← Pipeline|BIO-8650

BIO-8650

Phase 2
Source: Trial-derived·Trials: 1
Modality
Vaccine
MOA
PI3Ki
Target
CGRP
Pathway
Hedgehog
NASH
Development Pipeline
Preclinical
~Apr 2018
~Jul 2019
Phase 1
~Oct 2019
~Jan 2021
Phase 2
Apr 2021
Feb 2028
Phase 2Current
NCT06292983
579 pts·NASH
2021-042028-02·Not yet recruiting
579 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-02-111.9y awayPh2 Data· NASH
Trial Timeline
Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2
P2
Not yet…
Catalysts
Ph2 Data
2028-02-11 · 1.9y away
NASH
Not yet recruiting|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT06292983Phase 2NASHNot yet recr...579OS
Competitors (10)
DrugCompanyPhaseTargetMOA
TiramavacamtenRochePreclinicalSGLT2PI3Ki
NVS-5126NovartisPhase 3SHP2PI3Ki
VoxacilimabAstraZenecaPhase 1/2GLP-1RPI3Ki
CapifutibatinibSanofiApprovedPRMT5PI3Ki
RimatenlimabNovo NordiskPhase 2/3SGLT2PI3Ki
TAK-9344TakedaPhase 3CGRPHER2
REG-3155RegeneronPhase 1/2MDM2PI3Ki
ZenotinibBioNTechPhase 1CGRPAnti-Aβ
CapiglumideBioNTechPreclinicalCGRPMDM2i
BII-4342BiogenPhase 2/3CGRPCAR-T CD19