Modality
Bispecific Ab
MOA
CFTRmod
Target
PI3Kα
Pathway
Proteasome
RettPompeHNSCC
Development Pipeline
Preclinical
Nov 2021
→ Feb 2029
PreclinicalCurrent
NCT08568930
1,130 pts·Pompe
2021-11→2029-02·Terminated
NCT06146149
2,218 pts·HNSCC
2025-07→2025-06·Active
3,348 total pts2 indications
Phase 1
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-06-1010mo agoInterim· HNSCC
2029-02-122.9y awayInterim· Pompe
Trial Timeline
Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
Preclinical
Termina…
Preclinical
Active
Catalysts
Interim
2025-06-10 · 10mo ago
HNSCC
Interim
2029-02-12 · 2.9y away
Pompe
ActiveTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08568930 | Preclinical | Pompe | Terminated | 1130 | UPCR |
| NCT06146149 | Preclinical | HNSCC | Active | 2218 | SeizFreq |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| LLY-4358 | Eli Lilly | Phase 3 | B7-H3 | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| Darafutibatinib | BioNTech | Preclinical | PRMT5 | |
| ALN-8757 | Alnylam | Preclinical | TIGIT | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| 369-789 | Hansoh Pharma | Phase 3 | PI3Kα | |
| Mavutuximab | Hansoh Pharma | Phase 2/3 | PI3Kα |