Modality
Gene Therapy
MOA
CDK2i
Target
GPRC5D
Pathway
PI3K/AKT
Celiac
Development Pipeline
Preclinical
~May 2014
→ ~Aug 2015
Phase 1
~Nov 2015
→ ~Feb 2017
Phase 2
~May 2017
→ ~Aug 2018
Phase 3
~Nov 2018
→ ~Feb 2020
NDA/BLA
~May 2020
→ ~Aug 2021
Approved
Nov 2021
→ May 2028
ApprovedCurrent
NCT08064114
864 pts·Celiac
2021-11→2028-05·Completed
864 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2028-05-202.1y awayPh3 Readout· Celiac
Trial Timeline
Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
Approved
Complet…
Catalysts
Ph3 Readout
2028-05-20 · 2.1y away
Celiac
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08064114 | Approved | Celiac | Completed | 864 | PANSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| Ribotuximab | Merck & Co | Phase 2 | GPRC5D | |
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| AZN-6870 | AstraZeneca | Phase 2/3 | EGFR | |
| BMY-9931 | Bristol-Myers Squibb | Phase 1 | GPRC5D | |
| NVO-7877 | Novo Nordisk | Preclinical | GPRC5D | |
| Tirasotorasib | Takeda | NDA/BLA | IL-17A | |
| Mavuglumide | Bayer | Approved | GLP-1R |