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SKY 0515

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Drug Profile

SKY 0515

Alternative Names: SKY-0515

Latest Information Update: 16 Mar 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

  • 16 Mar 2026 9461556 - intro/kdm updated, dev line added, Georgia removed from dev line from the NCT06873334
  • 10 Mar 2026 Skyhawk Therapeutics anticipates launch of SKY 0515 in Huntington's disease
  • 10 Mar 2026 Skyhawk Therapeutics anticipates accelerated approval for SKY 0515 in Huntington's disease in Australia within the next twelve months

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