Inflammatory skin diseases are extremely common conditions and are the most frequently diagnosed dermatologic conditions that present to physician offices in the US each year. Topical corticosteroids are currently standard of care as first line therapy for most of these conditions. However, chronic use of topical corticosteroids is not recommended as they can result in irreversible skin thinning, striae (stretch marks), telangiectasia (spider veins), HPA axis suppression, and tachphylaxis. Topical calcineurin inhibitors (Elidel, Protopic) are effective for atopic dermatitis and eczema and avoid some of these pitfalls, but use has declined in recent years since the inclusion of a black box warning related to the potential risk of malignancy. The pipeline for topical immune modulating therapies is sparse and a significant need exists for new topical agents with novel activity that has the potential to avoid corticosteroid-related side effects and malignancy risks.

Topical calcineurin inhibitors (Protopic, Elidel) were launched in 2001 with sales peaking as a class at $528 million worldwide in 2004.

Sales of both products declined rapidly following the black box issued in early 2005, leaving a significant opportunity for new, safer therapies.