← Pipeline|Polainavolisib

Polainavolisib

Preclinical
ORY-8119
Source: Trial-derived·Trials: 1
Modality
ERT
MOA
WEE1i
Target
CFTR
Pathway
Angiogenesis
NMOSDCeliac
Development Pipeline
Preclinical
Dec 2025
Dec 2026
PreclinicalCurrent
NCT07516016
2,911 pts·NMOSD
2025-122026-12·Active
2,911 total pts1 indication
Phase 1
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2026-12-199mo awayInterim· NMOSD
Trial Timeline
2026Q2Q3Q4
Preclinical
Active
Catalysts
Interim
2026-12-19 · 9mo away
NMOSD
Active|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT07516016PreclinicalNMOSDActive2911DAS28
Competitors (10)
DrugCompanyPhaseTargetMOA
JNJ-8637Johnson & JohnsonNDA/BLACD20WEE1i
NidasacituzumabEli LillyApprovedCFTRTYK2i
MRK-853Merck & CoPhase 1PRMT5WEE1i
DatoglumideAbbVieApprovedCFTRCAR-T CD19
SNY-7254SanofiPhase 2CFTRHER2
SNY-5894SanofiApprovedCFTRSTINGag
DoxafotisoranDaiichi SankyoPhase 1Cl18.2WEE1i
GMA-1468GenmabNDA/BLAPI3KαWEE1i
SovarelsinBioMarinPhase 2CFTRJAK1/2i
FixatuximabLegend BiotechPreclinicalCFTRRAS(ON)i