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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 · View on ClinicalTrials.gov ↗
Study Summary
To evaluate the long-term safety and tolerability of oral dersimelagon.
Interventions
- DRUG MT-7117
Study Locations (20)
California
- Marvel Clinical Research, LLC — Huntington Beach
- University of California at San Francisco - CSF Porphyria Center — San Francisco
Massachusetts
- Massachusetts General Hospital — Boston
- MetroBoston Clinical Partners, LLC — Brighton
Ohio
- Cleveland Clinic - Taussig Cancer Institute — Cleveland
- Remington-Davis Clinical Research — Columbus
Pennsylvania
- Thomas Jefferson University — Philadelphia
- Einstein Medical Center, Philadelphia — Philadelphia
Florida
- University Of Miami School Of Medicine, Center For Liver Diseases — Miami
Michigan
- Henry Ford Health System — Detroit
Missouri
- Kansas City Research Institute — Kansas City
New York
- Icahn School of Medicine at Mount Sinai (ISSMS)-The Mount Sinai Hospital (MSH) — New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 301 participants |
| Start Date | 2021-08-10 |
| Est. Completion | 2027-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05005975
The ClinicalTrials.gov registry entry for NCT05005975 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 301 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tanabe Pharma America, which has 38 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with EPP appearing as the primary indexed condition, and to 1 intervention — of which MT-7117 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05005975 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, Massachusetts, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05005975 about?
NCT05005975 is a clinical study titled "Extension Study to Evaluate Safety and Tolerability of Oral Dersimelagon (MT-7117) in Subjects With Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)". To evaluate the long-term safety and tolerability of oral dersimelagon.
What is the current status of trial NCT05005975?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 301 participants. The study started on 2021-08-10. Estimated completion is 2027-12.
What conditions does trial NCT05005975 study?
This clinical trial studies the following conditions: EPP, XLP. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05005975?
The interventions under investigation include: MT-7117 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05005975?
This trial is sponsored by Tanabe Pharma America, which has 38 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05005975 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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