Modality
Bispecific Ab
MOA
SOS1i
Target
B7-H3
Pathway
NF-κB
CKDFTDPsA
Development Pipeline
Preclinical
~Jun 2014
→ ~Sep 2015
Phase 1
~Dec 2015
→ ~Mar 2017
Phase 2
Jun 2017
→ Apr 2028
Phase 2Current
NCT03885352
2,197 pts·CKD
2017-06→TBD·Completed
NCT04249711
2,298 pts·FTD
2022-09→2028-04·Not yet recruiting
4,495 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-04-102.0y awayPh3 Readout· FTD
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2
P2/3
Complet…
P2/3
Not yet…
Catalysts
Ph3 Readout
2028-04-10 · 2.0y away
FTD
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03885352 | Phase 2/3 | CKD | Completed | 2197 | PASI75 |
| NCT04249711 | Phase 2/3 | FTD | Not yet recr... | 2298 | HbA1c |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-2901 | Pfizer | Phase 2 | AHR | |
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| Ceviglumide | Roche | NDA/BLA | B7-H3 | |
| MRK-1380 | Merck & Co | Preclinical | SHP2 | |
| Terarelsin | AbbVie | Preclinical | SOS1 | |
| Doxarapivir | Bristol-Myers Squibb | Phase 3 | KRASG12C | |
| SNY-9600 | Sanofi | NDA/BLA | B7-H3 | |
| SNY-8628 | Sanofi | NDA/BLA | B7-H3 | |
| SNY-9073 | Sanofi | Phase 2 | B7-H3 | |
| NVO-7840 | Novo Nordisk | Phase 2/3 | B7-H3 |