Name: Dersimelagon (MT-7117) in Erythropoietic protoporphyria or X-linked protoporphyria: Special populations
Published: 2026-09-21T21:42:40-04:00

Product information and disease description Product description Product information

Special populations

4 evidence topics · 4 sources

Hepatic impairment

“Participants with mild (n = 7) or moderate (n = 8) hepatic impairment or normal hepatic function (n = 8) received a single oral 100-mg dersimelagon dose. Participants with mild (n = 8), moderate (n = 8), or severe (n = 8) renal impairment or normal renal function (n = 8) received a single 300-mg dose.” (opens the source at this quote in a new tab)
“Systemic exposure to dersimelagon was comparable with mild hepatic impairment but higher with moderate hepatic impairment (maximum observed plasma concentration, 1.56-fold higher; area under the plasma concentration-time curve from time 0 extrapolated to infinity, 1.70-fold higher) compared with normal hepatic function.” (opens the source at this quote in a new tab)

Renal impairment

“Maximum observed plasma concentration and area under the plasma concentration-time curve from time 0 extrapolated to infinity were similar with moderate renal impairment but higher with mild (1.86- and 1.87-fold higher, respectively) and severe (1.17- and 1.45-fold higher, respectively) renal impairment versus normal renal function. Dersimelagon was generally well tolerated.” (opens the source at this quote in a new tab)

Adolescents aged 12 to 17 years

“Subjects aged 12 years to 75 years, inclusive, at Screening.” (opens the source at this quote in a new tab)

“First Oral Therapy to achieve Phase 3 Primary endpoint in EPP and XLP for adults and adolescents” (opens the source at this quote in a new tab)
“Treatment options remain limited for adults, and there are no approved therapies for adolescents.” (opens the source at this quote in a new tab)

Children younger than 12 years

No evidence found.

Sex

“Plasma concentrations were higher in females than in males and overall exposure was not significantly impacted by food intake.” (opens the source at this quote in a new tab)