rifasutenizol (TNP-2198) / TenNor Therap - LARVOL DELTA

Rifasutenizol-based triple therapy for Helicobacter pylori infection. (PubMed, Lancet Infect Dis) - No abstract available

Journal • Infectious Disease

Rifasutenizol-based triple therapy versus bismuth plus clarithromycin-based triple therapy for first-line treatment of Helicobacter pylori infection in China (EVEREST-HP): a phase 3, multicentre, randomised, triple-dummy, double-blind, controlled, non-inferiority trial. (PubMed, Lancet Infect Dis) - P3 | "As the first novel antimicrobial agent specifically developed for H pylori infection, rifasutenizol represents a promising addition to the existing options for tackling antimicrobial resistance, and RTT represents a promising first-line treatment option for H pylori infection."

Head-to-Head • Journal • P3 data • Infectious Disease

THE EFFICACY AND SAFETY OF RIFASUTENIZOLE (TNP-2198) BASED TRIPLE REGIMEN AS FIRST-LINE THERAPY FOR HELICOBACTER PYLORI INFECTION: A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, CONTROLLED, PHASE 3 TRIAL (DDW 2025) - P3 | No abstract available

Clinical • P3 data • Infectious Disease

Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: TenNor Therapeutics Inc. | Recruiting ➔ Completed

Trial completion • Infectious Disease

Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin (clinicaltrials.gov) - P1 | N=32 | Recruiting | Sponsor: TenNor Therapeutics Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease

Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin (clinicaltrials.gov) - P1 | N=32 | Not yet recruiting | Sponsor: TenNor Therapeutics Inc.

New P1 trial • Infectious Disease

Efficacy and Safety of Rifasutenizol (TNP 2198) in Participants With H. Pylori Infection (clinicaltrials.gov) - P3 | N=700 | Completed | Sponsor: TenNor Therapeutics (Suzhou) Limited | Recruiting ➔ Completed | Trial completion date: Oct 2024 ➔ Mar 2024

Combination therapy • Trial completion • Trial completion date • Infectious Disease

Safety, pharmacokinetics, and efficacy of rifasutenizol, a novel dual-targeted antibacterial agent in healthy participants and patients in China with Helicobacter pylori infection: four randomised clinical trials. (PubMed, Lancet Infect Dis) - P1, P1/2, P2 | "Rifasutenizol monotherapy and combination therapy was generally safe and well tolerated in healthy participants and patients with H pylori infection. A triple regimen of 400 mg rifasutenizol capsules, 20 mg rabeprazole sodium enteric-coated tablets, and 1 g amoxicillin capsules twice a day for 14 days showed promising efficacy as a new treatment regimen for H pylori infection."

Journal • PK/PD data • Infectious Disease

Human Mass Balance and Biotransformation Study of [14C]TNP-2198 (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: TenNor Therapeutics (Suzhou) Limited

New P1 trial • Infectious Disease

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of TNP-2198 Capsules After Single Oral Dose in Healthy Participants (clinicaltrials.gov) - P1 | N=78 | Completed | Sponsor: TenNor Therapeutics (Suzhou) Limited

New P1 trial • Infectious Disease

A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of TNP-2198 Capsules in Asymptomatic Participants With Helicobacter Pylori Infection (clinicaltrials.gov) - P1 | N=48 | Completed | Sponsor: TenNor Therapeutics (Suzhou) Limited

New P1 trial • Infectious Disease

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 (clinicaltrials.gov) - P1/2 | N=40 | Completed | Sponsor: TenNor Therapeutics (Suzhou) Limited

New P1/2 trial • Infectious Disease

Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants (clinicaltrials.gov) - P2 | N=80 | Completed | Sponsor: TenNor Therapeutics (Suzhou) Limited

New P2 trial • Infectious Disease

Efficacy and Safety of Rifasutenizol (TNP 2198) in Participants With H. Pylori Infection (clinicaltrials.gov) - P3 | N=700 | Recruiting | Sponsor: TenNor Therapeutics (Suzhou) Limited | Not yet recruiting ➔ Recruiting

Combination therapy • Enrollment open • Infectious Disease

Efficacy and Safety of Rifasutenizol (TNP 2198) in Participants With H. Pylori Infection (clinicaltrials.gov) - P3 | N=700 | Not yet recruiting | Sponsor: TenNor Therapeutics (Suzhou) Limited

Combination therapy • New P3 trial • Infectious Disease