0417 Ointment

0417 Ointment is a generic topical formulation of tacrolimus (0.03%) developed by Fougera Pharmaceuticals Inc. for the treatment of atopic dermatitis. Tacrolimus is a small molecule calcineurin inhibitor that exerts its immunosuppressive effect by binding to the intracellular protein FKBP-12. The resulting tacrolimus-FKBP-12 complex specifically and competitively binds to and inhibits calcineurin, a calcium-dependent phosphatase. This inhibition prevents the dephosphorylation of the nuclear factor of activated T-cells (NFAT), blocking its translocation into the nucleus and subsequent transcription of genes for inflammatory cytokines such as interleukin-2 (IL-2). The drug was evaluated in a Phase 3, randomized, double-blind, vehicle-controlled study (NCT01139450) to demonstrate therapeutic equivalence to the reference product, Protopic (Tacrolimus Ointment 0.03%).

Other names

Tacrolimus Ointment 0.03%