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SKY 0515

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Drug Profile

SKY 0515

Alternative Names: SKY-0515

Latest Information Update: 20 Jul 2026

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At a glance

  • Originator Skyhawk Therapeutics
  • Class Antiparkinsonians; Small molecules
  • Mechanism of Action Huntingtin protein inhibitors; PMS1 protein inhibitors; RNA splicing modulators
  • 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

  • Preregistration Huntington's disease

Most Recent Events

  • 14 Jul 2026 Phase-II/III clinical trials in Huntington's disease in United Kingdom, Canada, USA (PO) (NCT06873334) (004-ANZ)
  • 14 Jul 2026 Skyhawk Therapeutics receives CTA acceptance for the phase II/III FALCON-HD (004-ANZ and 004-WW) pivotal trial of SKY 0515 in Huntington’s disease in Canada and the UK
  • 14 Jul 2026 The US FDA clears the IND application for the phase II/III FALCON-HD (004-ANZ and 004-WW) pivotal trial of SKY-0515 in Huntington’s disease in the US

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