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 |
|---|---|
| infections | D007239 |
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 |
|---|---|---|---|---|
| SIRTURO | Johnson & Johnson | N-204384 RX | 2012-12-28 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| sirturo | New Drug Application | 2025-08-14 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| multidrug-resistant tuberculosis | EFO_0007381 | D018088 | — |
| mycobacterium infections | — | D009164 | A31.9 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
BEDAQUILINE FUMARATE, SIRTURO, JANSSEN THERAP | |||
| 2027-05-27 | ODE-307 | ||
| 2026-08-09 | ODE-251 | ||
HCPCS
No data
Clinical
Clinical Trials
93 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 8 | 26 | 17 | 3 | 7 | 54 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | 1 | 27 | 19 | 1 | 1 | 41 |
| Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | — | 14 | 17 | 5 | 5 | 35 |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 1 | 1 | 1 | — | 2 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Extensively drug-resistant tuberculosis | D054908 | — | — | — | 5 | 7 | — | — | 8 |
| Leprosy | D007918 | EFO_0001054 | A30 | — | 2 | 1 | — | — | 3 |
| Latent tuberculosis | D055985 | — | Z22.7 | 1 | 1 | 2 | — | — | 3 |
| Mycobacterium infections | D009164 | — | A31.9 | — | 1 | 2 | — | — | 2 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | 1 | — | — | 2 |
| Bacterial infections | D001424 | — | A49 | — | — | 2 | — | — | 2 |
| Communicable diseases | D003141 | — | — | — | — | 1 | — | — | 1 |
| Gram-positive bacterial infections | D016908 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 1 | — | — | 2 | 4 |
| Hiv | D006678 | — | O98.7 | 3 | 2 | — | — | — | 4 |
| Multibacillary leprosy | D056006 | — | — | — | 1 | — | — | — | 1 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 6 | — | — | — | — | 6 |
| Biological availability | D001682 | — | — | 1 | — | — | — | — | 1 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Disease | D004194 | EFO_0000408 | R69 | 1 | — | — | — | — | 1 |
| Breast feeding | D001942 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Bedaquiline |
| INN | bedaquiline |
| 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 class | antibiotics, 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-ID | 843663-66-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL376488 |
| ChEBI ID | 72292 |
| PubChem CID | 5388906 |
| DrugBank | DB08903 |
| UNII ID | 78846I289Y (ChemIDplus, GSRS) |
Target
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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
Black-box warning for: Sirturo
Adverse Events
Top Adverse Reactions
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3,693 adverse events reported
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