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← Pipeline|MLY-3531

MLY-3531

NDA/BLA
By Mineralys
Source: Trial-derived·Trials: 2
Modality
ERT
MOA
CD47i
Target
JAK1
Pathway
RAS/MAPK
SMA
Development Pipeline
Preclinical
~Aug 2014
→ ~Nov 2015
Phase 1
~Feb 2016
→ ~May 2017
Phase 2
~Aug 2017
→ ~Nov 2018
Phase 3
~Feb 2019
→ ~May 2020
NDA/BLA
Aug 2020
→ Dec 2025
NDA/BLACurrent
NCT08130992
1,975 pts·SMA
2025-12→TBD·Terminated
NCT08021407
667 pts·SMA
2020-08→TBD·Active
2,642 total pts1 indication
Approved
CompletedCurrentUpcoming
Trial Timeline
Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q4
NDA/BLA
Active
NDA/BLA
Termina…
ActiveTerminated|StartCompletionToday
Trials (2)
NCTPhaseIndicationStatusNEP
NCT08130992NDA/BLASMATerminated1975LiverFat
NCT08021407NDA/BLASMAActive667UPDRS
Competitors (10)
DrugCompanyPhaseTargetMOA
NirarelsinJohnson & JohnsonPhase 2PRMT5CD47i
CevizanubrutinibJohnson & JohnsonPreclinicalFcRnCD47i
IvorelsinEli LillyApprovedJAK1Menini
RHH-974RochePreclinicalJAK1MALT1i
CeviglumideRocheNDA/BLAB7-H3CD47i
NVS-1475NovartisPhase 2MeninCD47i
AZN-6294AstraZenecaPhase 2/3APOC3CD47i
FixatenlimabGSKPhase 1/2JAK1CDK4/6i
ZenonesiranGSKPreclinicalDLL3CD47i
AMG-7379AmgenPreclinicalDLL3CD47i