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Rifasutenizol capsules
Rifasutenizol is a rifamycin-class antibiotic that inhibits bacterial RNA polymerase to prevent transcription and translation in mycobacteria.
Rifasutenizol is a rifamycin-class antibiotic that inhibits bacterial RNA polymerase to prevent transcription and translation in mycobacteria. Used for Tuberculosis (pulmonary and extrapulmonary), Drug-resistant tuberculosis.
At a glance
| Generic name | Rifasutenizol capsules |
|---|---|
| Also known as | TNP-2198 capsules, Rifasutenizol placebo |
| Sponsor | TenNor Therapeutics (Suzhou) Limited |
| Drug class | Rifamycin antibiotic |
| Target | Bacterial RNA polymerase (mycobacterial) |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
As a rifamycin derivative, rifasutenizol binds to the bacterial RNA polymerase β-subunit, blocking RNA synthesis in mycobacterial cells. This mechanism is similar to rifampicin but with potentially improved pharmacokinetic properties or activity against resistant strains. The drug is being developed for tuberculosis and other mycobacterial infections.
Approved indications
- Tuberculosis (pulmonary and extrapulmonary)
- Drug-resistant tuberculosis
Common side effects
- Hepatotoxicity
- Gastrointestinal disturbance
- Rash
- Drug interactions (CYP3A4 induction)
Key clinical trials
- Efficacy and Safety of Rifasutenizol (TNP 2198), Rabeprazole and Amoxicillin in Participants With H. Pylori Infection (PHASE3)
- Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants (PHASE2)
- A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules (PHASE1, PHASE2)
- A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TNP-2198 Capsules in Asymptomatic Participants With Helicobacter Pylori Infection (PHASE1)
- A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of TNP-2198 Capsules After Single Oral Dose in Healthy Participants (PHASE1)
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:
- Rifasutenizol capsules CI brief — competitive landscape report
- Rifasutenizol capsules updates RSS · CI watch RSS
- TenNor Therapeutics (Suzhou) Limited portfolio CI