← Pipeline|FLA-5216

FLA-5216

Approved
Source: Trial-derived·Trials: 4
Modality
ASO
MOA
Menini
Target
CD47
Pathway
Notch
CMLMeso
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
Sep 2031
ApprovedCurrent
NCT03844168
759 pts·Meso
2017-062025-03·Active
NCT05259219
175 pts·CML
2019-122031-09·Completed
NCT07354042
1,565 pts·CML
2023-012026-04·Not yet recruiting
+1 more trial
4,168 total pts2 indications
CompletedCurrentUpcoming
Catalysts (3)
2025-03-151.0y agoPh3 Readout· Meso
2026-04-033d awayPh3 Readout· CML
2031-09-185.5y awayPh3 Readout· CML
Trial Timeline
Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Active
Approved
Not yet…
Approved
Complet…
Approved
Not yet…
Catalysts
Ph3 Readout
2025-03-15 · 1.0y ago
Meso
Ph3 Readout
2026-04-03 · 3d away
CML
Ph3 Readout
2031-09-18 · 5.5y away
CML
ActiveCompletedNot yet recruiting|StartCompletionToday
Trials (4)
NCTPhaseIndicationStatusNEP
NCT03844168ApprovedMesoActive759UPCR
NCT05259219ApprovedCMLCompleted175ORR
NCT07354042ApprovedCMLNot yet recr...1565CR
NCT06524237ApprovedMesoNot yet recr...1669ACR20
Competitors (10)
DrugCompanyPhaseTargetMOA
MavutenlimabJohnson & JohnsonPhase 3Cl18.2Menini
IvorelsinEli LillyApprovedJAK1Menini
LLY-8903Eli LillyPreclinicalCD47HER2
NVO-2974Novo NordiskNDA/BLAPARPMenini
GSK-4334GSKPreclinicalCD47WRNi
MotainavolisibAmgenNDA/BLACD47PD-L1i
BMR-1165BioMarinPhase 2CD47TYK2i
INC-2432IncytePhase 2CD47CGRPant
CevifotisoranNeurocrineApprovedCD47PARPi
PemiinavolisibSareptaNDA/BLACD47GLP-1/GIP