← Pipeline|ONC-9294

ONC-9294

Approved
Source: Trial-derived·Trials: 4
Modality
Gene Editing
MOA
Cl18.2
Target
TIM-3
Pathway
Angiogenesis
TTR AmyloidosisT2DHNSCC
Development Pipeline
Preclinical
~Jan 2010
~Apr 2011
Phase 1
~Jul 2011
~Oct 2012
Phase 2
~Jan 2013
~Apr 2014
Phase 3
~Jul 2014
~Oct 2015
NDA/BLA
~Jan 2016
~Apr 2017
Approved
Jul 2017
Jun 2030
ApprovedCurrent
NCT07988680
1,691 pts·TTR Amyloidosis
2025-072027-05·Not yet recruiting
NCT04912953
1,604 pts·T2D
2020-01TBD·Completed
NCT07885646
2,901 pts·T2D
2017-072029-09·Recruiting
+1 more trial
6,801 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2027-05-061.1y awayPh3 Readout· TTR Amyloidosis
2029-09-223.5y awayPh3 Readout· T2D
2030-06-034.2y awayPh3 Readout· T2D
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3
Approved
Recruit…
Approved
Complet…
Approved
Complet…
Approved
Not yet…
Catalysts
Ph3 Readout
2027-05-06 · 1.1y away
TTR Amyloidosis
Ph3 Readout
2029-09-22 · 3.5y away
T2D
Ph3 Readout
2030-06-03 · 4.2y away
T2D
RecruitingCompletedNot yet recruiting|StartCompletionToday
Trials (4)
NCTPhaseIndicationStatusNEP
NCT07988680ApprovedTTR AmyloidosisNot yet recr...1691SeizFreq
NCT04912953ApprovedT2DCompleted1604EASI-75
NCT07885646ApprovedT2DRecruiting2901CfB
NCT03185113ApprovedT2DCompleted605LiverFat
Competitors (10)
DrugCompanyPhaseTargetMOA
ZorivorutinibBristol-Myers SquibbApprovedDLL3Cl18.2
REG-6699RegeneronPhase 2/3TIM-3FcRni
ElrarapivirRegeneronPhase 1GIP-RCl18.2
NidasacituzumabUnited TherapeuticsPhase 1/2TIM-3ALKi
HAL-9635HalozymePhase 2/3EZH2Cl18.2
VKT-6548Viking TherapeuticsPhase 2/3PD-L1Cl18.2
LiratinibKrystal BiotechNDA/BLATIM-3EZH2i
TiratapinarofIntelliaNDA/BLAAPOC3Cl18.2
DoxazasiranAxsomePhase 1TIM-3IL-17i
RimanesiranMerusPhase 1TIM-3FXIai