nadofaragene firadenovec

Trade name: Adstiladrin

Gene therapyapprovedBreakthrough Therapy FDA

Approved

Dec 16, 2022

Clinical trial activity

6 trials · 2 clinical orgs · 1 marketing orgs

Phase 1
1
Phase 2
5
Phase 3
3
Phase 4
1

Earliest trial started Dec 21, 2022 (NCT05704244)

Timeline

2020s

  1. Jan 1, 2022

    Ferring — Earliest Phase 3 Sponsor(trial)

  2. Dec 16, 2022

    Ferring — Earliest FDA Approval

  3. Dec 16, 2022

    Ferring — NDA Secondary Org

  4. Dec 16, 2022

    Ferring — NDA Organization

  5. Jan 1, 2024

    Ferring — Earliest Phase 1 Sponsor(trial)

  6. Jan 1, 2024

    Ferring — Earliest Phase 2 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedBreakthroughDec 16, 2022

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No

Oral

No

Parenteral

No

Topical

No

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06929286Phase 3Apr 11, 2025Memorial Sloan-Kettering Cancer Center
NCT06668493Phase 1/Phase 2 (Phase 2)Nov 30, 2024Ferring
NCT06510374Phase 3Oct 1, 2024Ferring
NCT06545955Phase 2Oct 1, 2024Ferring
NCT06390111Phase 4Jun 17, 2024Ferring
NCT05704244Phase 3Dec 21, 2022Ferring
Showing 6 of 6 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
FerringFor profit5532022
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital1112025
2 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
FerringFor profitNDA2Dec 16, 2022
FerringFor profitNDADec 16, 2022