NDAORALCAPSULEPriority Review
Approved
Dec 1992
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
MYCOBUTIN (rifabutin) by Pfizer is mechanism of action rifabutin inhibits dna-dependent rna polymerase in susceptible strains of escherichia coli and bacillus subtilis but not in mammalian cells. First approved in 1992.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MYCOBUTIN (rifabutin) is an oral rifamycin antimycobacterial small molecule approved in 1992 for prevention and treatment of Mycobacterium avium complex (MAC) infection. It inhibits bacterial DNA-dependent RNA polymerase, disrupting transcription in susceptible mycobacterial strains. This agent is primarily used in immunocompromised patients, particularly those with advanced HIV/AIDS.
$0.019BPart D
LOE ApproachingDeclining market opportunity with minimal Part D uptake (28 claims, 2023) signals a mature, niche product with limited team expansion potential.
Mechanism of Action
Mechanism of Action Rifabutin inhibits DNA-dependent RNA polymerase in susceptible strains of Escherichia coli and Bacillus subtilis but not in mammalian cells. In resistant strains of E. coli , rifabutin, like rifampin, did not inhibit this enzyme. It is not known whether rifabutin inhibits…
Pharmacologic Class:
Rifamycin Antimycobacterial
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
A Study of Rifabutin and MK-4646 in Healthy Participants (MK-4646-004)
Started Oct 2025
18 enrolled
Healthy
Study to Investigate the Penetration of Rifabutin Into the Lung After Multiple Intravenous Administrations of BV100
Started Sep 2023
35 enrolled
Bacterial Infections
A Clinical Trial of the Safety, Pharmacokinetics and Hematologic Effects of Imatinib on Myelopoiesis in Adults When Given With and Without Isoniazid and Rifabutin
Started Oct 2020
24 enrolled
Tuberculosis
The Effect of Moderate CYP3A Inducer Rifabutin on the Pharmacokinetics of Zanubrutinib in Healthy Males
Started Jul 2020
13 enrolled
HealthyMale
Rifampicin vs Rifabutin in HIV/AIDS Patients Combined With Tuberculosis
Started Apr 2018
230 enrolled
Tuberculosis, PulmonaryAIDS
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.