Davunetide
Also known as: AL-108, AL-208, AL‑108, Allon-108, NAP, NAPVSIPQ
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Summary
Davunetide (also called NAP or AL‑108) is an 8‑amino‑acid peptide (NAPVSIPQ) investigated for neurodegenerative disorders such as Alzheimer’s disease and progressive supranuclear palsy. Clinical trials have not demonstrated sufficient efficacy for regulatory approval.
Mechanism of Action
Derived from activity‑dependent neuroprotective protein (ADNP); stabilises microtubules, reduces tau hyperphosphorylation and oxidative stress, and exerts anti‑apoptotic neuroprotective effects.
Routes of Administration
Goals & Uses
- Tau pathology reductionNeurodegenerative DiseaseModerate
- Neuroprotection in progressive supranuclear palsyNeurodegenerative DiseaseLow
- Cognitive enhancement in schizophreniaPsychiatric DisorderLow
- Microtubule stabilizationMechanism Based TargetModerate
- Cognitive improvement in mild cognitive impairmentCognitive EnhancementLow
- Progressive supranuclear palsyMovement DisorderModerate
- Alzheimer's diseaseNeurodegenerationModerate
Contraindications
- Hypersensitivity to davunetide or excipientsAllergic/ImmunologicHigh
- Known hypersensitivity to peptide componentsAllergyModerate
Adverse Effects
- Nasal irritationLocal/NasalCommon
- NasopharyngitisInfectiousUncommon
- HeadacheNeurologicUncommonPain in the head or upper neck
- Epistaxis (nosebleed)Local/NasalUncommon
- Transient dizzinessSystemicRare
Drug Interactions
- Tau-targeting therapiesLow
- none identifiedLow
Population Constraints
- PregnancyReproductive SafetyRelative
- Pediatric populationsAgeRelative
- Pregnant womenReproductiveRelative
- Children <12 yearsAgeRelative
- Severe renal/hepatic impairmentOrgan ImpairmentRelative
Regulatory Status
- European UnionInvestigationalNo EMA marketing authorization.
- United StatesInvestigationalNo FDA approval; studied in clinical trials.
- United KingdomInvestigationalNot licensed for clinical use.
Not approved in any jurisdiction. Development was halted after the Phase 2/3 DAVUNETIDE trial in progressive supranuclear palsy did not meet its primary endpoint (2013). No active IND or regulatory filing known to be ongoing.
Evidence & Sources
No sources recorded yet.
Frequently Asked Questions
What is Davunetide?
Davunetide (also called NAP or AL‑108) is an 8‑amino‑acid peptide (NAPVSIPQ) investigated for neurodegenerative disorders such as Alzheimer’s disease and progressive supranuclear palsy. Clinical trials have not demonstrated sufficient efficacy for regulatory approval.
What is Davunetide used for?
Davunetide is educationally associated with: Tau pathology reduction, Neuroprotection in progressive supranuclear palsy, Cognitive enhancement in schizophrenia, Microtubule stabilization, Cognitive improvement in mild cognitive impairment, Progressive supranuclear palsy, Alzheimer's disease. Educational only — not medical advice.
How is Davunetide administered?
Recorded routes of administration: Intranasal, Intravenous, Subcutaneous.
What are the potential side effects of Davunetide?
Reported adverse effects include: Nasal irritation, Nasopharyngitis, Headache, Epistaxis (nosebleed), Transient dizziness. This list is not exhaustive — consult a qualified clinician.
Who should avoid Davunetide?
Recorded contraindications: Hypersensitivity to davunetide or excipients, Known hypersensitivity to peptide components. Consult a qualified clinician before use.