Davunetide (NAP/AL-108) Side Effects: Safety Signals and Warnings
Davunetide (NAP/AL-108) safety concerns are compound-specific. The main listed side effects are Nasal irritation, Headache, and Upper respiratory tract infection. The main warning signals are Phase 2/3 PSP trial failed to meet primary endpoint, raising questions about clinical translatability, Development was discontinued by Allon Therapeutics/Paladin Labs after PSP trial results, and Gap between robust preclinical and modest clinical results suggests challenges in human translation.
Direct Answer
Davunetide (NAP) has Phase 2 data in schizophrenia and PSP, but the PSP Phase 2 trial failed to meet its primary endpoint, which is a significant setback. The schizophrenia data showed cognitive improvement signals in a small trial. The ADNP-derived mechanism is scientifically interesting but clinical development is stalled. Current evidence does not support a confident research protocol.
- Evidence grade
- Level C
- Research status
- Phase 2
- Category
- Cognitive & Nootropic
- Evidence context
- ADNP-derived neuropeptide research, microtubule-stabilizing cognitive peptide mechanistic studies
Reported Side Effects
- Nasal irritation
- Headache
- Upper respiratory tract infection
- Rhinorrhea
- Generally well-tolerated in clinical trials
Warnings
- Phase 2/3 PSP trial failed to meet primary endpoint, raising questions about clinical translatability
- Development was discontinued by Allon Therapeutics/Paladin Labs after PSP trial results
- Gap between robust preclinical and modest clinical results suggests challenges in human translation
- Intranasal formulation stability and dosing consistency may vary
Known or Plausible Interactions
- Microtubule-disrupting agents (may counteract davunetide effects)
- Tau-targeting therapies (potential synergy or redundancy)
- Other neuroprotective peptides (Humanin, Colivelin - complementary mechanisms)
Regulatory Context
Investigational drug; clinical development paused after Phase 2/3; available as research compound.
Evidence Snapshot
| Evidence grade | Level C |
|---|---|
| Research status | Phase 2 |
| Best supported outcomes | Microtubule Stabilization (Level B), Cognitive Function (MCI) (Level C), PSP Disease Modification (Level C), and Neuroprotection in Animal Models (Level C) |
| Primary citation count | 3 |
| Last reviewed | 2026-08-27 |
Quick Answers
What are the side effects of Davunetide (NAP/AL-108)?
Davunetide (NAP/AL-108) safety concerns are compound-specific. The main listed side effects are Nasal irritation, Headache, and Upper respiratory tract infection. The main warning signals are Phase 2/3 PSP trial failed to meet primary endpoint, raising questions about clinical translatability, Development was discontinued by Allon Therapeutics/Paladin Labs after PSP trial results, and Gap between robust preclinical and modest clinical results suggests challenges in human translation.
What is the evidence level for Davunetide (NAP/AL-108)?
Davunetide (NAP/AL-108) is rated Level C. Its current research status is Phase 2.
What is Davunetide (NAP/AL-108) best known for?
ADNP-derived neuropeptide research, microtubule-stabilizing cognitive peptide mechanistic studies.
Where can I read the full Davunetide (NAP/AL-108) evidence review?
The full evidence review is available at https://examinepeptides.com/library/davunetide.
Related Guides
How to Cite This Page
ExaminePeptides. "Davunetide (NAP/AL-108) Side Effects: Safety Signals and Warnings." Last reviewed 2026-08-27. https://examinepeptides.com/answers/davunetide-side-effects-safety/
This static answer page is built for fast indexing and direct citation. It summarizes the matching full evidence review and links back to primary sources where the source database includes them.