Trials / Recruiting
RecruitingNCT05005975
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)
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 301 (estimated)
- Sponsor
- Tanabe Pharma America, Inc. · Industry
- Sex
- All
- Age
- 12 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the long-term safety and tolerability of oral dersimelagon.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MT-7117 | MT-7117 |
Timeline
- Start date
- 2021-08-10
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2021-08-16
- Last updated
- 2025-12-11
Locations
51 sites across 15 countries: United States, Australia, Belgium, Canada, Czechia, France, Germany, Italy, Japan, Netherlands, Norway, Poland, Spain, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05005975. Inclusion in this directory is not an endorsement.