Modality
Radioligand
MOA
PI3Ki
Target
B7-H3
Pathway
Autophagy
LGS
Development Pipeline
Preclinical
~Jan 2014
→ ~Apr 2015
Phase 1
~Jul 2015
→ ~Oct 2016
Phase 2
Jan 2017
→ May 2030
Phase 2Current
NCT04408639
1,282 pts·LGS
2017-01→2030-05·Completed
NCT06492531
61 pts·LGS
2022-05→2026-10·Recruiting
1,343 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-10-096mo awayPh2 Data· LGS
2030-05-124.1y awayPh2 Data· LGS
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
P2
Complet…
P2
Recruit…
Catalysts
Ph2 Data
2026-10-09 · 6mo away
LGS
Ph2 Data
2030-05-12 · 4.1y away
LGS
RecruitingCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04408639 | Phase 2 | LGS | Completed | 1282 | PANSS |
| NCT06492531 | Phase 2 | LGS | Recruiting | 61 | 6MWD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| Ceviglumide | Roche | NDA/BLA | B7-H3 | |
| Tiramavacamten | Roche | Preclinical | SGLT2 | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| Voxacilimab | AstraZeneca | Phase 1/2 | GLP-1R | |
| SNY-9600 | Sanofi | NDA/BLA | B7-H3 | |
| SNY-8628 | Sanofi | NDA/BLA | B7-H3 | |
| Capifutibatinib | Sanofi | Approved | PRMT5 | |
| SNY-9073 | Sanofi | Phase 2 | B7-H3 | |
| NVO-7840 | Novo Nordisk | Phase 2/3 | B7-H3 |