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Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)

A Phase 3, Multicenter, Open-label, Long-term, Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)

NCT05005975•Tanabe Pharma America, Inc.

View on ClinicalTrials.gov

Summary

To evaluate the long-term safety and tolerability of oral dersimelagon.

Eligibility

Age

12 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Additional screening criteria check may apply for qualification:
•1\. Subjects provided written informed consent to participate. For adolescent subjects, both adolescent assent and parental consent will be provided.
•2\. Subjects who have completed: MT-7117-G01 (completed through Week 58 \[Visit 12\]) or, MT-7117-A-302 (completed through Week 58 \[Visit 10\]) or, MT-7117-A-301 (completed EOT - Week 104 or Week 130) according to protocol amendment 1 or 2.
•3\. Subjects are willing and able to travel to the study sites for all scheduled visits.
•4\. In the Investigator's opinion, subject can understand the nature of the study and any risks involved in participation, and is willing to cooperate and comply with the protocol restrictions and requirements (including travel).
•5\. Female subjects who are non-lactating and have a negative urine pregnancy test at baseline visit prior to receiving the first dose of study drug.
•6\. Female subjects of childbearing potential and male subjects with partner of childbearing potential must agree to use 2 effective methods of contraception including barrier method (especially for female subjects, one method must be highly effective method)

Exclusion Criteria

•Additional screening criteria check may apply for qualification:
•A subject will NOT be eligible for this study if ANY of the following criteria apply:
•1\. History or presence of photodermatoses other than EPP or XLP.
•2\. Presence of clinically significant hepatobiliary disease at Screening, determined as clinically significant by the Investigator.
•4\. Subjects with or having a history (in the last 2 years) of excessive alcohol intake in the opinion of the Investigator.
•5\. History of melanoma.
•6\. 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.
•7\. History or presence of psychiatric disease judged to be clinically significant by the Investigator and which may interfere with the study evaluation and/or safety of the subjects.
•8\. Presence of clinically significant acute or chronic renal disease based upon the subject's medical records including hemodialysis; an estimated glomerular filtration rate (eGFR) \<60 mL/min/1.73m2 as calculated by the CKD-EPI creatinine equation (2009) for adults and by the Schwartz creatinine equation for adolescents (2009). MDRD can be used for adults per local recommendations.
•9\. Presence of any clinically significant disease or laboratory abnormality which, in the opinion of the Investigator, can interfere with the study objectives and/or safety of the subjects.
+11 more criteria

Locations (51)

Marvel Clinical Research, LLC

Huntington Beach, California, United States

University of California at San Francisco - CSF Porphyria Center

San Francisco, California, United States

University Of Miami School Of Medicine, Center For Liver Diseases

Miami, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

MetroBoston Clinical Partners, LLC

Brighton, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

Kansas City Research Institute

Kansas City, Missouri, United States

Icahn School of Medicine at Mount Sinai (ISSMS)-The Mount Sinai Hospital (MSH)

New York, New York, United States

Wake Forest University Baptist Health

Winston-Salem, North Carolina, United States

Cleveland Clinic - Taussig Cancer Institute

Cleveland, Ohio, United States

Key Dates

Start Date

August 10, 2021

Primary Completion Date

December 1, 2027

Completion Date

December 1, 2027

Last Updated

December 11, 2025

Enrollment

301

ESTIMATED participants

Conditions

EPPXLP

Interventions

MT-7117

DRUG

Contacts

Clinical Trials Information Desk, To prevent mis-communication,

CONTACT

please e-mail information.US@mb.tanabe-pharma.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)

Inclusion Criteria

Exclusion Criteria

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