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ARD 101

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Drug Profile

ARD 101

Alternative Names: ARD-101; Denatonium acetate monohydrate

Latest Information Update: 13 Apr 2026

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At a glance

  • Originator Aardvark Therapeutics
  • Class 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

  • 24 Mar 2026 Aardvark Therapeutics initiates safety clinical trial (In volunteers) for ARD 101 for Prader-Willi syndrome NDA support before March 2026
  • 24 Mar 2026 Aardvark Therapeutics announces intention to submit NDA for ARD 101 for Prader-Willi syndrome (In children, In adults, In adolescents, In the elderly) in USA
  • 19 Mar 2026 Aardvark Therapeutics suspends a phase-III clinical trials in Prader-Willi syndrome (In children, In adults, In adolescents, In the elderly) in the US, Australia, Canada, South Korea, United Kingdom, (PO) (NCT06828861)

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