Davunetide
Davunetide (NAP, NAPVSIPQ, AL-108, AL-208, CP201)
Clinical trials were conducted but did not demonstrate efficacy for the primary endpoint.
A nasal spray peptide that was developed to protect brain cells and slow the progression of progressive supranuclear palsy (PSP), a rare and serious brain disease. The main clinical trial of 313 patients did not show overall benefit, though researchers noted some differences in how men and women responded.
This entry is a cited research summary, not an established treatment reference. Dosing language is included as source context, not as medical instruction.
Safety Summary
In the PSP Phase 2/3 trial (n=313, PMID 24873720), nasal adverse events were more frequent with davunetide than placebo: epistaxis 12% vs 8%, rhinorrhea 10% vs 5%, nasal discomfort 10% vs <1%. These nasal events accounted for many of the treatment-related discontinuations. Serious adverse events were balanced between groups (54 per group), and deaths were similar (11 davunetide vs 10 placebo, consistent with natural PSP history). The source set did not identify a strong systemic ECG or routine laboratory toxicity signal in the PSP trial. Approximately 20% of subjects developed anti-davunetide antibodies in the PSP trial, though no clinical consequences were identified (PMID 23971871). In the aMCI trial (n=144), davunetide was well-tolerated with no serious drug-related adverse events (PMID 23971871). Pre-clinical toxicology studies in rats and dogs using maximum feasible dose showed no test article-related adverse events (PMID 23971871). The IV formulation (AL-208) was also well-tolerated in the CABG trial (PMID 41173865). Overall, safety data from over 700 human subjects supports a favorable safety profile with local nasal tolerability as the primary concern for intranasal dosing.
Clinical check-in
If real-world use or exposure is being considered, review potential interactions, contraindications, and monitoring needs with a licensed clinician rather than relying on summary copy alone.
Sources: [1-19]