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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
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 | 2024-08-01 |
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
85 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 2 | — | — | 1 | 3 |
| Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | — | 1 | — | — | 1 | 2 |
| Leprosy | D007918 | EFO_0001054 | A30 | — | 1 | — | — | — | 1 |
| Multibacillary leprosy | D056006 | — | — | — | 1 | — | — | — | 1 |
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | — | 2 |
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 5,760 documents
View more details
Safety
Black-box Warning
Black-box warning for: Sirturo
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
3,481 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use