2023-05-20

Rifasutenizole for H. pylori Completed First Patient in of Phase III Clinical Trials in China

Suzhou, China, May 20, 2023 – TenNor Therapeutics (Suzhou) Limited announced that its investigational new drug Rifasutenizole (TNP-2198) for the treatment of Helicobacter pylori infection has completed the first patient in (FPI) of a multi-center phase III trials in China.

 

Rifasutenizole is a new molecule entity discovered and developed by TenNor specifically for the treatment of H. pylori infection. Its multi-targeting synergistic mechanism delivers low drug resistance frequencies, maintaining excellent bactericidal activities against H. pylori strains isolated from various regions. So far TenNor has completed five clinical trials in China, and the product has been approved the IND and Qualified Infectious Drug Product (QIDP) status by the US FDA. TenNor owns the global intellectual property of Rifasutenizole.`

 

TenNor is currently conducting a multi-center, randomized, double-blind, bismuth-containing quadruple therapy-controlled Phase III study to evaluate the efficacy and safety of Rifasutenizole in the primary treatment of patients with H. pylori infection. The primary investigator of the study is Professor Liya ZHOU, director of gastroenterology department at Peking University Third Hospital, vice chairman and leader of H. pylori study group at the digestive branch of the Chinese Medical Association. The study will serve as the pivotal study to support the NDA of Rifasutenizole in China.

 

Rifasutenizole has the potential to streamline the eradication regimes of H. pylori so as to improve the compliance and enable a seamless connection to the urea breath test (UBT), rendering the possibility of carrying out screening-eradication on large scale.

 

About TenNor Therapeutics

Incorporated in 2013, TenNor Therapeutics is a near-commercial stage biotechnology company dedicated to the discovery, development and commercialization of differentiated therapies to address unmet medical needs in disease areas associated with bacterial infections and bacterial metabolism. Empowered by its proprietary multi-targeting conjugate molecule technology, TenNor Therapeutics aims to deliver the best therapeutic solutions to overcome the limitations of conventional treatments and improve patient outcomes. As of July 24, 2025, TenNor Therapeutics had built a differentiated pipeline of seven innovative assets, including three Core Products, namely, rifasutenizol (TNP-2198), the world’s first and only new molecular entity (“NME”) drug candidate developed for the treatment of Helicobacter pylori (“H. pylori”) infection; rifaquizinone (TNP-2092) injection, a potential first-in-class, triple-targeting antibacterial drug candidate for the treatment of implant-associated bacterial infections; and TNP-2092 oral, the world’s first multi-targeting antibacterial drug candidate for the treatment of diseases associated with gut bacterial metabolism.

For more information, please visit: www.tennortherapeutics.com