Modality
mRNA
MOA
IL-23i
Target
FLT3
Pathway
Amyloid
ACC
Development Pipeline
Preclinical
~Aug 2011
→ ~Nov 2012
Phase 1
~Feb 2013
→ ~May 2014
Phase 2
~Aug 2014
→ ~Nov 2015
Phase 3
~Feb 2016
→ ~May 2017
NDA/BLA
Aug 2017
→ Jan 2030
NDA/BLACurrent
NCT03780332
831 pts·ACC
2017-08→2030-01·Not yet recruiting
NCT06488273
1,228 pts·ACC
2022-09→2025-11·Completed
2,059 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-11-145mo agoPh3 Readout· ACC
2030-01-063.8y awayPh3 Readout· ACC
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
NDA/BLA
Not yet…
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2025-11-14 · 5mo ago
ACC
Ph3 Readout
2030-01-06 · 3.8y away
ACC
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03780332 | NDA/BLA | ACC | Not yet recr... | 831 | eGFR |
| NCT06488273 | NDA/BLA | ACC | Completed | 1228 | SeizFreq |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-8168 | Johnson & Johnson | Phase 2/3 | FLT3 | |
| GSK-6983 | GSK | Phase 2 | ALK | |
| Motarapivir | GSK | Preclinical | AuroraA | |
| Zenotapinarof | Vertex Pharma | Preclinical | CD38 | |
| Sotorapivir | Moderna | Approved | FLT3 | |
| Bemasotorasib | Exelixis | Phase 2 | CD38 | |
| Nidaratamab | Exelixis | Phase 3 | FLT3 | |
| Tirasotorasib | Viking Therapeutics | Phase 1 | CFTR | |
| Zanumavacamten | Iovance | Phase 2 | FLT3 | |
| RAR-440 | Ultragenyx | Phase 2 | FLT3 |