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Dersimelagon (MT-7117)

Erythropoietic protoporphyria or X-linked protoporphyria

Manufacturer
LEO Pharma
Regulatory submission
NDA submitted June 2026
Last updated
100 sources

Product information and disease descriptionPlace of product in therapyApproaches to treatment

Place in treatment, anticipated use, and care setting

2 evidence topics · 5 sources

Summary: anticipated position of an oral melanocortin 1 receptor agonist

Dersimelagon shares its mechanism with afamelanotide, the only approved therapy, but is taken as a once-daily oral tablet rather than a subcutaneous implant placed every 2 months by an accredited implanter. If approved on the submitted application, it would be the first therapy available to patients aged 12 to 17 years and the first approved specifically for X-linked protoporphyria as well as erythropoietic protoporphyria. The phase 3 INSPIRE population was treatment-naive for dersimelagon and excluded participants receiving other active treatment for either disorder, so no evidence describes use after or alongside afamelanotide. Care would remain specialist-led: clinical practice guidelines recommend annual liver chemistries, an annual complete blood count and iron panel, vitamin D screening, and total body skin examination every 6 months for patients receiving a melanocortin 1 receptor agonist.