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MedPlexus' L608 Inhaled Drug Receives FDA Phase 2 Approval for Scleroderma Treatment
Health Technology · Pharmaceuticals: Major · economic_daily · 2026-09-20
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MedPlexus has secured FDA approval for its Phase 2 clinical trial of L608, an inhaled drug candidate targeting systemic sclerosis-related digital ulcers.
What Happened
Clinical Milestone: MedPlexus announced that its long-acting inhaled drug candidate, L608, has received approval from the U.S. FDA to proceed with Phase 2 clinical trials. The company will initiate a multi-center, international study to evaluate the drug's efficacy in treating peripheral vascular complications associated with systemic sclerosis.
Study Design: The Phase 2 trial is structured as a randomized, double-blind, controlled study involving 40 patients over a 28-day treatment period. The trial is scheduled to begin by the end of this year, with the company aiming to complete patient enrollment by early 2028 to secure critical proof-of-concept data.
Unmet Need: CEO Kan Pei noted that there are currently no FDA-approved treatments for systemic sclerosis-related digital ulcers (SSc-DU) in the United States. While intravenous Iloprost is available in Europe, it requires clinical administration, whereas L608 aims to provide a convenient at-home inhalation therapy for patients.
Strategic Outlook: The successful execution of this Phase 2 trial is expected to provide the clinical validation necessary for future international licensing partnerships. This development marks a significant step forward for the company as it prepares for potential Phase 3 clinical trials and global market expansion.