Davunetide

Davunetide is an eight-amino-acid fragment derived from activity-dependent neuroprotective protein. Allon Therapeutics developed it for intranasal use. Studies included progressive supranuclear palsy, a rare tau-related neurodegenerative disorder, and earlier work in mild cognitive impairment and schizophrenia. It is not approved.

Proposed actions include stabilizing neuronal microtubules and reducing abnormal tau phosphorylation. Laboratory neuroprotection supplied a rationale, but that mechanism did not translate into benefit in the pivotal patient trial.

Davunetide remains unapproved. The progressive-supranuclear-palsy program stopped after its pivotal failure; later exploratory work in other settings remains early.

A Phase 2/3 progressive-supranuclear-palsy trial enrolled more than 300 people and found no difference from placebo on either co-primary endpoint. Its authors concluded that davunetide was not effective for PSP. Smaller earlier signals in mild cognitive impairment, schizophrenia and other settings were not confirmed in larger studies. The human evidence therefore does not support an established benefit.