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← Pipeline|Mirirasimod

Mirirasimod

Approved
151-2613
By Livzon Pharma
Source: Trial-derived·Trials: 3
Modality
Bispecific Ab
MOA
SHP2i
Target
FLT3
Pathway
Hedgehog
CMLAML
Development Pipeline
Preclinical
~Jul 2017
→ ~Oct 2018
Phase 1
~Jan 2019
→ ~Apr 2020
Phase 2
~Jul 2020
→ ~Oct 2021
Phase 3
~Jan 2022
→ ~Apr 2023
NDA/BLA
~Jul 2023
→ ~Oct 2024
Approved
Jan 2025
→ Sep 2025
ApprovedCurrent
NCT08697000
1,452 pts·CML
2025-01→2025-09·Terminated
NCT06090907
2,219 pts·CML
2025-09→TBD·Active
NCT05069583
2,019 pts·CML
2025-12→TBD·Active
5,690 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2025-09-206mo agoPh3 Readout· CML
2025-11-234mo agoPh1 Dose Esc· CML
Trial Timeline
2025Q2Q3Q4
Approved
Termina…
Approved
Active
Approved
Active
Catalysts
Ph3 Readout
2025-09-20 · 6mo ago
CML
Ph1 Dose Esc
2025-11-23 · 4mo ago
CML
ActiveTerminated|StartCompletionToday
Trials (3)
NCTPhaseIndicationStatusNEP
NCT08697000ApprovedCMLTerminated1452OS
NCT06090907ApprovedCMLActive2219CR
NCT05069583ApprovedCMLActive2019EFS
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-2191PfizerNDA/BLAGLP-1RSHP2i
JNJ-8168Johnson & JohnsonPhase 2/3FLT3GLP-1/GIP
DoxacageneSanofiApprovedPSMASHP2i
VRT-1576Vertex PharmaPhase 2/3RETSHP2i
SotorapivirModernaApprovedFLT3TYK2i
SovafutibatinibModernaApprovedFcRnSHP2i
DaratuximabBioMarinPhase 1PRMT5SHP2i
NidaratamabExelixisPhase 3FLT3AHRant
NirafotisoranJazz PharmaPhase 2/3TROP-2SHP2i
369-4107Hansoh PharmaPhase 2TNFαSHP2i