← Pipeline|Nidavorutinib

Nidavorutinib

NDA/BLA
ABE-4545
Source: Trial-derived·Trials: 1
Modality
Peptide
MOA
USP1i
Target
KRASG12C
Pathway
JAK/STAT
Parkinson'sOvarian CaFabry
Development Pipeline
Preclinical
~Feb 2016
~May 2017
Phase 1
~Aug 2017
~Nov 2018
Phase 2
~Feb 2019
~May 2020
Phase 3
~Aug 2020
~Nov 2021
NDA/BLA
Feb 2022
Jan 2029
NDA/BLACurrent
NCT03556415
567 pts·Ovarian Ca
2022-022029-01·Recruiting
567 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2029-01-032.8y awayPh3 Readout· Ovarian Ca
Trial Timeline
2022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2029-01-03 · 2.8y away
Ovarian Ca
Recruiting|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT03556415NDA/BLAOvarian CaRecruiting567eGFR
Competitors (10)
DrugCompanyPhaseTargetMOA
JNJ-179Johnson & JohnsonApprovedKRASG12CBETi
BMY-4586Bristol-Myers SquibbPreclinicalKRASG12CIL-13i
DoxarapivirBristol-Myers SquibbPhase 3KRASG12CSOS1i
SNY-2934SanofiPhase 3KRASG12DUSP1i
AMG-4531AmgenPhase 2/3KRASG12CPRMT5i
AMG-9052AmgenPhase 2/3CDK2USP1i
DatozumabRegeneronPhase 1B7-H3USP1i
REG-8074RegeneronPhase 2/3KRASG12CCAR-T BCMA
VRT-1891Vertex PharmaPhase 1KRASG12CPRMT5i
PemitapinarofBeiGeneApprovedKRASG12CWRNi