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Diazoxide choline controlled release - Soleno Therapeutics

Drug Profile

Diazoxide choline controlled release - Soleno Therapeutics

Alternative Names: C601; C602; DCCR; DCCR - Soleno Therapeutics; Diazoxide choline; Diazoxide choline controlled release; Diazoxide-choline-controlled-release-Essentialis

Latest Information Update: 02 Jan 2025

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At a glance

  • Originator Essentialis
  • Developer Essentialis; Soleno Therapeutics
  • Class Antihyperlipidaemics; Antihypertensives; Antihypoglycaemics; Benzothiadiazines; Chlorobenzenes; Ethanolamines; Obesity therapies; Peripheral vasodilators; Small molecules; Sulfonamides
  • Mechanism of Action Potassium channel agonists
  • Orphan Drug Status

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

    Yes - Prader-Willi syndrome; Glycogen storage disease type I
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Preregistration Prader-Willi syndrome
  • Phase II Hypertriglyceridaemia
  • Discontinued Hypoglycaemia; Obesity

Most Recent Events

  • 02 Jan 2025 Chemical structure information added.
  • 26 Nov 2024 FDA assigns PDUFA action date of (27/03/2025) for Diazoxide choline controlled release for Prader-Willi syndrome (In adolescents, In adults, In children, In the elderly)
  • 26 Nov 2024 US FDA extends the review period for the NDA for Diazoxide choline controlled release for Prader-Willi syndrome (In adolescents, In adults, In children, In the elderly)

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