Results showed investigational oral dersimelagon (MT-7117) met the primary endpoint and demonstrated a favorable safety and tolerability profile in adults and adolescents with EPP and XLP
JERSEY CITY, N.J. March 26, 2026 – Tanabe Pharma America, Inc. (TPA), today announced that results from its Phase 3 global INSPIRE study, evaluating investigational dersimelagon (MT-7117) in erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP), has been accepted for a late-breaking oral presentation at the 2026 American Academy of Dermatology (AAD) Annual Meeting in Denver, Colorado. The presentation, titled “Efficacy and Safety of Dersimelagon in Adults and Adolescents with Erythropoietic Protoporphyria (EPP) and X-linked Protoporphyria (XLP): Top-line Results from the INSPIRE Phase 3 Randomized Clinical Trial,” is scheduled for Saturday, March 28, 2026, during Late-Breaking Research: Session 1.
“We are honored that the Phase 3 INSPIRE data for MT-7117 have been selected for a late-breaking oral presentation at AAD 2026.”, said Yasutoshi Kawakami, President, Tanabe Pharma America., “EPP and XLP are devastating rare diseases with significant unmet need, and patients have long awaited new treatment options that may help address the daily burden of phototoxicity. We believe MT-7117 has the potential to be a first-in-class oral therapy and offer a meaningful new option for this highly underserved patient community.”
AAD 2026 Late-Breaking Presentation Details
- Abstract Title: 79275 – Efficacy and Safety of Dersimelagon in Adults and Adolescents with Erythropoietic protoporphyria (EPP) and X-linked protoporphyria (XLP): Top-line Results from the INSPIRE Phase 3 Randomized Clinical trial
- Presentation Date/Time: Mar 28, 2026, 11:00 AM – 11:12 AM
- Location: Bellco Theatre 3
About Dersimelagon (MT-7117):
Dersimelagon is a novel synthetic, orally‑administered, non‑peptide small molecule, which acts as a selective agonist of melanocortin‑1 receptor (MC1R) with a potential for being effective to increase pain free light exposure in patients with erythropoietic protoporphyria (EPP) and X-Linked Protoporphyria (XLP). Tanabe Pharma is developing dersimelagon for the treatment of EPP or XLP. Dersimelagon is an investigational medication and not approved by FDA or any other regulatory authority. Tanabe Pharma received Fast Track Designation for dersimelagon by the U.S. Food and Drug Administration in June 2018.
About INSPIRE Study
INSPIRE is a global, randomized, double-blind, placebo-controlled Phase 3 study investigating the efficacy, safety, and tolerability of dersimelagon (MT-7117) in 165 adults and adolescents with erythropoietic protoporphyria (EPP) or X-linked protoporphyria (XLP). After screening, study participants (ranging from 12 to 75 years of age) received either dersimelagon 200 mg or placebo once daily. The primary endpoint was change from baseline in average daily sunlight exposure time (in minutes) to first prodromal symptom (burning, tingling, itching, stinging) associated with sunlight exposure between 1-hour post-sunrise and 1-hour pre-sunset at week 16. Secondary endpoints were patient Global Impression of Change (PGIC) at week 16, the total number of sunlight-induced pain events defined as prodromal symptoms with pain rating of 1-10 on the Likert scale during the 16-week double-blind treatment period, and the total number of sunlight-induced non-prodrome, phototoxic reactions during the 16-week double-blind treatment period.
About Erythropoietic Protoporphyria and X-Linked Protoporphyria
Erythropoietic Protoporphyria (EPP) is an inherited disorder of the heme biosynthetic pathway that results from mutations of the ferrochelatase (FECH) gene or, less commonly X-Linked Protoporphyria (XLP) that results from mutations in the aminolevulinic acid synthase-2 (ALAS2) gene. Both EPP and XLP are characterized by accumulation of protoporphyrin in blood, erythrocytes and tissues and cutaneous photosensitivity. EPP and XLP usually present early in childhood with extremely painful phototoxic reactions which are preceded by a “prodrome” of tingling, stinging, and/or burning of sun-exposed skin. The onset of prodromal symptoms after direct sun exposure varies but may occur in less than 10 minutes. Importantly, continued exposure to sunlight following the onset of prodromal symptoms will lead to phototoxicity-induced pain.
About Tanabe Pharma America, Inc.
Based in Jersey City, N.J., Tanabe Pharma America, Inc. (TPA) is a wholly-owned subsidiary of Tanabe Pharma Corporation. It was established by Tanabe Pharma Corporation to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit https://us.tanabe-pharma.com or follow us on X (formerly Twitter), Facebook and LinkedIn.
About Tanabe Pharma Corporation
Tanabe Pharma Corporation is one of the oldest pharmaceutical companies in the world, founded in 1678. Tanabe Pharma is headquartered in Doshomachi, Osaka, the birthplace of Japan’s pharmaceutical industry. Tanabe Pharma sets the MISSION of “Creating hope for all facing illness.” To that end, Tanabe Pharma is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. Tanabe Pharma is focusing on “precision medicine” to provide drugs with high treatment satisfaction and additionally working to develop “around the pill solutions” to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to https://www.tanabe-pharma.com/en
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