Brain & sleep Neuroprotective peptide
Davunetide
Regulatory status
Status at a glance
503A compounding status
Not nominated
We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.
- FDA approval
- Not FDA-approved for any use
- 503B outsourcing
- Not determined
- Anti-doping (WADA)
- Not on the WADA Prohibited List
- DEA schedule
- Not a controlled substance
About peptide status
Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.
This is not medical or legal advice, and we do not publish dosing, sourcing or reconstitution information. Talk with a licensed clinician before using any peptide.
If you think you are having a medical emergency, call 911.
Key takeaway
Davunetide is an investigational neuroprotective peptide derived from a brain protein, studied as an intranasal treatment for the rare neurodegenerative disease progressive supranuclear palsy. Its large pivotal trial clearly failed, showing no benefit over placebo, and earlier signals in other conditions were small and never confirmed. As of 2026 it is not approved.
At a glance
- FDA status
- Investigational peptide, not approved by the FDA
- What it is
- Intranasal neuroprotective treatment, studied chiefly for progressive supranuclear palsy
- Key trial
- Pivotal Phase 2/3 trial clearly negative on both primary endpoints
- Other research
- Earlier signals in other conditions were small and unconfirmed
- Evidence strength
- Low research
Summary
Davunetide is an investigational neuroprotective peptide that failed its pivotal trial in progressive supranuclear palsy. See how it works and where it stands.
What is davunetide?
Davunetide is an experimental peptide of eight amino acids (also known as NAP) derived from activity-dependent neuroprotective protein, a protein involved in brain development and protection. Originally developed by Allon Therapeutics and delivered intranasally, it was studied for progressive supranuclear palsy, a rare disorder related to abnormal tau protein, and earlier for conditions such as mild cognitive impairment and schizophrenia. It is investigational and not approved.
How does it work?
Davunetide is proposed to stabilize microtubules, the internal scaffolding of nerve cells, and to reduce abnormal phosphorylation of tau, a protein that forms damaging tangles in several neurodegenerative diseases. It is derived from a neuroprotective protein and showed protective effects in laboratory models. This describes the proposed mechanism; as the pivotal trial below shows, it did not translate into clinical benefit.
Is it FDA-approved?
Safety note
Status: Investigational peptide, not approved by the FDA
Category: In clinical trials · Primary body area: Brain & sleep
No. Davunetide is investigational and not approved. Its lead program in progressive supranuclear palsy was halted after the pivotal trial, and later exploratory work in other conditions remains early-stage.
What does the research show?
Editor’s note
Evidence strength: Low research (1 human · 0 animal/cell studies)
The large, well-powered pivotal trial was clearly negative on both primary endpoints, and earlier signals in other conditions were small and never confirmed.
The pivotal evidence is clearly negative, and earlier signals in other conditions were never confirmed.
| Condition | Evidence | Result |
|---|---|---|
| Progressive supranuclear palsy | Phase 2/3 trial indexed on PubMed, over 300 patients enrolled | No difference from placebo on either co-primary endpoint |
| Conditions such as mild cognitive impairment and schizophrenia | Earlier, smaller exploratory signals, summarized in a review | Never confirmed in larger trials |
The authors of the pivotal trial concluded that davunetide is not an effective treatment for progressive supranuclear palsy. The human evidence does not support a benefit.
Sources: the Phase 2/3 progressive supranuclear palsy trial (Boxer et al., The Lancet Neurology, 2014, DOI: 10.1016/S1474-4422(14)70088-2) and a review of davunetide (Gozes, Current Pharmaceutical Design, 2011, DOI: 10.2174/138161211795589373), both indexed on PubMed. This document is educational, is not medical advice or a health claim, and is not an offer to sell any product.
Registered human trials
1 registered human trial on ClinicalTrials.gov that we reviewed
Sources
- [1]
- [2]
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