pp-161 Tablets
Dossier type
CTD
Dossier status
Under development
Country of origin
United States
GMP approvals
FDA
Comments
Indication: Major depressive disorder (MDD) in adults
Clinical stage: Phase 3
Modality: Small molecule
Mechanism / Target: Selective kappa opioid receptor (KOR) antagonist — blocks dynorphin-mediated KOR activation; reduces anhedonia, stress response and depressive-like behaviour; distinct from monoamine-based antidepressants
Route / form: Oral tablet (once daily)
Differentiation: Novel KOR mechanism; specifically addresses anhedonia — a core MDD symptom poorly served by SSRIs/SNRIs; no sexual dysfunction or weight gain expected; once-daily oral
Manufacturer #39188
Clinical-stage precision psychiatry company targeting validated neurobiological mechanisms in depression. Develops selective kappa opioid receptor antagonists with a differentiated mechanism of action. Wholly owned Phase 3 pipeline in major depressive disorder.