MYCOBUTIN (rifabutin)
Mycobutin helps prevent disseminated Mycobacterium avium complex (MAC) disease in patients living with advanced HIV infection. It is used as a preventive measure to protect these individuals from developing serious systemic bacterial infections. This medication belongs to the rifamycin group of antimycobacterials and is specifically aimed at high-risk patient populations.
How MYCOBUTIN Works
This drug works by inhibiting DNA-dependent RNA polymerase, an enzyme necessary for bacterial function, without affecting human cells. By blocking this enzyme, the medication interferes with the genetic processes of susceptible bacteria. While this mechanism is well-documented in certain bacterial strains, its specific action on the enzymes within the Mycobacterium avium complex is not yet fully understood.
Development Insights
Details
- Status
- Prescription
- First Approved
- 1992-12-23
- Routes
- ORAL
- Dosage Forms
- CAPSULE
MYCOBUTIN Approval History
What MYCOBUTIN Treats
2 indicationsMYCOBUTIN is approved for 2 conditions since its original approval in 1992. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Mycobacterium avium complex disease
- HIV infection
MYCOBUTIN Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
26 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04310930 FORMaT | U1111-1209-0672 | Ph 2, Ph 3 | recruiting | Finding the Optimal Regimen for Mycobacterium Abscessus Treatment |
| NCT04630145 results posted | CR108897 TMC207NTM3002 | Ph 2, Ph 3 | completed | A Study of Bedaquiline Administered as Part of a Treatment Regimen With Clarithromycin and Ethambutol in Adult Patients With Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD) |
| NCT07514364 | 202411007MINA | Ph 4 | recruiting | The Effect of Rifabutin in Mycobacterium Abscessus With Inducible Clarithromycin Resistance |
| NCT07485010 FORMaT-EVOLVE | FORMaT002 | Ph 2 | not yet recruiting | Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial |
| NCT07066722 | 219890 | Ph 1 | completed | A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults |
| NCT07199452 | 4646-004 MK-4646-004 | Ph 1 | completed | A Study of Rifabutin and MK-4646 in Healthy Participants (MK-4646-004) |
| NCT05766267 CRUSH-TB | 7406 | Ph 2, Ph 3 | active not recruiting | Short-course Regimens for the Treatment of Pulmonary Tuberculosis |
| NCT05874544 | rjhy20230001 | Ph 4 | completed | Rescue Therapy for Helicobacter Pylori Infection |
| NCT05458102 results posted | GS-US-382-1587 | Ph 1 | terminated | Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels |
| NCT04470908 results posted | BGB-3111-112 | Ph 1 | completed | The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males |
| NCT03891901 IMPACT-TB results posted | Aim 1 38518 | Ph 2 | completed | A Clinical Trial of the Safety, Pharmacokinetics and Hematologic Effects of Imatinib on Myelopoiesis in Adults When Given With and Without Isoniazid and Rifabutin |
| NCT02256696 results posted | NA_00093014 #FD-R-004794-01 | Ph 2 | completed | Assessing PA-824 for Tuberculosis (the APT Trial) |
| NCT04672525 RIFAMAB | RIPH_2019_01 | Ph 3 | recruiting | Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR |
| NCT03709355 | HIV-VM1500-08 | Ph 1 | completed | Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of Elpida® in Co-Administration With Other Drugs |
| NCT03149848 results posted | 205712 2017-000103-25 | Ph 1 | completed | Effect of Rifabutin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects |
| NCT01894776 RIFAMARA results posted | 2013 0080-01H | Ph 1 | completed | A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc |
| NCT02415985 | HIV-NAT 116 | Ph 2 | completed | Pharmacokinetics and Safety of Rifabutin 150 mg Once Daily Versus Rifabutin 300 mg Thrice Weekly |
| NCT01601626 results posted | ACTG A5290 1U01AI068636 | Ph 2 | terminated | Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV |
| NCT02138084 | 206282 AI438-041 | Ph 1 | completed | Drug-drug Interaction (DDI) Rifabutin |
| NCT01231542 | 113099 | Ph 1 | completed | Phase 1, Open Label, Two Arm, Fixed Sequence Study to Evaluate the Effect of Rifampin and Rifabutin on GSK1349572 Pharmacokinetics in Healthy Male and Female Volunteers |
| NCT01341184 | 10-0043 HHSN272201500007I | Ph 1 | completed | TMC207 +/- Rifabutin/Rifampin |
| NCT00877591 | R01DA013004 | Ph 1 | completed | Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications |
| NCT01615614 | CR100812 TMC278IFD1003, 2012-000141-12 | Ph 1 | completed | A Study to Explore the Pharmacokinetics of Rilpivirine With Rifabutin in Healthy Participants |
| NCT00646776 results posted | AI424-360 | Ph 1 | completed | Drug Interaction Study |
| NCT00743470 | M10-457 | Ph 1 | terminated | A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects |
| NCT00925535 | A5271043 | Ph 1 | completed | Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061) |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
MYCOBUTIN FDA Label Details
Indications & Usage
FDA Label (PDF)MYCOBUTIN is indicated for the treatment of Mycobacterium avium complex disease; HIV infection.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment