A Single Center, Open Label, Phase 1 Study in Healthy Participants to Investigate the Drug-Drug Interactions Between TNP-2198 and Midazolam, Clarithromycin

This is a single center, open label, drug-drug interaction, Phase 1 study of TNP-2198 in approximately 32 healthy participants, includes 2 cohorts (16 participants per cohort): Midazolam cohort and Clarithromycin cohort. Midazolam cohort will evaluate the effect of multiple oral doses of TNP-2198 capsules on the pharmacokinetics (PK) parameters of a single oral dose of midazolam, a cytochrome P-450 (CYP) 3A sensitive substrate, in healthy participants; Clarithromycin cohort will evaluate the effect of multiple oral doses of clarithromycin tablets, a strong CYP3A and P-gp inhibitor, on the PK parameters of multiple oral doses of TNP-2198 in healthy participants.

Start Date26 Aug 2024

Sponsor / Collaborator

TenNor Therapeutics Suzhou Ltd.

CTR20242839

/ CompletedPhase 1

在健康受试者中评价TNP-2198与咪达唑仑、克拉霉素药物相互作用的单中心、开放、I 期临床研究

[Translation] A single-center, open-label, phase I clinical study to evaluate the drug-drug interaction between TNP-2198 and midazolam and clarithromycin in healthy subjects

主要目的——咪达唑仑组：在健康受试者中评价TNP-2198 胶囊多次口服给药对咪达唑仑口服溶液单次口服给药药代动力学（PK）参数的影响；克拉霉素组：在健康受试者中评价克拉霉素片多次口服给药对TNP-2198 胶囊多次口服给药PK 参数的影响。次要目的——咪达唑仑组：在健康受试者中评价咪达唑仑口服溶液单次口服给药或与TNP-2198 胶囊多次同时口服给药的安全耐受性；克拉霉素组：在健康受试者中评价TNP-2198 胶囊多次口服给药或与克拉霉素片多次同时口服给药的安全耐受性。

[Translation]

Primary objective - midazolam group: to evaluate the effect of multiple oral administration of TNP-2198 capsules on the pharmacokinetic (PK) parameters of single oral administration of midazolam oral solution in healthy subjects; clarithromycin group: to evaluate the effect of multiple oral administration of clarithromycin tablets on the PK parameters of multiple oral administration of TNP-2198 capsules in healthy subjects. Secondary objective - midazolam group: to evaluate the safety and tolerability of single oral administration of midazolam oral solution or multiple simultaneous oral administration with TNP-2198 capsules in healthy subjects; clarithromycin group: to evaluate the safety and tolerability of multiple oral administration of TNP-2198 capsules or multiple simultaneous oral administration with clarithromycin tablets in healthy subjects.

Start Date22 Aug 2024

Sponsor / Collaborator

TenNor Therapeutics Suzhou Ltd.

NCT05857163

/ CompletedPhase 3

Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Rifasutenizol (TNP 2198) in Combination With Rabeprazole and Amoxicillin in the Primary Treatment of Participants With H. Pylori Infection

A multi-center, randomized, double-blind, bismuth-containing quadruple active comparator-controlled Phase 3 clinical study to evaluate the efficacy and safety of Rifasutenizol in combination with rabeprazole and amoxicillin in the primary treatment of participants with H. pylori infection using an adaptive design with sample size re-estimation.

Start Date18 May 2023

Sponsor / Collaborator

TenNor Therapeutics Suzhou Ltd.

