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
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| rubraca | New Drug Application | 2025-01-27 |
Indications
FDA
EMA
No data
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
68 clinical trials
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Indications Phases 4
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Indications Phases 3
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
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 | — |
| CAS-ID | 283173-50-2 |
| RxCUI | — |
| 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
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Variants
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Financial
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Trends
PubMed Central
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Safety
Black-box Warning
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Adverse Events
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8,696 adverse events reported
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