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: *
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: Jiangsu Hengrui Medicine Co
Company Location: Asia Pacific
Company Founding Year: 1970
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Australia, Canada, China, Comoros, France, Gabon, Korea, Madagascar, Malawi, Mozambique, South Africa, Spain, Tanzania, Uganda, United States
Active Clinical Trial Count: 55
Recent & Upcoming Milestones
Highest Development Phases
Phase 3: Fractures, Open|Hidradenitis Suppurativa|Leprosy
Phase 2: Tuberculosis, Pulmonary
Phase 1: Acute Lung Injury|Acute Respiratory Distress Syndrome|Alzheimer Disease|Arthritis, Rheumatoid|Breast Cancer|Bronchiectasis|COVID-19|Cystic Fibrosis|Depressive Disorder|Dermatitis, Atopic|Erectile Dysfunction|Evans Syndrome|Geographic Atrophy|Healthy Volunteers|Kidney Diseases|Lymphoma|Non-Small-Cell Lung Cancer|Oncology Hematological Unspecified|Oncology Solid Tumor Unspecified|Ovarian Cancer|Overweight|Pain Unspecified|Pain, Postoperative|Parkinson's Disease|Pneumonia|Polycystic Kidney, Autosomal Dominant|Prostate Cancer|Small Cell Lung Cancer|Tuberculosis|Type 2 Diabetes
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT03662022 |
PEOPLE | P3 |
Completed |
Leprosy |
2023-01-17 |
2025-03-05 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
|
NCT07014488 |
HRS-5041-105 | P1 |
Completed |
Prostate Cancer |
2025-08-01 |
50% |
2025-09-11 |
|
CTR20244177 |
CTR20244177 | P1 |
Completed |
Kidney Diseases|Polycystic Kidney, Autosomal Dominant |
2025-04-18 |
2025-06-01 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
CTR20242190 |
CTR20242190 | P1 |
Completed |
Erectile Dysfunction |
2024-11-15 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT06619951 |
VC004-106 | P1 |
Completed |
Oncology Solid Tumor Unspecified|Healthy Volunteers |
2024-10-31 |
12% |
2024-12-12 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
CTR20242344 |
CTR20242344 | P1 |
Completed |
Non-Small-Cell Lung Cancer|Lymphoma |
2024-10-07 |
2025-10-28 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
ACTRN12624000031561 |
ACTRN12624000031561 | P1 |
Completed |
Geographic Atrophy |
2024-05-31 |
2026-01-10 |
Treatments |
|
NCT06255951 |
TYKM1601105 | P1 |
Completed |
Small Cell Lung Cancer|Non-Small-Cell Lung Cancer |
2024-05-23 |
50% |
2025-01-03 |
Primary Endpoints |
CTR20241168 |
CTR20241168 | P1 |
Completed |
Tuberculosis |
2024-04-30 |
2025-06-22 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
CTR20231700 |
CTR20231700 | P1 |
Completed |
Breast Cancer |
2023-11-24 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
NCT06089733 |
ABSK021-103 | P1 |
Completed |
Evans Syndrome |
2023-08-30 |
23% |
2024-08-14 |
|
NCT05635110 |
VX22-548-013 | P1 |
Completed |
Healthy Volunteers|Pain Unspecified |
2023-06-08 |
23% |
2024-03-21 |
Primary Endpoints|Treatments |
CTR20231416 |
CTR20231416 | P1 |
Completed |
Pain, Postoperative |
2023-06-06 |
2025-04-29 |
Patient Enrollment|Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
CTR20222485 |
CTR20222485 | P1 |
Completed |
Parkinson's Disease |
2023-03-24 |
2025-04-29 |
||
NCT05685719 |
MPR-COV-102CN | P1 |
Completed |
COVID-19|Pneumonia |
2023-03-15 |
2023-12-08 |
Primary Endpoints |
|
CTR20222356 |
CTR20222356 | P1 |
Completed |
Alzheimer Disease |
2023-03-13 |
2025-04-29 |
Patient Enrollment|Treatments |
|
2023-508442-18-00 |
DURATIOM | P3 |
Not yet recruiting |
Fractures, Open |
2027-12-31 |
2025-05-02 |
Treatments |
|
NCT05821478 |
ABCESS2 | P3 |
Recruiting |
Hidradenitis Suppurativa |
2027-02-28 |
16% |
2025-07-10 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
NCT06701136 |
WX081-DDI | P1 |
Not yet recruiting |
Tuberculosis, Pulmonary |
2025-10-12 |
50% |
2025-02-13 |
Primary Completion Date|Primary Endpoints|Start Date|Treatments |
NCT06909162 |
INCB123667-102 | P1 |
Recruiting |
Healthy Volunteers |
2026-02-03 |
88% |
2025-11-05 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT07018635 |
INCB161734-103 | P1 |
Completed |
Healthy Volunteers |
2025-09-29 |
50% |
2025-11-27 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Trial Status |
NCT05807399 |
PanACEA - STEP2C -01 | P2 |
Recruiting |
Tuberculosis, Pulmonary |
2027-10-31 |
50% |
2025-10-08 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date |
NCT07357610 |
SIM0270-104 | P1 |
Recruiting |
Healthy Volunteers |
2026-10-30 |
88% |
2026-01-23 |
Primary Endpoints |
NCT07374224 |
LP-168-CN107 | P1 |
Not yet recruiting |
Healthy Volunteers |
2026-06-30 |
88% |
2026-01-29 |
Primary Endpoints |
NCT07242781 |
CA071-1006 | P1 |
Recruiting |
Healthy Volunteers |
2026-06-14 |
88% |
2025-12-25 |
Primary Endpoints|Start Date|Treatments|Trial Status |