ClostraBio, Inc. Obtains Self-Affirmed GRAS Status for Next-Gen Probiotic Ingredient CLB101™

CHICAGO--(BUSINESS WIRE)--ClostraBio, Inc., a biotech company pioneering microbiome-based solutions for gastrointestinal health, today announced that its unique, next-generation probiotic strain, Anaerostipes caccae CLB101™, has been granted self-affirmed GRAS (Generally Recognized as Safe) status by a panel of scientific experts. This milestone clears the path for CLB101™ to enter the U.S. market as the first and only commercially available strain of Anaerostipes caccae.

A strict anaerobe isolated from a healthy human, CLB101™ has been identified as a strain critical to gut health through its direct production of butyrate in targeted areas of the lower intestine. Butyrate is widely known as a key molecule to support gut health, and its mechanisms of action include strengthening intestinal barrier integrity, providing immune support, and promoting a diverse microbiome.

“Receiving GRAS status marks a critical milestone for ClostraBio and validates the safety of CLB101™ as we move towards commercial launch,” said Ritu Shah, CEO of ClostraBio. “This recognition reinforces our commitment to advancing safe, science-driven solutions that can help support gut health for the many people who are struggling today.”

The GRAS designation follows rigorous review of safety data, including genomic characterization, multiple toxicology studies, and a demonstrated manufacturing process with stringent quality control. ClostraBio is preparing to launch CLB101™ as a probiotic supplement in Fall 2025, through both direct and partnered distribution channels, including a strategic collaboration with a leading healthcare practitioner-focused supplement brand.

For more information on ClostraBio and CLB101™, please visit www.clostrabio.com.

About ClostraBio: ClostraBio is leveraging a science driven, multi-pronged approach to address conditions of the lower gut, using novel biotechnology to harness natural pathways. The Company is developing a next-generation probiotic that produces butyrate in the lower gut to impact intestinal barrier function and promote gut health, as well as a novel polymeric prodrug platform designed to deliver small molecules to the lower gut. ClostraBio was spun out of the University of Chicago and is incubated at Portal Innovations.