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

Therapeutic advances and future directions in Helicobacter pylori eradication. (PubMed, Front Microbiol) - "Although clarithromycin-based triple therapy continues to be effective in certain geographic areas, increasing global resistance highlights the need for treatment approaches tailored to local antibiotic susceptibility patterns. Recent clinical trials have shifted toward optimized quadruple regimens, particularly bismuth- and vonoprazan-based therapies, and resistance-guided treatment. Novel agents such as Rifasutenizol (TNP-2198) are entering phase 3 evaluation and show activity against multidrug-resistant strains...Multi-strain probiotic formulations and plant-derived compounds such as curcumin, catechins, and quercetin consistently suppress H. pylori virulence pathways and gastric inflammation in clinical and preclinical studies. This review provides an overview of current evidence from clinical trials and emerging therapeutic innovations, emphasizing balanced integration of conventional and next-generation approaches for sustainable global H. pylori management."

Journal • Review • Gastric Cancer • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Oncology • Peptic Ulcer

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