Alcresta Therapeutics Announces FDA Clearance for Expanded Use of RELiZORB® (iMMOBILIZED LIPASE) Cartridge for Neonates and Infants

RELiZORB is now available for patients of all ages to hydrolyze fats during enteral feeding

WALTHAM, Mass., Nov. 3, 2025 /PRNewswire/ -- Alcresta Therapeutics, Inc., a leading commercial-stage company focused on developing and commercializing novel enzyme-based products, today announced that the U.S. Food and Drug Administration (FDA) has cleared expanded use of RELiZORB to now include patients of all ages including neonates and infants. RELiZORB is a digestive enzyme cartridge designed to mimic the function of pancreatic lipase to provide nutritional support for enterally-fed patients. To meet the feeding needs of neonates and infants, this expansion for RELiZORB also broadens its compatibility, allowing for use with both infant formulas and pasteurized human milk.

The clearance is based on a retrospective evaluation of real-world data in neonates and infants <1 year old who utilized RELiZORB with their enteral nutrition as part of their feeding regimen. The real-world data showed significant improvement in weight observed as early as three months following initiation of RELiZORB. No additional safety concerns were identified with RELiZORB use in this younger patient population.

"Neonates and infants who require tube feeding represent a patient population whose current nutritional solutions are limited," said Michael Yeh, MD, Chief Medical Officer at Alcresta Therapeutics. "Nutrition in this age group is critical to early development as systems in the body are maturing. Proper nutrition, including fat digestion and absorption, contributes to caloric requirements that support development of these systems throughout an infant's body. The real-world data signifies RELiZORB's potential to improve nutrition for enterally-fed infants that is essential for growth and development."

This most recent FDA clearance enables more patients to potentially benefit from RELiZORB and reflects Alcresta's continued commitment to developing enzyme-based products for enterally-fed patients suffering from a range of conditions associated with fat malabsorption, including short bowel syndrome, cystic fibrosis, pancreatitis, GI cancers and other rare diseases. 

About RELiZORB^® (iMMOBILIZED LIPASE) CARTRIDGE 

RELiZORB is indicated for use in pediatric (including neonates and infants) and adult patients to hydrolyze fats during enteral feeding. RELiZORB is a first-of-its-kind digestive enzyme cartridge designed to mimic the function of pancreatic lipase. RELiZORB is developed using Alcresta's proprietary enzyme immobilization technology, iLipase^®, which is the digestive enzyme lipase bound to small polymeric bead carriers. RELiZORB connects in-line to enteral feeding systems. As enteral formula passes through RELiZORB, the bound lipase breaks down formula fats into an absorbable form prior to ingestion. RELiZORB was FDA cleared for adults in 2015, and subsequently expanded the age indication to children as young as 5 in 2017, children as young as 2 in August 2023, and children as young as 1 in January 2025, and for all ages including neonates in infants in April 2025. The next-generation RELiZORB device was introduced to market in May 2024 with broader formula compatibility, an increase in the number of devices used per day and use in both continuous and bolus-feeding set ups.

About Alcresta Therapeutics, Inc. 

Alcresta Therapeutics, Inc. is dedicated to developing and commercializing novel, enzyme-based products designed to address challenges faced by patients living with gastrointestinal disorders and rare diseases. Alcresta currently markets RELiZORB for enterally-fed patients with pancreatic insufficiency, which occurs in cystic fibrosis, pancreatic cancer, and pancreatitis, and short bowel syndrome, which is marked by significant malabsorption due to limited absorptive area as a result of resection. Alcresta is currently developing a platform application for prematurely born infants treated in the NICU. Alcresta Therapeutics, Inc. is backed by Linden Capital Partners and HealthQuest Capital. More information can be found at www.alcresta.com. 

Internal Media Contact:
Natalie Bronfin
Alcresta Therapeutics, Inc.
[email protected]
617-431-3600

SOURCE Alcresta Therapeutics, Inc.