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New pill aims to tackle Huntington's at its source

NCT ID NCT07378644

Disease control Sponsor: Skyhawk Therapeutics, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 14 times

Summary

This clinical trial tests an oral drug called SKY-0515 in 400 adults with Huntington's disease. The goal is to see if it can lower harmful proteins linked to the disease and improve symptoms like movement and thinking. Participants take the drug or a placebo daily for 18 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SKY-0515 (an oral small molecule drug)
What this could lead to
If successful, this could point toward a treatment that slows or improves Huntington's disease symptoms by lowering harmful proteins in the brain.
What could go wrong
This is an early-to-mid stage trial, so the drug may not work or could have side effects. The results may not apply to all people with Huntington's disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

About 400 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Aug 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 25 years or older. * Huntington's Disease confirmed through genetic testing, with a specific change in exon 1 of the HTT gene (CAG repeat of 40 or more). * Total Functional Capacity (TFC) score of 10 or more). * Total Motor Score (TMS) of 6 or more). * Independence Score (IS) of 70 or more). * Women who can have children must have a negative pregnancy test before starting and use two types of birth control during the study and for 30 days after the last dose of the study drug. * Men must agree to use birth control during the study and for 90 days after the last dose. * Agree to sign a consent form and follow the study's rules and schedule. Exclusion Criteria: * Other Serious health problems or brain/spinal issues that could interfere with the study or make procedures unsafe. * Conditions that interfere with protocol-specified assessments, like an implanted medical device or difficulty getting an MRI. * Cancer, except for some types of skin cancer, or a history of cancer in the last five years. * Severe allergies or have reacted badly to similar drugs in the past. * Taking medications or treatments that might interfere with the study. * Participated in another study or taken experimental drugs in the last two months (or longer for some drugs). * Any kind of gene therapy. * History of suicidal thoughts, severe depression, or have attempted suicide in the past year. * Liver function tests show significant abnormalities. * Positive for hepatitis B, hepatitis C, or HIV. * Pregnancy, breastfeeding, or planning to become pregnant during the study.

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Conditions

The condition(s) this trial relates to.

Huntington disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Huntington disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    24 sites in 9 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Buenos Aires British Hospital

    RECRUITING

    CABA, Buenos Aires, 1280AEB, Argentina

  • CETRAM (Centro de Trastornos del Movimiento)

    RECRUITING

    Santiago, Santiago Metropolitan, 9120500, Chile

    Contact Email: •••••@•••••

  • CINME Centro de Investigaciones Metabólicas

    RECRUITING

    CABA, Buenos Aires, C1056 AB, Argentina

  • CenExel Denver CO

    NOT_YET_RECRUITING

    Englewood, Colorado, 80113, United States

  • Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - Filial EBSERH

    ENROLLING_BY_INVITATION

    Belo Horizonte, Minas Gerais, 30130-100, Brazil

  • Clínica de la Costa S.A.S

    RECRUITING

    Barranquilla, Atlántico, 5001000, Colombia

  • Faculdade de Medicina de Ribeirão Preto - FMRP

    NOT_YET_RECRUITING

    Ribeirão Preto, São Paulo, 14049-900, Brazil

  • Fundación Scherbovsky

    RECRUITING

    Mendoza, Mendoza Province, M5500, Argentina

  • Hospital Angelina Caron

    NOT_YET_RECRUITING

    Campina Grande do Sul, Paraná, 83430-000, Brazil

  • Hospital El Cruce

    RECRUITING

    Buenos Aires, Buenos Aires, B1888AAE, Argentina

  • Hospital Universitario Pedro Ernesto (HUPE)

    RECRUITING

    Rio de Janeiro, Rio de Janiero, 20550, Brazil

  • Hospital Universitario Ramon y Cajal

    NOT_YET_RECRUITING

    Madrid, Madrid, 28034, Spain

  • Hospital Universitário Onofre Lopes (HUOL)

    NOT_YET_RECRUITING

    Natal, Rio Grande do Norte, 59010-056, Brazil

  • Hospital da Universidade Federal de São Paulo - UNIFESP

    NOT_YET_RECRUITING

    São Paulo, São Paulo, 04024-002, Brazil

  • IADIN (Instituto Argentino de Investigación Neurológica)

    RECRUITING

    CABA, Buenos Aires, C1015ABR, Argentina

  • Instituto de Neurologia de Curitiba

    RECRUITING

    Curitiba, Paraná, 81210-310, Brazil

  • Isar-Amper-Klinikum, Zentrum für Neuro- und Gerontopsychiatrie (ZNGP)

    NOT_YET_RECRUITING

    Taufkirchen, 84416, Germany

  • North York General Hospital

    RECRUITING

    Toronto, Ontario, M2K 1E1, Canada

  • PSEG Centro de Pesquisa Clinica

    RECRUITING

    São Paulo, São Paulo, 04038002, Brazil

  • PUCPR - Centro de Pesquisa da Pontifícia Universidade Católica do Paraná

    RECRUITING

    Curitiba, Paraná, 80215-901, Brazil

  • Pineo Medical Ecosystem

    RECRUITING

    Tbilisi, Georgia

  • Pontificia Universidad Católica de Chile

    RECRUITING

    Santiago, Santiago Metropolitan, 8331150, Chile

  • Sanatorio Mater Dei

    RECRUITING

    CABA, Buenos Aires, C1425, Argentina

  • Simon Khechinashvili University Hospital

    RECRUITING

    Tbilisi, Georgia

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