Modality
Gene Therapy
MOA
CDK4/6i
Target
FGFR
Pathway
Incretin
IgAN
Development Pipeline
Preclinical
~Jun 2017
→ ~Sep 2018
Phase 1
Dec 2018
→ Mar 2030
Phase 1Current
NCT03551154
342 pts·IgAN
2018-12→2028-01·Recruiting
NCT03559767
1,241 pts·IgAN
2019-10→2030-03·Active
1,583 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2028-01-081.8y awayInterim· IgAN
2030-03-264.0y awayInterim· IgAN
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
P1
Recruit…
P1
Active
Catalysts
Interim
2028-01-08 · 1.8y away
IgAN
Interim
2030-03-26 · 4.0y away
IgAN
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03551154 | Phase 1 | IgAN | Recruiting | 342 | ORR |
| NCT03559767 | Phase 1 | IgAN | Active | 1241 | ORR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5767 | Pfizer | Phase 1/2 | BET | |
| LLY-1592 | Eli Lilly | NDA/BLA | FGFR | |
| RHH-1969 | Roche | Approved | BET | |
| Doxarasimod | Merck & Co | NDA/BLA | FGFR | |
| AZN-7403 | AstraZeneca | Phase 2/3 | FGFR | |
| Ivocapivasertib | Bristol-Myers Squibb | Phase 1 | BET | |
| Zorimavacamten | Bristol-Myers Squibb | Preclinical | Cl18.2 | |
| Fixatenlimab | GSK | Phase 1/2 | JAK1 | |
| Cevitinib | Regeneron | Phase 3 | FGFR | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 |