Modality
Fusion Protein
MOA
MDM2i
Target
FcRn
Pathway
Epigenetic
DMD
Development Pipeline
Preclinical
~Dec 2016
→ ~Mar 2018
Phase 1
~Jun 2018
→ ~Sep 2019
Phase 2
~Dec 2019
→ ~Mar 2021
Phase 3
Jun 2021
→ Aug 2031
Phase 3Current
NCT06149442
243 pts·DMD
2021-06→2031-08·Completed
243 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2031-08-025.3y awayPh3 Readout· DMD
Trial Timeline
Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P3
Complet…
Catalysts
Ph3 Readout
2031-08-02 · 5.3y away
DMD
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06149442 | Phase 3 | DMD | Completed | 243 | NT-proBNP |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| Doxacapivasertib | Eli Lilly | Phase 3 | APOC3 | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| BMY-8678 | Bristol-Myers Squibb | Approved | RET | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| GIL-2037 | Gilead Sciences | Approved | KRASG12D | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| Capiglumide | BioNTech | Preclinical | CGRP | |
| ITC-879 | Intra-Cellular | Approved | FcRn |