Modality
Vaccine
MOA
PI3Ki
Target
KRASG12D
Pathway
Innate Imm
FTDTTR AmyloidosisALS
Development Pipeline
Preclinical
~Sep 2011
→ ~Dec 2012
Phase 1
~Mar 2013
→ ~Jun 2014
Phase 2
~Sep 2014
→ ~Dec 2015
Phase 3
~Mar 2016
→ ~Jun 2017
NDA/BLA
Sep 2017
→ Sep 2031
NDA/BLACurrent
NCT07822303
2,042 pts·FTD
2017-09→2031-09·Not yet recruiting
NCT04170207
2,238 pts·ALS
2023-07→2028-08·Recruiting
4,280 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (3)
2026-08-094mo awayOrphan Drug· TTR Amyloidosis
2028-08-202.4y awayPh3 Readout· ALS
2031-09-015.4y awayPh3 Readout· FTD
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Not yet…
NDA/BLA
Recruit…
Catalysts
Orphan Drug
2026-08-09 · 4mo away
TTR Amyloidosis
Ph3 Readout
2028-08-20 · 2.4y away
ALS
Ph3 Readout
2031-09-01 · 5.4y away
FTD
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07822303 | NDA/BLA | FTD | Not yet recr... | 2042 | SeizFreq |
| NCT04170207 | NDA/BLA | ALS | Recruiting | 2238 | eGFR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Tiramavacamten | Roche | Preclinical | SGLT2 | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| Rilulemzoparlimab | Novartis | Phase 2/3 | KRASG12D | |
| Voxacilimab | AstraZeneca | Phase 1/2 | GLP-1R | |
| BMY-2495 | Bristol-Myers Squibb | Phase 3 | KRASG12D | |
| SNY-2934 | Sanofi | Phase 3 | KRASG12D | |
| Capifutibatinib | Sanofi | Approved | PRMT5 | |
| Talainavolisib | Novo Nordisk | Preclinical | KRASG12D | |
| Rimatenlimab | Novo Nordisk | Phase 2/3 | SGLT2 | |
| GIL-2037 | Gilead Sciences | Approved | KRASG12D |