Modality
ADC
MOA
FGFRi
Target
IL-23
Pathway
DDR
PVPBCFTD
Development Pipeline
Preclinical
~Apr 2014
→ ~Jul 2015
Phase 1
~Oct 2015
→ ~Jan 2017
Phase 2
~Apr 2017
→ ~Jul 2018
Phase 3
~Oct 2018
→ ~Jan 2020
NDA/BLA
Apr 2020
→ Feb 2029
NDA/BLACurrent
NCT05408115
20 pts·PBC
2024-04→2029-02·Terminated
NCT03078799
1,929 pts·FTD
2020-04→2027-12·Recruiting
1,949 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-12-241.7y awayPh3 Readout· FTD
2029-02-122.9y awayPh3 Readout· PBC
Trial Timeline
Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
NDA/BLA
Recruit…
NDA/BLA
Termina…
Catalysts
Ph3 Readout
2027-12-24 · 1.7y away
FTD
Ph3 Readout
2029-02-12 · 2.9y away
PBC
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05408115 | NDA/BLA | PBC | Terminated | 20 | EDSS |
| NCT03078799 | NDA/BLA | FTD | Recruiting | 1929 | 6MWD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-9749 | Eli Lilly | Phase 3 | C5 | |
| LLY-1956 | Eli Lilly | Phase 1/2 | BCMA | |
| MRK-7739 | Merck & Co | Preclinical | IL-23 | |
| Terasacituzumab | Novo Nordisk | NDA/BLA | IL-23 | |
| DSN-6862 | Daiichi Sankyo | Preclinical | IL-23 | |
| Tezecilimab | Regeneron | Approved | IL-23 | |
| SRP-9822 | Sarepta | Phase 3 | SOS1 | |
| Fixalucimab | Innovent Bio | Phase 1/2 | IL-23 | |
| Gelisertib | Samsung Biologics | Approved | IL-23 | |
| Rimainavolisib | Illumina | Phase 2 | PD-1 |