FDA Expands RELiZORB Clearance to Include Infants as Young as One Year Old
Key Insights
The FDA has expanded the clearance for RELiZORB (search), an immobilized lipase cartridge, to include children as young as one year old, according to Alcresta Therapeutics (search).
This expanded indication is based on real-world data showing the safety of RELiZORB (search) in patients aged 1 to 2 years receiving enteral nutrition.
RELiZORB (search) is designed to mimic pancreatic lipase, hydrolyzing fats in enteral formula to improve absorption for patients with fat malabsorption (search).
Alcresta Therapeutics (search) announced that the U.S. Food and Drug Administration (FDA) has cleared the expanded use of RELiZORB (search), an immobilized lipase cartridge, for pediatric patients as young as one year old. This clearance, announced on January 15, 2025, broadens the availability of this digestive enzyme cartridge, which is designed to mimic the function of pancreatic lipase, to a younger patient population.
Clinical Basis for Expanded Clearance
The FDA's decision was based on a retrospective evaluation of real-world data from patients aged 1 to 2 years who used RELiZORB (search) as part of their enteral nutrition regimen. The evaluation found no new safety concerns associated with RELiZORB use in this younger population, supporting its safe and effective use in infants.
How RELiZORB Works
RELiZORB (search) is a first-of-its-kind digestive enzyme cartridge that connects in-line with enteral feeding systems. As enteral formula passes through the cartridge, the immobilized lipase breaks down fats into an absorbable form before ingestion. This process mimics the natural function of pancreatic lipase, aiding in the digestion and absorption of fats for patients with fat malabsorption (search).
Impact on Pediatric Nutrition
"Receiving clearance for children ages 1 and above signifies another meaningful milestone for RELiZORB (search) and enterally fed patients with fat malabsorption (search)," said Dan Orlando, Chief Executive Officer at Alcresta Therapeutics (search). He further noted that since its commercial availability in May 2024, the second-generation cartridge has seen expanded use, particularly in patients with short bowel syndrome (search) (SBS). This expansion aims to address the essential nutritional needs of these patients and others living with rare diseases, especially where nutritional goals are vital for growth and development.
History of RELiZORB Clearance
RELiZORB (search) was initially cleared by the FDA in 2015 for use in adult patients. The clearance was expanded in 2017 to include children as young as five years old, and again in August 2023 for patients aged two years and up. The latest clearance now includes infants as young as one year old, further extending its reach to a vulnerable patient population.
Addressing Fat Malabsorption
RELiZORB (search) is indicated for use in pediatric patients (ages 1 year and above) and adult patients to hydrolyze fats in enteral formula. It utilizes Alcresta’s proprietary enzyme immobilization technology, iLipase, where the digestive enzyme lipase is bound to small polymeric bead carriers. The next-generation RELiZORB device, introduced in May 2024, features broader formula compatibility, an increased number of devices used per day, and suitability for both continuous and bolus-feeding setups.