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SRP-9003

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Sarepta Therapeutics, Inc. SRPT · Limb-girdle Muscular Dystrophy

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Phase 3

    Not recorded

  • Linked trials

    1

    From ClinicalTrials.gov

  • Latest FDA action

    None on record

    From Drugs@FDA

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
Sarepta Therapeutics, Inc. SRPT Source: Company record for Sarepta Therapeutics, Inc. (opens in a new tab)
Indication
Limb-girdle Muscular Dystrophy Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 Current stageFirst trial start 15 Jan 20241 linked trial
  5. Filed Not yet
  6. Approved Not yet

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for SRP-9003. Editors add each one with its source.

Filed application

No filed application is on record for SRP-9003. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for SRP-9003.

Clinical trials

Trials linked to SRP-9003
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT06246513ClinicalTrials.gov record for NCT06246513 (opens in a new tab)EMERGENEA Trial to Learn More About an Experimental Gene Therapy Called Bidridistrogene Xeboparvovec (SRP-9003) as a Possible Treatment for Limb Girdle Muscular Dystrophy 2E/R4Phase 3Active, not recruiting17 (actual)4 Mar 2025 (actual) No

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

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FDA actions

No FDA approvals on record for this drug.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

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EU status (EMA)

EMA's medicines data lists no human medicine with the same active substance as SRP-9003.

Source: European Medicines Agency (EMA), medicines data download.

Related news

No recent headlines mention this drug.

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.