Is davunetide FDA-approved, and what does the research show?

What is davunetide?

Davunetide is an investigational peptide drug: a short chain of eight amino acids, the building blocks of proteins ¹, ². It is not FDA-approved ³. It is not a wellness, weight-loss, memory-boosting or performance product: the trials cited here tested it as a possible treatment for brain conditions ², ⁴, ⁵. Research papers also call it NAP or AL-108 ².

The peptide is a fragment of a much larger natural protein, activity-dependent neuroprotective protein, or ADNP ¹, ². A 2011 review describes ADNP as "a molecule that is essential for brain formation" ¹. One trial record says ADNP is assumed to be too large to pass from the blood into the brain ⁵. The fragment was chosen for study as a drug instead, the same record says ⁵.

The trials cited here in progressive supranuclear palsy, mild cognitive impairment and schizophrenia gave davunetide as a nasal spray ², ⁴, ⁵. One record describes AL-108 as "an intranasal drug product containing NAP" ⁵. A separate record covers "AL208" given into a vein, and indexes it under davunetide ⁹; a 2025 paper calls it "intravenous davunetide" ¹⁰.

Is davunetide FDA-approved?

Davunetide is not FDA-approved: Drugs@FDA lists no approved davunetide product as of November 9, 2026 ³. FDA's rules count an amino acid chain as a protein, a biologic, only above 40 amino acids; davunetide has eight ², ¹¹. Because no product is approved, there is no FDA label for it ³.

ClinicalTrials.gov is the U.S. government's registry of clinical studies. The five ClinicalTrials.gov records cited here each read "Completed", with last updates posted from October 24, 2012 to April 5, 2019 ⁵, ⁶, ⁷, ⁸, ⁹. The latest completion date among the five is December 2012 ⁶, ⁸. The largest was a phase 2/3 trial in progressive supranuclear palsy ², ⁶. A phase 2/3 trial combines the middle and late stages of drug testing; its authors called it "pivotal (intended for registration)" ².

Allon Therapeutics sponsored three of the five trials ⁶, ⁷, ⁹. The largest trial's paper says Allon "was purchased in August, 2013, by Paladin Laboratories" ². None of the sources cited here says whether any company is developing davunetide today. A 2024 paper's authors state that a patent application naming two of them as inventors is licensed to ExoNavis Therapeutics Ltd ¹².

None of the sources cited here states a lawful route to davunetide outside a clinical trial. Compounding is the preparation of a medicine by a pharmacy or an outsourcing facility rather than by a drug manufacturer. FDA's list of bulk substances nominated for compounding under section 503A of the drug law, updated May 14, 2026, does not name davunetide, NAP or AL-108 ¹³. Neither does the matching 503B list for outsourcing facilities, updated March 21, 2025 ¹⁴. None of the five registry records cited here lists expanded access ⁵, ⁶, ⁷, ⁸, ⁹.

See the FDA status of every peptide, updated weekly.

How does davunetide work?

How davunetide might work is proposed from laboratory and animal studies ¹, ². The proposed target is the microtubule, part of a nerve cell's internal skeleton ², ⁵. Microtubules "function to transport nutrients and chemical messengers along the cell," one trial record explains ⁵. A protein called tau normally binds to microtubules and steadies them ⁵. In some brain diseases tau comes loose and clumps inside brain cells, and those diseases are called tauopathies ¹, ², ⁵.

Shown in cells: davunetide protected against cell death and microtubule damage from several toxic insults ². Studied in mice that carry human tau gene mutations: it lessened deposits of abnormal tau and improved scores on behavioral tests such as a water maze ².

The authors of the largest human trial added a caution. Their trial measured neither the drug's level in the body nor any marker of its action. So, they wrote, "we cannot be certain that sufficient concentrations of davunetide entered the CNS to exert an effect" ². CNS means the central nervous system, the brain and spinal cord.

What does the research show?

