Modality
siRNA
MOA
PD-1i
Target
KIF18A
Pathway
Complement
MGWet AMD
Development Pipeline
Preclinical
~Dec 2012
→ ~Mar 2014
Phase 1
~Jun 2014
→ ~Sep 2015
Phase 2
~Dec 2015
→ ~Mar 2017
Phase 3
~Jun 2017
→ ~Sep 2018
NDA/BLA
~Dec 2018
→ ~Mar 2020
Approved
Jun 2020
→ Aug 2030
ApprovedCurrent
NCT06027091
813 pts·MG
2021-03→2030-08·Not yet recruiting
NCT04205444
2,970 pts·Wet AMD
2020-06→2028-01·Active
NCT05683239
159 pts·MG
2024-02→2028-01·Active
+1 more trial
6,546 total pts2 indications
CompletedCurrentUpcoming
Catalysts (4)
2028-01-111.8y awayPh3 Readout· MG
2028-01-231.8y awayPh3 Readout· Wet AMD
2029-03-173.0y awayPh3 Readout· Wet AMD
2030-08-054.3y awayPh3 Readout· MG
Trial Timeline
Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
Approved
Active
Approved
Not yet…
Approved
Not yet…
Approved
Active
Catalysts
Ph3 Readout
2028-01-11 · 1.8y away
MG
Ph3 Readout
2028-01-23 · 1.8y away
Wet AMD
Ph3 Readout
2029-03-17 · 3.0y away
Wet AMD
Ph3 Readout
2030-08-05 · 4.3y away
MG
ActiveNot yet recruiting|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06027091 | Approved | MG | Not yet recr... | 813 | SeizFreq |
| NCT04205444 | Approved | Wet AMD | Active | 2970 | Safety |
| NCT05683239 | Approved | MG | Active | 159 | HAM-D |
| NCT05835473 | Approved | Wet AMD | Not yet recr... | 2604 | EFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| GSK-7987 | GSK | Phase 3 | MDM2 | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| Nirabrutinib | BioNTech | Phase 2/3 | CDK2 | |
| Cevinaritide | Genmab | Phase 2/3 | DLL3 | |
| NUV-2032 | Nuvalent | Preclinical | KIF18A | |
| DNL-9555 | Denali | Phase 1/2 | KIF18A | |
| Lisoosocimab | Zealand Pharma | Approved | KIF18A | |
| Talatenlimab | Praxis Precision | Phase 1/2 | KIF18A | |
| ZYM-2450 | Zymeworks | Phase 2 | GLP-1R |