← Pipeline|Datorasimod

Datorasimod

NDA/BLA
ELI-8500
Source: Trial-derived·Trials: 1
Modality
Vaccine
MOA
ALKi
Target
FGFR
Pathway
Innate Imm
T2DPancreatic CaNB
Development Pipeline
Preclinical
~Jun 2018
~Sep 2019
Phase 1
~Dec 2019
~Mar 2021
Phase 2
~Jun 2021
~Sep 2022
Phase 3
~Dec 2022
~Mar 2024
NDA/BLA
Jun 2024
Oct 2026
NDA/BLACurrent
NCT04506094
348 pts·NB
2024-062026-10·Active
348 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2026-10-116mo awayPh3 Readout· NB
Trial Timeline
Q3Q42025Q2Q3Q42026Q2Q3Q4
NDA/BLA
Active
Catalysts
Ph3 Readout
2026-10-11 · 6mo away
NB
Active|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT04506094NDA/BLANBActive348VA
Competitors (10)
DrugCompanyPhaseTargetMOA
MiriosocimabPfizerPhase 1PARPALKi
LLY-1592Eli LillyNDA/BLAFGFRBETi
MRK-7739Merck & CoPreclinicalIL-23ALKi
DoxarasimodMerck & CoNDA/BLAFGFRKRASG12Di
AZN-7403AstraZenecaPhase 2/3FGFRTNFi
BMY-2495Bristol-Myers SquibbPhase 3KRASG12DALKi
DSN-5254Daiichi SankyoPhase 1B7-H3ALKi
SovacapivasertibAmgenPhase 3WEE1ALKi
ZanuratamabGilead SciencesPhase 1/2CDK2ALKi
GIL-2445Gilead SciencesPhase 2/3PSMAALKi