pp-200 Tablets
Dossier type
CTD
Dossier status
Under development
Country of origin
India
GMP approvals
India
Comments
Indication: Excessive daytime sleepiness (EDS) in narcolepsy (type 1 and type 2)
Clinical stage: Phase 3 — ongoing
Modality: Small molecule (first-in-class dual H3 antagonist / D1 agonist)
Mechanism / Target: First-in-class dual-mechanism: histamine H3 receptor antagonist (promotes wakefulness via histaminergic activation) + dopamine D1 receptor agonist (enhances cognitive arousal); unique dual monoaminergic wake-promoting mechanism
Route / form: Oral tablet
Differentiation: First-in-class dual H3 antagonist/D1 agonist; novel dual mechanism provides complementary wakefulness promotion vs. pitolisant (H3 only) or modafinil/oxybates; Phase 3 for narcolepsy EDS;
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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