Davunetide dosage in published studies and labels

These are the doses used for Davunetide in FDA labelling and published clinical studies, reported as each source states them, one row per regimen. They describe what was studied or approved for a specific population. They are not a recommendation, and none of them is a dose for any individual.

Research and educational reference only. This is not medical advice, and no figure on this page is a dosing recommendation.

Last checked against primary sources:

Studied regimens and sources

Davunetide has no approved dosage; there is no davunetide label on DailyMed. Human dosing comes from intranasal trials: the phase 2/3 trial in progressive supranuclear palsy gave 30 mg twice daily for 52 weeks and found no difference from placebo on either primary endpoint, and a 12-week schizophrenia trial of 5 mg and 30 mg found no significant effect on its cognitive battery.

Clinical Trial Evidence
Dosage evidence summary for Davunetide
Human dosing establishedYes
Studied dose range5–30 mg intranasally in trials
RouteIntranasal
FrequencyTwice daily in the progressive supranuclear palsy trial
Duration studied12–52 weeks in the published trials
Evidence levelClinical Trial Evidence
Last reviewed2026-11-07

Research-reported dosing

Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.

Research-reported dosing for Davunetide, one row per studied regimen
Study / contextPopulationDoseRouteFrequencyDurationOutcome studiedSource
Progressive supranuclear palsy — phase 2/3, Lancet Neurology 2014 (NCT01110720)Clinical trial · Randomised, double-blind, placebo-controlled phase 2/3 trialAdults with progressive supranuclear palsy at 48 centres (313 randomised)30 mg, or placeboIntranasalTwice daily52 weeksNo difference from placebo on the PSP Rating Scale (p=0.41) or the Schwab and England daily-living scale (p=0.92); nosebleeds, runny nose and nasal discomfort were more frequent; the authors concluded it is not an effective treatment for PSPDavunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial. Lancet Neurol. 2014.
Schizophrenia cognition trial — Schizophr Res 2012Clinical trial · Randomised, double-blind, placebo-controlled trialAdults with schizophrenia continuing their antipsychotic treatment (n=63)5 mg or 30 mg, or placeboIntranasalNot stated in the indexed abstract12 weeksNo significant difference on the MATRICS cognitive battery (p=0.45); a significant treatment effect on the UPSA functional-capacity test (p=0.048); well toleratedEffect of the neuroprotective peptide davunetide (AL-108) on cognition and functional capacity in schizophrenia. Schizophr Res. 2012.

Where sources disagree

  • Davunetide (NAP, AL-108) was given intranasally in these trials. Its largest trial, in progressive supranuclear palsy, found no benefit on either primary endpoint.
  • The FDA has not approved davunetide, and no regulator-approved dosage exists.