← Pipeline|Lirainavolisib

Lirainavolisib

Approved
BIV-7820
Source: Trial-derived·Trials: 1
Modality
Degrader
MOA
CD3xCD20
Target
ALK
Pathway
DDR
CML
Development Pipeline
Preclinical
~Nov 2016
~Feb 2018
Phase 1
~May 2018
~Aug 2019
Phase 2
~Nov 2019
~Feb 2021
Phase 3
~May 2021
~Aug 2022
NDA/BLA
~Nov 2022
~Feb 2024
Approved
May 2024
Oct 2029
ApprovedCurrent
NCT07397318
2,547 pts·CML
2024-052029-10·Recruiting
2,547 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2029-10-263.6y awayPh3 Readout· CML
Trial Timeline
Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
Approved
Recruit…
Catalysts
Ph3 Readout
2029-10-26 · 3.6y away
CML
Recruiting|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT07397318ApprovedCMLRecruiting2547UPDRS
Competitors (10)
DrugCompanyPhaseTargetMOA
LLY-1184Eli LillyNDA/BLAC5CD3xCD20
ZanuderotideNovartisPhase 1/2VEGFCD3xCD20
MRK-8368Merck & CoPhase 3ALKPCSK9i
NVO-1361Novo NordiskPhase 3CD38CD3xCD20
ZorizanubrutinibNovo NordiskPhase 1BTKCD3xCD20
GSK-6983GSKPhase 2ALKIL-23i
BAY-3308BayerPhase 1ALKSGLT2i
PexamavacamtenDaiichi SankyoNDA/BLATIGITCD3xCD20
TixarelsinVertex PharmaPhase 1ALKRAS(ON)i
VRT-6833Vertex PharmaPreclinicalALKVEGFi