Modality
Gene Therapy
MOA
BTKi
Target
BCL-2
Pathway
Proteasome
CTCLACC
Development Pipeline
Preclinical
~Feb 2018
→ ~May 2019
Phase 1
~Aug 2019
→ ~Nov 2020
Phase 2
Feb 2021
→ Mar 2030
Phase 2Current
NCT03309524
1,491 pts·CTCL
2021-02→2030-03·Active
NCT08871581
1,318 pts·CTCL
2025-06→2025-12·Completed
2,809 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-12-084mo agoPh3 Readout· CTCL
2030-03-264.0y awayPh3 Readout· CTCL
Trial Timeline
2021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
P2/3
Active
P2/3
Complet…
Catalysts
Ph3 Readout
2025-12-08 · 4mo ago
CTCL
Ph3 Readout
2030-03-26 · 4.0y away
CTCL
ActiveCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03309524 | Phase 2/3 | CTCL | Active | 1491 | HAM-D |
| NCT08871581 | Phase 2/3 | CTCL | Completed | 1318 | EASI-75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| RHH-8550 | Roche | Approved | BCL-2 | |
| AZN-8281 | AstraZeneca | Phase 1 | SHP2 | |
| BMY-3371 | Bristol-Myers Squibb | Phase 3 | WRN | |
| NVO-7872 | Novo Nordisk | NDA/BLA | B7-H3 | |
| NVO-6275 | Novo Nordisk | Phase 1 | SMN2 | |
| Zanumavacamten | GSK | Phase 2/3 | TROP-2 | |
| TAK-2403 | Takeda | Phase 2 | WEE1 | |
| Lisorapivir | Takeda | Preclinical | WRN | |
| Ivosotorasib | Vertex Pharma | Preclinical | CD38 | |
| MRN-8133 | Moderna | Phase 2 | PD-1 |