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

Recruiting Phase 3 Interventional Study
EPP XLP
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
12 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
301 (estimated)
Sponsor
Tanabe Pharma America, Inc. · Industry
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About This Trial

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

Trial Locations
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Eligibility Criteria
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 thr…
Contacts

Clinical Trials Information Desk, To prevent mis-communication,

please e-mail

information.US@mb.tanabe-pharma.com

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