Evidence review: Open Peptide Project (verified against primary PubMed, ClinicalTrials.gov & FDA records) · Last checked 2026-10-26. ← Back to Evidence Library
Davunetide (NAP, AL-108): what the evidence says
At a glance
What it is: an 8-amino-acid peptide (NAPVSIPQ) from the brain protein ADNP, given as a nasal spray. Developed by Allon Therapeutics for tau-related brain diseases. R1, R2
What the evidence says: in its largest trial, 313 people with progressive supranuclear palsy, it did not work (no difference on either primary outcome). R2 It also failed to improve cognition in schizophrenia. R3 Later post-hoc analyses by the inventor's group suggest benefit in women (PSP) and sex-dependent memory effects (MCI). R4, R5
Biggest risks: nasal side effects (nosebleeds, runny nose, discomfort). R2
Rating
| Human Human evidence | Not effective in PSP (RCT, n = 313) and schizophrenia (RCT, n = 63) R2, R3 · Very limited for MCI and women with PSP (post-hoc only) R5, R4 |
| Animal Animal / lab evidence | Tau and microtubule protection in cells, flies and rodents R6 |
| Regulatory | Never approved · not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page · WADA: not named R7, R8, R9 |
| Established human dose | None. Study details lists what studies used |
Evidence verdict: Progressive supranuclear palsy: Not effective (313-patient phase 2/3 RCT) · Schizophrenia cognition: Not effective (63-patient RCT) · Mild cognitive impairment: Very limited (post-hoc sex analyses)
This page reports what studies used. It is not dosing advice.
Legend: HUMAN data · ANIMAL / LAB data · UNKNOWN · UNVERIFIED: not yet confirmed against a primary source
About the evidence: the PSP trial was large, blinded and multinational. The positive sex-based findings are re-analyses by the inventor's lab, which can find chance results. R2, R4, R5
What is it?
NAP is the active fragment of activity-dependent neuroprotective protein (ADNP) and is thought to stabilize microtubules. R1, R6 Related pages: Semax, Selank, Dihexa, Cerebrolysin, Humanin.
Does it work?
- Human PSP (Boxer 2014): 313 patients for 52 weeks; PSPRS change 11.8 vs 11.8 (p = 0.41); daily-living score identical (p = 0.92). "Davunetide is not an effective treatment for PSP." R2, R10
- Human Schizophrenia: 63 patients, 12 weeks; no significant cognitive difference vs placebo (p = 0.45). R3
- Human Amnestic MCI: 144 people, 12 weeks; a 2024 sex-based re-analysis reported dose-related memory gains in some tests. R5, R11
- Human Women with PSP: a 2023 re-analysis reported slower decline in women. R4 Caution post-hoc; not confirmed in a new trial.
Is it safe?
- Human PSP trial: 54 serious adverse events in each group; 11 deaths on davunetide vs 10 on placebo; more nosebleeds (12% vs 8%), runny nose (10% vs 5%) and nasal discomfort (10% vs <1%). R2
- Human A 2013 review of 10 trials called it generally well tolerated. R6
Gray-market "research use only" davunetide: extra risks
A gray-market vial has no quality control and no guarantee of identity, strength or sterility. We test retail vials blind under the Open Peptide Standard; see /tests/. A passing test covers one batch on one date and does not mean the compound is safe.
What we don't know
- Unknown Whether the post-hoc benefit in women is real
- Unknown Effects in healthy people
Is it legal?
- US (FDA): not approved; not on FDA's 503A or 503B bulk-substance category lists and not on FDA's compounding safety-risk page. R7, R8, R9
- Athletes: not named on the WADA 2026 list. UNVERIFIED
Study details
Study details
These are amounts researchers used, not recommendations.
| Study | People / model | Route | Amount used | Follow-up | Reported | Citation |
|---|---|---|---|---|---|---|
| Boxer 2014 (PSP) | 313 patients | Nasal | 30 mg twice daily | 52 weeks | No benefit | PMID 24873720 |
| Javitt 2012 | 63 patients with schizophrenia | Nasal | 5 mg once daily or 30 mg/day (15 mg twice daily) | 12 weeks | No cognitive benefit | PMID 22169248 |
| Gozes 2024 (MCI re-analysis) | 144 people | Nasal | 5 mg daily or 15 mg twice daily | 12 weeks + 4 follow-up | Sex-dependent memory effects | PMID 39358355 |
Full reference list (PubMed, CT.gov, FDA and WADA checked Oct 26, 2026)
- R1 Bassan M, et al. J Neurochem. 1999. PMID 10037502
- R2 Boxer AL, et al. Lancet Neurol. 2014. PMID 24873720
- R3 Javitt DC, et al. Schizophr Res. 2012. PMID 22169248
- R4 Gozes I, et al. Transl Psychiatry. 2023. PMID 37845254
- R5 Gozes I, et al. Transl Psychiatry. 2024. PMID 39358355
- R6 Morimoto BH, et al. Expert Rev Clin Pharmacol. 2013. PMID 23971871
- R7 FDA, 503A bulk drug substances categories list (updated May 14, 2026). https://www.fda.gov/media/94155/download
- R8 FDA, 503B bulk drug substances categories list (updated Mar 21, 2025). https://www.fda.gov/media/94164/download
- R9 FDA, Certain bulk drug substances for use in compounding that may present significant safety risks (content current Apr 22, 2026). https://www.fda.gov/drugs/human-drug-compounding/certain-bulk-drug-substances-use-compounding-may-present-significant-safety-risks
- R10 ClinicalTrials.gov NCT01110720, davunetide in PSP, Allon, completed (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT01110720
- R11 ClinicalTrials.gov NCT00422981, davunetide in amnestic MCI, Allon, completed (CT.gov API v2, checked Oct 26, 2026). https://clinicaltrials.gov/study/NCT00422981
Disclaimer
This page is for education and harm reduction, not medical advice or a recommendation to use Davunetide (NAP, AL-108). Talk to a clinician you trust, especially if you have a neurological illness, are pregnant, or take nasal medicines. Report problems to FDA MedWatch (https://www.fda.gov/safety/medwatch).