Also known as: NAP, AL-108, CP201
Neuroprotection in tauopathies
Amount
30 mg twice daily
Frequency
Twice daily
Duration
52 weeks
Route
IntranasalTiming
Administered as a nasal spray solution. Intranasal delivery provides direct CNS access via olfactory and trigeminal nerve pathways.
Duration
52 weeks
Repeatable
Single cycle
CBC with differential
When: Baseline
Why: Baseline blood cell counts
CMP (Comprehensive Metabolic Panel)
When: Baseline
Why: Liver and kidney function baseline
Neurological assessment (PSP Rating Scale)
When: Baseline and every 13 weeks
Why: Monitor disease progression and treatment response
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Davunetide (NAP, AL-108, CP201) is a synthetic octapeptide with the sequence NAPVSIPQ (Asn-Ala-Pro-Val-Ser-Ile-Pro-Gln), derived from the activity-dependent neuroprotective protein (ADNP). It has a molecular weight of 824.93 Da (C36H60N10O12, CAS 211439-12-2). Davunetide was originally developed by Allon Therapeutics (Vancouver, Canada) as an intranasal neuroprotective agent for neurodegenerative diseases.
The compound interacts with tubulin to stabilize microtubules, a mechanism thought to protect neuronal integrity and promote cell survival. After Allon Therapeutics became insolvent following the failure of a pivotal PSP trial, davunetide was acquired by Paladin Labs in 2013. More recently, ExoNavis licensed the compound from Tel Aviv University in 2021 and initiated a phase 3 trial in children with ADNP syndrome in 2024.
Davunetide's neuroprotective mechanism centers on microtubule stabilization.
Microtubules are dynamic cytoskeletal structures essential for neuronal shape, intracellular transport, and synaptic function. Davunetide interacts with both neuronal and glial tubulin to modulate microtubule assembly, promoting stability without rigidifying the dynamic instability that microtubules require for normal function.
ADNP is one of the most essential proteins for brain formation. The NAP motif (NAPVSIPQ) represents the shortest active fragment of ADNP that retains full neuroprotective activity. ADNP mutations cause Helsmoortel-Van der Aa syndrome (ADNP syndrome), a rare neurodevelopmental disorder characterized by intellectual disability, autism-like features, and motor delays.
Davunetide has been evaluated in phase 2/3 clinical trials but failed to demonstrate efficacy in PSP. It remains under active investigation for ADNP syndrome.
Davunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial, published in Lancet Neurology (Boxer AL et al., 2014; PMID: 24873720):
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This website is for educational and informational purposes only. The information provided is not intended to diagnose, treat, cure, or prevent any disease. Always consult with a qualified healthcare professional before using any peptide or supplement.
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