Modality
Multispecific
MOA
CFTRmod
Target
KIF18A
Pathway
STING
CFCeliac
Development Pipeline
Preclinical
~Nov 2017
→ ~Feb 2019
Phase 1
May 2019
→ Aug 2029
Phase 1Current
NCT07611342
2,801 pts·CF
2019-05→2029-08·Active
NCT03140504
1,779 pts·Celiac
2020-04→TBD·Active
4,580 total pts2 indications
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2029-08-283.4y awayInterim· CF
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
P1
Active
P1
Active
Catalysts
Interim
2029-08-28 · 3.4y away
CF
Active|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07611342 | Phase 1 | CF | Active | 2801 | OS |
| NCT03140504 | Phase 1 | Celiac | Active | 1779 | LiverFat |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| Darafutibatinib | BioNTech | Preclinical | PRMT5 | |
| ALN-8757 | Alnylam | Preclinical | TIGIT | |
| NUV-2032 | Nuvalent | Preclinical | KIF18A | |
| Ivotuximab | Madrigal Pharma | Phase 2 | CD123 | |
| DNL-9555 | Denali | Phase 1/2 | KIF18A | |
| Talazasiran | Kymera | NDA/BLA | MET |