Modality
ADC
MOA
SHP2i
Target
PCSK9
Pathway
DDR
MelanomaFSGSCF
Development Pipeline
Preclinical
~Oct 2018
→ ~Jan 2020
Phase 1
Apr 2020
→ Sep 2031
Phase 1Current
NCT06957021
2,085 pts·Melanoma
2020-04→2026-01·Active
NCT04364972
1,409 pts·FSGS
2022-02→2031-09·Completed
3,494 total pts2 indications
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-01-242mo agoPh2 Data· Melanoma
2031-09-285.5y awayPh2 Data· FSGS
Trial Timeline
Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P1/2
Active
P1/2
Complet…
Catalysts
Ph2 Data
2026-01-24 · 2mo ago
Melanoma
Ph2 Data
2031-09-28 · 5.5y away
FSGS
ActiveCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06957021 | Phase 1/2 | Melanoma | Active | 2085 | HbA1c |
| NCT04364972 | Phase 1/2 | FSGS | Completed | 1409 | SeizFreq |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-2191 | Pfizer | NDA/BLA | GLP-1R | |
| Zanusertib | AbbVie | Approved | PCSK9 | |
| Doxacagene | Sanofi | Approved | PSMA | |
| GIL-4361 | Gilead Sciences | Preclinical | PCSK9 | |
| REG-2172 | Regeneron | Phase 1/2 | PCSK9 | |
| VRT-1576 | Vertex Pharma | Phase 2/3 | RET | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| Daratuximab | BioMarin | Phase 1 | PRMT5 | |
| BMR-8377 | BioMarin | Phase 1/2 | PCSK9 | |
| Capifutibatinib | Incyte | Phase 3 | PCSK9 |