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Mycobutin

(Rifabutin)

ApprovedSmall molecule

Rifabutin is used to prevent and treat tuberculosis infections, particularly in people with weakened immune systems like those with HIV/AIDS. It works by killing the bacteria that cause tuberculosis.[2] Mycobutin is currently approved and in use across 11 indications[4].[1]

Mycobutin is one of 250 small molecule programs targeting Mycobacterium infection. It is currently in Approved.

11

Indications

57

Total Trials

5

Active Trials

249

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

Mycobacterium InfectionActive, not recruiting

Mitral Annular CalcificationActive, not recruiting

Mycobacterial Infectious DiseaseActive, not recruiting

HIV InfectionActive, not recruiting

Microphthalmia, Isolated, With ColobomaActive, not recruiting

OsteomyelitisApproved

Crohn's DiseaseApproved

TreatmentRecruiting

Cystic FibrosisNot yet recruiting

AbscessRecruiting

Mycobacterium InfectionApproved

Active, not recruiting

Mitral Annular CalcificationApproved

Active, not recruiting

Mycobacterial Infectious DiseaseApproved

Active, not recruiting

HIV InfectionApproved

Active, not recruiting

Microphthalmia, Isolated, With ColobomaApproved

Active, not recruiting

OsteomyelitisApproved

Approved

Crohn's DiseaseApproved

Approved

TreatmentPhase 3

Recruiting

Cystic FibrosisPhase 2

Not yet recruiting

AbscessPhase 3

Recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

350 competitors in Treatment

#DrugCompanyPhaseTrials

Mycobutin

Dexilant

Alfenta

Jazz Pharmaceuticals

Niclocide

Hivid

CConrado Roberto Hoffmann Filho

Valium

Akero Therapeutics

Clomid

Aurlumyn

BBTG International Inc.

Lotemax

Norpramin

VValidus Pharmaceuticals

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Not yet recruiting

Helicobacter Pylori Infection

NCT06731023

Q2 2027

Phase 3Recruiting

Treatment

NCT04672525

Q4 2027

Phase 2/3Active, not recruiting

Pulmonary Tuberculosis

NCT05766267

Q2 2030

Phase 2/3Recruiting

Abscess

NCT04310930

Clinical

Trials by Indication[1]

Tics9 trials

EARNEST Rifabutin Pharmacokinetics (PK) Substudy

Unknown status·JJustine Boles·Phase 2·NCT01663168·140 enrolled

Impact of Rifabutin on the Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor

Completed·UUniversity of Southern California·Phase 4·NCT04840862·6 enrolled

TBTC Study 23A: Pharmacokinetics of Intermittent Isoniazid and Rifabutin in HIV-TB

Completed·CCenters for Disease Control and Prevention·Phase 2/3·NCT00023348·150 enrolled

Show 6 more trials

TBTC Study 23C: Pharmacokinetics of Intermittent Rifabutin and Isoniazid With Daily Efavirenz

Completed·CCenters for Disease Control and Prevention·Phase 2·NCT00023413·20 enrolled

Pharmacokinetics and Safety of Rifabutin 150 mg Once Daily Versus Rifabutin 300 mg Thrice Weekly

Completed·TThe HIV Netherlands Australia Thailand Research Collaboration·Phase 2·NCT02415985·40 enrolled

A Study to Explore the Pharmacokinetics of Rilpivirine With Rifabutin in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT01615614·20 enrolled

Study to Determine the Effects of Nevirapine (VIRAMUNE®) on the Steady State Pharmacokinetics of Rifabutin (MYCOBUTIN®) in HIV+ Patients

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 4·NCT02184078·19 enrolled

Effect of Fluconazole, Clarithromycin, and Rifabutin on the Pharmacokinetics of Sulfamethoxazole-Trimethoprim and Dapsone and Their Hydroxylamine Metabolites

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000826·48 enrolled

The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males

Completed· BeiGene logo

BeiGene·Phase 1·NCT04470908·13 enrolled

Mycobacterium Avium Complex8 trials

A Randomized Study of Daily and Intermittent Prophylactic Regimens for the Prevention of Disseminated Mycobacterium Avium Complex (MAC) and Fungal Infections in HIV-Infected Patients

Completed· Pfizer logo

Pfizer·Phase 3·NCT00002122·720 enrolled

Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial

Completed·PPharmacia·N/A·NCT00002032·750 enrolled

Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in AIDS Patients With CD4 Counts = or < 200: A Double-Blind, Placebo-Controlled Trial

Completed·PPharmacia·N/A·NCT00002267·750 enrolled

Show 5 more trials

Effectiveness of Rifabutin in the Treatment of Mycobacterium Avium Complex

Completed·TThe University of Texas Health Science Center at Tyler·Phase 3·NCT03164291·170 enrolled

