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pp-142

Inhalation solution

Dossier type
CTD
Dossier status
Under development
Country of origin
European Union
GMP approvals
EU GMP
Comments
Indication: Treatment-resistant depression (TRD; adults failing ≥2 antidepressants) Clinical stage: Phase 2b Modality: Small molecule (synthetic 5-MeO-DMT) Mechanism / Target: 5-HT2A/2C agonist and sigma-1 receptor ligand — induces acute psychoplastogen effect promoting synaptic plasticity and rapid antidepressant neuroadaptation Route / form: Inhalation solution (metered-dose inhaler; single or small number of clinic sessions) Differentiation: Single-session treatment potential; faster onset vs ketamine/esketamine; inhaled route avoids IV; no dependency risk reported vs classic opioids; profound rapid antidepressant data
Manufacturer #39173

Clinical-stage psychiatry company developing single-session psychedelic medicines for TRD. Pioneers inhaled 5-MeO-DMT as a rapid-acting, clinic-based antidepressant treatment. Wholly owned pipeline advancing through Phase 2 in high unmet-need psychiatric indications.
 

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