Modality
Fusion Protein
MOA
CFTRmod
Target
FGFR
Pathway
DDR
IgAN
Development Pipeline
Preclinical
~Nov 2017
→ ~Feb 2019
Phase 1
~May 2019
→ ~Aug 2020
Phase 2
~Nov 2020
→ ~Feb 2022
Phase 3
~May 2022
→ ~Aug 2023
NDA/BLA
~Nov 2023
→ ~Feb 2025
Approved
May 2025
→ Apr 2028
ApprovedCurrent
NCT05270941
581 pts·IgAN
2025-05→2028-04·Active
581 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2025-10-165mo agoFast Track· IgAN
2028-04-042.0y awayPh3 Readout· IgAN
Trial Timeline
Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2
Approved
Active
Catalysts
Fast Track
2025-10-16 · 5mo ago
IgAN
Ph3 Readout
2028-04-04 · 2.0y away
IgAN
Active|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05270941 | Approved | IgAN | Active | 581 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| LLY-1592 | Eli Lilly | NDA/BLA | FGFR | |
| Doxarasimod | Merck & Co | NDA/BLA | FGFR | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| AZN-7403 | AstraZeneca | Phase 2/3 | FGFR | |
| Cevitinib | Regeneron | Phase 3 | FGFR | |
| Darafutibatinib | BioNTech | Preclinical | PRMT5 | |
| ALN-8757 | Alnylam | Preclinical | TIGIT | |
| Ivotuximab | Madrigal Pharma | Phase 2 | CD123 | |
| Tixatapinarof | Recursion | Approved | FGFR |