Modality
mRNA
MOA
KIF18Ai
Target
Menin
Pathway
Fibrosis
Prostate CaSMA
Development Pipeline
Preclinical
~Sep 2016
→ ~Dec 2017
Phase 1
Mar 2018
→ Aug 2031
Phase 1Current
NCT06877157
2,525 pts·SMA
2018-03→2029-07·Not yet recruiting
NCT06289549
810 pts·SMA
2024-07→2031-08·Recruiting
3,335 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2029-07-223.3y awayPh2 Data· SMA
2031-08-225.4y awayPh2 Data· SMA
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P1/2
Not yet…
P1/2
Recruit…
Catalysts
Ph2 Data
2029-07-22 · 3.3y away
SMA
Ph2 Data
2031-08-22 · 5.4y away
SMA
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06877157 | Phase 1/2 | SMA | Not yet recr... | 2525 | EDSS |
| NCT06289549 | Phase 1/2 | SMA | Recruiting | 810 | PASI75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| LLY-8369 | Eli Lilly | Approved | Menin | |
| Ribosacituzumab | Roche | Approved | Cl18.2 | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| NVS-1475 | Novartis | Phase 2 | Menin | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| VRT-9481 | Vertex Pharma | Phase 1/2 | Menin | |
| Olpainavolisib | Moderna | Phase 1 | Menin | |
| Fixaglumide | Genmab | Phase 2/3 | WEE1 |