Davunetide: Dosing Protocols
Dosing guidelines, reconstitution, and administration information
๐TL;DR
- โข1 dosing protocols documented
- โขReconstitution instructions included
- โขStorage: Store nasal spray at controlled room temperature. Lyophilized research material stored at -20 degrees C.
Protocol Quick-Reference
Neuroprotection in tauopathies
Dosing
Amount
30 mg twice daily
Frequency
Twice daily
Duration
52 weeks
Administration
Route
IntranasalTiming
Administered as a nasal spray solution. Intranasal delivery provides direct CNS access via olfactory and trigeminal nerve pathways.
Cycle
Duration
52 weeks
Repeatable
Single cycle
โ๏ธ Suggested Bloodwork (3 tests)
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
๐ก Key Considerations
- โFailed efficacy: the Phase 2/3 PSP trial showed no difference from placebo on primary endpoints
- โOriginal developer (Allon Therapeutics) became insolvent after trial failure
- โCurrently being evaluated only for ADNP syndrome by ExoNavis (Phase 3 initiated 2024)
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| Purpose | Dose | Frequency | Duration | Notes |
|---|---|---|---|---|
| PSP Phase 2/3 Trial (Boxer et al., 2014) | 30 mg twice daily via intranasal spray | Twice daily | 52 weeks | Trial failed to show efficacy. Davunetide did not differ from placebo on primary endpoints. |
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๐Reconstitution Instructions
Davunetide was formulated as a ready-to-use intranasal spray solution in clinical trials. No reconstitution required for the nasal spray formulation.
Recommended Injection Sites
- โIntranasal (nasal spray delivery)
๐งStorage Requirements
Store nasal spray at controlled room temperature. Lyophilized research material stored at -20 degrees C.
Community Dosing Protocols
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Before You Begin
Review safety warnings and contraindications before starting any protocol.
Important Disclaimer#
Davunetide is not approved for any therapeutic use. The PSP trial failed, and the compound is currently being evaluated only for ADNP syndrome in a phase 3 trial. All dosing information is from clinical trial protocols.
Clinical Trial Dosing#
PSP Phase 2/3 Trial (Failed)#
The pivotal trial enrolled 313 participants randomized to davunetide (30 mg twice daily intranasally) or placebo for 52 weeks. The trial failed to show efficacy on primary endpoints.
ADNP Syndrome Phase 3 Trial (Ongoing)#
ExoNavis initiated a phase 3 trial in October 2024 testing davunetide in 97 children with ADNP mutations. Specific dosing details for this trial are available through clinical trial registries.
Route of Administration#
Intranasal delivery provides direct CNS access via olfactory and trigeminal nerve pathways, avoiding the need for injection and bypassing the blood-brain barrier.
Dosing Context#
Davunetide belongs to the Neuroprotective category of research peptides. Dosing protocols for Davunetide are derived from available clinical trial data. These protocols are provided for research reference only and do not constitute medical advice. Actual dosing decisions should be made by qualified healthcare providers based on individual patient factors.
Research Protocols#
The following dosing protocols have been documented in clinical research for Davunetide:
PSP Phase 2/3 Trial (Boxer et al., 2014)#
Dose: 30 mg twice daily via intranasal spray
Frequency: Twice daily
Duration: 52 weeks
Trial failed to show efficacy. Davunetide did not differ from placebo on primary endpoints.
Reconstitution and Preparation#
Davunetide was formulated as a ready-to-use intranasal spray solution in clinical trials. No reconstitution required for the nasal spray formulation.
Injection Sites#
Recommended injection sites for Davunetide include:
- Intranasal (nasal spray delivery)
Site rotation is recommended to minimize local tissue reactions and ensure consistent absorption.
Storage Requirements#
Store nasal spray at controlled room temperature. Lyophilized research material stored at -20 degrees C.
Related Reading#
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Medical Disclaimer
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.