Davunetide (NAP)

Human clinical Neuroprotection 3 sources

Davunetide, also known as NAP, is an 8-amino acid neuroprotective peptide derived from activity-dependent neuroprotective protein (ADNP). Research indicates it interacts with microtubules to maintain cellular structure and function, and it has been investigated in clinical trials for neurodegenerative conditions like progressive supranuclear palsy and schizophrenia.

01Dosing reference

Amount

15 mg (intranasal) in clinical trials

Frequency

Twice daily

Cycle

Studied in 12 to 52-week trials

Reference figures, not a recommendationThese values reflect amounts described in the literature and vendor documentation this database indexes. Use the reconstitution calculator to convert them into syringe units.

02Mechanism of action

Microtubule Interaction

Davunetide binds to tubulin, the fundamental building block of cellular microtubules.

Microtubule Stabilization

It prevents microtubule depolymerization and breakdown, promoting structural stability within the cell, particularly in neurons.

Neuroprotection

By maintaining neuronal structure and facilitating axonal transport, it protects against neurodegeneration and cellular stress.

03Human evidence

Failed to show efficacy in a Phase III trial for progressive supranuclear palsy (PSP).

A randomized, double-blind, placebo-controlled trial in patients with PSP showed no significant difference from placebo on clinical rating scales after 52 weeks.

Showed potential cognitive benefits in early trials for schizophrenia and amnestic mild cognitive impairment.

Phase II trials suggested some improvements in cognitive function and daily living activities, though larger confirmatory studies are needed.

04Preclinical evidence

Protected against neurotoxicity and cognitive deficits in animal models of Alzheimer's disease.

Studies in transgenic mice showed reduced tau hyperphosphorylation and improved memory performance.

Promoted neuronal survival and axonal transport in vitro.

Cell culture models demonstrated enhanced microtubule stability and protection against various neurotoxins.

05What is known vs. unknown

Reasonably established

Derived from the activity-dependent neuroprotective protein (ADNP).
Acts primarily by stabilizing microtubules in neurons.
Has been extensively studied in both animal models and human clinical trials.
Administered intranasally in several clinical trials to bypass the blood-brain barrier.

Unknowns & limits

Failed to meet primary endpoints in a major Phase III trial for PSP, raising questions about its clinical efficacy for certain tauopathies.
Optimal dosing and delivery methods for other neurodegenerative diseases remain uncertain.

06Safety & regulatory context

Regulatory statusDavunetide has generally been well-tolerated in clinical trials, with a safety profile comparable to placebo in studies for progressive supranuclear palsy and schizophrenia. Common side effects reported were mild and included nasal discomfort when administered intranasally. It is not FDA-approved for any condition and remains an investigational compound.

07Compared with Semax

Davunetide (NAP) vs. Semax

Key difference

Davunetide specifically targets microtubule stability via ADNP, whereas Semax is an ACTH analogue that modulates BDNF and enkephalin levels.

When researchers discuss each

Davunetide is often discussed in the context of neurodegenerative diseases and tauopathies, while Semax is typically explored for acute ischemic stroke recovery and general cognitive enhancement.

08Glossary

Microtubules

Structural components of cells that are crucial for maintaining cell shape and transporting materials, especially in neurons.

Tauopathy

A class of neurodegenerative diseases associated with the pathological aggregation of tau protein in the brain.

ADNP

Activity-dependent neuroprotective protein, a protein essential for brain formation and function, from which Davunetide is derived.

09Knowledge check

Q1What is the primary cellular mechanism of action for Davunetide (NAP)?

Q2From which naturally occurring protein is Davunetide derived?

Q3How should the Phase III trial result in progressive supranuclear palsy (PSP) be interpreted based on the dossier's evidence and limitations?

Q4According to the dossier's stated comparison, in which research contexts are Davunetide and Semax most commonly discussed, respectively?

Q5Which statement best reflects the safety and regulatory status of Davunetide as presented in the dossier?

10Sources

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Research and educational use onlyNothing on this site is medical advice, a prescription, or a recommendation for human use. Compounds documented here are research chemicals. Consult a qualified clinician before making any health decision.