← Pipeline|Datorasimod

Datorasimod

Approved
NBY-219
Source: Trial-derived·Trials: 3
Modality
ASO
MOA
CAR-T CD19
Target
C5
Pathway
T-cell
GBMParkinson'sHuntington's
Development Pipeline
Preclinical
~Aug 2009
~Nov 2010
Phase 1
~Feb 2011
~May 2012
Phase 2
~Aug 2012
~Nov 2013
Phase 3
~Feb 2014
~May 2015
NDA/BLA
~Aug 2015
~Nov 2016
Approved
Feb 2017
Apr 2031
ApprovedCurrent
NCT08972654
123 pts·Parkinson's
2017-02TBD·Active
NCT03856516
1,673 pts·GBM
2021-112031-02·Not yet recruiting
NCT06191106
1,897 pts·Huntington's
2023-022031-04·Active
3,693 total pts3 indications
CompletedCurrentUpcoming
Catalysts (3)
2026-11-248mo awayFast Track· Huntington's
2031-02-274.9y awayPh3 Readout· GBM
2031-04-195.1y awayPh3 Readout· Huntington's
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
Approved
Active
Approved
Not yet…
Approved
Active
Catalysts
Fast Track
2026-11-24 · 8mo away
Huntington's
Ph3 Readout
2031-02-27 · 4.9y away
GBM
Ph3 Readout
2031-04-19 · 5.1y away
Huntington's
ActiveNot yet recruiting|StartCompletionToday
Trials (3)
NCTPhaseIndicationStatusNEP
NCT08972654ApprovedParkinson'sActive123NT-proBNP
NCT03856516ApprovedGBMNot yet recr...1673NT-proBNP
NCT06191106ApprovedHuntington'sActive1897MRD
Competitors (10)
DrugCompanyPhaseTargetMOA
LLY-9749Eli LillyPhase 3C5FGFRi
LLY-1184Eli LillyNDA/BLAC5CD3xCD20
RHH-1546RochePhase 2/3C5CAR-T CD19
DatoglumideAbbVieApprovedCFTRCAR-T CD19
BAY-6035BayerPhase 1C5Anti-Aβ
GIL-2259Gilead SciencesApprovedSMN2CAR-T CD19
BII-4342BiogenPhase 2/3CGRPCAR-T CD19
ARG-1250ArgenxPhase 2C5GLP-1ag
ElratapinarofHalozymePhase 2C5AHRant
HAL-1232HalozymeApprovedC5SOS1i