Evicenter
P&T meetings

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 descriptionProduct descriptionProduct information

Contraindications/Warnings/Precautions/Adverse effects

4 evidence topics · 5 sources

Warnings and precautions
Approved labeling

No evidence found.

Dermatologic conditions excluded from the phase 3 trial

“History of melanoma.” (opens the source at this quote in a new tab)

“Presence of squamous cell carcinoma, basal cell carcinoma, or other malignant skin lesions. Any suspicious lesions or nevi will be evaluated. If the suspicious lesion or nevi cannot be resolved through biopsy or excision, the subject will be excluded from the study.” (opens the source at this quote in a new tab)

Adverse events reported in the phase 3 trial

“The most common adverse events, occurring more frequently than placebo, were melanocytic nevi (benign moles), headache, nausea, diarrhea, and skin hyperpigmentation, with the mechanism of MC1R agonist.” (opens the source at this quote in a new tab)

“Dersimelagon was generally well-tolerated, with a safety profile consistent with its mechanism of action.” (opens the source at this quote in a new tab)

“In the INSPIRE study, dersimelagon demonstrated a favorable safety and tolerability profile, with most adverse events being mild or moderate in severity.” (opens the source at this quote in a new tab)

Adverse events reported in the phase 2 trial

“The most common adverse events that occurred or worsened during treatment were nausea, freckles, headache, and skin hyperpigmentation.” (opens the source at this quote in a new tab)

Adverse events reported in healthy participants

“Dersimelagon was generally well tolerated in healthy participants, with the most common TEAEs being lentigo (52.8%) and skin hyperpigmentation (50.0%) after multiple doses.” (opens the source at this quote in a new tab)

“Overall, the incidence of TEAEs was relatively low, with most events occurring during Part A (SAD) and Part E (MAD) and the majority being mild to moderate in severity. No deaths or serious AEs were reported during any part of the study.” (opens the source at this quote in a new tab)

“These TEAEs related to changes in skin pigmentation may be attributable to the study drug based on the pharmacological effects of dersimelagon by virtue of its mechanism of action as a selective MC1R agonist.” (opens the source at this quote in a new tab)

Contraindications

No evidence found.