Davunetide has been studied in people in randomized, placebo-controlled trials. Randomized means that chance decided who got the drug. A placebo is a look-alike treatment with no drug in it. The primary outcome is the main measure a trial names in advance.

Progressive supranuclear palsy (PSP). PSP is a degenerative brain disease whose most common form is marked by early falls, slowed eye movements, stiffness and slowed movement ². The 2014 trial paper said PSP had "no approved or effective therapies" ². The phase 2/3 trial randomized 313 people with PSP at 48 centers in six countries ². For 52 weeks, 157 were assigned davunetide nasal spray twice a day and 156 a matching placebo spray ². The trial was double-blind: neither participants nor study staff knew who received which spray ².

Its primary outcomes were "the change from baseline in PSP Rating Scale (PSPRS) and Schwab and England Activities of Daily Living (SEADL) scale at up to 52 weeks" ². The PSPRS scores 28 signs and symptoms from 0, normal, to 100, most disability ². The SEADL rates overall disability in daily life ². In the paper's words, "The davunetide and placebo groups did not differ in the change from baseline in PSPRS ... or SEADL" ².

The median PSPRS change was 11.8 points in each group, with a 95% confidence interval of 10.5 to 13.0 in both (p = 0.41) ². A confidence interval is the range in which the true value probably lies. The median SEADL change was −0.20 in each group (p = 0.92) ². A p value gauges how easily chance alone could produce a difference, and by convention a value under 0.05 counts as statistically significant. That analysis covered 151 people on davunetide and 153 on placebo ².

An analysis of the 241 people with complete 52-week data also found no difference: mean PSPRS change 11.3 on davunetide, 10.9 on placebo (p = 0.72) ². The two secondary outcomes showed no group difference either: a clinician's overall rating of change, and the volume of the brain's fluid spaces on MRI scans ². Complete 52-week data were recorded for 241 people, 118 on davunetide and 123 on placebo ². The authors concluded that davunetide "is not an effective treatment for PSP" ².

Mild cognitive impairment. This trial enrolled people aged 55 to 85 with a memory complaint, confirmed by a spouse or companion, and a low score on a memory test ⁷. The 2011 review calls this condition, amnestic mild cognitive impairment, "a precursor to Alzheimer's disease" ¹. The phase 2 trial randomized 144 people, two to one, to AL-108 nasal spray or placebo for 12 weeks ⁴, ⁷. It was an ascending-dose study: a first group of participants was assigned a low dose or placebo, and a second group a high dose or placebo ⁴. Pooling the placebo groups gave three groups of about 48 each ⁴.

The registered primary outcome was "Change from baseline to Week 12 on the Composite Memory Variable" ⁷. The trial's paper reports that the analyses "failed to detect a statistically significant difference between the treatment groups on the composite cognitive memory score" ⁴. The registry lists the individual tests of the battery as secondary outcomes ⁷. The paper also reports "signals of potential efficacy in 2 tests of memory and attention" ⁴.

Schizophrenia. Schizophrenia is a long-term psychiatric illness, and this trial studied the problems with attention, memory and planning that often come with it ⁵. UCLA sponsored the 12-week, double-blind, phase 2 trial under a contract funded by the National Institute of Mental Health ⁵. It added AL-108 nasal spray or placebo to each participant's antipsychotic medicine ⁵. Sixty-nine people were randomized and 63 started treatment ⁵. Of those, 21 were in the higher of two dose arms, 20 in the lower and 22 on placebo ⁵.

The primary outcome, listed at weeks 6 and 12, was the change in the overall score of the MATRICS Consensus Cognitive Battery, a set of ten thinking tests ⁵. At 12 weeks the mean change was 3.9 points in the higher-dose arm (18 people analyzed) and 4.6 in the lower-dose arm (17) ⁵. On placebo it was 3.2 (19 people) ⁵. Neither arm differed from placebo in the posted analysis: p = 0.44 for the higher dose and p = 0.21 for the lower ⁵. At week 6 the mean changes were 1.3, 2.3 and −0.2 in the same order, and the record posts no statistical test for that time point ⁵.

