Greater than 98.0% as determined by RP-HPLC.
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Enfuvirtide has an amino acid sequence Ac-Tyr-Thr-Ser-Leu-Ile-His-Ser-Leu-Ile-Glu-Glu-Ser-Gln-Asn-Gln-Gln-Glu-Lys-Asn-Glu-Gln-Glu-Leu-Leu-Glu-Leu-Asp-Lys-Trp-Ala-Ser-Leu-Trp-Asn-Trp-Phe-NH2, molecular formula of C204H301N51O64 and a molecular weight of 4488.9 Dalton.
Enfuvirtide is a 36-amino acid biomimetic peptide that mimics the structure of HIV proteins responsible for the fusion of the virus to cell membranes. The drug works by binding to the gp41 transmembrane protein of the HIV envelope, which is crucial for the fusion of the viral and host cell membranes. By interfering with the conformational changes required for membrane fusion, enfuvirtide effectively blocks the entry of the virus into the host cell .
Enfuvirtide represents the first of a new class of antiretroviral drugs known as fusion inhibitors. Its development marked a significant advancement in the treatment of HIV, particularly for patients who have developed resistance to other classes of antiretroviral drugs. The introduction of enfuvirtide provided a new option for heavily treated patients with advanced HIV disease .