Modality
Fusion Protein
MOA
MALT1i
Target
USP1
Pathway
Fibrosis
HS
Development Pipeline
Preclinical
~Apr 2011
→ ~Jul 2012
Phase 1
~Oct 2012
→ ~Jan 2014
Phase 2
~Apr 2014
→ ~Jul 2015
Phase 3
~Oct 2015
→ ~Jan 2017
NDA/BLA
~Apr 2017
→ ~Jul 2018
Approved
Oct 2018
→ Mar 2031
ApprovedCurrent
NCT08854505
638 pts·HS
2018-10→2026-12·Active
NCT06224165
25 pts·HS
2023-12→2026-10·Recruiting
NCT08722902
514 pts·HS
2020-11→2031-03·Terminated
1,177 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2026-10-056mo awayPh3 Readout· HS
2026-12-179mo awayPh3 Readout· HS
2031-03-104.9y awayPh3 Readout· HS
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2
Approved
Active
Approved
Termina…
Approved
Recruit…
Catalysts
Ph3 Readout
2026-10-05 · 6mo away
HS
Ph3 Readout
2026-12-17 · 9mo away
HS
Ph3 Readout
2031-03-10 · 4.9y away
HS
RecruitingActiveTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08854505 | Approved | HS | Active | 638 | NT-proBNP |
| NCT06224165 | Approved | HS | Recruiting | 25 | Biomarker |
| NCT08722902 | Approved | HS | Terminated | 514 | Mayo |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| JNJ-2735 | Johnson & Johnson | Phase 2/3 | Cl18.2 | |
| Riboinavolisib | Johnson & Johnson | Phase 2/3 | GLP-1R | |
| RHH-974 | Roche | Preclinical | JAK1 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| ABB-2476 | AbbVie | Phase 1/2 | USP1 | |
| ABB-8985 | AbbVie | Phase 2 | CD20 | |
| Sovarelsin | Alnylam | Phase 2/3 | LAG-3 | |
| ITC-6153 | Intra-Cellular | Phase 3 | KRASG12C | |
| Gelisertib | Samsung Biologics | Approved | IL-23 | |
| RVM-7089 | Revolution Medicines | Phase 3 | IL-17A |