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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)

NCT05005975 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 301

Last updated 2025-12-11

No results posted yet for this study

Summary

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

Conditions

Interventions

DRUG

MT-7117

MT-7117

Sponsors & Collaborators

  • Tanabe Pharma America, Inc.

    lead INDUSTRY

Principal Investigators

  • Head of Medical Science · Tanabe Pharma America, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-10
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Czechia
  • France
  • Germany
  • Italy
  • Japan
  • Netherlands
  • Norway
  • Poland
  • Spain
  • Sweden
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05005975 on ClinicalTrials.gov