The Safety and Effectiveness of Clarithromycin and Rifabutin Used Alone or in Combination to Prevent Mycobacterium Avium Complex (MAC) or Disseminated MAC Disease in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001030·1,100 enrolled

Rifabutin Therapy for the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in HIV Positive Patients With CD4 Counts = or < 200: Treatment IND Study

Completed·PPharmacia·N/A·NCT00002080

A Study of Rifabutin, Used Alone or With Ethambutol in the Prevention of Mycobacterium Avium Complex (MAC) Bacteremia in Patients With AIDS

Completed·PPharmacia·Phase 4·NCT00002343·200 enrolled

A Comparison of Three Drug Combinations Containing Clarithromycin in the Treatment of Mycobacterium Avium Complex (MAC) Disease in Patients With AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT00001058·246 enrolled

Interaction7 trials

Drug Interaction Study Between Rifabutin And Lersivirine (UK-453,061)

Completed· Pfizer logo

Pfizer·Phase 1·NCT00925535·18 enrolled

Drug-drug Interaction (DDI) Rifabutin

Completed· GSK logo

GSK·Phase 1·NCT02138084·102 enrolled

A Study to Evaluate VH4524184 Tablet Absorption, Effects of Food, and Interactions With Other Drugs in Healthy Adults

Completed· GSK logo

GSK·Phase 1·NCT07066722·126 enrolled

Show 4 more trials

A Drug Interaction Study Investigating the Effect of Rifabutin on the Pharmacokinetics of Maraviroc

Completed·OOttawa Hospital Research Institute·Phase 1·NCT01894776·15 enrolled

TBTC Study 23B:Intensive PK of the Nelfinavir Rifabutin Interaction in Patients With HIV-TB

Completed·CCenters for Disease Control and Prevention·Phase 4·NCT00023400·20 enrolled

Drug-Drug Interaction Study of Vesatolimod in Adults With HIV-1 Who Have Very Low or Undetectable Virus Levels

Terminated· Gilead logo

Gilead·Phase 1·NCT05458102·18 enrolled

Drug Interaction Study

Completed· Bristol-Myers Squibb logo

Bristol-Myers Squibb·Phase 1·NCT00646776·85 enrolled

Tuberculosis7 trials

Interaction of Buprenorphine With HIV Medications and Tuberculosis Medications

Completed·UUniversity of California, San Francisco·Phase 1·NCT00877591·63 enrolled

Assessing PA-824 for Tuberculosis (the APT Trial)

Completed·JJohns Hopkins University·Phase 2·NCT02256696·157 enrolled

Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis

Unknown status·SShanghai Public Health Clinical Center·N/A·NCT03478033·230 enrolled

Show 4 more trials

Intensive Pharmacokinetics of the Nelfinavir-Rifabutin Interaction in Patients With HIV-Related Tuberculosis Treated With a Rifabutin-Based Regimen

Unknown status·NNational Center for Research Resources (NCRR)·N/A·NCT00018083

TBTC Study 23: Treatment of HIV-Related Tuberculosis Using a Rifabutin-Based Regimen

Completed·CCenters for Disease Control and Prevention·N/A·NCT00023361·215 enrolled

Effectiveness of Anti-HIV Therapy (HAART) in HIV-Infected Patients With Tuberculosis

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00004736·44 enrolled

Rifampin-Based Tuberculosis Treatment Versus Rifabutin-Based Tuberculosis Treatment in Persons With HIV

Terminated·AAdvancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections·Phase 2·NCT01601626·71 enrolled

Clinical Trial2 trials

A Double-Blind Randomized Clinical Trial of a Rifabutin Regimen in the Treatment of Mycobacterium-Avium Complex (MAC) Bacteremia in Patients With AIDS

Completed·PPharmacia·N/A·NCT00001995·200 enrolled

A Clinical Trial of the Safety, Pharmacokinetics and Hematologic Effects of Imatinib on Myelopoiesis in Adults When Given With and Without Isoniazid and Rifabutin

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 2·NCT03891901·24 enrolled

21 more indications

Safety and Efficacy2 trials

Safety And Efficacy Of Rifabutin In HIV Patients

Completed· Pfizer logo

Pfizer··NCT00810446·72 enrolled

Safety And Efficacy Of Rifabutin In Patients For Non-HIV Patients

Completed· Pfizer logo

Pfizer··NCT00810407·628 enrolled

Helicobacter Pylori Infection2 trials

Efficacy of a 14-Day Bismuth-Containing Quadruple Therapy Guided by Drug Susceptibility Testing in Patients with Extremely Refractory Helicobacter Pylori Infection: an Exploratory Study

Not yet recruiting·XXiuli Zuo··NCT06731023·30 enrolled

Non-invasive Test-guided Tailored Therapy Versus Empiric Treatment for Helicobacter Pylori Infection.

