← Pipeline|Talavorutinib

Talavorutinib

NDA/BLA
ZLA-4375
Source: Trial-derived·Trials: 2
Modality
Radioligand
MOA
BCMA ADC
Target
Cl18.2
Pathway
Autophagy
FL
Development Pipeline
Preclinical
~May 2019
~Aug 2020
Phase 1
~Nov 2020
~Feb 2022
Phase 2
~May 2022
~Aug 2023
Phase 3
~Nov 2023
~Feb 2025
NDA/BLA
May 2025
Aug 2027
NDA/BLACurrent
NCT05804000
2,027 pts·FL
2025-122026-04·Recruiting
NCT08592486
556 pts·FL
2025-052027-08·Completed
2,583 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-04-243w awayPh3 Readout· FL
2027-08-161.4y awayPh3 Readout· FL
Trial Timeline
Q3Q42026Q2Q3Q42027Q2Q3
NDA/BLA
Complet…
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2026-04-24 · 3w away
FL
Ph3 Readout
2027-08-16 · 1.4y away
FL
RecruitingCompleted|StartCompletionToday
Trials (2)
NCTPhaseIndicationStatusNEP
NCT05804000NDA/BLAFLRecruiting20276MWD
NCT08592486NDA/BLAFLCompleted556Safety
Competitors (10)
DrugCompanyPhaseTargetMOA
MavutenlimabJohnson & JohnsonPhase 3Cl18.2Menini
JNJ-2735Johnson & JohnsonPhase 2/3Cl18.2MALT1i
RibosacituzumabRocheApprovedCl18.2KIF18Ai
AdagrazumabNovartisPhase 2/3Cl18.2EZH2i
AZN-3724AstraZenecaPreclinicalPSMABCMA ADC
ZorimavacamtenBristol-Myers SquibbPreclinicalCl18.2CDK4/6i
OlpatinibGSKPreclinicalPD-L1BCMA ADC
DoxafotisoranDaiichi SankyoPhase 1Cl18.2WEE1i
GIL-9779Gilead SciencesPhase 1IL-17ABCMA ADC
SematenlimabSamsung BiologicsPhase 3PI3KαBCMA ADC