Modality
mAb
MOA
Anti-Tau
Target
KIF18A
Pathway
Autophagy
FSGSAngelmanIgAN
Development Pipeline
Preclinical
~Aug 2015
→ ~Nov 2016
Phase 1
~Feb 2017
→ ~May 2018
Phase 2
~Aug 2018
→ ~Nov 2019
Phase 3
Feb 2020
→ Apr 2027
Phase 3Current
NCT03957454
1,380 pts·IgAN
2023-09→2026-06·Completed
NCT03336725
2,564 pts·FSGS
2020-02→2027-04·Recruiting
NCT08515799
634 pts·IgAN
2020-02→2026-07·Active
+1 more trial
7,180 total pts3 indications
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2026-06-273mo awayPh3 Readout· IgAN
2026-07-133mo awayPh3 Readout· IgAN
2027-04-051.0y awayPh3 Readout· FSGS
Trial Timeline
2020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2
P3
Recruit…
P3
Active
P3
Complet…
P3
Complet…
Catalysts
Ph3 Readout
2026-06-27 · 3mo away
IgAN
Ph3 Readout
2026-07-13 · 3mo away
IgAN
Ph3 Readout
2027-04-05 · 1.0y away
FSGS
RecruitingActiveCompleted|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03957454 | Phase 3 | IgAN | Completed | 1380 | NT-proBNP |
| NCT03336725 | Phase 3 | FSGS | Recruiting | 2564 | CfB |
| NCT08515799 | Phase 3 | IgAN | Active | 634 | EDSS |
| NCT08254384 | Phase 3 | Angelman | Completed | 2602 | PFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| RHH-7558 | Roche | Phase 1 | SGLT2 | |
| NVS-5439 | Novartis | Preclinical | BET | |
| NVO-9630 | Novo Nordisk | Phase 2 | CD3 | |
| REG-2172 | Regeneron | Phase 1/2 | PCSK9 | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| BGN-3305 | BeiGene | Phase 2 | BCMA | |
| Sovarasimod | Halozyme | Phase 1/2 | WEE1 | |
| NUV-2032 | Nuvalent | Preclinical | KIF18A | |
| Voxamavacamten | Corcept | Approved | BET |