Modality
ERT
MOA
GLP-1/GIP
Target
Aβ
Pathway
NF-κB
CMLUC
Development Pipeline
Preclinical
~Oct 2012
→ ~Jan 2014
Phase 1
~Apr 2014
→ ~Jul 2015
Phase 2
~Oct 2015
→ ~Jan 2017
Phase 3
~Apr 2017
→ ~Jul 2018
NDA/BLA
~Oct 2018
→ ~Jan 2020
Approved
Apr 2020
→ Apr 2030
ApprovedCurrent
NCT04384552
882 pts·CML
2021-12→2030-04·Completed
NCT08726847
316 pts·UC
2025-10→TBD·Active
NCT06419051
210 pts·CML
2020-04→2030-04·Completed
1,408 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2030-04-024.0y awayPh3 Readout· CML
2030-04-244.1y awayPh3 Readout· CML
Trial Timeline
Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
Approved
Complet…
Approved
Complet…
Approved
Active
Catalysts
Ph3 Readout
2030-04-02 · 4.0y away
CML
Ph3 Readout
2030-04-24 · 4.1y away
CML
ActiveCompleted|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04384552 | Approved | CML | Completed | 882 | BodyWt |
| NCT08726847 | Approved | UC | Active | 316 | DAS28 |
| NCT06419051 | Approved | CML | Completed | 210 | BodyWt |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| Sotovorutinib | Pfizer | Approved | Aβ | |
| Zanuderotide | Johnson & Johnson | Phase 2/3 | TIGIT | |
| JNJ-8168 | Johnson & Johnson | Phase 2/3 | FLT3 | |
| AZN-5171 | AstraZeneca | Approved | GLP-1R | |
| Bemalucimab | Bristol-Myers Squibb | Phase 1/2 | Aβ | |
| Datobrutinib | Sanofi | Phase 3 | Aβ | |
| DSN-791 | Daiichi Sankyo | NDA/BLA | Aβ | |
| VRT-5853 | Vertex Pharma | Phase 3 | Aβ | |
| ARG-314 | Argenx | Approved | Aβ |