Mycobutin
(Rifabutin)ApprovedSmall molecule
PfizerRifabutin 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 10 indications[4].[1]
Mycobutin is one of 227 small molecule programs targeting HIV infection. It is currently in Approved.
10
Indications
57
Total Trials
5
Active Trials
226
Competitors
1
FDA Application
NDA/BLA/ANDA regulatory filings
Pipeline
Status by Indication[4][1]
Indication
Competition
Competitive Landscape
332 competitors in Treatment
#DrugCompanyPhaseTrials
1Mycobutin
PfizerApproved
Biltricide
BayerPreclinical
Lamprene
NovartisPreclinical
Levulan
Sun Pharmaceutical Industries, Inc.Preclinical
Theo-Dur
PfizerPreclinical
Minipress
PfizerPreclinical
Niclocide
BayerPreclinical
Emtriva
GileadPreclinical
Foscavir
CClinigen, Inc.
Preclinical
Brevibloc
MMcNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Preclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Tics9 trials
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
Show 6 more trials
Mycobacterium Avium Complex8 trials
Tuberculosis7 trials
Show 4 more trials
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
Interaction7 trials
21 more indications
Helicobacter Pylori Infection2 trials
Adult2 trials
Clinical Trial2 trials
Effectiveness1 trial
Lung Disease1 trial
Cystic Fibrosis1 trial
Bacteremia1 trial
Drug Interactions1 trial
Heart Disease1 trial
Resistance1 trial
Genotypic Resistance-guided Versus Empirical Therapy for H. Pylori Eradication.
Unknown status·—·Phase 4·NCT04090021·304 enrolled
Adult Subject1 trial
Phase 11 trial
Tuberculosis, Pulmonary1 trial
Phase 2C Clinical Trial of Novel, Short-course Regimens for the Treatment of Pulmonary Tuberculosis: CRUSH-TB (Combination Regimens for Shortening TB Treatment)
Active, not recruiting·CCenters for Disease Control and Prevention·Preclinical·NCT05766267·288 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]
- [2]MedlinePlus Drug Information — Mycobutin drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for Rifabutin. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]