100 Clinical Results associated with Rifasutenizol

100 Translational Medicine associated with Rifasutenizol

100 Patents (Medical) associated with Rifasutenizol

Literatures (Medical) associated with Rifasutenizol

01 Sep 2025·LANCET INFECTIOUS DISEASES

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

Article

Author: Liao, Aijun ; Zheng, Pengyuan ; Zuo, Xiuli ; Li, Fangfang ; Yang, Shaoqi ; Gao, Xiang ; Zeng, Zhirong ; Chen, Lei ; Zou, Chuanxin ; Ma, Zhenkun ; Xu, Min ; Gu, Yongsong ; Song, Zhiqiang ; Lan, Cheng ; Zheng, Jianwei ; Gao, Hong ; Zhen, Yanbo ; Zeng, Xin ; Wang, Xuehong ; Chen, Huixin ; Du, Qin ; Chen, Zhengyi ; Li, Xing ; Geng, Guozhu ; Xu, Meihua ; Zhou, Liya ; Chen, Jing ; Zhang, Hong ; Xie, Jun ; Chen, Tao ; Liu, Gaifang ; Xu, Jianguang ; Wang, Weihong ; Zhang, Xiaojie ; Zhu, Yin ; Tang, Tongyu ; Fan, Huizhen ; Wang, Hong ; Wang, Qizhi ; Feng, Huang ; Liu, Chengxia ; Tan, Shiyun ; Xu, Hongzhi ; Zhang, Qing

BACKGROUND:

Rifasutenizol (TNP-2198) is a new molecular entity with a synergistic dual mechanism of action under clinical development for the treatment of Helicobacter pylori infection. We aimed to evaluate the efficacy and safety of a rifasutenizol-based triple therapy (RTT) versus bismuth plus clarithromycin-based triple therapy (BCTT) for the treatment of H pylori infection in treatment-naive patients.

METHODS:

EVEREST-HP was a phase 3, randomised, triple-dummy, double-blind, active-controlled, non-inferiority trial with adaptive design for sample size re-estimation conducted at 40 research hospitals in China. Treatment-naive patients aged 18-65 years, with a positive [¹³C]urea breath test ([¹³C]UBT), further confirmed by gastric biopsy and histological examination, were randomly assigned (1:1) to receive RTT (rifasutenizol 400 mg oral capsules, amoxicillin 1 g oral capsules, and rabeprazole 20 mg enteric-coated tables) or BCTT (bismuth potassium citrate 240 mg oral tablets, clarithromycin 500 mg oral tablets, amoxicillin 1 g oral capsules, and rabeprazole 20 mg enteric-coated tablets), all twice a day for 14 days. Randomisation was done centrally by a secure interactive web response system using block sizes of two or four and stratified by study site. RTT was compared against BCTT using a triple-dummy approach to ensure masking. The primary endpoint was H pylori eradication rate based on [¹³C]UBT 4-6 weeks after the end of treatment in the modified intention-to-treat population, which included all participants who received at least one dose of the study drugs. The eradication rates of RTT and BCTT were compared using a one-sided α value of 0·025 and a non-inferiority margin of -10%. Safety endpoints included investigator assessed treatment-emergent adverse events, the severity and relationship with study drugs, findings from physical examinations, vital signs, laboratory tests, and electrocardiogram. An interim analysis was conducted by an independent data monitoring committee after 50% (350) of patients completed the last [¹³C]UBT. The trial is registered with ClinicalTrials.gov, NCT05857163.

FINDINGS:

Between May 18, 2023, and Nov 10, 2023, 1267 patients were screened and 700 patients were randomly assigned to receive either RTT (n=353) or BCTT (n=347). 261 (37%) patients were men and 439 (63%) were women. 351 patients in the RTT group and 346 in the BCTT group took at least one dose of the study drugs and were included in the modified intention-to-treat group and the safety set. H pylori was successfully cultured from 579 (83%) of 697 patients. 236 (41%) of 579 patients had H pylori infection resistant to clarithromycin, 395 (68%) to metronidazole, 203 (35%) to levofloxacin, and 47 (8%) to amoxicillin. All H pylori clinical isolates were susceptible to rifasutenizol. In the modified intention-to-treat analysis, the H pylori eradication rate in the RTT group was non-inferior to that in the BCTT group (92·0% [95% CI 88·7 to 94·6; 323 of 351] vs 87·9% [83·9 to 91·1; 304 of 346]; absolute difference 4·2% [95% CI -0·3 to 8·8]). 131 (37%) of 351 patients in the RTT group and 184 (53%) of 346 in the BCTT group had treatment-emergent adverse events. Treatment-emergent adverse events occurring in more than 5% of patients in the RTT group were diarrhoea (in 24 [7%] patients), nausea (22 [6%]), and dizziness (21 [6%]), and in more than 5% of patients in the BCTT group were taste perversion (125 [36%]), nausea (21 [6%]), and diarrhoea (19 [5%]) Most of the treatment-emergent adverse events were mild or moderate in severity. No serious adverse event related to study drugs was reported.