A secondary outcome, the UPSA, tests everyday living skills on a scale of 0 to 100 ⁵. At 12 weeks its mean change was 4.9 points in the higher-dose arm, 8.9 in the lower-dose arm and 0.3 on placebo ⁵. The record posts no statistical test for that measure ⁵.

Two records without posted results. A pilot study at the University of California, San Francisco, randomized 12 people with PSP or a related tau disease ⁸. They received davunetide nasal spray or placebo for 12 weeks ⁸. The primary outcome was safety, and the record reads "Completed" with no results posted ⁸.

The fifth record covers the product named "AL208", given into a vein as a single dose to people having heart bypass surgery ⁹. It enrolled 234 people, was completed in June 2008 and posts no results ⁹.

The registry lists a 2025 paper on davunetide in bypass surgery as derived from that record ⁹. It lists a 2024 paper on davunetide as derived from the mild cognitive impairment record ⁷.

A 2024 paper reanalyzed the mild cognitive impairment trial by sex and reported gains on single memory tests ¹². A 2025 paper on the bypass-surgery trial reported sex differences in drug levels, findings "requiring caution due to the small cohort size" ¹⁰. Of its 33 test scores in men, one reached a P value below 0.05 ¹⁰. None of the sources cited here studies davunetide for weight loss, athletic performance, or memory in healthy people.

What are the side effects?

An adverse event is any health problem recorded during a trial, whether or not the drug caused it. In the PSP trial, 145 of 156 people on davunetide (92.9%) and 148 of 156 on placebo (94.9%) had at least one adverse event over the year ². One person assigned davunetide did not receive it, so the safety counts are out of 156 in each group ². Nasal events were more frequent with davunetide: nosebleed in 18 of 156 people against 13 of 156 on placebo, and runny nose in 15 against 8 ². Nasal congestion occurred in 18 against 3, and nasal discomfort in 15 against 1 ².

Twenty-one people on davunetide and 12 on placebo stopped the study drug because of adverse events, "with most related to epistaxis or nasal congestion" ². Epistaxis is the medical word for nosebleed. There were 54 serious adverse events in each group, among them 11 deaths in the davunetide group and 10 in the placebo group ². The paper counted an event as serious if it led to hospitalization or death, and it described davunetide as "well tolerated" ².

In the schizophrenia trial, restlessness was reported in 4 of 21 people in the higher-dose arm and 9 of 20 in the lower-dose arm ⁵. It was reported in 2 of 22 on placebo ⁵. One serious event, palpitations, occurred in the higher-dose arm, and none in the other two groups ⁵. Three people left that trial because of an adverse event: one in the higher-dose arm, two in the lower and none on placebo ⁵.

The mild cognitive impairment paper says the spray "was generally safe and well tolerated" ⁴. The longest treatment in these sources lasted 52 weeks ². None of the sources cited here reports the safety of davunetide beyond one year, or in healthy people.

In sport

Davunetide is not named on the 2026 Prohibited List of WADA, the World Anti-Doping Agency ¹⁵. The names NAP and AL-108 do not appear on it either ¹⁵. Section S2, on peptide hormones and growth factors, does not name ADNP, the protein davunetide comes from ¹⁵.

Section S0 of the list deals with non-approved substances: "Any pharmacological substance which is not addressed by any of the subsequent sections of the List and with no current approval by any governmental regulatory health authority for human therapeutic use (e.g. drugs under pre-clinical or clinical development or discontinued, designer drugs, substances approved only for veterinary use) is prohibited at all times" ¹⁵. Only FDA's records were read for approvals, and Drugs@FDA lists no approved davunetide product ³.

What JumpstartMD offers

JumpstartMD does not prescribe davunetide. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.