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Ecopipam - Emalex Biosciences

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Drug Profile

Ecopipam - Emalex Biosciences

Alternative Names: EBS-101; Ecopipam HCl; Ecopipam Hydrochloride; PSYRX 101; SCH-39166

Latest Information Update: 17 Mar 2026

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At a glance

  • Originator Schering-Plough
  • Developer Emalex Biosciences; Psyadon Pharmaceuticals; Schering-Plough
  • Class Alcohols; Antipsychotics; Behavioural disorder therapies; Benzazepines; Cardiovascular therapies; Chlorinated hydrocarbons; Drug withdrawal therapies; Heterocyclic compounds with 4 or more rings; Naphthalenes; Obesity therapies; Small molecules
  • Mechanism of Action Dopamine D1 receptor antagonists
  • Orphan Drug Status

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

    Yes - Lesch-Nyhan syndrome; Gilles de la Tourette's syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Gilles de la Tourette's syndrome; Lesch-Nyhan syndrome
  • Phase II Speech disorders
  • Phase I/II Restless legs syndrome
  • Phase I Cardiovascular disorders
  • No development reported Gambling
  • Discontinued Cocaine-related disorders; Obesity; Schizophrenia

Most Recent Events

  • 11 Mar 2026 Emalex Biosciences initiates an Expanded Access Programme (EAP) for Gilles de la Tourette's syndrome (In Children, In adolescents, In adults) in USA (PO) (NCT07093541)
  • 08 Oct 2025 Emalex Biosciences plans to submit a New Drug Application (NDA) to the US FDA for Tourette syndrome in late 2025
  • 08 Oct 2025 US FDA authorizes Expanded Access Program (EAP) for ecopipam for the treatment of Tourette syndrome

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