delandistrogene moxeparvovec
Trade name: ELEVIDYS
Gene therapyapprovedOrphan Drug FDA
Approved
Jun 22, 2023
Clinical trial activity
9 trials · 3 clinical orgs · 1 marketing orgs
Phase 1
4
Phase 2
6
Phase 3
3
Phase 4
0
Earliest trial started Jan 4, 2018 (NCT03375164)
Timeline
2010s
- Jan 1, 2018
Sarepta Therapeutics — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2018
Sarepta Therapeutics — Earliest Phase 2 Sponsor(trial)
- Jun 21, 2018
Orphan Drug Designation
2020s
- Jan 1, 2021
Sarepta Therapeutics — Earliest Phase 3 Sponsor(trial)
- Jun 22, 2023
Sarepta Therapeutics — Earliest FDA Approval
- Jun 22, 2023
Sarepta Therapeutics — NDA Secondary Org
- Jun 22, 2023
Sarepta Therapeutics — NDA Organization
Indications
Approved for
Studied for
Mechanism of action
- DystrophinEXOGENOUS GENE
Dystrophin exogenous gene
- Dystrophin pre-mRNASupplementation
Dystrophin pre-mRNA supplementation
Approval history
- approvedAcceleratedJun 22, 2023
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4650241 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06597656 | Phase 1 | Sep 18, 2024 | Sarepta Therapeutics |
| NCT06241950 | Phase 1 | Jan 29, 2024 | HansaBioMed, Sarepta Therapeutics |
| NCT06128564 | Phase 2 | Nov 29, 2023 | Roche, Sarepta Therapeutics |
| NCT05967351 | Phase 3 | Sep 27, 2023 | Roche, Sarepta Therapeutics |
| NCT05881408 | Phase 3 | May 31, 2023 | Roche, Sarepta Therapeutics |
| NCT05096221 | Phase 3 | Oct 27, 2021 | Roche, Sarepta Therapeutics |
| NCT04626674 | Phase 1 | Nov 23, 2020 | Roche, Sarepta Therapeutics |
| NCT03769116 | Phase 2 | Dec 22, 2018 | Sarepta Therapeutics |
| NCT03375164 | Phase 1/Phase 2 (Phase 2) | Jan 4, 2018 | Sarepta Therapeutics |
Showing 9 of 9 trials
Page 1 / 1
Organizations
Research & Development (3)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sarepta Therapeutics | For profit | 9 | 8 | 3 | 2018 |
| Roche | For profit | 5 | 1 | 3 | 2020 |
| HansaBioMed | For profit | 1 | 0 | 1 | 2024 |
3 organizations
Page 1 / 1
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Sarepta Therapeutics | For profit | NDA2 | Jun 22, 2023 |
| Sarepta Therapeutics | For profit | NDA | Jun 22, 2023 |