Satellite Bio Receives FDA IND Clearance for SB-101 Targeting Urea Cycle Disorders
Satellite Biosciences has obtained FDA clearance for its IND application regarding SB-101, a liver cell therapy aimed at treating urea cycle disorders (UCDs). This marks the company's transition to a clinical-stage biotechnology firm, with plans for a Phase 1/2 trial set to begin in late 2026.
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Satellite Biosciences, Inc. has received FDA approval for its IND application for SB-101, aimed at treating urea cycle disorders (UCDs). This investigational therapy is designed to restore liver function and protect brain health in individuals with severe liver disease.
UCDs are rare inherited conditions leading to toxic ammonia accumulation, resulting in severe health complications. The company plans to commence a Phase 1/2 clinical trial in late 2026 to assess SB-101's safety and efficacy in infants. The IND clearance and Rare Pediatric Disease designation are significant developments for the company as it expands its clinical pipeline.
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