TheraRadar
Data updated: May 26, 2026

RIMACTANE (rifampin)

Trial Activity: Declining 14 active trials
Infectious Disease Approved 1971-05-21

RIMACTANE is indicated for the treatment of Tuberculosis.

Source: FDA Label • OXFORD PHARMS • Rifamycin Antibacterial
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How RIMACTANE Works

Rifampin inhibits DNA-dependent RNA polymerase activity in susceptible organisms, including *Mycobacterium tuberculosis*. By specifically interacting with bacterial RNA polymerase, it blocks the initiation of RNA transcription. It does not inhibit the mammalian enzyme, which accounts for its selective toxicity against bacteria.

Source: FDA Label

Development Insights

Bristol-Myers Squibb conducting 8 trials (6%)
110 indications explored (Broad Platform)
→ healthy (17 trials)
→ healthy volunteers (15 trials)
→ healthy participants (9 trials)
3
Indications
--
Phase 3 Trials
55
Years on Market

Details

Status
Prescription
First Approved
1971-05-21
Routes
ORAL
Dosage Forms
CAPSULE

Companies

OXFORD PHARMS
Active Ingredient: RIFAMPIN

RIMACTANE Approval History

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Original
New Indication
New Form
Label Update
83 FDA actions from 1971 to 2023 · 2 indication expansions
Aug 2023 SUPPL
Label · Labeling
FDA Letter Label
Jan 2019 SUPPL
Label · Labeling
FDA Letter Label
Nov 2004 SUPPL
Label · Labeling
FDA Letter Label

What RIMACTANE Treats

1 indications

RIMACTANE is approved for 1 conditions since its original approval in 1971. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Tuberculosis
Source: FDA Label

RIMACTANE Competitive Set

Pro

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

MoA expansion candidates

3

Same target(s), different indications — where else is this mechanism being explored?

MULTRYS
AM REGENT
2020
TRALEMENT
AM REGENT
2020

Indication competitors

6

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

PRETOMANID
Viatris
2019 1 indic.
SIRTURO
Johnson &
2012 1 indic.
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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 RIMACTANE

3 of 5

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

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

136 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
NCT06253715 SMILE-TB IRB00388853 Ph 3 recruiting Shortened Regimen for Drug-susceptible TB in Children
NCT05556746 PRESCIENT 2022p003075 U01AI170426 Ph 2 active not recruiting Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible TB
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
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
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
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
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
NCT06917495 SDU-2024-RPT-003 Ph 2 not yet recruiting Short-Course Anti-tuberculosis Regimens for Mild Spinal Tuberculosis
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
NCT04537715 results posted EZH-108 2020-002669-33 Ph 1 completed Effects of Itraconazole and Rifampin on the Blood Tazemetostat Levels
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
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
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
NCT05899829 results posted 221853 BUS-P1-11 Ph 1 completed Evaluation of the Effect of Rifampin and Rabeprazole on the Pharmacokinetics of Camlipixant
NCT03994211 results posted BGB-290-105 2019-000112-28 Ph 1 completed Study to Investigate the Effect of Rifampin and Itraconazole on the Action of Pamiparib in Participants With Cancer
NCT06363630 CA073-1000 Ph 1 completed A Study to Evaluate the Effect of Cytochrome P450 (CYP) 3A Inhibitor (Itraconazole) and Inducer (Rifampin) on the Drug Levels of Golcadomide (BMS-986369) in Healthy Participants
NCT04166669 APX001-107 C4791007 Ph 1 completed A Drug-Drug Interaction Study of CYP3A4 Inhibition and Pan-CYP Induction on APX001
NCT05255276 516-013 Ph 1 completed PK Study to Assess Drug-drug Interaction Between Sitravatinib and a P-gp Inducer and an Inhibitor.
NCT06031454 RAY1216-23-05 Ph 1 completed Drug-durg Interaction of Leritrelvir(RAY1216) With Midazolam, Omeprazole, Rosuvastatin, Verapamil, and Rifampin
NCT05635110 VX22-548-013 Ph 1 completed Evaluation of the Effects of Omeprazole and Rifampin on the Pharmacokinetics of VX-548 in Healthy Participants
NCT05685719 MPR-COV-102CN Ph 1 completed A Study to Evaluate the Relative Bioavailability of STI-1558 and the Effect of Itraconazole and Rifampin on the Pharmacokinetics of STI-1558
NCT05098041 results posted TAK-935-1009 Ph 1 completed A Study of Soticlestat and Rifampin in Healthy Adults
NCT03307252 results posted 0352-2100 2017-001549-29 Ph 1 completed This Study Tests the Effect of Certain Medicines on the Transport of Other Medicines in the Body of Healthy Men
NCT02807116 PAC106 Ph 1 completed Drug-Interaction Study to Evaluate the Effect of Rifampin, a Potent CYP3A4 Inducer, on the Systemic Exposure of Pacritinib in Healthy Subjects
NCT05826574 INS1007-106 Ph 1 completed A Study to Assess Pharmacokinetics (PK) of Brensocatib Alone and With Multiple Doses of Rifampin or Esomeprozole in Healthy Participants
NCT03174184 results posted IRB00119017 FD-R-05724 Ph 2 completed Early Bactericidal Activity of Rifampin + Meropenem + Amoxicillin/Clavulanate in Adults With Pulmonary TB
NCT02256696 results posted NA_00093014 #FD-R-004794-01 Ph 2 completed Assessing PA-824 for Tuberculosis (the APT Trial)
NCT05389722 CA057-002 Ph 1 completed A Study to Assess the Drug Levels of CC-92480 After Coadministration With Rifampin and Itraconazole, and the Drug Levels of Digoxin and Rosuvastatin After Coadministration With CC-92480 in Healthy Participants
NCT05720767 2022-523-00US2 Ph 1 completed HMPL-523 CYP3A/P-gp Inhibitor and CYP Inducer Study
NCT05497674 DJT1116PG-DM-108 Ph 1 completed Effects of Rifampicin and Probenecid On The Pharmacokinetic Profile Of Rongliflozin In Healthy Subjects
NCT04933682 ALXN2050-HV-105 Ph 1 completed Drug Interaction Study of ALXN2050 With Fluconazole and Rifampin in Healthy Adult Participants
NCT05359055 SPH3127-104 Ph 1, Ph 2 completed Drug-drug Interaction Study of SPH3127
NCT05454345 yzhang207 Ph 3 not yet recruiting Sitafloxacin-containing Regimens for Shortening Tuberculosis Treatment
NCT03486314 results posted Pevonedistat-1015 U1111-1202-2144 Ph 1 completed A Study to Evaluate the Effects of Rifampin on Pharmacokinetics (PK) of Pevonedistat in Participants With Advanced Solid Tumors
NCT04558216 VONO-102 Ph 1 withdrawn Evaluation of Effect of Rifampin on the Pharmacokinetics of Vonoprazan in Healthy Participants
NCT03709355 HIV-VM1500-08 Ph 1 completed Pharmacokinetics Study to Evaluate Drug-Drug Interactions and Safety of Elpida® in Co-Administration With Other Drugs

Showing 50 of 136 trials

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Active Pipeline

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Ongoing clinical trials by development phase

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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.

RIMACTANE FDA Label Details

Indications & Usage

FDA Label (PDF)

RIMACTANE is indicated for the treatment of Tuberculosis.

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Data Sources

FDA Approval: NDA050429 → Label: DailyMed → Patents: FDA Orange Book → 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