TheraRadar
Data updated: May 26, 2026

RIFAMPIN

Trial Activity: Declining 12 active trials
Infectious Disease Approved 1997-05-28

RIFAMPIN is indicated for the treatment of Tuberculosis; Meningococcal Carrier State.

Source: FDA Label • EPIC PHARMA LLC
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

Development Insights

Boehringer Ingelheim conducting 10 trials (10%)
67 indications explored (Broad Platform)
→ healthy (16 trials)
→ tuberculosis (11 trials)
→ tuberculosis, pulmonary (7 trials)
11
Indications
--
Phase 3 Trials
28
Years on Market

Details

Status
Prescription
First Approved
1997-05-28
Routes
ORAL, INJECTION
Dosage Forms
CAPSULE, INJECTABLE

Companies

EPIC PHARMA LLC Hikma Viatris Fresenius Kabi WATSON PHARMS TEVA CHARTWELL MOLECULAR Lupin AVET LIFESCIENCES
Active Ingredient: RIFAMPIN

RIFAMPIN Approval History

1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
146 FDA actions from 1997 to 2025
Jul 2025 SUPPL
Label · Labeling
May 2025 SUPPL
Label · Labeling
Apr 2025 SUPPL
Label · Labeling

What RIFAMPIN Treats

2 indications

RIFAMPIN is approved for 2 conditions since its original approval in 1997. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Tuberculosis
  • Meningococcal Carrier State
Source: FDA Label

RIFAMPIN Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

6

Same indication, different mechanism — what else might this patient receive?

PRETOMANID
Viatris
2019 1 indic.
SIRTURO
Johnson &
2012 1 indic.
Unlock 4 more competitors across all three rings.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to RIFAMPIN

3 of 5

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

RIFADIN
RIFAMPIN
2 shared
Sanofi
Shared indications:
TuberculosisMeningococcal Carrier State
PRETOMANID
PRETOMANID
1 shared
Viatris
Shared indications:
Tuberculosis
PYRAZINAMIDE
PYRAZINAMIDE
1 shared
NOVITIUM PHARMA
Shared indications:
Tuberculosis
View all 5 similar drugs Pro
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Clinical Trial Registry

231 trials
Trial Sponsor ID Phase Status Title
NCT07550621 MDR-001-CN-06 Ph 1 not yet recruiting Drug-Drug Interaction Study of MDR-001 With Rifampin and Itraconazole in Healthy Adult Participants
NCT03012529 VA INTREPID 2001 Ph 4 completed Investigation of Rifampin to Reduce Pedal Amputations for Osteomyelitis in Diabetics
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)
NCT06192160 RAD-TB A5409 DOH-27-032024-5399 Ph 2 recruiting Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
NCT04930744 METHOD AUR1-1-199 5U01AI134585 Ph 2 completed Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV)
NCT06253715 SMILE-TB IRB00388853 Ph 3 recruiting Shortened Regimen for Drug-susceptible TB in Children
NCT03082183 results posted 1346-0018 2016-004862-24 Ph 1 completed A Study in Healthy Men to Test Whether Rifampicin Influences the Amount of BI 425809 in the Blood
NCT05994742 Co-SAM 150522 Ph 3 active not recruiting An Adaptive Multi-arm Trial to Improve Clinical Outcomes Among Children Recovering From Complicated SAM
NCT05556746 PRESCIENT 2022p003075 U01AI170426 Ph 2 active not recruiting Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible TB
NCT02701608 RODEO 1 Ph 3 completed Oral Switch During Treatment of Left-sided Endocarditis Due to Multi-susceptible Staphylococcus
NCT05372367 1403-0004 2021-006565-38, 2024-514532-24-00 Ph 1 completed A Study in People With Advanced Cancer to Test Whether the Amount of BI 907828 in the Blood is Influenced by Taking an OATP Inhibitor or a CYP3 Inhibitor
NCT03672630 MAC2v3 18819 PCS-2017C2-7764 Ph 2, Ph 3 completed Comparison of Two- Versus Three-antibiotic Therapy for Pulmonary Mycobacterium Avium Complex Disease
NCT07357610 SIM0270-104 SIM0270-104 Ph 1 recruiting An Open-Label Drug Interaction Clinical Study to Evaluate Itraconazole, Rifampin, Midazolam and SIM0270 in Chinese Healthy Adult Participants
NCT04951986 NEW-STRAT TB HREC REF: 001/2021 Ph 3 active not recruiting Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis
NCT06489431 21120903 Ph 3 active not recruiting Irrisept vs Traditional Antibiotic Irrigation for Virgin Penile Prosthesis Placement
NCT07242781 CA071-1006 Ph 1 recruiting A Study to Evaluate the Effect of Itraconazole and Rifampin on the Drug Levels of AR-LDD (BMS-986365) in Healthy Adult Male Participants
NCT05592223 results posted 10903 RG1122457 Ph 1 completed Phase I Open Label BCG Clinical Trial Assessing TB Drugs and Vaccines
NCT04606537 KBP5074-1-008 Ph 1 completed Drug to Drug Interaction Study of KBP-5074 in Healthy Subjects
NCT07253688 RIFA-SNAP 2025-10882 Ph 3 recruiting Adjunctive Rifampin for the Treatment of Prosthetic Valve Endocarditis Due to S. Aureus
NCT05383742 A5384 Ph 2 recruiting Trial of a Six-Month Regimen of High-Dose Rifampicin, High-Dose Isoniazid, Linezolid, and Pyrazinamide Versus a Standard Nine-Month Regimen for the Treatment of Adults and Adolescents With Tuberculous Meningitis
NCT05069688 2021P002401 Ph 1 recruiting Dolutegravir Pharmacokinetics Among HIV/TB Coinfected Children Receiving Standard and High-dose Rifampicin
NCT07018635 INCB161734-103 Ph 1 completed A Study to Assess the Effect of Itraconazole, Rifampin, and Acid-Reducing Agents on INCB161734 Pharmacokinetics When Administered Orally in Healthy Participants
NCT03236987 CLAZI PI2017_843_0010 Ph 3 recruiting CLArithromycin Versus AZIthromycin in the Treatment of Mycobacterium Avium Complex (MAC) Lung Infections
NCT05807399 PanACEA - STEP2C -01 Ph 2 recruiting PanACEA - STEP2C -01
NCT07196449 MRCI MRCI Ph 1 active not recruiting Drug-Drug Interaction of Rifampicin and Cyclosporine on Methotrexate Pharmacokinetics in Healthy Subjects
NCT05338489 results posted 17751 J2G-OX-JZJP, LOXO-RET-18014 Ph 1 completed A Study of Effects of Itraconazole and Rifampin on Selpercatinib (LY3527723) in Healthy Participants
NCT02563327 S31PK/PD CDC-NCHHSTP-6719 Ph 3 completed Pharmacokinetic and Pharmacodynamic Study of High-Dose Rifapentine and Moxifloxacin for Treatment of Tuberculosis