Unknown status·UUniversity of Bari·Phase 3·NCT04107194·362 enrolled

Adult2 trials

Study of How Indinavir (an Anti-HIV Drug) and Rifabutin (a Drug Used to Treat MAC, an HIV-Associated Disease) Interact in HIV-Positive and HIV-Negative Adults

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT00000877·31 enrolled

Effects of Steady-state TPV/RTV on the Single-dose Pharmacokinetics of Rifabutin and the Effects of Single-dose Rifabutin on the Steady-state Pharmacokinetics of TPV in Healthy Adult Volunteers

Completed· Boehringer Ingelheim logo

Boehringer Ingelheim·Phase 1·NCT02251171·24 enrolled

Helicobacter Pylori1 trial

Effectiveness of Rifabutin for Treatment of Helicobacter Pylori

Unknown status·RRabin Medical Center·Phase 3·NCT04652284·300 enrolled

Phase 11 trial

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

Completed· GSK logo

GSK·Phase 1·NCT01231542·27 enrolled

Effectiveness1 trial

The Safety and Effectiveness of Rifabutin, Combined With Clarithromycin or Azithromycin, in HIV-Infected Patients

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·N/A·NCT00001023·91 enrolled

Mycobacterium avium complex disease1 trial

Study of Four Different Treatment Approaches for Patients Who Have Mycobacterium Avium Complex Disease (MAC) Plus AIDS

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 3·NCT00001047·400 enrolled

Oral1 trial

Effect of Rifabutin on the Pharmacokinetics of Oral Cabotegravir in Healthy Subjects

Completed· GSK logo

GSK·Phase 1·NCT03149848·15 enrolled

Drug Interactions1 trial

Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of Elpida® in Co-Administration With Other Drugs

Completed·VViriom·Phase 1·NCT03709355·56 enrolled

ART1 trial

A Study of Rifabutin and MK-4646 in Healthy Participants (MK-4646-004)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT07199452·18 enrolled

Rescue Therapy for Helicobacter Pylori1 trial

Rescue Therapy for Helicobacter Pylori Infection

Completed·SShanghai Jiao Tong University School of Medicine·Phase 4·NCT05874544·360 enrolled

Abscess1 trial

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Recruiting·TThe University of Queensland·Phase 2/3·NCT04310930·300 enrolled

Treatment1 trial

Rifabutin Versus Rifampicin for Treatment of Staphylococcal PJI Treated With DAIR

Recruiting·TTourcoing Hospital·Phase 3·NCT04672525·436 enrolled

Cystic Fibrosis1 trial

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

Not yet recruiting·TThe University of Queensland·Phase 2·NCT07485010·300 enrolled

Bacteremia1 trial

A Three-Arm Comparative Trial for the Treatment of MAC Bacteremia in AIDS: A Clarithromycin/Ethambutol Regimen Containing Rifabutin (450 Mg) or Rifabutin (300 Mg) or Placebo

Completed·PPharmacia·Phase 3·NCT00002101·450 enrolled

Heart Disease1 trial

Anti-chlamydophila Antibiotic Combination Therapy in the Treatment of Patients With Coronary Heart Disease

Terminated·CCadrock Pty. Ltd.·Phase 2·NCT03618108·20 enrolled

Resistance1 trial

Genotypic Resistance-guided Versus Empirical Therapy for H. Pylori Eradication.

Unknown status·—·Phase 4·NCT04090021·304 enrolled

Adult Subject1 trial

A Bioavailability Study of Rifabutin and Lopinavir/Ritonavir in Healthy Adult Subjects

Terminated·AAbbott·Phase 1·NCT00743470·15 enrolled

Pulmonary Tuberculosis1 trial

Short-course Regimens for the Treatment of Pulmonary Tuberculosis

Active, not recruiting·CCenters for Disease Control and Prevention·Phase 2/3·NCT05766267·288 enrolled

Lung Disease1 trial

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)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2/3·NCT04630145·129 enrolled

Unspecified1 trial

TMC207 +/- Rifabutin/Rifampin

Completed·NNational Institute of Allergy and Infectious Diseases (NIAID)·Phase 1·NCT01341184·33 enrolled

Regulatory

FDA Approval Timeline[5]

Dec 23, 1992

MYCOBUTIN

NDA NDA050689

Sources

References

[1]
ClinicalTrials.gov — 57 trial records for Rifabutin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Mycobutin drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Rifabutin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Rifabutin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA050689). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Pfizer company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bacterial DNA-Directed RNA Polymerase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Pfizer

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