
NCT03954366 CO-338-095 Ph 1 completed Drug-Drug Interaction Study of Rucaparib, Rosuvastatin and Oral Contraceptives
NCT02505048 RUBY UC-0105/1501 Ph 2 completed A Study to Assess the Efficacy of Rucaparib in Metastatic Breast Cancer Patients With a BRCAness Genomic Signature
NCT03572478 results posted IRB18-0154 Ph 1, Ph 2 terminated Rucaparib and Nivolumab in Patients With Prostate or Endometrial Cancer

Showing 50 of 53 trials

🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

RUBRACA FDA Label Details

Indications & Usage

FDA Label (PDF)

RUBRACA is indicated for the treatment of Ovarian Cancer; Prostate Cancer.

View full patent landscape →
9 OB patents · 4 families · 245 international docs across 36 countries

RUBRACA Patents & Exclusivity

Latest Patent: Aug 2035
Exclusivity: Dec 2028

Patents (9 active)

US10130636 Expires Aug 17, 2035
US9987285 Expires Aug 17, 2035
US8859562 Expires Aug 4, 2031
US9861638 Expires Feb 10, 2031
US8754072 Expires Feb 10, 2031
US9045487 Expires Feb 10, 2031
US10278974 Expires Feb 10, 2031
US8143241 Expires Aug 12, 2027
US8071579 Expires Aug 12, 2027

Exclusivity

I-982 Until Dec 2028
I-982 Until Dec 2028
I-982 Until Dec 2028
I-982 Until Dec 2028
I-982 Until Dec 2028
I-982 Until Dec 2028
I-982 Until Dec 2028
I-982 Until Dec 2028
I-982 Until Dec 2028
Source: FDA Orange Book

Pro Intelligence Preview

Deep insights for RUBRACA

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2035
  • • 171 active patents

Trial Analysis

  • • 54 total trials
  • • Stage: Declining

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
Unlock Full Intelligence

Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA209115 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment