CDEK
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casimersen

Trade name: Amondys 45

Gene therapyapprovedOrphan Drug FDAFast Track FDA

Approved

Feb 25, 2021

Clinical trial activity

4 trials · 2 clinical orgs · 1 marketing orgs

Phase 1
1
Phase 2
3
Phase 3
2
Phase 4
0

Earliest trial started Oct 1, 2015 (NCT02530905)

Timeline

2010s

  1. Jan 1, 2015

    Sarepta Therapeutics — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2016

    Sarepta Therapeutics — Earliest Phase 3 Sponsor(trial)

  3. Jun 4, 2019

    Orphan Drug Designation

2020s

  1. Jan 1, 2020

    Earliest Phase 2 Sponsor(trial)

  2. Feb 25, 2021

    Sarepta Therapeutics — Earliest FDA Approval

  3. Feb 25, 2021

    Sarepta Therapeutics — Marketing Organization

  4. Feb 25, 2021

    Sarepta Therapeutics — NDA Secondary Org

  5. Feb 25, 2021

    Sarepta Therapeutics — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewAcceleratedFast trackFeb 25, 2021

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Prescription Only

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • srp-4045

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04179409Phase 2Jan 1, 2020Ohio State University, Sarepta Therapeutics
NCT03532542Phase 3Aug 2, 2018Sarepta Therapeutics
NCT02500381Phase 3Aug 1, 2016Sarepta Therapeutics
NCT02530905Phase 1Oct 1, 2015Sarepta Therapeutics
Showing 4 of 4 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Sarepta TherapeuticsFor profit4332015
Ohio State UniversityAcademic/Hospital1112020
2 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Sarepta TherapeuticsFor profitMKTGFeb 25, 2021
Sarepta TherapeuticsFor profitNDA2Feb 25, 2021
Sarepta TherapeuticsFor profitNDAFeb 25, 2021