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Home/Compounds/Davunetide

CognitiveRx required

Davunetide

Also known as: NAP · AL-108 · NAPVSIPQ

Investigational 8-amino-acid peptide derived from activity-dependent neuroprotective protein (ADNP).

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Grade B

Human observational studies

Human studies23

PubMed citations30

Routeintranasal, intravenous

Regulatory (US)Rx required

Last verified2 days ago

Mechanism of action

Active fragment of ADNP; interacts with microtubules and promotes neuronal survival.

Evidence summary

Human studies

PubMed citations

Clinical trials

Evidence grade

Phase 2/3 trial in progressive supranuclear palsy (PSP) did not meet primary endpoint in 2013. Re-explored for ADNP syndrome and schizophrenia.

Dosing protocols

Educational information only. Consult a licensed provider before using any peptide.

Administration routes

intranasalintravenous

Side effects & safety

No FDA label or editorial side-effect profile is on file for this compound yet. See the clinical trials and citations sections for study-reported safety data.

Interactions

No documented drug interactions on file.

Regulatory status

United States

Not FDA approved

Investigational. Rare-disease orphan drug activity continuing.

Compounding

Not permitted

Not available via 503A/503B compounding pharmacies.

Regulatory data last verified 4/19/2026

Clinical trials

NCT01056965A 12 Week Randomized, Double Blind, Placebo-Controlled Pilot Study of Davunetide (NAP, AL-108) in Predicted TauopathiesCompleted · Phase 1 · Predicted Tauopathies, Including · n=12 NCT00505765A Multicenter Ascending Dose, Double Blind, Placebo-controlled Study of NAP (AL-108) in Chronic SchizophreniaCompleted · Phase 2 · Schizophrenia · n=63 NCT01110720A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear PalsyCompleted · Phase 2 · Progressive Supranuclear Palsy · n=313 NCT00404014A Phase II Study Designed to Evaluate the Safety, Tolerability, and Effect of a Single, Rising Dose of Intravenous AL-208, Followed by a Placebo-Controlled, Double-Blind, Parallel-Group Evaluation of a Single Dose of AL-208, on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery.Completed · Phase 2 · Mild Cognitive Impairment · n=234 NCT00422981A Phase 2, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Effect on Cognitive Function of AL-108 After 12 Weeks of Intranasal Administration in Subjects With Mild Cognitive ImpairmentCompleted · Phase 2 · Mild Cognitive Impairment, So Stated · n=144

Citations

PMID 40185278Galushkin A, Gozes I · Intranasal NAP (Davunetide): Neuroprotection and circadian rhythmicity.Advanced drug delivery reviews (2025)Human PMID 39906645Zhang Y, Liu H et al. · Injectable iodine-containing peptide hydrogel for treatment of MRSA infection.Bioactive materials (2025)Human PMID 39482804Meng CF, Lee YC et al. · Characterizing Nonarticular Pain at Early Rheumatoid Arthritis Diagnosis: Evolution Over the First Year of Treatment and Impact on Remission in a Prospective Real-World Early Rheumatoid Arthritis Cohort.Arthritis & rheumatology (Hoboken, N.J.) (2025)Human PMID 40145989Chen Y, Liu R et al. · Davunetide promotes structural and functional recovery of the injured spinal cord by promoting autophagy.Neural regeneration research (2025)PMID 40650770Ma J, Sarén T et al. · Pre-clinical safety and efficacy evaluation of Helicobacter Pylori neutrophil-activating protein (NAP)-armed CAR-T cells targeting B cell lymphomas.Cancer immunology, immunotherapy : CII (2025)Human PMID 37294500Ząbczyk M, Natorska J et al. · Neutrophil-activating Peptide 2 as a Novel Modulator of Fibrin Clot Properties in Patients with Atrial Fibrillation.Translational stroke research (2024)Human PMID 39251453Toren Y, Ziv Y et al. · Sex-Specific ADNP/NAP (Davunetide) Regulation of Cocaine-Induced Plasticity.Journal of molecular neuroscience : MN (2024)Human PMID 38766748Liang LR, Liu B et al. · Integrated ribosome and proteome analyses reveal insights into sevoflurane-induced long-term social behavior and cognitive dysfunctions through ADNP inhibition in neonatal mice.Zoological research (2024)Human PMID 37572043Gozes I · Tau, ADNP, and sex.Cytoskeleton (Hoboken, N.J.) (2024)Human PMID 37845254Gozes I, Shapira G et al. · Unexpected gender differences in progressive supranuclear palsy reveal efficacy for davunetide in women.Translational psychiatry (2023)Human PMID 36880480Zhan W, Gao G et al. · Enzymatic Self-Assembly of Adamantane-Peptide Conjugate for Combating Staphylococcus aureus Infection.Advanced healthcare materials (2023)PMID 36708851Hu Y, Shi H et al. · Highly stable fibronectin-mimetic-peptide-based supramolecular hydrogel to accelerate corneal wound healing.Acta biomaterialia (2023)PMID 33403597D'Amico AG, Maugeri G et al. · PACAP and NAP: Effect of Two Functionally Related Peptides in Diabetic Retinopathy.Journal of molecular neuroscience : MN (2022)Human PMID 31640849Dou X, Lee JY et al. · Neuroprotective Peptide NAPVSIPQ Antagonizes Ethanol Inhibition of L1 Adhesion by Promoting the Dissociation of L1 and Ankyrin-G.Biological psychiatry (2021)Human PMID 33329371Gozes I · The ADNP Syndrome and CP201 (NAP) Potential and Hope.Frontiers in neurology (2020)Human PMID 28257938Zhang J, Wei SY et al. · Davunetide improves spatial learning and memory in Alzheimer's disease-associated rats.Physiology & behavior (2018)PMID 24533805Magen I, Gozes I · Davunetide: Peptide therapeutic in neurological disorders.Current medicinal chemistry (2015)Human PMID 25505609Magen I, Ostritsky R et al. · Intranasal NAP (davunetide) decreases tau hyperphosphorylation and moderately improves behavioral deficits in mice overexpressing α-synuclein.Pharmacology research & perspectives (2014)Human PMID 23971871Morimoto BH, Fox AW et al. · Davunetide: a review of safety and efficacy data with a focus on neurodegenerative diseases.Expert review of clinical pharmacology (2014)Human PMID 21827858Idan-Feldman A, Schirer Y et al. · Davunetide (NAP) as a preventative treatment for central nervous system complications in a diabetes rat model.Neurobiology of disease (2012)Human

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