← Pipeline|FLA-9061

FLA-9061

NDA/BLA
Source: Trial-derived·Trials: 2
Modality
Multispecific
MOA
Cl18.2
Target
JAK2
Pathway
mTOR
SCDEwing Sarcoma
Development Pipeline
Preclinical
~Aug 2012
~Nov 2013
Phase 1
~Feb 2014
~May 2015
Phase 2
~Aug 2015
~Nov 2016
Phase 3
~Feb 2017
~May 2018
NDA/BLA
Aug 2018
Apr 2029
NDA/BLACurrent
NCT04526575
1,411 pts·SCD
2018-082029-04·Recruiting
NCT06427650
2,996 pts·SCD
2025-022026-03·Active
4,407 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-03-231w agoPh3 Readout· SCD
2029-04-233.1y awayPh3 Readout· SCD
Trial Timeline
Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3
NDA/BLA
Recruit…
NDA/BLA
Active
Catalysts
Ph3 Readout
2026-03-23 · 1w ago
SCD
Ph3 Readout
2029-04-23 · 3.1y away
SCD
RecruitingActive|StartCompletionToday
Trials (2)
NCTPhaseIndicationStatusNEP
NCT04526575NDA/BLASCDRecruiting1411PASI75
NCT06427650NDA/BLASCDActive2996HAM-D
Competitors (10)
DrugCompanyPhaseTargetMOA
ZorivorutinibBristol-Myers SquibbApprovedDLL3Cl18.2
ElrarapivirRegeneronPhase 1GIP-RCl18.2
GMA-5010GenmabPhase 3JAK2TROP-2 ADC
HAL-9635HalozymePhase 2/3EZH2Cl18.2
TeravorutinibIlluminaPhase 2JAK2PRMT5i
VKT-6548Viking TherapeuticsPhase 2/3PD-L1Cl18.2
TiratapinarofIntelliaNDA/BLAAPOC3Cl18.2
AXS-4984AxsomePreclinicalJAK2BiTE
CapirapivirTG TherapeuticsApprovedJAK2AuroraAi
ZenorelsinDisc MedicineNDA/BLAJAK2CD47i