← Pipeline|Pemiinavolisib

Pemiinavolisib

NDA/BLA
SRP-4631
Source: Trial-derived·Trials: 1
Modality
siRNA
MOA
GLP-1/GIP
Target
CD47
Pathway
Tau
CTCLPBCFSGS
Development Pipeline
Preclinical
~Jul 2011
~Oct 2012
Phase 1
~Jan 2013
~Apr 2014
Phase 2
~Jul 2014
~Oct 2015
Phase 3
~Jan 2016
~Apr 2017
NDA/BLA
Jul 2017
Nov 2025
NDA/BLACurrent
NCT06675074
1,453 pts·PBC
2017-072025-11·Completed
1,453 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2025-11-075mo agoPh3 Readout· PBC
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q4
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2025-11-07 · 5mo ago
PBC
Completed|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT06675074NDA/BLAPBCCompleted1453UPDRS
Competitors (10)
DrugCompanyPhaseTargetMOA
ZanuderotideJohnson & JohnsonPhase 2/3TIGITGLP-1/GIP
JNJ-8168Johnson & JohnsonPhase 2/3FLT3GLP-1/GIP
LLY-8903Eli LillyPreclinicalCD47HER2
AZN-5171AstraZenecaApprovedGLP-1RGLP-1/GIP
GSK-4334GSKPreclinicalCD47WRNi
MotainavolisibAmgenNDA/BLACD47PD-L1i
BMR-1165BioMarinPhase 2CD47TYK2i
INC-2432IncytePhase 2CD47CGRPant
CevifotisoranNeurocrineApprovedCD47PARPi
BEA-4274BeamPhase 1/2ALKGLP-1/GIP