INTERPRETATION:

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.

FUNDING:

TenNor Therapeutics.

TRANSLATION:

For the Chinese translation of the abstract see Supplementary Materials section.

01 Sep 2025·LANCET INFECTIOUS DISEASES

Rifasutenizol-based triple therapy for Helicobacter pylori infection

Article

Author: Chen, Jinnan ; Lu, Hong

01 Jun 2024·The Lancet. Infectious diseases

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

Article

Author: Liu, Jingrui ; Ma, Zhenkun ; Liu, Yusi ; Wu, Min ; Geng, Guozhu ; Wang, Meng ; Gao, Lei ; Ding, Yanhua ; Wang, Jing ; Li, Xiaojiao ; Lou, Jinfeng ; Zhang, Hong ; Chen, Hong ; Chen, Jing

BACKGROUND:

Due to the rapid development of antimicrobial resistance, the efficacy of most Helicobacter pylori eradication therapies have progressively decreased to an unacceptable level. Rifasutenizol (TNP-2198) is a new molecular entity with a synergistic dual mechanism of action currently under clinical development for the treatment of microaerophilic and anaerobic bacterial infections. We aimed to evaluate the safety, pharmacokinetics, and efficacy of rifasutenizol in healthy Chinese participants and patients with H pylori.

METHODS:

We conducted four clinical trials of rifasutenizol capsules in healthy participants (aged 18-55 years) and patients with asymptomatic H pylori infection (aged 18-65 years) in a clinical trial centre in Jilin province, China. Trial 1 was a phase 1, double-blind, randomised, placebo-controlled, single ascending dose study, in which participants were enrolled into one of seven rifasutenizol dose groups (50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 800 mg, or 1000 mg) and were randomly assigned in a 4:1 ratio to study drug or placebo. Trial 2 was a phase 1, double-blind, randomised, placebo-controlled, multiple ascending dose study, in which patients were enrolled into one of three rifasutenizol dose groups (200 mg, 400 mg, or 600 mg) and were randomly assigned in a 3:1 ratio to study drug or placebo. Trial 3 was a phase 2a, open-label, randomised, multiple-dose, dose-finding study in which patients enrolled into one of four cohorts were randomly assigned in a 1:1:1:1 ratio to a rifasutenizol dual or triple regimen. Trial 4 was a phase 2b, open-label, randomised, multiple-dose, regimen exploration study, in which patients enrolled into one of five cohorts were randomly assigned in a 2:2:1:1:2 ratio to a rifasutenizol dual therapy, triple therapy, or a control cohort. Block randomisation (block size 4 or 8) was used in all four trials. The key primary endpoints for trials 1, 2, and 3 were the tolerability, safety, and pharmacokinetics of rifasutenizol. For trial 4, the primary endpoint was the eradication rate of H pylori. These four trials were registered at ClinicalTrials.gov (NCT06081699, NCT06081712, NCT06076681, and NCT06076694) and chinadrugtrials.org.cn (CTR20190734, CTR20192553, CTR20212050, and CTR20220625) and are completed.

FINDINGS:

