This milestone clears the path for CLB101 to enter the US 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 characterisation, multiple toxicology studies and a demonstrated manufacturing process with stringent quality control.
ClostraBio is preparing to launch CLB101 as a probiotic supplement in autumn 2025, through both direct and partnered distribution channels, including a strategic collaboration with a leading healthcare practitioner-focused supplement brand.