Modality
siRNA
MOA
PI3Ki
Target
CGRP
Pathway
Autophagy
CLL
Development Pipeline
Preclinical
~Oct 2014
→ ~Jan 2016
Phase 1
~Apr 2016
→ ~Jul 2017
Phase 2
~Oct 2017
→ ~Jan 2019
Phase 3
~Apr 2019
→ ~Jul 2020
NDA/BLA
Oct 2020
→ Jul 2029
NDA/BLACurrent
NCT07501366
2,881 pts·CLL
2020-10→2026-11·Terminated
NCT03309315
2,910 pts·CLL
2024-05→2029-07·Recruiting
5,791 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-11-037mo awayPh3 Readout· CLL
2029-07-013.3y awayPh3 Readout· CLL
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3
NDA/BLA
Termina…
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2026-11-03 · 7mo away
CLL
Ph3 Readout
2029-07-01 · 3.3y away
CLL
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07501366 | NDA/BLA | CLL | Terminated | 2881 | HbA1c |
| NCT03309315 | NDA/BLA | CLL | Recruiting | 2910 | EFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Tiramavacamten | Roche | Preclinical | SGLT2 | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| Voxacilimab | AstraZeneca | Phase 1/2 | GLP-1R | |
| Capifutibatinib | Sanofi | Approved | PRMT5 | |
| Rimatenlimab | Novo Nordisk | Phase 2/3 | SGLT2 | |
| TAK-9344 | Takeda | Phase 3 | CGRP | |
| REG-3155 | Regeneron | Phase 1/2 | MDM2 | |
| Zenotinib | BioNTech | Phase 1 | CGRP | |
| Capiglumide | BioNTech | Preclinical | CGRP | |
| BII-4342 | Biogen | Phase 2/3 | CGRP |