Between May 9, 2019, and Sept 14, 2022, 78 healthy participants (trial 1: n=10 per cohort in a 4:1 rifasutenizol:placebo ratio; and an additional eight for the food-effect cohort) and 168 patients with asymptomatic H pylori infection (trial 2: n=16 per cohort in a 3:1 rifasutenizol:placebo ratio; trial 3: n=10 per cohort; trial 4: n=10 or n=20 per cohort) were enrolled in the four clinical trials. Single doses of rifasutenizol (50-1000 mg) and multiple doses of rifasutenizol (200 mg to 600 mg, twice a day), either as monotherapy or co-administered with rabeprazole and amoxicillin, showed favourable safety and tolerability profiles. Most adverse events were mild, and no serious adverse events were reported. Rifasutenizol demonstrated a linear pharmacokinetic profile over the dose range of 50-800 mg, and there were no apparent pharmacokinetic interactions between rifasutenizol and the co-administrated drugs. Food intake slightly elevated the area under the plasma concentration-time curve (AUC) of rifasutenizol, and the geometric mean of AUC from time 0 to the last timepoint with a quantifiable concentration (AUC_0-t) and AUC from time 0 to infinity (AUC_0-∞) in the fed state were 1·334 and 1·396 times of those in the fasted state, respectively. There was mild accumulation after continuous administration of rifasutenizol, and the R_ac(AUC) of rifasutenizol 400 mg in the dual and triple regiments in trial 3 were 1·37 and 1·49, respectively. In trial 3, the eradication rates of H pylori with 200 mg, 400 mg, or 600 mg of rifasutenizol in combination with rabeprazole, twice a day for 14 days, were 0% (95% CI 0-31), 30% (7-65), and 40% (12-74), respectively, identifying rifasutenizol 400 mg as the effective dose. In trial 4, H pylori eradication rates with the triple regimen in cohort A (400 mg rifasutenizol, 20 mg rabeprazole sodium, and 1 g amoxicillin) twice a day for 14 days was 95% (95% CI 74-100), and triple therapy (600 mg rifasutenizol, 20 mg rabeprazole sodium, and 1 g amoxicillin) three times a day for 7 days was 100% (69-100).

INTERPRETATION:

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.

FUNDING:

TenNor Therapeutics and National Natural Science Foundation of China.

TRANSLATION:

For the Chinese translation of the abstract see Supplementary Materials section.

News (Medical) associated with Rifasutenizol

18 Nov 2024

·www.prnewswire.com

TenNor Announces Positive Topline Results from Rifasutenizol Phase III Trial for H. pylori Infection

SUZHOU, China, Nov 18, 2024 /PRNewswire/ -- TenNor Therapeutics, a clinical-stage company dedicated to developing novel therapies to address unmet needs in infectious diseases, announced today the successful completion of a phase III clinical trial of rifasutenizol (TNP-2198) for the treatment of Helicobacter pylori (H. pylori) infection. The study met its primary endpoints, showing multiple advantages of rifasutenizol regimen compared with bismuth-containing quadruple therapy (BQT), the current standard of care. The completed study is a multicenter, randomized, double-blind, controlled phase III clinical trial to evaluate the efficacy and safety of TNP-2198 in combination with amoxicillin and rabeprazole for the treatment of H. pylori infection in treatment-naive patients. The study was conducted in 40 hospitals in China. A total of 700 treatment-naive patients with H. pylori infection confirmed by a positive carbon-13 urea breath test (C-13 UBT) and histological examination were randomly assigned in a 1:1 ratio to receive rifasutenizol triple therapy (rifasutenizol 400 mg, amoxicillin 1 g and rabeprazole 20 mg) or BQT (bismuth potassium citrate 240 mg, clarithromycin 500 mg, amoxicillin 1 g and rabeprazole 20 mg) treatment, twice a day for 14 days. The efficacy endpoint was the C-13 UBT test result 4 to 6 weeks after the end of treatment. Patient compliance was high in the study with a low dropout rate of 3%. H. pylori was successfully cultured in 87% patients. There were no significant differences in demographics or baseline antibiotic resistance characteristics between the two treatment groups that could affect the study outcomes. Resistance rates to clarithromycin, metronidazole, levofloxacin and amoxicillin among H. pylori clinical isolates from this study were 41%, 68%, 35% and 8% respectively, which are consistent with data reported recently by other studies, indicating antibiotic resistance to H. pylori is a serious problem in China. All clinical isolates from the study were susceptible to rifasutenizol. Rifasutenizol triple therapy achieved >90% eradication rate in the modified intention-to-treat (mITT) population, higher than BQT control (92.0% vs. 87.9%, difference 4.1%, non-inferiority test p<0.0001, superiority test p= 0.0338). The rifasutenizol regimen also achieved a higher eradication rate than BQT in the per protocol (PP) population (93.7% vs. 90.3%, difference 3.4%, non-inferiority test p<0.0001, superiority test p=0.0563). In patients infected with H. pylori resistant to any of the current antibiotics, rifasutenizol triple therapy also achieved a higher eradication rate than BQT (90.9% vs. 87.2%, difference 3.7%, non-inferiority test p<0.0001), indicating rifasutenizol regimen is highly effective in patients with antibiotic-resistant H. pylori infections. Rifasutenizol regimen showed better safety and tolerability profile than BQT. The treatment-emergent adverse events (TEAEs), investigational drug related TEAEs, TEAEs with grade 3 or above are all lower in the rifasutenizol arm. Most TEAEs were Grade 1 and no investigational drug related serious adverse events (SAEs) reported. Rifasutenizol is a novel multi-targeting drug candidate with a synergistic mechanism of action against anaerobic and microaerophile bacteria. It has potential to become the first new drug developed specifically for H. pylori infection in more than 30 years. Rifasutenizol could play an important role in supporting the large-scale test-and-treatment strategy to prevent gastric cancers in populations with high gastric cancer risk, as the rifasutenizol regimen does not require drug sensitivity test and can be seamlessly integrated with the UBT testing. TenNor completed 7 phase I-III clinical trials in China and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration (FDA). About TenNor Therapeutics TenNor Therapeutics is a clinical-stage company specialized in the discovery and development of differentiated new drug products for diseases associated with bacterial infection and metabolism. TenNor possesses a unique multi-targeting drug conjugate technology and a strong new drug development portfolio with global IP protection. Several products are currently in late-stage of clinical development targeting H. pylori infection, medical device infections, hepatic encephalopathy and irritable bowel syndrome with diarrhea. The company is committed to address unmet needs in the disease area and provide safe and effective therapies for patients in China and around the world. For more information please visit: . SOURCE TenNor Therapeutics (Suzhou) Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 3Fast TrackClinical ResultQualified Infectious Disease Product

