Modality
Peptide
MOA
CD3xCD20
Target
GLP-1R
Pathway
Sphingolipid
MGFSGS
Development Pipeline
Preclinical
~Jul 2018
→ ~Oct 2019
Phase 1
~Jan 2020
→ ~Apr 2021
Phase 2
~Jul 2021
→ ~Oct 2022
Phase 3
~Jan 2023
→ ~Apr 2024
NDA/BLA
Jul 2024
→ Aug 2031
NDA/BLACurrent
NCT05167192
2,554 pts·FSGS
2024-07→2031-08·Recruiting
2,554 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-08-044mo awayAdCom· MG
2031-08-225.4y awayPh3 Readout· FSGS
Trial Timeline
Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
NDA/BLA
Recruit…
Catalysts
AdCom
2026-08-04 · 4mo away
MG
Ph3 Readout
2031-08-22 · 5.4y away
FSGS
Recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05167192 | NDA/BLA | FSGS | Recruiting | 2554 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-2191 | Pfizer | NDA/BLA | GLP-1R | |
| Riboinavolisib | Johnson & Johnson | Phase 2/3 | GLP-1R | |
| Tirzepatide | Eli Lilly | Approved | GLP-1R | |
| LLY-1184 | Eli Lilly | NDA/BLA | C5 | |
| Zanuderotide | Novartis | Phase 1/2 | VEGF | |
| MRK-5413 | Merck & Co | Phase 1 | GLP-1R | |
| Voxacilimab | AstraZeneca | Phase 1/2 | GLP-1R | |
| AZN-5171 | AstraZeneca | Approved | GLP-1R | |
| NVO-1361 | Novo Nordisk | Phase 3 | CD38 | |
| Zorizanubrutinib | Novo Nordisk | Phase 1 | BTK |