← Pipeline|Mirifotisoran

Mirifotisoran

Approved
451-1125
Source: Trial-derived·Trials: 4
Modality
Radioligand
MOA
EGFRi
Target
BET
Pathway
Ferroptosis
PSPCML
Development Pipeline
Preclinical
~Dec 2009
~Mar 2011
Phase 1
~Jun 2011
~Sep 2012
Phase 2
~Dec 2012
~Mar 2014
Phase 3
~Jun 2014
~Sep 2015
NDA/BLA
~Dec 2015
~Mar 2017
Approved
Jun 2017
Aug 2028
ApprovedCurrent
NCT03518582
2,679 pts·CML
2024-042028-08·Not yet recruiting
NCT08319372
1,815 pts·PSP
2025-122028-05·Terminated
NCT08327401
2,466 pts·CML
2017-06TBD·Recruiting
+1 more trial
8,122 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2026-08-094mo awayPh3 Readout· CML
2028-05-172.1y awayPh3 Readout· PSP
2028-08-242.4y awayPh3 Readout· CML
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
Approved
Recruit…
Approved
Complet…
Approved
Not yet…
Approved
Termina…
Catalysts
Ph3 Readout
2026-08-09 · 4mo away
CML
Ph3 Readout
2028-05-17 · 2.1y away
PSP
Ph3 Readout
2028-08-24 · 2.4y away
CML
RecruitingCompletedTerminatedNot yet recruiting|StartCompletionToday
Trials (4)
NCTPhaseIndicationStatusNEP
NCT03518582ApprovedCMLNot yet recr...26796MWD
NCT08319372ApprovedPSPTerminated1815EASI-75
NCT08327401ApprovedCMLRecruiting2466EASI-75
NCT08287403ApprovedCMLCompleted1162FEV1
Competitors (10)
DrugCompanyPhaseTargetMOA
PFE-5767PfizerPhase 1/2BETCDK4/6i
NiranesiranJohnson & JohnsonPhase 2KIF18AEGFRi
JNJ-5094Johnson & JohnsonPhase 2/3GIP-REGFRi
RHH-1969RocheApprovedBETCDK4/6i
NVS-5439NovartisPreclinicalBETAnti-Tau
IvocapivasertibBristol-Myers SquibbPhase 1BETCDK4/6i
GSK-2051GSKPhase 1PSMAEGFRi
GIL-8529Gilead SciencesPhase 1/2JAK1EGFRi
AdagracapivasertibBeiGeneNDA/BLABETCDK4/6i
207-5197Samsung BiologicsApprovedBETPD-L1i