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NCT06100887ACTIVE_NOT_RECRUITINGanonymous

A Phase 2 Study to Evaluate the Effect of EDG-5506 on Safety, Pharmacokinetics, and Biomarkers in Children and Adolescents With Duchenne Muscular Dystrophy Previously Treated With Gene Therapy

Sponsor

Source record

Edgewise Therapeutics, Inc.

Phase

Source record

Phase 2

Modality

AI-normalized

small molecule

Target

AI-normalized

Sevasemten (EDG-5506) targets muscle damage biomarkers in Duchenne muscular dystrophy (DMD) patients, potentially modulating muscle regeneration and function.

Indication / condition

AI-normalized

Duchenne Muscular Dystrophy

Intervention

Source record

Sevasemten Dose 1, Sevasemten Dose 2, Sevasemten Dose 3, Placebo

Source & freshness

Source record

NCT ID

NCT06100887

Original source

ClinicalTrials.gov

Source last updated

Nov 06, 2025

Ingested at

Jun 12, 2026

Internal sync

Jun 12, 2026

Model version

trialsignal-ai-v1

Normalized confidence

96%

Validation status

validated

Open original registry record
View original source fields

NCT ID

NCT06100887

Title

A Phase 2 Study to Evaluate the Effect of EDG-5506 on Safety, Pharmacokinetics, and Biomarkers in Children and Adolescents With Duchenne Muscular Dystrophy Previously Treated With Gene Therapy

Sponsor

Edgewise Therapeutics, Inc.

Status

ACTIVE_NOT_RECRUITING

Phase

Phase 2

Condition raw

Duchenne Muscular Dystrophy

Condition normalized

Duchenne Muscular Dystrophy

Modality raw

small molecule

Modality normalized

small molecule

Target raw

Sevasemten (EDG-5506) targets muscle damage biomarkers in Duchenne muscular dystrophy (DMD) patients, potentially modulating muscle regeneration and function.

Target normalized

Sevasemten (EDG-5506) targets muscle damage biomarkers in Duchenne muscular dystrophy (DMD) patients, potentially modulating muscle regeneration and function.

Interventions

Sevasemten Dose 1, Sevasemten Dose 2, Sevasemten Dose 3, Placebo

Public preview

Source record

Edgewise Therapeutics is advancing EDG-5506 through a Phase 2 study (FOX) aimed at assessing its safety and efficacy in children and adolescents with Duchenne muscular dystrophy (DMD) who have previously received gene therapy. The study's design includes a randomized, double-blind, placebo-controlled phase followed by an open-label extension, which may provide robust data on long-term safety and efficacy. Given the unmet medical need in DMD and the increasing focus on gene therapy, successful outcomes could position Edgewise favorably in a competitive landscape that includes established players in the DMD space. The market for DMD therapies is expanding, with a growing number of gene therapies and supportive treatments, indicating potential for significant commercial opportunity if EDG-5506 demonstrates positive results.

AI-generated analysis supports research triage only. Verify source records, publications, sponsor disclosures and IP databases before making diligence decisions. Model: trialsignal-ai-v1.

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TrialSignal

Clinical trial intelligence report

A Phase 2 Study to Evaluate the Effect of EDG-5506 on Safety, Pharmacokinetics, and Biomarkers in Children and Adolescents With Duchenne Muscular Dystrophy Previously Treated With Gene Therapy

Source-linked diligence brief with registry provenance, taxonomy normalization and premium analytical context.

Generated

Jun 13, 2026

NCT ID

NCT06100887

Status

ACTIVE_NOT_RECRUITING

Phase

Phase 2

Sponsor

Edgewise Therapeutics, Inc.

Executive brief

Investment-Ready Snapshot

Edgewise Therapeutics is advancing EDG-5506 through a Phase 2 study (FOX) aimed at assessing its safety and efficacy in children and adolescents with Duchenne muscular dystrophy (DMD) who have previously received gene therapy. The study's design includes a randomized, double-blind, placebo-controlled phase followed by an open-label extension, which may provide robust data on long-term safety and efficacy. Given the unmet medical need in DMD and the increasing focus on gene therapy, successful outcomes could position Edgewise favorably in a competitive landscape that includes established players in the DMD space. The market for DMD therapies is expanding, with a growing number of gene therapies and supportive treatments, indicating potential for significant commercial opportunity if EDG-5506 demonstrates positive results.

Source & freshness

Provenance

SourceClinicalTrials.gov
Source updatedNov 06, 2025
Internal syncJun 12, 2026
Model versiontrialsignal-ai-v1

https://clinicaltrials.gov/study/NCT06100887

Indication

Duchenne Muscular Dystrophy

Modality

small molecule

Target

Sevasemten (EDG-5506) targets muscle damage biomarkers in Duchenne muscular dystrophy (DMD) patients, potentially modulating muscle regeneration and function.

Intervention

Sevasemten Dose 1, Sevasemten Dose 2, Sevasemten Dose 3, Placebo

Source record

Protocol Description

Detailed source ingestion pending.

Source record

Outcome Measures

Detailed source ingestion pending.

Source record

Eligibility

Detailed source ingestion pending.

AI analysis

Known Results And Readout Context

Detailed source ingestion pending.

IP intelligence

Patent And IP Landscape

Detailed source ingestion pending.

Source record

Contacts

Detailed source ingestion pending.