At a glance
- Davunetide (NAP) is not an FDA-approved drug: Drugs@FDA has no record of it.
- PubMed lists 179 publications mentioning it, including 8 randomized controlled trials and 72 animal-only studies.
- ClinicalTrials.gov lists 5 registered studies testing it (0 active).
- FDA’s adverse event system (FAERS) has no reports mentioning it.
Research topics
Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).
Regulatory status
Drugs@FDA applications
No application found in Drugs@FDA, FDA's database of approved drugs.
Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query
FDA compounding safety list
Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.
Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026
Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.
Scientific publications
Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.
Latest publications
- NAP peptide modulated proteome profiling of rat brain cortex under hypobaric hypoxia.
- Activity-dependent neuroprotective protein (ADNP) derived peptide NAP prevents musculoskeletal abnormalities in ovariectomized mice.
- Dramatic sex differences leading to different brain disease presentation: The requirement for sex-specific medications with ADNP/davunetide as a case study.
- ADNP Functions During Early Brain Development and Their Relevance to ASD and ADNP Syndrome.
- Opposite molecular sex correlations in tauopathy paralleled by motor and cognitive efficacy of davunetide in women.
- Microtubule-stabilizing drugs suppress convulsions in a C. elegans model of CAMSAP disorders.
- Drosophila wing is a high-throughput and versatile screening tool for Tau-mediated disease mechanisms and drug discovery.
- Potential role of MRI to optimize clinical trial design for progressive supranuclear palsy and corticobasal degeneration.
- Davunetide promotes structural and functional recovery of the injured spinal cord by promoting autophagy.
- Systemic davunetide provides sex-specific neuroprotection during Coronary Artery Bypass Grafting (CABG).
Source: PubMed (NCBI) · verified October 30, 2026
Clinical trials
- Registered
- 5
- Active
- 0
- With posted results
- 1
Conditions studied
| Study | Status | Phase | Start |
|---|---|---|---|
| Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy | Completed | Phase 2, Phase 3 | Oct 2010 |
| Davunetide (AL-108) in Predicted Tauopathies - Pilot Study | Completed | Phase 1 | Jan 2010 |
| A Multicenter Study of NAP (AL-108) in Schizophrenia | Completed | Phase 2 | Jul 2007 |
| Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment | Completed | Phase 2 | Jan 2007 |
| Study to Evaluate Safety, Tolerability, and Effect of AL208 on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery | Completed | Phase 2 | Aug 2006 |
All 5 studies on ClinicalTrials.gov ↗
Source: ClinicalTrials.gov · verified October 30, 2026
Adverse event reports
No FAERS reports mention this peptide.
Change history
No changes since monitoring began on October 30, 2026.