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A Phase 2/3 Randomized, Double Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease

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Trial Profile

A Phase 2/3 Randomized, Double Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease

Status: Recruiting
Phase of Trial: Phase II/III

Latest Information Update: 04 Feb 2026

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At a glance

  • Drugs SKY 0515 (Primary)
  • Indications Huntington's disease
  • Focus Therapeutic Use
  • Acronyms Falcon-HD
  • Sponsors Skyhawk Therapeutics

Most Recent Events

  • 27 Jan 2026 According to a Skyhawk Therapeutics media release, this trial is open at twelve sites in Australia and New Zealand, has expanded worldwide and now dosed more than 90 patients with SKY-0515.
  • 18 Jun 2025 Status changed from not yet recruiting to recruiting.
  • 15 Mar 2025 According to a Skyhawk Therapeutics media release, the study will be presented at the biannual HYDO International Congress in Prague, Czech Republic

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