Modality
mAb
MOA
Anti-Aβ
Target
KIF18A
Pathway
Apoptosis
EoE
Development Pipeline
Preclinical
~Oct 2010
→ ~Jan 2012
Phase 1
~Apr 2012
→ ~Jul 2013
Phase 2
~Oct 2013
→ ~Jan 2015
Phase 3
~Apr 2015
→ ~Jul 2016
NDA/BLA
~Oct 2016
→ ~Jan 2018
Approved
Apr 2018
→ Jan 2030
ApprovedCurrent
NCT08293070
144 pts·EoE
2020-01→2030-01·Not yet recruiting
NCT04411353
1,028 pts·EoE
2023-03→2028-02·Not yet recruiting
NCT03040036
787 pts·EoE
2018-04→2026-09·Completed
1,959 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2026-09-176mo awayPh3 Readout· EoE
2028-02-131.9y awayPh3 Readout· EoE
2030-01-223.8y awayPh3 Readout· EoE
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
Approved
Complet…
Approved
Not yet…
Approved
Not yet…
Catalysts
Ph3 Readout
2026-09-17 · 6mo away
EoE
Ph3 Readout
2028-02-13 · 1.9y away
EoE
Ph3 Readout
2030-01-22 · 3.8y away
EoE
CompletedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08293070 | Approved | EoE | Not yet recr... | 144 | VA |
| NCT04411353 | Approved | EoE | Not yet recr... | 1028 | SeizFreq |
| NCT03040036 | Approved | EoE | Completed | 787 | EDSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| LLY-8369 | Eli Lilly | Approved | Menin | |
| ABB-8696 | AbbVie | Phase 3 | BCMA | |
| BAY-6035 | Bayer | Phase 1 | C5 | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| Zenotinib | BioNTech | Phase 1 | CGRP | |
| NUV-2032 | Nuvalent | Preclinical | KIF18A | |
| DNL-9555 | Denali | Phase 1/2 | KIF18A | |
| RLA-6817 | Relay Therapeutics | Phase 3 | TIGIT | |
| PRA-419 | Praxis Precision | Approved | Cl18.2 |