Product Description
Rifabutin is a derivative of rifamycin S with activity against mycobacteria including atypical organisms such as Mycobacterium avium and M. intracellulare, also referred to as Mycobacterium avium-intracellulare complex (MAC). To date, rifabutin is the only drug to have been studied in large prospective placebo-controlled trials that has been shown to significantly reduce the incidence of disseminated MAC infection when administered prophylactically as a single agent to patients with acquired immune deficiency syndrome (AIDS). (Sourced from: https://pubmed.ncbi.nlm.nih.gov/7521834/)
Mechanisms of Action: CYP3A4 Activator
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: None
Known Adverse Events: None
Company: Bristol-Myers Squibb
Company Location: NEW YORK NY 10016
Company CEO: Giovanni Caforio
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Canada, China, Comoros, France, Korea, Madagascar, Spain, United Kingdom, United States, Zambia, Zimbabwe
Active Clinical Trial Count: 53
Highest Development Phases
Phase 3: Child Nutrition Disorders|Fractures, Open|Hidradenitis Suppurativa|Leprosy|Severe Acute Malnutrition|Tuberculosis, Pulmonary
Phase 1: Acute Myeloid Leukemia|Acute Pain|Alzheimer Disease|Arthritis, Rheumatoid|Bladder Cancer|Breast Cancer|COVID-19|Chronic Pain|Erectile Dysfunction|Esophageal Cancer|Evans Syndrome|Fatty Liver, Alcoholic|Geographic Atrophy|HIV Infections|Healthy Volunteers|Insomnia|Low Back Pain|Lymphoma|Lymphoma, B-Cell|Neuralgia|Non-Small-Cell Lung Cancer|Oncology Hematological Unspecified|Oncology Solid Tumor Unspecified|Oncology Unspecified|Pain Unspecified|Pain, Postoperative|Parkinson's Disease|Pneumonia|Prostate Cancer|Small Cell Lung Cancer|Type 2 Diabetes|Urinary Calculi
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| Co-SAM | P3 |
Recruiting |
Severe Acute Malnutrition|Child Nutrition Disorders |
2026-07-15 |
|
| DURATIOM | P3 |
Not yet recruiting |
Fractures, Open |
2026-01-31 |
|
| ABCESS2 | P3 |
Not yet recruiting |
Hidradenitis Suppurativa |
2025-12-15 |
|
| Hi-DoRi-3 | P3 |
Not yet recruiting |
Tuberculosis, Pulmonary |
2025-08-01 |