pp-199 Tablets
Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
India
Comments
Indication: Agitation in Alzheimer's dementia (moderate to severe AD)
Clinical stage: Phase 3 — ongoing
Modality: Small molecule (first-in-class selective 5-HT6 receptor antagonist)
Mechanism / Target: First-in-class highly selective 5-HT6 (serotonin-6) receptor antagonist; modulates serotonin, dopamine, and glutamate neurotransmission in prefrontal cortex and striatum; reduces neuropsychiatric agitation symptoms in Alzheimer's
Route / form: Oral tablet (once daily)
Differentiation: First-in-class 5-HT6 antagonist in Phase 3 for AD agitation — the most common and distressing neuropsychiatric symptom (no approved treatment); novel CNS mechanism without black-box safety warnings of antipsychotics;
Manufacturer #39338
India-based clinical-stage biopharmaceutical company with decades of expertise in CNS and neurodegenerative drug discovery. Develops proprietary Rx new chemical entities and provides drug-discovery services to global pharma and biotech companies. Listed on a domestic exchange.
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