Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Rifasutenizol · 1 trial · 1 indication
The eradication rate of H. pylori is defined as the percentage of participants with negative results of 13C UBT.
| Arm | Type | Description |
|---|---|---|
| Test Group | EXPERIMENTAL | Rifasutenizol capsules 400 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Amoxicillin capsules 1 g + Bismuth potassium citrate placebo capsules + Clarithromycin placebo tablets, twice daily (BID) for 14 days |
| Control Group | ACTIVE_COMPARATOR | Amoxicillin capsules 1 g + Clarithromycin tablets 500 mg + Rabeprazole sodium enteric-coated tablets 20 mg + Bismuth potassium citrate capsules 240 mg + Rifasutenizol placebo capsules, BID for 14 days |
| Name | Type | Description |
|---|---|---|
| Rifasutenizol capsules | DRUG | 400 mg, BID, taken orally within half an hour after breakfast and dinner. |
| Rabeprazole sodium enteric-coated tablets | DRUG | 20 mg, BID, taken orally within half an hour before breakfast and dinner. |
| Amoxicillin Capsules | DRUG | 1 g, BID, taken orally within half an hour after breakfast and dinner. |
| Clarithromycin placebo tablets | DRUG | BID, taken orally within half an hour after breakfast and dinner. |
| Bismuth potassium citrate placebo capsules | DRUG | BID, taken orally within half an hour before breakfast and dinner. |
| Clarithromycin tablets | DRUG | 500 mg, BID, taken orally within half an hour after breakfast and dinner. |
| Bismuth potassium citrate capsules | DRUG | 240 mg, BID, taken orally within half an hour before breakfast and dinner. |
| Rifasutenizol placebo capsules | DRUG | BID, taken orally within half an hour before breakfast and dinner. |
Inclusion Criteria: * Voluntarily sign the informed consent form. * Age 18-65 years (inclusive), male or female. * The result of 13C-UBT is positive (≥ 4 Delta Over Baseline), and the infection of H. pylori are confirmed by gastroscopic biopsy histology. * Subjects agree to refrain from taking any ...
Rifasutenizol is an investigational small molecule being developed for the treatment of H. pylori infection. It is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Rifasutenizol is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The drug is currently in Phase 3 clinical trials for H. pylori infection.
Rifasutenizol is in Phase 3 clinical development. It is an investigational drug and has not yet received regulatory approval. A Phase 3 trial for H. pylori infection has been completed.
Rifasutenizol has one completed Phase 3 clinical trial, NCT05857163, which evaluated its efficacy and safety in combination with rabeprazole and amoxicillin in participants with H. pylori infection. The trial enrolled 700 participants in China.
Yes, Rifasutenizol is also known as TNP 2198. The Phase 3 clinical trial NCT05857163 refers to the drug as Rifasutenizol (TNP 2198), confirming that these names refer to the same investigational drug.