16 Oct 2024

·endpts.com

Exscientia’s $15M milestone from Sanofi; Lilly to take Gateway Labs to China

Plus, news about TenNor Therapeutics, Gan & Lee Pharmaceuticals, Orasis and Optus Pharmaceuticals: Exscientia receives $15M milestone from Sanofi: The companies are advancing two programs as part of a deal first announced in 2022. Exscientia said it’s now eligible for additional milestones worth more than $600 million, in addition to royalties. — Jaimy Lee Eli Lilly brings Gateway Labs to China: The drugmaker is launching one of its Gateway Labs in China, the company said Tuesday, the day after announcing plans to open one in the UK. Lilly also said it’s opening a research hub in Beijing called the Lilly China Medical Innovation Center. — Anna Brown TenNor raises more than $42M in Series E: The Chinese company plans to use the funds to support the development and potential approval in China of rifasutenizol, its candidate for Helicobacter pylori infection. AMR Action Fund chipped in as a new investor, alongside existing supporters such as Zhongshan Venture Capital. — Ayisha Sharma Gan & Lee’s trio of diabetes drugs passes mid-stage trials: The Beijing-based biotech unveiled promising blood sugar data from its GLP-1 agonist (GZR18), once-weekly insulin analog (GZR4) and premixed dual insulin analog (GZR101) from their respective mid-stage studies. Notably, the GLP-1 agonist showed greater reductions in HbA1c and body weight than Novo Nordisk’s semaglutide. — Ayisha Sharma Orasis signs licensing deal with Korean drugmaker: Optus is paying $18 million to commercialize, import and market Qlosi, an eye drop for presbyopia, in South Korea. It plans to launch the treatment there by 2026. — Jaimy Lee

License out/inDrug Approval

16 Oct 2024

·www.prnewswire.com

TenNor Announces More than 300 Million RMB Financing to Support Development and Commercialization of Late-Stage Assets Including Rifasutenizol for Heliobacter pylori Infections

