← Pipeline|Nidacilimab

Nidacilimab

Approved
AUR-8315
Source: Trial-derived·Trials: 1
Modality
ASO
MOA
CDK2i
Target
JAK2
Pathway
Angiogenesis
PsoriasisADPKDGBM
Development Pipeline
Preclinical
~Feb 2013
~May 2014
Phase 1
~Aug 2014
~Nov 2015
Phase 2
~Feb 2016
~May 2017
Phase 3
~Aug 2017
~Nov 2018
NDA/BLA
~Feb 2019
~May 2020
Approved
Aug 2020
Mar 2030
ApprovedCurrent
NCT07782320
1,263 pts·Psoriasis
2020-082030-03·Completed
1,263 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2030-03-123.9y awayPh3 Readout· Psoriasis
Trial Timeline
Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
Approved
Complet…
Catalysts
Ph3 Readout
2030-03-12 · 3.9y away
Psoriasis
Completed|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT07782320ApprovedPsoriasisCompleted1263Biomarker
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-3703PfizerPhase 1/2CDK2CDK2i
TirafotisoranRochePhase 2CD38CDK2i
ABB-3951AbbViePhase 2/3TNFαCDK2i
AZN-6870AstraZenecaPhase 2/3EGFRCDK2i
TirasotorasibTakedaNDA/BLAIL-17ACDK2i
MavuglumideBayerApprovedGLP-1RCDK2i
DSN-3066Daiichi SankyoPhase 3IL-13CDK2i
GIL-9227Gilead SciencesPhase 2/3GPRC5DCDK2i
REG-2328RegeneronPhase 1BCMACDK2i
MRN-7409ModernaNDA/BLASHP2CDK2i