- Trial Phase
- Late-stage development (Phase 3 completed for certain indications)
- Time to Market
- Unknown — no regulatory filing has been announced. The drug is in late-stage development but RedHill has not disclosed a specific NDA/PDUFA timeline. Given the company's severe cash constraints, any path to market likely depends on finding a partner.
- Why 3/10
- No hard dated catalyst (PDUFA, pivotal readout, or regulatory decision) is scheduled for RHB-102 in the next ~12 months. The drug is in late-stage development with no announced filing timeline. RHB-102 is one of several pipeline assets at a company whose stock is driven by solvency risk. ImpactScore 3: a minor pipeline asset with no imminent binary catalyst.
RHB-102 has no hard dated catalyst (no PDUFA, no pivotal readout scheduled in the next ~12 months). The stock is driven almost entirely by RedHill's solvency risk, not pipeline progress. Watch for partnership announcements on RHB-102 or emergency financing — either could cause a short-term move, but the going-concern risk dominates.
Price Chart
Executive Summary
RHB-102 is RedHill Biopharma's once-daily bimodal extended-release ondansetron, a reformulation of the well-known anti-nausea drug ondansetron (generic Zofran). It is being developed for chemotherapy-induced nausea and vomiting (CINV) and GI indications, including GLP-1/GIP-associated GI intolerance. RedHill recently regained full worldwide rights after terminating its license with Hyloris Pharmaceuticals. However, the drug has no near-term approval catalyst, and the developer is in severe financial distress — only $4.1M cash, a going-concern warning, Nasdaq delisting risk, and an active dilutive ATM offering. RHB-102 is a minor pipeline asset at a company fighting for survival.
How It Works
RHB-102 is a once-daily pill version of ondansetron, a well-known anti-nausea drug. Ondansetron works by blocking serotonin (a chemical that triggers nausea and vomiting) from activating the vomiting center in the brain. RHB-102 uses a special "bimodal" extended-release technology that releases the drug in two phases — an immediate burst followed by a sustained release — so a single daily dose can prevent nausea and vomiting for a full 24 hours, unlike standard ondansetron which requires multiple doses per day.
Trial Status
RHB-102 has completed late-stage clinical development. RedHill previously conducted a Phase 3 study for acute gastroenteritis (the GUARDIAN study) and has studied it for chemotherapy-induced nausea and vomiting (CINV). The company now plans to continue development for oncology support and GI indications, including GLP-1/GIP-associated GI intolerance. No specific ongoing trial enrollment data is publicly available in the local database.
The Two-Sided Case
Upcoming Catalysts
- Potential partnership/licensing deal for RHB-102 (company exploring partnerships)
- Any update on late-stage development plans for GLP-1/GIP-associated GI intolerance indication
Source Filing
The SecBot filing or press-release report that triggered this drug report:
RedHill Biopharma Ltd. 6-K RDHL ·Originating report