SUZHOU, China, Oct. 16, 2024 /PRNewswire/ -- TenNor Therapeutics, a clinical stage company dedicated to developing new therapies to address unmet needs in infectious diseases, announced today the initial closing of a Series E financing round for more than 300 million RMB. New investor AMR Action Fund joined Zhongshan Venture Capital and other existing investors in the round. The proceeds will be used to support the development and to seek regulatory approval in China of rifasutenizol, which could become the first new drug developed specifically for Helicobacter pylori infection in more than 30 years. "We are extremely glad to have the financial support from AMR Action Fund, Zhongshan Venture Capital, and other existing investors," said Dr. Zhenkun Ma, Founder and CEO of TenNor Therapeutics. "TenNor is dedicated to addressing the challenges of drug-resistant infections in China and around the world by innovating solutions for diseases currently without adequate therapies. With the additional funding, TenNor is well positioned to seek regulatory approval and bring to market rifasutenizol, a novel therapy for Helicobacter pylori infections, while also advancing a second product that will target prosthetic joint infections and similar infections associated with medical devices." "The global burden of drug-resistant bacterial infections is staggering and only getting worse, with recent data in The Lancet indicating that nearly 40 million people will die from antimicrobial resistance by 2050," said AMR Action Fund Chief Executive Officer Henry Skinnner, PhD. "We are pleased to support the team at TenNor as they advance the development of novel antibiotics that could save the lives of patients around the world and significantly reduce the suffering associated with these intractable infections." "TenNor is a leading company with multiple assets in late-stage of clinical development for the treatment of diseases associated with bacterial infections and metabolism," said Cheng Zhang, Chairman of Zhongshan Venture Capital, "TenNor adopts a first-line strategy to address major unmet needs in China. The products TenNor is developing has significant market potential in China and around the world. We are very glad to support this round of investment together with AMR Action Fund, a global leader in the antimicrobial space." TenNor develops differentiated products for diseases associated with bacterial infections and metabolism that currently lack adequate therapeutic options. The company adopts a business strategy to develop first-line therapies for indications with clear unmet medical needs and major market potential to ensure commercial success. TNP-2198 (rifasutenizol) is a novel multi-targeting drug candidate with a synergistic mechanism of action against anaerobic and microaerophile bacteria. It has potential to become the first new drug developed specifically for Helicobacter pylori infection in more than 30 years. TNP-2198 could play an important role in supporting the large-scale screening-and-eradication strategy to prevent gastric cancers in regions with high gastric cancer rate. TenNor is completing a phase 3 clinical trial of TNP-2198 in China and has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the U.S. Food and Drug Administration (FDA). TNP-2092 (rifaquizinone) is a novel triple targeting drug candidate designed to address the dual challenges of antimicrobial resistance and persistence associated with medical device infections. TenNor has completed six phase 1 and phase 2 clinical trials for TNP-2092 for injection and is planning for a phase 3 multiregional clinical trial for the treatment of prosthetic joint infections. TNP-2092 has received QIDP, Fast Track and Orphan Drug designations from the U.S. FDA. About TenNor Therapeutics TenNor Therapeutics is a clinical-stage company specialized in the discovery and development of differentiated new drug products against diseases associated with bacterial infection and metabolism. TenNor possesses a unique multi-targeting drug conjugate technology platform and a strong new drug development portfolio with global IP protection. Several products are currently in late-stage of clinical development targeting H. pylori infection, medical device infections, hepatic encephalopathy and irritable bowel syndrome with diarrhea. The company is committed to address the unmet needs in the disease area and provide safe and effective therapies for patients in China and around the world. For more information please visit: . SOURCE TenNor Therapeutics (Suzhou) Limited WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Fast TrackQualified Infectious Disease ProductOrphan DrugPhase 2Phase 3

100 Deals associated with Rifasutenizol

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Helicobacter pylori infection	NDA/BLA	China	WUXI APPTEC, INC	22 Aug 2025
Helicobacter pylori infection	NDA/BLA	China	TenNor Therapeutics Suzhou Ltd.	22 Aug 2025
Anaerobic bacterial infection	Phase 3	China	TenNor Therapeutics Suzhou Ltd.	06 May 2023
Bacterial Vaginosis	Phase 3	China	TenNor Therapeutics Suzhou Ltd.	06 May 2023
Clostridium difficile diarrhea	Phase 3	China	TenNor Therapeutics Suzhou Ltd.	06 May 2023
Infection of digestive system	Phase 3	China	TenNor Therapeutics Suzhou Ltd.	06 May 2023
Clostridium Infections	Phase 1	China	TenNor Therapeutics Suzhou Ltd.	16 Sep 2021
Diarrhea	Phase 1	China	TenNor Therapeutics Suzhou Ltd.	16 Sep 2021
Clostridium difficile infection	Preclinical	United States	Jones Microbiology Institute, Inc.	17 Feb 2022
Clostridium difficile infection	Preclinical	China	TenNor Therapeutics Suzhou Ltd.	17 Feb 2022

