Modality
Bispecific Ab
MOA
KIF18Ai
Target
Cl18.2
Pathway
Autophagy
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
→ Sep 2028
ApprovedCurrent
NCT07290098
1,616 pts·DLBCL
2018-06→2028-09·Active
NCT03093965
2,190 pts·DLBCL
2020-02→2025-08·Recruiting
NCT07722438
2,981 pts·DLBCL
2019-09→2027-06·Recruiting
+1 more trial
9,099 total pts1 indication
CompletedCurrentUpcoming
Catalysts (3)
2025-08-118mo agoPh3 Readout· DLBCL
2027-06-151.2y awayPh3 Readout· DLBCL
2028-09-202.5y awayPh3 Readout· DLBCL
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
Approved
Active
Approved
Recruit…
Approved
Active
Approved
Recruit…
Catalysts
Ph3 Readout
2025-08-11 · 8mo ago
DLBCL
Ph3 Readout
2027-06-15 · 1.2y away
DLBCL
Ph3 Readout
2028-09-20 · 2.5y away
DLBCL
RecruitingActive|StartCompletionToday
Trials (4)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07290098 | Approved | DLBCL | Active | 1616 | CR |
| NCT03093965 | Approved | DLBCL | Recruiting | 2190 | EDSS |
| NCT07722438 | Approved | DLBCL | Recruiting | 2981 | NT-proBNP |
| NCT06475856 | Approved | DLBCL | Active | 2312 | VA |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| Mavutenlimab | Johnson & Johnson | Phase 3 | Cl18.2 | |
| JNJ-2735 | Johnson & Johnson | Phase 2/3 | Cl18.2 | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| Adagrazumab | Novartis | Phase 2/3 | Cl18.2 | |
| Zorimavacamten | Bristol-Myers Squibb | Preclinical | Cl18.2 | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| Doxafotisoran | Daiichi Sankyo | Phase 1 | Cl18.2 | |
| Fixaglumide | Genmab | Phase 2/3 | WEE1 |