Modality
Gene Therapy
MOA
IL-17i
Target
CD19
Pathway
NF-κB
RSVT2D
Development Pipeline
Preclinical
~Mar 2011
→ ~Jun 2012
Phase 1
~Sep 2012
→ ~Dec 2013
Phase 2
~Mar 2014
→ ~Jun 2015
Phase 3
~Sep 2015
→ ~Dec 2016
NDA/BLA
Mar 2017
→ Feb 2031
NDA/BLACurrent
NCT03154117
1,578 pts·T2D
2024-07→2031-02·Recruiting
NCT06650109
2,091 pts·T2D
2017-03→2028-02·Completed
3,669 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-02-221.9y awayPh3 Readout· T2D
2031-02-264.9y awayPh3 Readout· T2D
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
NDA/BLA
Complet…
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2028-02-22 · 1.9y away
T2D
Ph3 Readout
2031-02-26 · 4.9y away
T2D
RecruitingCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03154117 | NDA/BLA | T2D | Recruiting | 1578 | BodyWt |
| NCT06650109 | NDA/BLA | T2D | Completed | 2091 | eGFR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-8662 | Pfizer | NDA/BLA | CD19 | |
| NVS-6974 | Novartis | Preclinical | CD19 | |
| Voxarasimod | Merck & Co | Phase 1/2 | CD19 | |
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| Elrarapivir | Vertex Pharma | NDA/BLA | PRMT5 | |
| Rimaglumide | Biogen | Phase 1/2 | BCL-2 | |
| ARG-3458 | Argenx | Preclinical | RET | |
| Nidaratamab | Krystal Biotech | Preclinical | RET | |
| Doxazasiran | Axsome | Phase 1 | TIM-3 |