Clofazimine
Lamprene (clofazimine) is a small molecule pharmaceutical. Clofazimine was first approved as Lamprene on 1986-12-15. It is used to treat borderline leprosy, lepromatous leprosy, mycobacterium avium-intracellulare infection, mycobacterium infections, and pyoderma gangrenosum in the USA.
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Drug Products
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New Drug Application (NDA)
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Clofazimine
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| LAMPRENE | Novartis | N-019500 DISCN | 1986-12-15 | 2 products, RLD |
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Labels
FDA
EMA
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Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| borderline leprosy | EFO_0001055 | D015439 | A30.3 |
| lepromatous leprosy | EFO_0001057 | D015440 | A30.5 |
| mycobacterium avium-intracellulare infection | EFO_0007386 | D015270 | — |
| mycobacterium infections | — | D009164 | A31.9 |
| pyoderma gangrenosum | EFO_0006835 | D017511 | L88 |
Agency Specific
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Clinical
Clinical Trials
34 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 tuberculosis | D018088 | EFO_0007381 | — | 6 | 8 | 1 | 1 | 12 | |
| Crohn disease | D003424 | EFO_0000384 | K50 | — | — | 1 | 1 | — | 2 |
| Leprosy | D007918 | EFO_0001054 | A30 | — | — | — | 1 | 1 | 2 |
| Lepromatous leprosy | D015440 | EFO_0001057 | A30.5 | — | — | — | 1 | — | 1 |
| Multibacillary leprosy | D056006 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pulmonary tuberculosis | D014397 | EFO_1000049 | A15 | — | 7 | 6 | — | — | 9 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | 1 | — | 4 | 6 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 2 | 2 | — | 1 | 5 |
| Mycobacterium avium-intracellulare infection | D015270 | EFO_0007386 | — | 1 | 1 | — | 2 | 4 | |
| Extensively drug-resistant tuberculosis | D054908 | — | 3 | 4 | — | — | 4 | ||
| Bacterial infections | D001424 | A49 | — | — | 2 | — | — | 2 | |
| Mycobacterium infections | D009164 | A31.9 | — | — | 1 | — | 1 | 2 | |
| Lung diseases | D008171 | EFO_0003818 | J98.4 | — | 1 | 1 | — | — | 1 |
| Gram-positive bacterial infections | D016908 | — | — | 1 | — | — | 1 |
Indications Phases 1
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | CLOFAZIMINE |
| INN | clofazimine |
| Description | Clofazimine is 3-Isopropylimino-3,5-dihydro-phenazine in which the hydrogen at position 5 is substituted substituted by a 4-chlorophenyl group, and that at position 2 is substituted by a (4-chlorophenyl)amino group. A dark red crystalline solid, clofazimine is an antimycobacterial and is one of the main drugs used for the treatment of multi-bacillary leprosy. However, it can cause red/brown discolouration of the skin, so other treatments are often preferred in light-skinned patients. It has a role as a leprostatic drug, a non-steroidal anti-inflammatory drug and a dye. It is a member of phenazines and a member of monochlorobenzenes. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC(C)/N=c1\cc2n(-c3ccc(Cl)cc3)c3ccccc3nc-2cc1Nc1ccc(Cl)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 2030-63-9 |
| RxCUI | 2592 |
| ChEMBL ID | CHEMBL1292 |
| ChEBI ID | — |
| PubChem CID | 2794 |
| DrugBank | DB00845 |
| UNII ID | D959AE5USF (ChemIDplus, GSRS) |
Target
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Trends
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Safety
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1 adverse events reported
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