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Denatonium - Aardvark Therapeutics

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Drug Profile

Denatonium - Aardvark Therapeutics

Alternative Names: ARD-101; Denatonium acetate monohydrate - Aardvark Therapeutics

Latest Information Update: 12 Sep 2026

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At a glance

  • Originator Aardvark Therapeutics
  • Class Acetates; Amines; Anilides; Anti-inflammatories; Obesity therapies; Small molecules
  • Mechanism of Action G protein-coupled receptor 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
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Prader-Willi syndrome
  • Phase I Obesity
  • Discontinued Weight gain

Most Recent Events

  • 05 Sep 2026 Chemical structure information added
  • 30 Jun 2026 Aardvark Therapeutics terminates the phase-III HERO trial in Prader-Willi syndrome (In children, In adults, In adolescents, In the elderly) in the US, Australia, Canada, South Korea, United Kingdom, (PO) (NCT06828861)
  • 15 May 2026 US FDA places a full clinical hold on investigational new drug application (IND) for ARD 101 related to the Company’s previously announced voluntary pause

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