NCT05766267 CRUSH-TB 7406 Ph 2, Ph 3 active not recruiting Short-course Regimens for the Treatment of Pulmonary Tuberculosis
NCT06064539 INT16726 U1111-1244-2759 Ph 1 completed Study of Drug-drug Interaction of the Effects of Gemfibrozil and Rifampicin on SAR442168 in Healthy Adult Subjects
NCT04311502 results posted ACTG A5362 30148 Ph 2 terminated Clofazimine- and Rifapentine-Containing Treatment Shortening Regimens in Drug-Susceptible Tuberculosis: The CLO-FAST Study
NCT04921943 MAC-HS Ph 4 recruiting Hypertonic Saline for MAC
NCT03301038 RICHH 16-013429 R01DK112955 Ph 2 recruiting Rifampin in CYP24A1-related Hypercalcemia and Hypercalciuria
NCT03814200 ID-076-106 2018-004226-28 Ph 1 completed A Study to Investigate the Effect of Rifampicin on the Uptake and Breakdown of ACT-246475 in Healthy Subjects
NCT05057949 Z650 Z650-DDI-104 Ph 1 completed A Study to Evaluate Drug-Drug Interaction of Larotinib With Itraconazole and Rifampin in Healthy Adult Participants
NCT06835465 GP45718 Ph 1 completed A Study to Evaluate the Effect of Rifampin on the Pharmacokinetics of Divarasib in Healthy Participants
NCT02846519 CR108128 ESKETINTRD1008 Ph 1 completed Pharmacokinetic, Safety, and Tolerability Study of Intranasally Administered Esketamine in Healthy Han Chinese, Korean, Japanese, and Caucasian Participants and the Effects of Rifampin on the Pharmacokinetics of Intranasally Administered Esketamine
NCT02875223 results posted CC-90011-ST-001 Ph 1 terminated A Safety and Efficacy Study of CC-90011 in Participants With Relapsed and/or Refractory Solid Tumors and Non-Hodgkin's Lymphomas
NCT06917495 SDU-2024-RPT-003 Ph 2 not yet recruiting Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis
NCT06162169 JAB-21822-1010 Ph 1 completed A Clinical Trial to Evaluate JAB-21822 Drug-drug Interactions in Healthy Subjects
NCT06191692 TBIshort Ph 3 not yet recruiting 1HP Versus 3HR in the Treatment of Tuberculosis Infection in Vietnam
NCT05577624 20190319 Ph 1 completed A Study to Evaluate the Drug-drug Interaction Effect of Rifampin on the Pharmacokinetics of AMG 510 in Healthy Participants
NCT03662022 PEOPLE results posted 1248/18 Ph 3 completed Post ExpOsure Prophylaxis for LEprosy in the Comoros and Madagascar
NCT05388448 TASK-009-SANF Ph 2 completed EBA, Safety and Tolerability of Sanfetrinem Cilexetil
NCT04537715 results posted EZH-108 2020-002669-33 Ph 1 completed Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels
NCT06822166 ET-26-HCL-CP-006 Ph 1 completed Drug Interactions Trial of Methoxyethyl Etomidate Hydrochloride
NCT06701136 WX081-DDI JYP0081M103 CTR20221162 Ph 1 not yet recruiting Drug-Drug Interaction and Food Effect of Sudapyridine(WX-081) With Itraconazole and Rifampin in Healthy Chinese Adults
NCT02770222 AC-065-113 2016-000811-34 Ph 1 completed A Clinical Study to Investigate the Effect of Gemfibrozil or Rifampicin on Blood Concentrations of Selexipag in Healthy Subjects
NCT02661893 CR108077 42847922EDI1009 Ph 1 completed A Drug Interaction Study in Healthy Participants to Assess the Effect of Rifampin on the Pharmacokinetics of JNJ-42847922
NCT02729467 CR108127 53718678RSV1006 Ph 1 completed A Study to Assess the Effects of Itraconazole and Rifampicin on the Single-Dose Pharmacokinetics of JNJ-53718678 in Healthy Adults
NCT05134337 results posted LOXO-BTK-20006 J2N-OX-JZNC Ph 1 completed Study of the Effects of Itraconazole and Rifampin on LOXO-305 in Healthy Participants

Showing 50 of 231 trials

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

RIFAMPIN FDA Label Details

Indications & Usage

FDA Label (PDF)

RIFAMPIN is indicated for the treatment of Tuberculosis; Meningococcal Carrier State.

Looking for the branded version?

RIMACTANE

Full clinical data, patents, trials, and competitive landscape for rifampin.

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Data Sources

FDA Approval: ANDA064150 → Label: DailyMed → Trials: ClinicalTrials.gov →

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