Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
RHB-102 · 1 trial · 2 indications
Number of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose until 24 hours post dose
| Arm | Type | Description |
|---|---|---|
| RHB-102 | EXPERIMENTAL | RHB-102, Bimodal Release Ondansetron Tablets |
| Placebo | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| RHB-102 | DRUG | RHB-102, Bimodal Release Ondansetron Tablets |
| Placebo Oral Tablet | DRUG | Placebo |
Inclusion Criteria: * Patients must have vomited at least twice in the 4 hours preceding signing informed consent. A vomiting episode is defined as an episode of forceful expulsion of stomach contents. Retching if a patient has already emptied his or her gastric contents is also considered vomiting...
RHB-102 is an investigational small molecule being developed for the treatment of gastroenteritis. It is designed to address vomiting associated with presumed acute gastroenteritis or gastritis. The drug is currently in Phase 3 clinical development and has not yet been approved by regulatory authorities.
RHB-102 is a bimodal release tablet formulation of ondansetron, a 5-HT3 receptor antagonist. It works by blocking serotonin receptors in the gut and brain, which helps reduce nausea and vomiting. The bimodal release design is intended to provide both rapid and sustained symptom relief.
RHB-102 is being developed by Redhill Biopharma Ltd., a biopharmaceutical company traded on the NASDAQ under the ticker symbol RDHL. The company is conducting clinical trials to evaluate the drug's safety and efficacy for gastroenteritis-related vomiting.
RHB-102 is in Phase 3 clinical development. It is an investigational drug and has not received FDA approval. The Phase 3 trial, known as BEKINDA, has been completed, and the drug remains under evaluation for its intended use in gastroenteritis.
RHB-102 has one completed Phase 3 clinical trial registered as NCT02246439, titled 'BEKINDA (Ondansetron 24 mg Bimodal Release Tablets) for Vomiting Due to Presumed Acute Gastroenteritis or Gastritis.' The trial enrolled 330 participants in the United States, was randomized, double-blind, and placebo-controlled, and included patients aged 12 years and older.
RHB-102 is a specific bimodal release formulation of ondansetron, a well-known antiemetic medication. While the active ingredient is ondansetron, RHB-102 is a proprietary extended-release version designed to offer a different pharmacokinetic profile compared to standard ondansetron products.