RedHill Biopharma (NASDAQ:RDHL) is positioning its proprietary oral drug, RHB-102 (Bekinda), as a critical solution to the "discontinuation crisis" facing the blockbuster weight-loss drug market.
The specialty biopharmaceutical company announced today it is advancing a once-daily, bimodal extended-release tablet designed to treat gastrointestinal (GI) side effects associated with GLP-1 and GIP receptor agonists—a market segment estimated to face a $35 billion valuation impact by 2030 due to patient drop-off.
The company plans to initiate a Phase 2 proof-of-concept study for GLP-1-related GI side effects as early as 2026.
This development will follow the accelerated FDA 505(b)(2) regulatory pathway, leveraging the established safety profile of ondansetron.
RedHill’s strategy addresses a significant bottleneck in the obesity and diabetes sector: while over 2% of Americans are now on GLP-1 therapies, nearly 50% of patients discontinue treatment within three months, primarily due to severe nausea and vomiting.
Beyond the weight-loss sector, RedHill is progressing RHB-102 across a broad range of indications, including oncology support, acute gastroenteritis, and IBS-D.
The program is bolstered by positive results from the U.S. Phase 3 GUARD study in gastroenteritis and a Phase 2 study in IBS-D.
With more than 22 million annual U.S. prescriptions for ondansetron in emergency rooms alone, RedHill aims to convert this high-volume clinical standard into a more effective, 24-hour controlled-release therapy.