Modality
Gene Therapy
MOA
USP1i
Target
IL-23
Pathway
T-cell
CLLADHD
Development Pipeline
Preclinical
~Apr 2012
→ ~Jul 2013
Phase 1
~Oct 2013
→ ~Jan 2015
Phase 2
~Apr 2015
→ ~Jul 2016
Phase 3
~Oct 2016
→ ~Jan 2018
NDA/BLA
~Apr 2018
→ ~Jul 2019
Approved
Oct 2019
→ Nov 2027
ApprovedCurrent
NCT08203569
2,430 pts·CLL
2025-04→TBD·Not yet recruiting
NCT08599534
2,384 pts·CLL
2024-09→2027-11·Active
NCT04036943
617 pts·ADHD
2019-10→TBD·Terminated
5,431 total pts2 indications
CompletedCurrentUpcoming
Catalysts (1)
2027-11-031.6y awayPh3 Readout· CLL
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q4
Approved
Termina…
Approved
Active
Approved
Not yet…
Catalysts
Ph3 Readout
2027-11-03 · 1.6y away
CLL
ActiveTerminatedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08203569 | Approved | CLL | Not yet recr... | 2430 | CfB |
| NCT08599534 | Approved | CLL | Active | 2384 | UPCR |
| NCT04036943 | Approved | ADHD | Terminated | 617 | EDSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| MRK-7739 | Merck & Co | Preclinical | IL-23 | |
| SNY-2934 | Sanofi | Phase 3 | KRASG12D | |
| Terasacituzumab | Novo Nordisk | NDA/BLA | IL-23 | |
| DSN-6862 | Daiichi Sankyo | Preclinical | IL-23 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| Datozumab | Regeneron | Phase 1 | B7-H3 | |
| Tezecilimab | Regeneron | Approved | IL-23 | |
| GMA-729 | Genmab | Phase 2 | BCL-2 | |
| Fixalucimab | Innovent Bio | Phase 1/2 | IL-23 | |
| Pexanaritide | Innovent Bio | Preclinical | SGLT2 |