Modality
ERT
MOA
BCL-2i
Target
CD19
Pathway
T-cell
HNSCCBreast CaMCC
Development Pipeline
Preclinical
~Apr 2014
→ ~Jul 2015
Phase 1
~Oct 2015
→ ~Jan 2017
Phase 2
Apr 2017
→ Sep 2031
Phase 2Current
NCT08810682
2,570 pts·MCC
2017-04→2031-09·Completed
NCT03321882
851 pts·Breast Ca
2022-10→2028-10·Recruiting
3,421 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (3)
2026-11-218mo awayNDA· HNSCC
2028-10-212.6y awayPh2 Data· Breast Ca
2031-09-225.5y awayPh2 Data· MCC
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P2
Complet…
P2
Recruit…
Catalysts
NDA
2026-11-21 · 8mo away
HNSCC
Ph2 Data
2028-10-21 · 2.6y away
Breast Ca
Ph2 Data
2031-09-22 · 5.5y away
MCC
RecruitingCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08810682 | Phase 2 | MCC | Completed | 2570 | BodyWt |
| NCT03321882 | Phase 2 | Breast Ca | Recruiting | 851 | PFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5501 | Pfizer | Phase 1 | BTK | |
| PFE-8662 | Pfizer | NDA/BLA | CD19 | |
| RHH-3592 | Roche | Phase 1/2 | GIP-R | |
| NVS-6974 | Novartis | Preclinical | CD19 | |
| Geliderotide | Novartis | NDA/BLA | IL-17A | |
| Voxarasimod | Merck & Co | Phase 1/2 | CD19 | |
| Tezecilimab | Takeda | NDA/BLA | Tau | |
| Rimaosocimab | Amgen | Preclinical | FXIa | |
| Capifutibatinib | Incyte | Phase 3 | PCSK9 | |
| NBI-408 | Neurocrine | Phase 2/3 | KRASG12D |