Drug intelligence / Profile preview

Surgifort

Development stage
Unknown
Lead developer
Prolacta Bioscience
Modality
Recombinant Proteins and Enzymes, Peptides
Administration
Enteral, Oral
01

Overview

Surgifort is a human milk-based nutritional fortifier developed by Prolacta Bioscience. It is a pasteurized, concentrated, liquid product that contains calories, protein, fat, and carbohydrates all derived from donated human milk with added minerals. The FDA approved Surgifort in February 2025 as the first human milk-based fortifier indicated for term infants (≥37 weeks gestational age) following corrective surgery for gastroschisis, a birth defect where the intestines and sometimes other organs protrude through the abdominal wall. This is a nutritional product rather than a traditional pharmaceutical drug - it does not have a specific molecular target or active pharmaceutical ingredient, but rather functions as a specialized medical food/fortifier. The product is designed to be mixed with term human milk to provide optimal nutrition for recovery and growth in this fragile surgical population. Clinical data has shown that as part of an Exclusive Human Milk Diet, Surgifort reduces time to full feeds and improves weight gain velocity (33.3 g/day) in babies recovering from gastroschisis repair.

Brand names
Surgifort
Other names
human milk-based nutritional fortifier

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