The safety and toxicity of LAT8881 has been evaluated using conventional acute and chronic repeat-dose studies in animals. Toxicology data from rodents and primates indicated no significant safety signals attributable to LAT8881 up to doses of 100mg/kg/day for 6 months following oral delivery in rats and 50mg/kg/day for 9 months in cynomolgous monkeys.
In the six (6) human clinical trials involving 925 patients conducted at Medeval, Manchester, UK and seventeen (17) major Australian hospitals and medical centres between 2001 and 2007 with 694 patients dosed with LAT8881 it has been shown that LAT8881 is safe and well tolerated in humans.
This safety and tolerability record of LAT8881 was further validated in July 2014 by the receipt of a self-affirmed GRAS (Generally Recognized as Safe) status recognition to enter the U.S. market as a food additive. The peptide had received in June 2012, GRAS status in the USA conditional on the publication of safety related data in peer-reviewed scientific journals. Two such scientific papers detailing these safety aspects are available for downloading here.
GRAS status allows LAT8881 to be sold as a component in conventional and functional foods, drinks and dietary supplements in the USA at the daily level of up to 1 mg per person.