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NM5TFV is an ultra-long-acting, amino acid-free, lipophilic crystalline phosphonate prodrug nanoformulation of tenofovir (TFV) developed by the University of Nebraska Medical Center (UNMC). It is formulated as an aqueous nanosuspension of the prodrug M5TFV, stabilized with PEG-3350 and Tween 20 (polysorbate 20). NM5TFV is designed to provide sustained suppression of hepatitis B virus (HBV) replication and is being investigated for the treatment of chronic hepatitis B (CHB), HIV infection, and HIV/HBV coinfection. Following a single intramuscular or subcutaneous injection, NM5TFV acts as a long-acting depot that slowly releases the prodrug M5TFV, which is intracellularly converted to active tenofovir diphosphate to inhibit viral polymerase and reverse transcriptase, thereby suppressing viral DNA and covalently closed circular DNA (cccDNA) replication without inducing interferon-stimulated genes (ISGs).
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