Rubraca(rucaparib)
Rubraca (rucaparib) is a small molecule pharmaceutical. Rucaparib was first approved as Rubraca on 2016-12-19. It is used to treat ovarian neoplasms in the USA. It has been approved in Europe to treat ovarian neoplasms. The pharmaceutical is active against poly [ADP-ribose] polymerase 1.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
---|---|
neoplasms | D009369 |
urogenital diseases | D000091642 |
endocrine system diseases | D004700 |
Trade Name
FDA
EMA
Rubraca
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Rucaparib camsylate
Tradename | Company | Number | Date | Products |
---|---|---|---|---|
RUBRACA | Pharma& | N-209115 RX | 2016-12-19 | 3 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
---|---|---|
rubraca | New Drug Application | 2020-10-12 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
---|---|---|---|
ovarian neoplasms | EFO_0003893 | D010051 | C56 |
Agency Specific
FDA
EMA
Expiration | Code | ||
---|---|---|---|
RUCAPARIB CAMSYLATE, RUBRACA, ZR PHARMA | |||
2025-04-06 | ODE-168 | ||
2023-12-19 | ODE-126 | ||
2023-05-15 | I-830 |
Patent Expiration
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Rucaparib Camsylate, Rubraca, Zr Pharma | |||
9987285 | 2035-08-17 | DP | |
10130636 | 2035-08-17 | U-2012, U-2101, U-2273, U-2830 | |
8859562 | 2031-08-04 | U-2012, U-2273, U-2830 | |
8754072 | 2031-02-10 | DS, DP | |
9045487 | 2031-02-10 | DS, DP | |
9861638 | 2031-02-10 | U-2012, U-2273 | |
10278974 | 2031-02-10 | DP | |
8071579 | 2027-08-12 | U-2012, U-2273, U-2830 | |
8143241 | 2027-08-12 | U-2012, U-2273, U-2830 | |
7351701 | 2024-07-23 | U-2012, U-2273, U-2830 | |
7531530 | 2024-07-23 | U-2012, U-2273, U-2830 | |
6495541 | 2023-11-22 | DS, DP |
HCPCS
No data
Clinical
Clinical Trials
62 clinical trials
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Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Neoplasms | D009369 | C80 | 10 | 6 | 1 | — | 1 | 15 | |
Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 5 | 6 | 4 | — | — | 12 |
Fallopian tube neoplasms | D005185 | 3 | 5 | 5 | — | 1 | 12 | ||
Castration-resistant prostatic neoplasms | D064129 | 2 | 3 | 3 | — | — | 7 | ||
Prostatic neoplasms | D011471 | C61 | 2 | 4 | 1 | — | — | 6 | |
Ovarian epithelial carcinoma | D000077216 | — | 2 | 3 | — | 1 | 6 | ||
Peritoneal neoplasms | D010534 | 1 | 3 | 3 | — | — | 6 | ||
Adenocarcinoma | D000230 | — | 2 | 1 | — | — | 3 | ||
Large cell carcinoma | D018287 | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Breast neoplasms | D001943 | EFO_0003869 | C50 | 3 | 3 | — | — | — | 6 |
Endometrial neoplasms | D016889 | EFO_0004230 | 1 | 4 | — | — | — | 4 | |
Small cell lung carcinoma | D055752 | 1 | 3 | — | — | — | 3 | ||
Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 1 | 3 | — | — | — | 3 |
Carcinosarcoma | D002296 | 1 | 1 | — | — | — | 2 | ||
Uterine cervical neoplasms | D002583 | — | 2 | — | — | — | 2 | ||
Biliary tract neoplasms | D001661 | C24.9 | 1 | 2 | — | — | — | 2 | |
Non-small-cell lung carcinoma | D002289 | 1 | 2 | — | — | — | 2 | ||
Urologic neoplasms | D014571 | C64-C68 | 1 | 2 | — | — | — | 2 | |
Malignant mesothelioma | D000086002 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Female genital neoplasms | D005833 | 1 | — | — | — | — | 1 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common name | RUCAPARIB |
INN | rucaparib |
Description | Rucaparib is a member of the class of azepinoindoles that is 1,3,4,5-tetrahydro-6H-azepino[5,4,3-cd]indol-6-one carrying additional 4-[(methylamino)methyl]phenyl and fluoro substituents at positions 2 and 8 respectively. It is an inhibitor of poly (ADP-ribose) polymerase and is used (as the camsylate salt) as monotherapy for advanced ovarian cancer and deleterious germline or somatic BRCA mutation. It has a role as an EC 2.4.2.30 (NAD(+) ADP-ribosyltransferase) inhibitor and an antineoplastic agent. It is an azepinoindole, a member of caprolactams, an organofluorine compound and a secondary amino compound. It is a conjugate base of a rucaparib(1+). |
Classification | Small molecule |
Drug class | poly-ADP-ribose polymerase inhibitors |
Image (chem structure or protein) | |
Structure (InChI/SMILES or Protein Sequence) | CNCc1ccc(-c2[nH]c3cc(F)cc4c3c2CCNC4=O)cc1 |
Identifiers
PDB | 4RV6 |
CAS-ID | 283173-50-2 |
RxCUI | 1862579 |
ChEMBL ID | CHEMBL1173055 |
ChEBI ID | — |
PubChem CID | 9931954 |
DrugBank | DB12332 |
UNII ID | 8237F3U7EH (ChemIDplus, GSRS) |
Target
Agency Approved
PARP1
PARP1
Organism
Homo sapiens
Gene name
PARP1
Gene synonyms
ADPRT, PPOL
NCBI Gene ID
Protein name
poly [ADP-ribose] polymerase 1
Protein synonyms
ADP-ribosyltransferase (NAD+; poly (ADP-ribose) polymerase), ADP-ribosyltransferase diphtheria toxin-like 1, ADP-ribosyltransferase NAD(+), ADPRT 1, ARTD1, DNA ADP-ribosyltransferase PARP1, NAD(+) ADP-ribosyltransferase 1, poly (ADP-ribose) polymerase family, member 1, poly(ADP-ribose) synthetase, poly(ADP-ribosyl)transferase, Poly[ADP-ribose] synthase 1, Protein poly-ADP-ribosyltransferase PARP1
Uniprot ID
Mouse ortholog
Parp1 (11545)
poly [ADP-ribose] polymerase 1 (P11103)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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1 adverse events reported
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