Pep2Dia’s New Dietary Ingredient (NDI) registration approved by the US FDA

Published: 13-Oct-2021

Ingredia has now been granted the New Dietary Ingredient (NDI) registration for Pep2Dia

What is Pep2Dia?

Pep2Dia is a patented whey protein hydrolysate containing an active dipeptide AP, designed for people willing to maintain healthy blood sugar levels. Among them are glucose intolerant or prediabetic people, a healthy population with glycaemia levels irregularly above normal and with a higher risk of developing type 2 diabetes.

The peptide AP acts as an inhibitor of the α-glucosidase, thus lowers glucose absorption into the blood stream.

Pep2Dia’s safety validated by New Dietary Ingredient registration

Pep2Dia’s toxicity has been evaluated, both acutely (dose of 2000 mg/kg body weight) and sub chronically (90 days at dose levels up to 1000mg/kg body weight/day). In both studies, no toxicological effects were observed.

Previously, Pep2Dia had proven its efficacy in clinical studies (2019) in glucose intolerant volunteers, at a dose of 1400 mg to be taken daily before lunch for 6 weeks as a supplement. It has successfully decreased their glycated hemoglobin (HbA1c) level. Pep2Dia thus lowers the risk of developing type 2 diabetes.

The future of type 2 diabetes market

In 2019, 375 million people worldwide were at risk of getting type 2 diabetes. 80% of those prediabetic people will develop type 2 diabetes within 5 to 10 years if nothing is done*.

In the US, about 88 million adults had prediabetes in 2018 with 67% of them being 45 or older.

Only 15.3% of them were aware of it and according to Centers for Diseases Control, the percentage who had ever been told by a health care professional that they had prediabetes has doubled over the 2005-2016 period**.

Knowing prediabetes is a reversible state, this high prevalence makes prevention all the more crucial.


  • * IDF Atlas, 2019.
  • ** CDC, 2021.

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