Modality
Cell Therapy
MOA
SHP2i
Target
FcRn
Pathway
Sphingolipid
MG
Development Pipeline
Preclinical
~Apr 2014
→ ~Jul 2015
Phase 1
~Oct 2015
→ ~Jan 2017
Phase 2
~Apr 2017
→ ~Jul 2018
Phase 3
Oct 2018
→ May 2030
Phase 3Current
NCT06896937
1,584 pts·MG
2018-10→TBD·Completed
NCT07163735
144 pts·MG
2020-08→2030-05·Not yet recruiting
NCT07498666
1,825 pts·MG
2024-01→TBD·Completed
3,553 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2030-05-154.1y awayPh3 Readout· MG
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
P3
Complet…
P3
Not yet…
P3
Complet…
Catalysts
Ph3 Readout
2030-05-15 · 4.1y away
MG
CompletedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06896937 | Phase 3 | MG | Completed | 1584 | SRI-4 |
| NCT07163735 | Phase 3 | MG | Not yet recr... | 144 | PANSS |
| NCT07498666 | Phase 3 | MG | Completed | 1825 | DAS28 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-2191 | Pfizer | NDA/BLA | GLP-1R | |
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| Doxacagene | Sanofi | Approved | PSMA | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| VRT-1576 | Vertex Pharma | Phase 2/3 | RET | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| Daratuximab | BioMarin | Phase 1 | PRMT5 | |
| ITC-879 | Intra-Cellular | Approved | FcRn | |
| JAZ-8729 | Jazz Pharma | Phase 2/3 | FcRn |