← Pipeline|Mavuinavolisib

Mavuinavolisib

NDA/BLA
PCV-2619
Source: Trial-derived·Trials: 1
Modality
ASO
MOA
C5i
Target
SHP2
Pathway
PD-1/PD-L1
PompeCrohn'sCKD
Development Pipeline
Preclinical
~Sep 2018
~Dec 2019
Phase 1
~Mar 2020
~Jun 2021
Phase 2
~Sep 2021
~Dec 2022
Phase 3
~Mar 2023
~Jun 2024
NDA/BLA
Sep 2024
May 2027
NDA/BLACurrent
NCT05710052
1,820 pts·Pompe
2024-092027-05·Not yet recruiting
1,820 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2027-05-241.1y awayPh3 Readout· Pompe
Trial Timeline
Q42025Q2Q3Q42026Q2Q3Q42027Q2
NDA/BLA
Not yet…
Catalysts
Ph3 Readout
2027-05-24 · 1.1y away
Pompe
Not yet recruiting|StartCompletionToday
Trials (1)
NCTPhaseIndicationStatusNEP
NCT05710052NDA/BLAPompeNot yet recr...1820DOR
Competitors (10)
DrugCompanyPhaseTargetMOA
NVS-5126NovartisPhase 3SHP2PI3Ki
MRK-1380Merck & CoPreclinicalSHP2SOS1i
ABB-1817AbbViePhase 3SHP2WRNi
AZN-8281AstraZenecaPhase 1SHP2BTKi
AZN-8478AstraZenecaNDA/BLASHP2KRASG12Ci
DSN-2247Daiichi SankyoNDA/BLAEZH2C5i
MRN-7409ModernaNDA/BLASHP2CDK2i
180-3597Innovent BioPreclinicalSHP2RAS(ON)i
TezelucimabAscendis PharmaPreclinicalSHP2STINGag
RimabrutinibMadrigal PharmaPhase 1/2GPRC5DC5i