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pp-060

Tablets

Dossier type
CTD
Dossier status
Under development
Country of origin
South Korea
Comments
Indication: Autism spectrum disorder (ASD), including pediatric patients with social-communication deficits and neurobehavioral symptoms; additional evaluation in neurological conditions characterized by lysosomal dysfunction, mitochondrial stress, and dopaminergic pathway abnormalities. Clinical stage: Phase 2 clinical development in pediatric ASD, supported by completed Phase 1 PK/PD modeling and randomized placebo-controlled studies. Modality: Small molecule (essential amino acid formulation) Mechanism / Target: Pharmaceutical-grade L-serine supporting neuronal metabolism; modulates mitochondrial function, reduces oxidative and lysosomal stress, restores cathepsin activity, and improves dopaminergic neuronal signaling—mechanisms implicated in ASD pathophysiology. Route / form: Oral administration (dose-titrated formulations used in clinical studies) Differentiation: First-in-class neurometabolic therapy targeting cellular stress pathways in ASD; demonstrated improvements in social communication in clinical trials and robust neuroprotective effects in multiple preclinical models.
Manufacturer #38614

 clinical-stage biopharmaceutical company developing small molecule-based therapies for intractable neurological disorders, including autism spectrum disorder. It focuses on rapid translation from clinical insight to treatment options with global development and partnership goals. The organization leverages clinician-led research to advance patient-relevant medicines.

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