Modality
Multispecific
MOA
CGRPant
Target
IL-23
Pathway
Lipid Met
DLBCL
Development Pipeline
Preclinical
~Dec 2010
→ ~Mar 2012
Phase 1
~Jun 2012
→ ~Sep 2013
Phase 2
~Dec 2013
→ ~Mar 2015
Phase 3
~Jun 2015
→ ~Sep 2016
NDA/BLA
~Dec 2016
→ ~Mar 2018
Approved
Jun 2018
→ Nov 2028
ApprovedCurrent
NCT06491569
39 pts·DLBCL
2018-06→2028-11·Recruiting
NCT08362290
1,441 pts·DLBCL
2024-06→2027-03·Not yet recruiting
NCT04386940
1,505 pts·DLBCL
2018-12→2027-11·Completed
2,985 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2027-03-1812mo awayPh3 Readout· DLBCL
2027-11-111.6y awayPh3 Readout· DLBCL
2028-11-012.6y awayPh3 Readout· DLBCL
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
Approved
Recruit…
Approved
Complet…
Approved
Not yet…
Catalysts
Ph3 Readout
2027-03-18 · 12mo away
DLBCL
Ph3 Readout
2027-11-11 · 1.6y away
DLBCL
Ph3 Readout
2028-11-01 · 2.6y away
DLBCL
RecruitingCompletedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06491569 | Approved | DLBCL | Recruiting | 39 | ORR |
| NCT08362290 | Approved | DLBCL | Not yet recr... | 1441 | UPCR |
| NCT04386940 | Approved | DLBCL | Completed | 1505 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Terafutibatinib | Pfizer | Phase 1/2 | CD38 | |
| Sotovorutinib | Pfizer | Approved | Aβ | |
| MRK-7739 | Merck & Co | Preclinical | IL-23 | |
| ABB-3060 | AbbVie | Phase 2 | LAG-3 | |
| Terasacituzumab | Novo Nordisk | NDA/BLA | IL-23 | |
| DSN-6862 | Daiichi Sankyo | Preclinical | IL-23 | |
| GIL-6239 | Gilead Sciences | Phase 2 | TNFα | |
| INC-2432 | Incyte | Phase 2 | CD47 | |
| Sematapinarof | Legend Biotech | NDA/BLA | VEGF | |
| Fixalucimab | Innovent Bio | Phase 1/2 | IL-23 |