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05857163 (EVEREST-HP, Pubmed \| Lancet Infect Dis \| NEWS) Manual	Phase 3	Helicobacter pylori infection First line	697	RTT(rifasutenizol 400 mgrifasutenizol 400 mg +amoxicillin 1 gamoxicillin 1 g+rabeprazole 20 mg )rabeprazole 20 mg )	rbmxcobuui(tbkfhthand) = cmgfbjqevq tldzlgtunm (vzthzxidaq, 88.7 - 94.6) View more	Non-inferior	10 Sep 2025
				BCTT（bismuth potassium citrate 240 mg +clarithromycinclarithromycin 500 mg +amoxicillin 1 gamoxicillin 1 g + rabeprazole 20 mg）rabeprazole 20 mg）	rbmxcobuui(tbkfhthand) = rrwyvpvvps tldzlgtunm (vzthzxidaq, 83.9 - 91.1) View more
NCT05857163 (EVEREST-HP, CTgov)	Phase 3	Helicobacter pylori infection	700	Clarithromycin placebo tablets+Rifasutenizol capsules+Amoxicillin Capsules+Rabeprazole sodium enteric-coated tablets (Test Group)	releplcmmb = rldaaojqqa ogybasnxrw (qigkyxihuv, itreyiydea - oipgswgore) View more	-	17 Aug 2025
				Rifasutenizol placebo capsules+Amoxicillin Capsules+Clarithromycin tablets+Rabeprazole sodium enteric-coated tablets+Bismuth potassium citrate capsules (Control Group)	releplcmmb = gsurnhvkvm ogybasnxrw (qigkyxihuv, rzroveotlw - jkqsqbuzjb) View more
NCT05857163 (NEWS) Manual	Phase 3	Helicobacter pylori infection	700	TNP-2198三联方案	cpmgwxsrwv(ewpttfalws) = nbdwwqxrck gcnypxqpiz (mxddwpcmsh ) Met View more	Positive	18 Nov 2024
				铋剂四联方案	cpmgwxsrwv(ewpttfalws) = rvdgffitbm gcnypxqpiz (mxddwpcmsh ) Met View more
NCT06076681 \| NCT06076694 \| NCT06081699 \| NCT06081712 (Pubmed)	Phase 1/2	Helicobacter pylori infection	-	Rifasutenizol 400 mg	muyviutgqn(auksyqswsx) = bwjvbcegiz cjvniylvdh (bjfvulzknf, 7 - 65)	-	01 Feb 2024
				Rifasutenizol 600 mg	muyviutgqn(auksyqswsx) = exdqbjtmuv cjvniylvdh (bjfvulzknf, 12 - 74)
NCT06076694 (CTgov)	Phase 2	Helicobacter pylori infection	80	TNP-2198+Amoxicillin+Rabeprazole Sodium (Group A)	nqnzhgbssx = znucjtdddt ionwsvzewq (rpjehumkjs, wjumjanqtu - yqzjtuxmak) View more	-	12 Dec 2023
				TNP-2198+Amoxicillin+Rabeprazole Sodium (Group B)	nqnzhgbssx = efvaqojbxj ionwsvzewq (rpjehumkjs, rghcmcrtpy - scrchyklhd) View more
NCT06076681 (CTgov)	Phase 1/2	Helicobacter pylori infection	40	TNP-2198+Rabeprazole Sodium (Group A)	dgtwklkxnc = xfvenesiwn thsciowphs (unvfelugkq, gaizpgsgsp - njtrtalazi) View more	-	22 Nov 2023
				TNP-2198+Rabeprazole Sodium (Group B)	dgtwklkxnc = emfozgfjwr thsciowphs (unvfelugkq, fohqfcdcie - almzldpssf) View more

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