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FEB 28 2027
UPCOMING · PROJECTED · 152 DAYS TO PDUFA

LEO Pharma — dersimelagon

for erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP) in adults

NDA · Priority Review

Accepted SEP 18 2026.

Pivotal trial

INSPIRE Phase 3 completed NCT06144840

To investigate the efficacy of MT-7117 on time to onset and severity of first prodromal symptoms (burning, tingling, itching, or stinging) associated with sunlight exposure in adults and adolescents with EPP or XLP.

Source: ClinicalTrials.gov

Also in development