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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
neoplasmsD009369
urogenital diseasesD000091642
endocrine system diseasesD004700
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
RUBRACAPharma&N-209115 RX2016-12-19
3 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
rubracaNew Drug Application2020-10-12
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
ovarian neoplasmsEFO_0003893D010051C56
Agency Specific
FDA
EMA
Expiration
Code
RUCAPARIB CAMSYLATE, RUBRACA, ZR PHARMA
2025-04-06ODE-168
2023-12-19ODE-126
2023-05-15I-830
Patent Expiration
Patent
Expires
Flag
FDA Information
Rucaparib Camsylate, Rubraca, Zr Pharma
99872852035-08-17DP
101306362035-08-17U-2012, U-2101, U-2273, U-2830
88595622031-08-04U-2012, U-2273, U-2830
87540722031-02-10DS, DP
90454872031-02-10DS, DP
98616382031-02-10U-2012, U-2273
102789742031-02-10DP
80715792027-08-12U-2012, U-2273, U-2830
81432412027-08-12U-2012, U-2273, U-2830
73517012024-07-23U-2012, U-2273, U-2830
75315302024-07-23U-2012, U-2273, U-2830
64955412023-11-22DS, DP
ATC Codes
L: Antineoplastic and immunomodulating agents
— L01: Antineoplastic agents
— L01X: Other antineoplastic agents in atc
— L01XK: Poly (adp-ribose) polymerase (parp) inhibitors
— L01XK03: Rucaparib
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
NeoplasmsD009369C801061—115
Ovarian neoplasmsD010051EFO_0003893C56564——12
Fallopian tube neoplasmsD005185355—112
Castration-resistant prostatic neoplasmsD064129233——7
Prostatic neoplasmsD011471C61241——6
Ovarian epithelial carcinomaD000077216—23—16
Peritoneal neoplasmsD010534133——6
AdenocarcinomaD000230—21——3
Large cell carcinomaD018287——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Breast neoplasmsD001943EFO_0003869C5033———6
Endometrial neoplasmsD016889EFO_000423014———4
Small cell lung carcinomaD05575213———3
Pancreatic neoplasmsD010190EFO_0003860C2513———3
CarcinosarcomaD00229611———2
Uterine cervical neoplasmsD002583—2———2
Biliary tract neoplasmsD001661C24.912———2
Non-small-cell lung carcinomaD00228912———2
Urologic neoplasmsD014571C64-C6812———2
Malignant mesotheliomaD000086002—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 neoplasmsD0058331————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameRUCAPARIB
INNrucaparib
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 classpoly-ADP-ribose polymerase inhibitors
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CNCc1ccc(-c2[nH]c3cc(F)cc4c3c2CCNC4=O)cc1
Identifiers
PDB4RV6
CAS-ID283173-50-2
RxCUI1862579
ChEMBL IDCHEMBL1173055
ChEBI ID—
PubChem CID9931954
DrugBankDB12332
UNII ID8237F3U7EH (ChemIDplus, GSRS)
Target
Agency Approved
PARP1
PARP1
Organism
Homo sapiens
Gene name
PARP1
Gene synonyms
ADPRT, PPOL
NCBI Gene ID
142
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
Q8IUZ9
Mouse ortholog
Parp1 (11545)
poly [ADP-ribose] polymerase 1 (P11103)
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 3,822 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
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1 adverse events reported
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