Davunetide

Also known as: NAP, AL-108

Davunetide (NAP, AL-108) is an eight-amino-acid peptide fragment derived from the activity-dependent neuroprotective protein (ADNP). Its primary mechanism of action involves binding to and stabilizing microtubules, thereby promoting cytoskeletal integrity and neuronal survival. This microtubule-stabilizing effect is thought to counteract tau pathology and axonal transport deficits, which are central to neurodegenerative diseases. Additionally, davunetide exhibits neuroprotective properties by reducing oxidative stress and inflammation, and it may modulate synaptic plasticity through interactions with the microtubule-associated protein tau. Key research findings from preclinical and clinical studies indicate that davunetide improves cognitive function and reduces tau hyperphosphorylation in animal models of tauopathy. In clinical trials, it has been investigated primarily for progressive supranuclear palsy (PSP) and schizophrenia. A Phase II/III trial in PSP (NCT01110720) showed no significant benefit on the primary endpoint (PSP Rating Scale), though post-hoc analyses suggested potential effects in subgroups. In schizophrenia, a Phase II trial (NCT00505765) demonstrated improvements in verbal memory and functional capacity, particularly in patients with lower baseline cognitive performance. Despite these mixed results, davunetide has been generally well-tolerated with a favorable safety profile. Clinically, davunetide remains an investigational compound with no approved indications. Its potential relevance lies in targeting microtubule dysfunction, a common pathway in tauopathies and neuropsychiatric disorders. However, the lack of consistent efficacy in larger trials has limited its advancement. Further research may focus on identifying responsive patient subgroups or combining davunetide with other therapies to enhance its neuroprotective effects. For research purposes only — not medical advice.

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