The FDA has granted Breakthrough Therapy Designation to enpatoran, an oral TLR 7/8 inhibitor made by Merck KGaA, for cutaneous lupus erythematosus (CLE) — making it the second drug to receive this status in 2026. No treatment has been specifically approved for CLE in over 50 years. Phase 2 data showed 91% of patients achieved a meaningful skin improvement response at week 24, with two phase 3 trials now underway.
The FDA is fast-tracking not one, but two potential treatments for a long-neglected skin condition.
The FDA has awarded Breakthrough Therapy Designation to enpatoran, an oral selective toll-like receptor (TLR) 7/8 inhibitor developed by Merck KGaA, for cutaneous lupus erythematosus (CLE). This follows a similar designation granted to litifilimab earlier in January 2026 — marking the first time two drugs have received this status for CLE, a condition that has gone without a specifically approved treatment for over 50 years. Between 70–85% of lupus patients experience skin manifestations, which can range from butterfly rashes to scarring and hair loss.
The FDA's decision was based on Merck KGaA's phase 2 WILLOW trial, which showed clinically meaningful improvements in disease activity scores. Two phase 3 trials (ELOWEN-1 and ELOWEN-2) are now enrolling patients. Meanwhile, litifilimab's phase 3 AMETHYST trial is fully enrolled with results expected in 2027, and anifrolumab's phase 3 study results are anticipated in December.
By the Numbers
Why it matters: After decades of unmet need, the CLE treatment landscape is finally heating up. With two drugs on expedited FDA pathways and multiple phase 3 trials underway, clinicians and patients may soon have purpose-built options for managing lupus skin disease.
