Eight-amino-acid fragment of the ADNP protein, studied as a nasal spray for neurodegenerative diseases. It failed in a large trial in progressive supranuclear palsy and is not approved.
Regulatory status
Not approved
Family
Neuroprotective peptide derived from ADNP (microtubule stabilizer)
Scientific evidence
Low
Number of findings
2
Where it acts
Brain and sleep
Also known as
davunetide, NAP, AL-108, NAPVSIPQ
Regulatory status
FDA (US): Not approved.
EMA (EU): Not approved.
Dose
There is no established dose in humans. In the progressive supranuclear palsy trial, 30 mg intranasally twice a day for 52 weeks was used (Lancet Neurol 2014).
Safety
In the progressive supranuclear palsy trial it was similar to placebo in serious effects; it caused more nasal discomfort (nosebleed 12% versus 8%, rhinorrhea 10% versus 5%). Use only in clinical trials or research, under medical supervision; buying it is not recommended.
Differences between women and men
A sex-based analysis of a trial in amnestic mild cognitive impairment (144 people, 12 weeks) described different effects: in men a visual memory test improved in a dose-dependent manner; in women digit memory improved at a high dose. It is a secondary analysis with declared conflicts of interest (patent on sex-specific use). View the study →
Effect by goal · level of evidence
Progressive supranuclear palsy
no clear effectHighRCT (AA)in people
No difference
Phase 2/3 trial in 313 patients over 52 weeks: progression on the PSPRS scale was identical with davunetide and placebo (median 11.8 points in both) and there was also no difference in activities of daily living.
Sex-based reanalysis of a 12-week trial (68 men and 76 women): improvements were seen on different memory tests in men and in women. Small sample, analysis not originally planned.
Derived from the ADNP protein, which is important for the development and protection of neurons. In laboratory studies it interacts with microtubules (the neuron's internal skeleton) and with the tau protein, helping to maintain transport inside the cell. It is administered intranasally.
What the evidence says
In people
Progressive supranuclear palsy. Phase 2/3 trial in 313 patients over 52 weeks: progression on the PSPRS scale was identical with davunetide and placebo (median 11.8 points in both), and there was also no difference in activities of daily living. PubMed 24873720
Memory in mild cognitive impairment, by sex. Sex-based reanalysis of a 12-week trial (68 men and 76 women): improvements were seen on different memory tests in men and in women. Small sample, analysis not originally planned. PubMed 39358355