
Astrogen is developing AST-001 (Speragen), an L-serine syrup being studied for its potential effects on social communication and adaptive behaviour in children with autism spectrum disorder. It remains an investigational drug candidate undergoing clinical evaluation.
An earlier Phase III trial in South Korea was completed in 2024. The company publicly reported that the prespecified primary endpoint at week 12 did not reach statistical significance and is preparing a new confirmatory trial. At the meeting on 28 October, the Astrogen team shared its plan to begin a second Phase III trial in November 2026.
Europe also features in the company’s public plans: on 26 October, Astrogen reported submitting a Scientific Advice request in September to seek guidance on its clinical development strategy for Europe. The agreement to cooperate reached in Seoul provides a basis for further dialogue between LukoLab and Astrogen in this direction.
Sources & context
AST-001 formulation · peer-reviewed paper ↗Earlier Phase III trial record · ClinicalTrials.gov ↗Plans for a new confirmatory trial · Astrogen, 13 August 2026 ↗Clinical development and European plans · Astrogen, 26 October 2026 ↗