Modality
Vaccine
MOA
KIF18Ai
Target
Tau
Pathway
Sphingolipid
AngelmanUrothelial CaCeliac
Development Pipeline
Preclinical
~Jan 2013
→ ~Apr 2014
Phase 1
~Jul 2014
→ ~Oct 2015
Phase 2
~Jan 2016
→ ~Apr 2017
Phase 3
Jul 2017
→ Jan 2031
Phase 3Current
NCT05789092
1,951 pts·Celiac
2022-03→2030-06·Completed
NCT03571329
1,614 pts·Urothelial Ca
2017-12→2031-01·Terminated
NCT08358107
2,917 pts·Celiac
2017-07→2029-10·Completed
+1 more trial
7,889 total pts3 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (4)
2026-06-193mo awayPh3 Readout· Angelman
2029-10-133.5y awayPh3 Readout· Celiac
2030-06-064.2y awayPh3 Readout· Celiac
2031-01-074.8y awayPh3 Readout· Urothelial Ca
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
P3
Complet…
P3
Termina…
P3
Complet…
P3
Complet…
Catalysts
Ph3 Readout
2026-06-19 · 3mo away
Angelman
Ph3 Readout
2029-10-13 · 3.5y away
Celiac
Ph3 Readout
2030-06-06 · 4.2y away
Celiac
Ph3 Readout
2031-01-07 · 4.8y away
Urothelial Ca
CompletedTerminated|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05789092 | Phase 3 | Celiac | Completed | 1951 | HAM-D |
| NCT03571329 | Phase 3 | Urothelial Ca | Terminated | 1614 | DAS28 |
| NCT08358107 | Phase 3 | Celiac | Completed | 2917 | BodyWt |
| NCT05316986 | Phase 3 | Angelman | Completed | 1407 | Mayo |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| Ribosacituzumab | Roche | Approved | Cl18.2 | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| NVO-9087 | Novo Nordisk | Phase 1/2 | Tau | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| Tezecilimab | Takeda | NDA/BLA | Tau | |
| TAK-8262 | Takeda | NDA/BLA | Tau | |
| Fixaglumide | Genmab | Phase 2/3 | WEE1 | |
| BMR-8526 | BioMarin | Phase 1/2 | CD38 |