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


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

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

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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