NCT05996003 is a Phase 2 clinical trial of NS-089/NCNP-02 in Duchenne Muscular Dystrophy, sponsored by NS Pharma, Inc..

Who is sponsoring NCT05996003?

NCT05996003 is sponsored by NS Pharma, Inc..

What drugs are being tested in NCT05996003?

Interventions in NCT05996003: NS-089/NCNP-02.

What condition does NCT05996003 study?

NCT05996003 studies Duchenne Muscular Dystrophy, Exon 44, DMD.

Is NCT05996003 still recruiting?

NCT05996003 is currently recruiting now. Last updated 6 March 2026.

Last reviewed 2026-03-06 · How we verify

NCT05996003

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

NS-089/NCNP-02-201 in Boys With Duchenne Muscular Dystrophy (DMD)

Recruiting now Phase 2 Last updated 6 March 2026

What this trial tests

Phase 2 trial testing NS-089/NCNP-02 in Duchenne Muscular Dystrophy in 20 participants. Currently enrolling.

Timeline

22 February 2024

Primary endpoint
11 September 2026

11 September 2026

Quick facts

Lead sponsor	NS Pharma, Inc.
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	22 February 2024
Primary completion	11 September 2026
Estimated completion	11 September 2026
Sites	25 locations across New Zealand, Japan, South Korea, Canada, Australia, United States, Turkey (Türkiye)

Drugs / interventions tested

NS-089/NCNP-02 — full drug profile →

Conditions studied

Duchenne Muscular Dystrophy — all drugs for Duchenne Muscular Dystrophy →
Exon 44 — all drugs for Exon 44 →
DMD — all drugs for DMD →

Sponsor

NS Pharma, Inc. — full company profile →

Who can join

Adults 4 to 14, male only, with Duchenne Muscular Dystrophy or Exon 44. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 2, open-label, multi-center, 2-part study of NS-089/NCNP-02 administered by weekly IV infusion to ambulant boys aged ≥4 to \<15 years with DMD due to mutations amenable to exon 44 skipping. Participants will receive a selected dose of NS-089/NCNP-02 administered once weekly. The study consists of 2 parts: Part 1 and Part 2. Six participants (Cohort 1) will participate in both Part 1 and Part 2, and 14 participants (Cohort 2) will be added for Part 2.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Clinical applications of exon-skipping antisense oligonucleotides in neuromuscular diseases.
Torres-Masjoan L, Aguti S, Zhou H, Muntoni F. · · 2025 · cited 21× · PMID 40308063 · DOI 10.1016/j.ymthe.2025.04.038
Molecular mechanisms and therapeutic strategies for neuromuscular diseases.
Zambon AA, Falzone YM, Bolino A, Previtali SC. · · 2024 · cited 7× · PMID 38678519 · DOI 10.1007/s00018-024-05229-9
DG9 boosts PMO nuclear uptake and exon skipping to restore dystrophic muscle and cardiac function.
Shah MNA, Wilton-Clark H, Haque F, Powell B, et al · · 2025 · cited 4× · PMID 40368879 · DOI 10.1038/s41467-025-59494-8
Brogidirsen and Exon 44 Skipping for Duchenne Muscular Dystrophy: Advances and Challenges in RNA-Based Therapy.
Tang A, Yokota T, Yokota T. · · 2025 · PMID 40725431 · DOI 10.3390/genes16070777

Verify or expand the search:

Other trials of NS-089/NCNP-02

Trials testing the same drug.

NCT05135663 — Extension Study of NS-089/NCNP-02 in DMD · Phase 2 · active not recruiting
NCT04129294 — Exploratory Study of NS-089/NCNP-02 in DMD · Phase 1, PHASE2 · completed

Other recruiting trials for Duchenne Muscular Dystrophy

Currently open trials in the same condition.

NCT07287189 — Phase 2 Study of SAT-3247 in Pediatric Ambulatory Patients · Phase 2 · recruiting
NCT06817382 — A Study to Investigate the Safety and Biodistribution of a Single Intrathecal (IT) Injection of INS1201 in Ambulatory Ma · Phase 1 · recruiting
NCT06402942 — Gamified Occupational Therapy for Adolescents With Duchenne Muscular Dystrophy · NA · recruiting
NCT06450639 — A Study to Assess the Efficacy and Safety of Satralizumab in Duchenne Muscular Dystrophy (DMD) · Phase 2 · active not recruiting
NCT06692426 — Trial of Cell Based Therapy for DMD · Phase 1 · recruiting

Other NS Pharma, Inc. trials

Trials by the same sponsor.

NCT07441278 — A Clinical Trial of NS-863 in Participants With Pulmonary Hypertension Associated With Interstitial Lung Disease (PH-ILD · Phase 2 · not yet recruiting
NCT07441200 — Clinical Trial of NS-863 in Participants With Pulmonary Arterial Hypertension (PAH) · Phase 2 · not yet recruiting
NCT04854096 — Study to Assess Efficacy and Safety of NS-018 Compared to BAT in Patients With Myelofibrosis · Phase 2 · terminated
NCT04956289 — Study to Assess the Safety, Tolerability, and Efficacy of Viltolarsen in Ambulant and Non-Ambulant Boys With DMD (Galact · Phase 2 · completed
NCT04060199 — Study to Assess the Efficacy and Safety of Viltolarsen in Ambulant Boys With DMD (RACER53) · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05996003 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by NS Pharma, Inc.
Last refreshed: 6 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05996003.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing