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
- Best for
- 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 | 2026-04-04 |
Related Guides
How to Cite This Page
ExaminePeptides. "Davunetide (NAP/AL-108) Side Effects: Safety Signals and Warnings." Last reviewed 2026-04-04. https://examinepeptides.com/answers/davunetide-side-effects-safety/
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