Merck announces FDA breakthrough therapy designation for enpatoran in lupus patients with active skin manifestations

Merck KGaA

8 July 2026 - Merck today announced that the US FDA has granted breakthrough therapy designation to enpatoran for the treatment of lupus with active cutaneous manifestations. 

Enpatoran is an oral selective toll-like receptor (TLR) 7/8 inhibitor, designed to modulate pathways central to lupus-related inflammation.

Read Merck press release

Michael Wonder

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Michael Wonder