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NV 5138

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Drug Profile

NV 5138

Alternative Names: NV-5138; SPN 820; SPN-820/821; SPN-821

Latest Information Update: 07 Apr 2026

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At a glance

  • Originator Navitor Pharmaceuticals; X-Chem
  • Developer Navitor Pharmaceuticals; Supernus Pharmaceuticals
  • Class Amines; Antidepressants; Fluorinated hydrocarbons; Pentanoic acids; Small molecules
  • Mechanism of Action MTORC1 protein stimulants
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Major depressive disorder; Treatment-resistant depressive disorder

Most Recent Events

  • 19 Jan 2026 Navitor Pharmaceuticals initiates a phase II trial in Major depressive disorder (Adjunctive treatment) in USA (PO) (NCT07226661)
  • 17 Sep 2025 Chemical structure information added.
  • 05 Aug 2025 Supernus Pharmaceuticals plans a phase IIb trial for Major depressive disorders (Adjunctive treatment) in 2025

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