deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT04956289

Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys With DMD (Galactic53)

A Phase 2 Open-label Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys With Duchenne Muscular Dystrophy (DMD) Compared to Natural History Controls

Sponsor: NS Pharma, Inc.

Conditions Duchenne Muscular Dystrophy
Interventions Viltolarsen
Updated 11 times since 2021 Last updated: Jul 25, 2024 Started: Jul 1, 2021 Primary completion: Jun 20, 2023 Completion: Jul 13, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Duchenne Muscular Dystrophy, this trial is completed. The trial is conducted by NS Pharma, Inc. and has accumulated 11 data snapshots since 2021. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Sep 2021 – ~Nov 2021 · 2 months · monthly snapshotRecruiting~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshotRecruiting~Dec 2021 – ~Feb 2022 · 2 months · monthly snapshotRecruiting~Feb 2022 – ~Apr 2022 · 59 days · monthly snapshotRecruiting~Apr 2022 – ~May 2022 · 30 days · monthly snapshotRecruiting~May 2022 – ~Sep 2022 · 4 months · monthly snapshotRecruiting~Sep 2022 – ~Aug 2023 · 11 months · monthly snapshotActive Not Recruiting~Aug 2023 – ~Jul 2024 · 11 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 10 months · monthly snapshotCompleted

Change History

11 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Aug 2023 — Jul 2024 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  5. Sep 2022 — Aug 2023 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

▶ Show 6 earlier versions

  1. May 2022 — Sep 2022 [monthly]

    Recruiting PHASE2

  2. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE2

  3. Feb 2022 — Apr 2022 [monthly]

    Recruiting PHASE2

  4. Dec 2021 — Feb 2022 [monthly]

    Recruiting PHASE2

  5. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE2

  6. Sep 2021 — Nov 2021 [monthly]

    Recruiting PHASE2

    First recorded

Jul 2021

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • NS Pharma, Inc.
  • Nippon Shinyaku Co., Ltd.
Data source: NS Pharma, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations