Modality
Small Molecule
MOA
FXIai
Target
Nectin-4
Pathway
RNA Splicing
IgANHCC
Development Pipeline
Preclinical
~Apr 2017
→ ~Jul 2018
Phase 1
~Oct 2018
→ ~Jan 2020
Phase 2
~Apr 2020
→ ~Jul 2021
Phase 3
~Oct 2021
→ ~Jan 2023
NDA/BLA
Apr 2023
→ Apr 2031
NDA/BLACurrent
NCT07307636
2,111 pts·IgAN
2025-10→2030-08·Recruiting
NCT06477691
725 pts·HCC
2023-04→2031-04·Active
2,836 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2030-08-184.4y awayPh3 Readout· IgAN
2031-04-105.0y awayPh3 Readout· HCC
Trial Timeline
Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
NDA/BLA
Active
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2030-08-18 · 4.4y away
IgAN
Ph3 Readout
2031-04-10 · 5.0y away
HCC
RecruitingActive|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07307636 | NDA/BLA | IgAN | Recruiting | 2111 | SeizFreq |
| NCT06477691 | NDA/BLA | HCC | Active | 725 | PANSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| NVS-6360 | Novartis | Approved | CD38 | |
| MRK-3745 | Merck & Co | Phase 2 | WRN | |
| MRK-2473 | Merck & Co | Phase 1/2 | Nectin-4 | |
| AZN-1715 | AstraZeneca | Phase 3 | AHR | |
| BMY-9931 | Bristol-Myers Squibb | Phase 1 | GPRC5D | |
| NVO-7877 | Novo Nordisk | Preclinical | GPRC5D | |
| TAK-8730 | Takeda | Phase 2 | VEGF | |
| DSN-1421 | Daiichi Sankyo | Phase 3 | Nectin-4 | |
| Semazasiran | BeiGene | Phase 1 | PD-1 | |
| ION-3857 | Ionis | Preclinical | Nectin-4 |