Modality
Peptide
MOA
CD3xCD20
Target
HER2
Pathway
Cell Cycle
CTCL
Development Pipeline
Preclinical
~Aug 2009
→ ~Nov 2010
Phase 1
~Feb 2011
→ ~May 2012
Phase 2
~Aug 2012
→ ~Nov 2013
Phase 3
~Feb 2014
→ ~May 2015
NDA/BLA
~Aug 2015
→ ~Nov 2016
Approved
Feb 2017
→ Jan 2029
ApprovedCurrent
NCT03044528
2,126 pts·CTCL
2017-02→TBD·Completed
NCT06115767
2,359 pts·CTCL
2017-03→2029-01·Recruiting
NCT06222360
1,947 pts·CTCL
2025-03→2026-05·Recruiting
6,432 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2026-05-021mo awayPh3 Readout· CTCL
2029-01-042.8y awayPh3 Readout· CTCL
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
Approved
Complet…
Approved
Recruit…
Approved
Recruit…
Catalysts
Ph3 Readout
2026-05-02 · 1mo away
CTCL
Ph3 Readout
2029-01-04 · 2.8y away
CTCL
RecruitingCompleted|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03044528 | Approved | CTCL | Completed | 2126 | SRI-4 |
| NCT06115767 | Approved | CTCL | Recruiting | 2359 | ACR20 |
| NCT06222360 | Approved | CTCL | Recruiting | 1947 | PANSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-1184 | Eli Lilly | NDA/BLA | C5 | |
| Zanuderotide | Novartis | Phase 1/2 | VEGF | |
| Gozesotorasib | Bristol-Myers Squibb | NDA/BLA | HER2 | |
| NVO-1361 | Novo Nordisk | Phase 3 | CD38 | |
| Zorizanubrutinib | Novo Nordisk | Phase 1 | BTK | |
| Pexamavacamten | Daiichi Sankyo | NDA/BLA | TIGIT | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 | |
| ITC-1028 | Intra-Cellular | Phase 2 | BCMA | |
| ROI-9675 | Roivant Sciences | NDA/BLA | HER2 | |
| Cevizasiran | Acadia Pharma | Phase 1/2 | GPRC5D |