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Expanded Access to 0.5 mg eRapa for Familial Adenomatous Polyposis
Sponsor: Biodexa Pharmaceuticals
Summary
This expanded access program provides 0.5 mg eRapa (encapsulated rapamycin) to patients with familial adenomatous polyposis (FAP) who have no satisfactory alternative treatment options and are not eligible to participate in a clinical trial. The objective is to provide access to eRapa based on the treating physician's assessment that the potential benefits outweigh the potential risks, with appropriate clinical monitoring for safety and tolerability.
Official title: Expanded Access Program for 0.5 mg eRapa in Familial Adenomatous Polyposis
Key Details
Gender
All
Age Range
Any - Any
Study Type
EXPANDED_ACCESS
Enrollment
Not specified
Start Date
Not specified
Completion Date
Not specified
Last Updated
2026-07-08
Healthy Volunteers
Not specified
Conditions
Interventions
eRapa (encapsulated rapamycin)
eRapa is a proprietary oral encapsulated formulation of rapamycin (sirolimus) provided as 0.5 mg capsules. This expanded access program uses the 0.5 mg formulation specifically developed for long-term administration.