Name: SKY-0515 in Huntington's disease: Dosage forms and strengths
Published: 2026-09-16T18:00:43-04:00

Product information and disease description Product description Product information

Dosage forms and strengths

5 evidence topics · 4 sources

Oral tablet: open-label extension study

“initiate open label treatment with 9 mg tablets of SKY-0515” (opens the source at this quote in a new tab)

Oral capsule: phase 1 placebo matching

“Capsules of matching appearance and formulation to the investigational product, however without the SKY-0515 active ingredient will be administered as placebo in this study.” (opens the source at this quote in a new tab)

Strengths studied: healthy volunteers

“In Part A, five cohorts of participants were dosed with escalating single doses of SKY-0515 ranging from 1mg to 16mg or placebo.” (opens the source at this quote in a new tab)
“In Part B, three cohorts of participants were randomized to receive multiple ascending doses of SKY-0515 ranging from 1mg to 9mg or placebo administered daily from days 1 to 14 (inclusive).” (opens the source at this quote in a new tab)

Strengths studied: participants with HD

“Part C (ii): Two dose levels (3mg and 9mg) of study drug SKY-0515-001 will be evaluated.” (opens the source at this quote in a new tab)
“Part C (ii) Extension: Two dose levels (9mg and 4 mg) of study drug SKY-0515-001 will be evaluated.” (opens the source at this quote in a new tab)

Strengths studied: phase 2/3 FALCON-HD

“Dosage Level(s): Low, mid, high” (opens the source at this quote in a new tab)

Commercial formulation and strength

No evidence found.