Drug intelligence / Profile preview

FX005

Development stage
Phase 2
Lead developer
Pacira BioSciences
Modality
Small Molecules
Administration
Intraarticular
01

Overview

FX005 (also written as FX-005) is a small molecule drug that acts as an inhibitor of p38α mitogen-activated protein kinase (MAPK). It was initially developed by Flexion Therapeutics for the treatment of pain, particularly in the context of osteoarthritis and knee pain. The drug is formulated as sustained-release intra-articular microspheres designed to provide prolonged local inhibition of p38 MAPK, a clinically validated target involved in pain and inflammation pathways. As of March 2025, its highest global development status is Phase 2 clinical trials for pain indications[1][4]. Development for osteoarthritis/knee has been listed as inactive[1]. Flexion Therapeutics was acquired by Pacira BioSciences; however, Flexion remains listed as the active organization in some sources[1][2].

Other names
p38 MAP kinase inhibitor microspheresp-38 MAP kinase inhibitor microspheresp 38 MAP kinase inhibitor microspheres
02

Targets

MAPK14 (p38 mitogen-activated protein kinase alpha)

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