Modality
Radioligand
MOA
CAR-T CD19
Target
CFTR
Pathway
Apoptosis
SLE
Development Pipeline
Preclinical
~Jul 2011
→ ~Oct 2012
Phase 1
~Jan 2013
→ ~Apr 2014
Phase 2
~Jul 2014
→ ~Oct 2015
Phase 3
~Jan 2016
→ ~Apr 2017
NDA/BLA
~Jul 2017
→ ~Oct 2018
Approved
Jan 2019
→ Feb 2031
ApprovedCurrent
NCT04223419
2,549 pts·SLE
2022-10→2030-01·Active
NCT08352219
1,099 pts·SLE
2019-01→2028-02·Terminated
NCT05907357
1,318 pts·SLE
2025-01→2031-02·Recruiting
4,966 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2028-02-201.9y awayPh3 Readout· SLE
2030-01-263.8y awayPh3 Readout· SLE
2031-02-114.9y awayPh3 Readout· SLE
Trial Timeline
2019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
Approved
Termina…
Approved
Active
Approved
Recruit…
Catalysts
Ph3 Readout
2028-02-20 · 1.9y away
SLE
Ph3 Readout
2030-01-26 · 3.8y away
SLE
Ph3 Readout
2031-02-11 · 4.9y away
SLE
RecruitingActiveTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04223419 | Approved | SLE | Active | 2549 | HbA1c |
| NCT08352219 | Approved | SLE | Terminated | 1099 | LiverFat |
| NCT05907357 | Approved | SLE | Recruiting | 1318 | Safety |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Nidasacituzumab | Eli Lilly | Approved | CFTR | |
| RHH-1546 | Roche | Phase 2/3 | C5 | |
| 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 | |
| Doxasotorasib | Samsung Biologics | Phase 2/3 | CFTR |