Who is sponsoring NCT04587908?

NCT04587908 is sponsored by Taiho Pharmaceutical Co., Ltd..

What condition does NCT04587908 study?

NCT04587908 studies Duchenne Muscular Dystrophy.

Is NCT04587908 still recruiting?

NCT04587908 is currently active, enrolled. Last updated 4 September 2025.

Last reviewed 2025-09-04 · How we verify

NCT04587908

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

A Phase 3, Randomized, Placebo-controlled, Double-blind and Open-label, Extension Study of TAS-205 in Patients With Duchenne Muscular Dystrophy

Active, enrolled Phase 3 Last updated 4 September 2025

What this trial tests

Phase 3 trial testing TAS-205 [Ambulatory Cohort] [Non-ambulatory Cohort] in Duchenne Muscular Dystrophy in 104 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 November 2020

Primary endpoint
1 May 2027

1 May 2027

Quick facts

Lead sponsor	Taiho Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	104
Start date	1 November 2020
Primary completion	1 May 2027
Estimated completion	1 May 2027
Sites	5 locations across Japan

Drugs / interventions tested

TAS-205 [Ambulatory Cohort] [Non-ambulatory Cohort] — full drug profile →
Placebo [Ambulatory Cohort] only — full drug profile →

Conditions studied

Duchenne Muscular Dystrophy — all drugs for Duchenne Muscular Dystrophy →

Sponsor

Taiho Pharmaceutical Co., Ltd. — full company profile →

Who can join

5 and older, male only, with Duchenne Muscular Dystrophy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Mean change from baseline to Week 52 in the time to rise from the floor
Time frame: Baseline to Week 52 of treatment
Ambulatory Cohort
Incidence of Adverse Events and Adverse Reactions
Time frame: Week 52
Non-ambulatory Cohort

Sponsor's own description

The purpose of this study is to evaluate the efficacy and safety of TAS-205 in patients with Duchenne muscular dystrophy

Publications & conference data

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

Prostaglandins in the Inflamed Central Nervous System: Potential Therapeutic Targets.
Sheremeta CL, Yarlagadda S, Smythe ML, Noakes PG. · · 2024 · cited 8× · PMID 39177131 · DOI 10.2174/0113894501323980240815113851
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
Hematopoietic Prostaglandin D Synthase Is Increased in Mast Cells and Pericytes in Autopsy Myocardial Specimens from Patients with Duchenne Muscular Dystrophy.
Hamamura K, Yoshida Y, Oyama K, Li J, et al · · 2024 · cited 4× · PMID 38339125 · DOI 10.3390/ijms25031846
Urinary prostaglandin D<sub>2</sub> and E<sub>2</sub> metabolites are elevated with disease severity in patients with Fukuyama congenital muscular dystrophy.
Ishigaki K, Takeuchi A, Taniguchi-Ikeda M, Sato T, et al · · 2025 · cited 1× · PMID 40011677 · DOI 10.1038/s41598-025-91539-2
Pharmacology and macrophage modulation of HPGDS inhibitor PK007 demonstrate reduced disease severity in DMD-affected muscles of the mdx mouse model.
Yarlagadda S, Sheremeta CL, Cheung SW, Cuffe A, et al · · 2025 · PMID 40275384 · DOI 10.1186/s13395-025-00379-1
Phase 1 Mass Balance Study of Pizuglanstat: An Investigational Hematopoietic Prostaglandin D Synthase Inhibitor.
Hanada R, Takenaka T. · · 2025 · PMID 39840517 · DOI 10.1002/cpdd.1504

Verify or expand the search:

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 Taiho Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT05691660 — A Study of TAS3731 in Healthy Adults · Phase 1 · completed
NCT05621447 — A Mass Balance Study of [14C] TAS-303 in Healthy Adult Male Subjects · Phase 1 · completed
NCT05335499 — A Phase 2a Study of TAS5315 in Patients With Chronic Spontaneous Urticaria · Phase 2 · completed
NCT04825431 — Mass Balance Study of [14C] TAS-205 in Healthy Volunteers · Phase 1 · completed
NCT04512053 — A Phase 2 Study of TAS-303 in Female Patients With Stress Urinary Incontinence · Phase 2 · 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 NCT04587908 (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 Taiho Pharmaceutical Co., Ltd.
Last refreshed: 4 September 2025

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/NCT04587908.

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