Modality
mAb
MOA
CAR-T CD19
Target
CFTR
Pathway
mTOR
DLBCLCML
Development Pipeline
Preclinical
~Jul 2009
→ ~Oct 2010
Phase 1
~Jan 2011
→ ~Apr 2012
Phase 2
~Jul 2012
→ ~Oct 2013
Phase 3
~Jan 2014
→ ~Apr 2015
NDA/BLA
~Jul 2015
→ ~Oct 2016
Approved
Jan 2017
→ Oct 2031
ApprovedCurrent
NCT07797858
452 pts·CML
2024-08→2031-10·Terminated
NCT08647571
2,317 pts·CML
2017-01→TBD·Recruiting
NCT03312508
812 pts·DLBCL
2024-08→2030-12·Terminated
3,581 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2030-12-124.7y awayPh3 Readout· DLBCL
2031-10-095.5y awayPh3 Readout· CML
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Recruit…
Approved
Termina…
Approved
Termina…
Catalysts
Ph3 Readout
2030-12-12 · 4.7y away
DLBCL
Ph3 Readout
2031-10-09 · 5.5y away
CML
RecruitingTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07797858 | Approved | CML | Terminated | 452 | BodyWt |
| NCT08647571 | Approved | CML | Recruiting | 2317 | MRD |
| NCT03312508 | Approved | DLBCL | Terminated | 812 | HAM-D |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Nidasacituzumab | Eli Lilly | Approved | CFTR | |
| RHH-1546 | Roche | Phase 2/3 | C5 | |
| Datoglumide | AbbVie | Approved | CFTR | |
| SNY-7254 | Sanofi | Phase 2 | CFTR | |
| SNY-5894 | Sanofi | Approved | CFTR | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 | |
| BII-4342 | Biogen | Phase 2/3 | CGRP | |
| Sovarelsin | BioMarin | Phase 2 | CFTR | |
| Fixatuximab | Legend Biotech | Preclinical | CFTR | |
| Talasotorasib | Exelixis | Preclinical | APOC3 |