Last reviewed · How we verify
rifampin, randomized, open label
rifampin, randomized, open label is a Rifamycin antibiotic Small molecule drug developed by National Taiwan University Hospital. It is currently in Phase 3 development for Tuberculosis, Mycobacterial infections, Bacterial infections (as part of combination therapy).
Rifampin inhibits bacterial RNA polymerase, preventing transcription and blocking bacterial protein synthesis.
Rifampin is a small molecule inhibitor of bacterial DNA-directed RNA polymerase, classified as an INHIBITOR. It is used to treat conditions such as tuberculosis, pulmonary tuberculosis, and HIV-1 infection, among others, as indicated by ClinicalTrials.gov.
-
Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | rifampin, randomized, open label |
|---|---|
| Sponsor | National Taiwan University Hospital |
| Drug class | Rifamycin antibiotic |
| Target | Bacterial RNA polymerase β-subunit |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Rifampin is a rifamycin antibiotic that binds to the bacterial RNA polymerase enzyme, specifically the β-subunit, and inhibits RNA synthesis. This prevents bacteria from transcribing DNA into RNA, which is essential for protein production and survival. It is bactericidal and has broad-spectrum activity against many gram-positive and gram-negative bacteria, as well as mycobacteria.
Approved indications
- Tuberculosis
- Mycobacterial infections
- Bacterial infections (as part of combination therapy)
Common side effects
- Hepatotoxicity
- Discoloration of body fluids (orange-red)
- Gastrointestinal disturbances
- Rash
- Drug interactions (enzyme induction)
Key clinical trials
- Safety and Tolerability of Metformin in People With Tuberculosis (TB) and Human Immunodeficiency Virus (HIV) (PHASE2)
- Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis (PHASE2)
- Phase 2a Trial of Alpibectir Plus Ethionamide for Tuberculosis Meningitis (PHASE2)
- Ultra-Short Course Bedaquiline, Clofazimine, Pyrazinamide and Delamanid Versus Standard Therapy for Drug-Susceptible TB (PHASE2)
- A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis (PHASE3)
- Pharmacokinetics of Antituberculosis Drugs in Breastfeeding Women (PHASE1)
- A Phase 2b Clinical Study of JDB0131 Benzenesulfonate Tablets (PHASE2)
- Comparison Between Two Durations of Antibiotherapy for Non-surgically-treated Diabetic Foot Osteomyelitis (CHRONOS-2) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- rifampin, randomized, open label CI brief — competitive landscape report
- rifampin, randomized, open label updates RSS · CI watch RSS
- National Taiwan University Hospital portfolio CI
Frequently asked questions about rifampin, randomized, open label
What is rifampin, randomized, open label?
How does rifampin, randomized, open label work?
What is rifampin, randomized, open label used for?
Who makes rifampin, randomized, open label?
What drug class is rifampin, randomized, open label in?
What development phase is rifampin, randomized, open label in?
What are the side effects of rifampin, randomized, open label?
What does rifampin, randomized, open label target?
Related
- Drug class: All Rifamycin antibiotic drugs
- Target: All drugs targeting Bacterial RNA polymerase β-subunit
- Manufacturer: National Taiwan University Hospital — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Tuberculosis
- Indication: Drugs for Mycobacterial infections
- Indication: Drugs for Bacterial infections (as part of combination therapy)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing