← Pipeline|Gelibrutinib

Gelibrutinib

NDA/BLA
SUN-2382
Source: Trial-derived·Trials: 1
Modality
Cell Therapy
MOA
WEE1i
Target
EZH2
Pathway
Wnt
ETMDDRB
Development Pipeline
Preclinical
~Aug 2017
~Nov 2018
Phase 1
~Feb 2019
~May 2020
Phase 2
~Aug 2020
~Nov 2021
Phase 3
~Feb 2022
~May 2023
NDA/BLA
Aug 2023
NDA/BLACurrent
NCT08596977
2,498 pts·ET
2023-08TBD·Not yet recruiting
2,498 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2026-10-026mo awayEnrollment Complete· RB
Trial Timeline
Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
NDA/BLA
Not yet…
Catalysts
Enrollment Complete
2026-10-02 · 6mo away
RB
Not yet recruiting|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT08596977NDA/BLAETNot yet recr...2498VA
Competitors (10)
DrugCompanyPhaseTargetMOA
JNJ-8637Johnson & JohnsonNDA/BLACD20WEE1i
MRK-853Merck & CoPhase 1PRMT5WEE1i
DoxafotisoranDaiichi SankyoPhase 1Cl18.2WEE1i
DSN-2247Daiichi SankyoNDA/BLAEZH2C5i
GMA-1468GenmabNDA/BLAPI3KαWEE1i
HAL-9635HalozymePhase 2/3EZH2Cl18.2
TalatuximabSamsung BiologicsPreclinicalCD3WEE1i
MDG-611Madrigal PharmaApprovedCGRPWEE1i
CevicapivasertibCorceptPhase 2CFTRWEE1i
MotanaritideIntelliaApprovedPD-1WEE1i