Product Description
Clofazimine is a drug used to treat leprosy. It can slow down the growth and weakly kill Mycobacterium leprae, the bacterium that causes leprosy. It is used in combination with rifampicin and dapsone for the treatment of the many forms of leprosy. (Sourced from: https://dermnetnz.org/topics/clofazimine)
Mechanisms of Action: ET-C Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: Fast Track - Nontuberculous Mycobacterial Lung Disease *
Approval Status: Approved
Approved Countries: Australia | Colombia | Czech | France | Greece | India | Ireland | Korea | Lithuania | Malaysia | Malta | New Zealand | Pakistan | Romania | Russia | Slovenia | South Africa | Spain | Switzerland | Taiwan | Thailand | Ukraine | United Kingdom | Uruguay
Approved Indications: Erythema | Erythema Nodosum | Leprosy | Leprosy, Lepromatous
Known Adverse Events: Abdominal Pain | Pain Unspecified | Diarrhea
Company: Novartis
Company Location: BASEL V8 CH 4056
Company CEO: Vasant Narasimhan
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Philippines, United States, Vietnam
Active Clinical Trial Count: 3
Highest Development Phases
Phase 3: Communicable Diseases|Mycobacterium Infections, Nontuberculous
Phase 2: Tuberculosis, Multidrug-Resistant
Phase 1: Healthy Volunteers
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| DRAMATIC | P2 |
Recruiting |
Tuberculosis, Multidrug-Resistant |
2027-05-01 |
|
| ICoN-1 | P3 |
Recruiting |
Mycobacterium Infections, Nontuberculous|Communicable Diseases |
2026-08-01 |
|
| ACTRN12621001702808 | P1 |
Completed |
Healthy Volunteers |
2022-06-19 |