Trofinetide API CAS 853400-76-7

NNZ2566 Introduction

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Trofinetide is a synthetic tri-peptide analogue, with the CAS number: 853400-76-7; molecular weight: 315.32; this compound was originally developed by Neuren Pharmaceuticals and later jointly developed with Acadia Pharmaceuticals. It was approved by the US FDA in March 2023. Its molecular formula is C₁₃H₂₁N₃O₆, and it has water solubility and the ability to penetrate the blood-brain barrier. In terms of application, the Trofinetide API is mainly used for the treatment of Rett syndrome, exerting effects through mechanisms such as regulating neuroinflammation, improving synaptic function, and protecting neurons. Additionally, this compound has shown potential application prospects in the treatment research of neurodevelopmental disorders such as Fragile X syndrome.

What are the main application areas of NNZ2566?

The main application area of Trofinetide is the treatment of Rett syndrome. Rett syndrome is a rare neurodevelopmental disorder caused by mutations in the MECP2 gene, mainly affecting girls and leading to severe cognitive, motor and social functional impairments. The Trofinetide API is the first product approved by the US FDA for the treatment of Rett syndrome. In clinical applications, it is administered orally, aiming to improve symptoms such as communication, hand function, and respiratory rhythm in patients.

How does Trofinetide work?

The mechanism of action of Trofinetide API is related to a natural substance called glycyl-prolyl-glutamic acid. GPE is one of the degradation products of insulin-like growth factor 1 (IGF-1) in the human body, and IGF-1 plays an important role in the growth, survival, and functional maintenance of neurons. As a synthetic analogue of GPE, Trofinetide aims to simulate and enhance these neuroprotective effects. Its specific effects are multifaceted: studies have shown that it can alleviate neuroinflammation, inhibit tissue damage caused by excitotoxicity, and reduce cell apoptosis, thereby protecting neurons and their surrounding supportive structures. Additionally, research has found that this peptide segment can restore the bioavailability of IGF-1 by promoting the degradation of IGF-binding protein in astrocytes, thereby repairing synaptic function.

MF of Trofinetide

CAS	853400-76-7
Molecular formula	C13H21N3O6
Molecular weight	315.32
Melting point	144 °C
Boiling point	655.4±55.0 °C
Density	1.377±0.06 g/cm3

Specification

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FAQ: 

Q1:How is trofinetide metabolized and eliminated in the body?
Trofinetide is mainly excreted from the body by the kidneys in its original form, with a half-life of approximately 2-4 hours. It does not rely on the liver's cytochrome P450 enzyme system for metabolism, thus having a lower likelihood of undergoing metabolic interactions with other products.
Q2:Is this product suitable for all age groups of Rett patients?

Currently, the FDA has approved it for use in children aged 2 and above as well as adults. Studies for the younger age group (under 2 years old) are still ongoing, and the safety data has not yet been fully established.

Q3:Is Trofinetide applicable to other rare diseases?

Currently, clinical trials are mainly focused on Rett syndrome. However, in the fields of fragile X syndrome and other neurodevelopmental disorders related to synaptic function, Trofinetide and related peptide segments have also attracted attention. Early exploratory studies related to this are currently underway.

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