Ondansetron hydrochloride CR, what is the likelihood that the drug will be approved?

Ondansetron hydrochloride CR is under clinical development by RedHill Biopharma and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Ondansetron hydrochloride CR’s likelihood of approval (LoA) and phase transition for Diarrhea took place on 21 Nov 2022, which decreased the likelihood that the drug progresses to the next phase in its clinical pathway and decreased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Ondansetron hydrochloride CR Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Ondansetron hydrochloride CR overview

Ondansetron hydrochloride (RHB-102, Bekinda) is under development for the treatment of acute gastroenteritis, gastritis, diarrhea-predominant irritable bowel syndrome (IBS-D). The drug candidate is administered orally as a tablet. It is a once daily controlled release proprietary formulation of ondansetron. The drug candidate is developed based on CDT (Controlled Delivery Technology) technology. It was also under development for the treatment of radiotherapy induced nausea and vomiting (RINV) and chemotherapy-induced nausea and vomiting (CINV). It is a controlled release formulation.

RedHill Biopharma overview

RedHill Biopharma (RedHill) is a specialty biopharmaceutical company that develops and commercializes therapeutics for gastrointestinal (GI) diseases and cancer. The company’s commercial product portfolio consists of branded prescription drugs including a combination of omeprazole, amoxicillin and rifabutinomeprazole; naloxegol; and rifamycin. It is investigating its pipeline candidates for the treatment of Crohn’s disease, non-tuberculous mycobacterial infection (NTM) infections, gastroenteritis, gastritis, irritable bowel syndrome with diarrhea (IBS-D), bowel cleanser, cancer and novel coronavirus disease (COVID-19). The company has a subsidiary in the US. RedHill is headquartered in Tel Aviv, Israel.

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