Modality
Vaccine
MOA
SHP2i
Target
FcRn
Pathway
Hedgehog
CTCLGAObesity
Development Pipeline
Preclinical
~Apr 2016
→ ~Jul 2017
Phase 1
~Oct 2017
→ ~Jan 2019
Phase 2
~Apr 2019
→ ~Jul 2020
Phase 3
~Oct 2020
→ ~Jan 2022
NDA/BLA
~Apr 2022
→ ~Jul 2023
Approved
Oct 2023
→ Jun 2030
ApprovedCurrent
NCT08277736
601 pts·Obesity
2024-10→TBD·Terminated
NCT08029422
2,065 pts·CTCL
2023-10→2030-06·Active
2,666 total pts2 indications
CompletedCurrentUpcoming
Catalysts (1)
2030-06-084.2y awayPh3 Readout· CTCL
Trial Timeline
Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
Approved
Active
Approved
Termina…
Catalysts
Ph3 Readout
2030-06-08 · 4.2y away
CTCL
ActiveTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08277736 | Approved | Obesity | Terminated | 601 | NT-proBNP |
| NCT08029422 | Approved | CTCL | Active | 2065 | ORR |
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 | |
| Daratuximab | BioMarin | Phase 1 | PRMT5 | |
| ITC-879 | Intra-Cellular | Approved | FcRn | |
| JAZ-8729 | Jazz Pharma | Phase 2/3 | FcRn | |
| Nirafotisoran | Jazz Pharma | Phase 2/3 | TROP-2 |