Peptide LibraryDavunetide
Davunetide is a neuroprotective octapeptide. Davunetide corresponds to the NAPVSIPQ motif of activity-dependent neuroprotective protein. Preclinical work describes interaction with tubulin and microtubule-end-binding proteins, promoting microtubule assembly and stability and reducing tau hyperphosphorylation. The microtubule hypothesis was the rationale for testing it in tauopathies, where it ultimately failed to show clinical benefit.
For research use only.
Key Facts
- CAS
- —
- Molecular Weight (MW)
- 824.9 g/mol
- Half-life
- —
- FDA status
- Withdrawn / Rejected
- Evidence level
- Clinical Trial Evidence
- Human dose established
- Yes
- Administration Route
- Intranasal
- Frequency
- Twice daily in the progressive supranuclear palsy trial
- Last updated
- Nov 7, 2026
- Reviewed
- Nov 7, 2026
Research summary
Eight-amino-acid fragment of activity-dependent neuroprotective protein, investigated for tauopathies. A phase 3 trial in progressive supranuclear palsy did not meet its endpoints and development for that indication stopped. Not FDA-approved.
Research evidence
- Regulatory review (FDA label)None in reviewed sources
- Controlled human trials2 reviewed sources
- Early or uncontrolled human studiesNone in reviewed sources
- Lab & animal studiesNone in reviewed sources
How it works
Each step shows whether the sources Peptide Library has reviewed include that kind of research. Counts are reviewed sources, not every study ever published. Reviews and programme summaries that describe human use are shown as "reported", not as trials, and registered trials without published results are listed but not counted. A higher step means research has progressed further; it does not mean a compound works better or is safer. Compounds whose evidence has not been reviewed yet show "Not reviewed" instead of a guess.
Peptide Library's Davunetide profile summarises 5 cited studies listed in the Science section, the compound's regulatory status, and research-protocol parameters reported for it. It is a research reference, not medical advice.
Davunetide dosage evidence
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.
| Human dosing established | Yes |
|---|---|
| Studied dose range | 5–30 mg intranasally in trials |
| Route | Intranasal |
| Frequency | Twice daily in the progressive supranuclear palsy trial |
| Duration studied | 12–52 weeks in the published trials |
| Evidence level | Clinical Trial Evidence |
| Last reviewed | 2026-11-07 |
Research-reported dosing
Doses as studied, one row per regimen. Different trials used different regimens; they are listed separately rather than averaged.
| Study / context | Population | Dose | Route | Frequency | Duration | Outcome studied | Source |
|---|---|---|---|---|---|---|---|
| Progressive supranuclear palsy — phase 2/3, Lancet Neurology 2014 (NCT01110720)Clinical trial · Randomised, double-blind, placebo-controlled phase 2/3 trial | Adults with progressive supranuclear palsy at 48 centres (313 randomised) | 30 mg, or placebo | Intranasal | Twice daily | 52 weeks | No 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 PSP | Davunetide 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 trial | Adults with schizophrenia continuing their antipsychotic treatment (n=63) | 5 mg or 30 mg, or placebo | Intranasal | Not stated in the indexed abstract | 12 weeks | No significant difference on the MATRICS cognitive battery (p=0.45); a significant treatment effect on the UPSA functional-capacity test (p=0.048); well tolerated | Effect 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.
Sequence & molecular data
| Amino acid sequence | Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln |
|---|---|
| Molecular formula | C36H60N10O12 |
| Molecular weight | 824.9 g/mol |
| PubChem CID | 9832404 |
| FDA UNII | GF00K3IIWE |
| ChEMBL | CHEMBL2103826 |
| DrugBank | DB12613 |
Identifiers link to the public PubChem, FDA Substance Registration (UNII), ChEMBL and DrugBank records for the same entity.
Science
Mechanism of Action
Davunetide corresponds to the NAPVSIPQ motif of activity-dependent neuroprotective protein. Preclinical work describes interaction with tubulin and microtubule-end-binding proteins, promoting microtubule assembly and stability and reducing tau hyperphosphorylation. The microtubule hypothesis was the rationale for testing it in tauopathies, where it ultimately failed to show clinical benefit.
Studies
- Systemic davunetide provides sex-specific neuroprotection during Coronary Artery Bypass Grafting (CABG)
- Davunetide sex-dependently boosts memory in prodromal Alzheimer's disease
- Effect of the neuroprotective peptide davunetide (AL-108) on cognition and functional capacity in schizophrenia
- Intranasal NAP (Davunetide): Neuroprotection and circadian rhythmicity
- An update on the efficacy of anti-inflammatory agents for patients with schizophrenia: a meta-analysis
Research statistics
174 PubMed publications · 8.1% human clinical research · 5 registered trials
Counts of published research through 2026-11-01, not evidence that it works. Publications by year, study types and trials · How publications are counted
Regulatory & research status
Davunetide was withdrawn from the market or rejected for approval. It is not an approved product.
| FDA status | Withdrawn / Rejected |
|---|---|
| Research status | Development discontinued |
| Availability | Research-Only |
| WADA (sport) | Unknown / Not Listed |
| Library classification | Clinical Trial |
How FDA approval, compounding and research-only status differ
Benefits
—
Davunetide side effects
No side effects listed yet for this entry.
Storage & stability
This compound is not supplied as a powder to be mixed, so the freeze-dried powder and reconstitution handling described for research peptides does not apply. Storage conditions are product-specific: follow the label or packaging of the product itself.
Davunetide: frequently asked questions
What is Davunetide?
Eight-amino-acid fragment of activity-dependent neuroprotective protein, investigated for tauopathies. A phase 3 trial in progressive supranuclear palsy did not meet its endpoints and development for that indication stopped. Not FDA-approved.
How does Davunetide work?
Davunetide corresponds to the NAPVSIPQ motif of activity-dependent neuroprotective protein. Preclinical work describes interaction with tubulin and microtubule-end-binding proteins, promoting microtubule assembly and stability and reducing tau hyperphosphorylation.
Is Davunetide FDA approved?
No. Davunetide is not currently FDA-approved. Its development or marketing was discontinued, which can happen for commercial reasons as well as safety or efficacy ones. Any material available today is not an approved product.
What is the amino acid sequence of Davunetide?
Davunetide has the sequence Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln, giving a chain of 8 amino acids. Its molecular formula is C36H60N10O12.
References
- Systemic davunetide provides sex-specific neuroprotection during Coronary Artery Bypass Grafting (CABG) — Transl Psychiatry, 2025External reference
- Davunetide sex-dependently boosts memory in prodromal Alzheimer's disease — Transl Psychiatry, 2024External reference
- Effect of the neuroprotective peptide davunetide (AL-108) on cognition and functional capacity in schizophrenia — Schizophr Res, 2012External reference
- Intranasal NAP (Davunetide): Neuroprotection and circadian rhythmicity — Adv Drug Deliv Rev, 2025External reference
- An update on the efficacy of anti-inflammatory agents for patients with schizophrenia: a meta-analysis — Psychol Med, 2019External reference
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Compiled by Peptide Library Editorial · Reviewed Aug 30, 2026 · Updated Nov 7, 2026 · Version 2
This Davunetide profile is compiled from published literature (5 cited studies linked above), public regulatory records and chemical registries. It describes what research reports; it is not medical advice, and nothing here is a dosing recommendation for humans. Peptide Library does not sell peptides. Editorial policy · How profiles are compiled · Report an error
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