Modality
Fusion Protein
MOA
PI3Ki
Target
SHP2
Pathway
Sphingolipid
CeliacRAAS
Development Pipeline
Preclinical
~Oct 2013
→ ~Jan 2015
Phase 1
~Apr 2015
→ ~Jul 2016
Phase 2
~Oct 2016
→ ~Jan 2018
Phase 3
Apr 2018
→ Oct 2029
Phase 3Current
NCT07984809
2,652 pts·Celiac
2018-04→2029-08·Recruiting
NCT04271069
2,370 pts·RA
2018-11→2029-10·Completed
5,022 total pts2 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2029-08-273.4y awayPh3 Readout· Celiac
2029-10-213.6y awayPh3 Readout· RA
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
P3
Recruit…
P3
Complet…
Catalysts
Ph3 Readout
2029-08-27 · 3.4y away
Celiac
Ph3 Readout
2029-10-21 · 3.6y away
RA
RecruitingCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07984809 | Phase 3 | Celiac | Recruiting | 2652 | FEV1 |
| NCT04271069 | Phase 3 | RA | Completed | 2370 | Mayo |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Tiramavacamten | Roche | Preclinical | SGLT2 | |
| MRK-1380 | Merck & Co | Preclinical | SHP2 | |
| ABB-1817 | AbbVie | Phase 3 | SHP2 | |
| Voxacilimab | AstraZeneca | Phase 1/2 | GLP-1R | |
| AZN-8281 | AstraZeneca | Phase 1 | SHP2 | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| Capifutibatinib | Sanofi | Approved | PRMT5 | |
| Rimatenlimab | Novo Nordisk | Phase 2/3 | SGLT2 | |
| REG-3155 | Regeneron | Phase 1/2 | MDM2 | |
| MRN-7409 | Moderna | NDA/BLA | SHP2 |