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Sirturo(bedaquiline)
Sirturo (bedaquiline) is a small molecule pharmaceutical. Bedaquiline was first approved as Sirturo on 2012-12-28. It is used to treat multidrug-resistant tuberculosis and mycobacterium infections in the USA. It has been approved in Europe to treat multidrug-resistant tuberculosis.
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
Trade Name
FDA
EMA
Sirturo
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Bedaquiline fumarate
Tradename
Company
Number
Date
Products
SIRTUROJohnson & JohnsonN-204384 RX2012-12-28
2 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
sirturoNew Drug Application2020-05-27
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
multidrug-resistant tuberculosisEFO_0007381D018088—
mycobacterium infections—D009164A31.9
Agency Specific
FDA
EMA
Expiration
Code
BEDAQUILINE FUMARATE, SIRTURO, JANSSEN THERAP
2027-05-27ODE-307
2026-08-09ODE-251
Patent Expiration
Patent
Expires
Flag
FDA Information
Bedaquiline Fumarate, Sirturo, Janssen Therap
85464282029-03-19DS, DPU-1321
74983432026-12-01DS, DPU-1321
ATC Codes
J: Antiinfectives for systemic use
— J04: Antimycobacterials
— J04A: Drugs for treatment of tuberculosis
— J04AK: Other drugs for treatment of tuberculosis in atc
— J04AK05: Bedaquiline
HCPCS
No data
Clinical
Clinical Trials
61 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Multidrug-resistant tuberculosisD018088EFO_0007381—11121119
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A196136—223
Pulmonary tuberculosisD014397EFO_1000049A15—149——18
Extensively drug-resistant tuberculosisD054908—46——6
Bacterial infectionsD001424A49——2——2
LeprosyD007918EFO_0001054A30—11——2
Lung diseasesD008171EFO_0003818J98.4—11——1
Gram-positive bacterial infectionsD016908——1——1
Mycobacterium infectionsD009164A31.9——1——1
Indications Phases 2
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B2022——14
HivD006678O98.721———3
InfectionsD007239EFO_0000544—1———1
Multibacillary leprosyD056006—1———1
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients—3————3
Hepatic insufficiencyD0485501————1
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
Drug common nameBEDAQUILINE
INNbedaquiline
Description
Bedaquiline is a quinoline-based antimycobacterial drug used (as its fumarate salt) for the treatment of pulmonary multi-drug resistant tuberculosis by inhibition of ATP synthase, an enzyme essential for the replication of the mycobacteria. It has a role as an antitubercular agent and an ATP synthase inhibitor. It is a member of quinolines, a member of naphthalenes, an organobromine compound, an aromatic ether, a tertiary alcohol and a tertiary amino compound. It is a conjugate base of a bedaquiline(2+).
Classification
Small molecule
Drug classantibiotics, diarylquinoline structure
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
COc1nc2ccc(Br)cc2cc1[C@@H](c1ccccc1)[C@@](O)(CCN(C)C)c1cccc2ccccc12
Identifiers
PDB—
CAS-ID843663-66-1
RxCUI1364504
ChEMBL IDCHEMBL376488
ChEBI ID72292
PubChem CID5388906
DrugBankDB08903
UNII ID78846I289Y (ChemIDplus, GSRS)
Target
Agency Approved
No data
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 3,850 documents
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Safety
Black-box Warning
Black-box warning for: Sirturo
Adverse Events
Top Adverse Reactions
Mock data
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6,060 adverse events reported
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