Biopharmaceutical company RedHill Biopharma Ltd (Nasdaq: RDHL) revealed on Monday that development of RHB-102 (Bekinda) is progressing across multiple gastrointestinal indications, including a planned programme targeting gastrointestinal side effects associated with GLP-1 and GIP receptor agonist therapies.

RHB-102 is a proprietary, once-daily, bimodal extended-release oral formulation of the 5-HT3 antagonist ondansetron, designed to address nausea, vomiting and diarrhoea. The company said the therapy is clinically aligned to improve dose titration success and reduce treatment discontinuation for diabetes and weight loss drugs such as Mounjaro, Zepbound, Ozempic and Wegovy.

Development is largely de-risked, supported by positive published US Phase 3 data in gastroenteritis and gastritis and Phase 2 data in diarrhoea-predominant irritable bowel syndrome, alongside a positive comparative pharmacokinetic study in oncology support and extensive real-world ondansetron use. RedHill plans to pursue the GLP-1-associated GI side effects indication via the accelerated FDA 505(b)(2) pathway, with a Phase 2 proof-of-concept study designed and intellectual property expanded.

RedHill is also advancing RHB-102 toward potential U.S. Food and Drug Administration approval in oncology support, with possible use in chemotherapy- and radiotherapy-induced nausea and vomiting, where it could become the first oral 24-hour extended-release ondansetron therapy.

The company highlighted that more than 2% of Americans take GLP-1 receptor agonists, but up to 50% are estimated to discontinue within three months, with GI side effects a key driver and a factor in potential reductions of GLP-1 market value projected to reach USD35bn by 2030.