Davunetide

Overview

Davunetide has been used in trials studying the treatment of Progressive Nonfluent Aphasia, Progressive Supranuclear Palsy, Predicted Tauopathies, Including, Corticobasal Degeneration Syndrome, and Frontotemporal Dementia With Parkinsonism Linked to Chromosome 17. Davunetide is the first drug to improve memory performance by impacting the mechanisms that lead to physical damage in the brain caused by neurofibrillary tangles, one of the two established pathological hallmarks that are common to amnestic mild cognitive impairment (aMCI) and Alzheimer's disease (AD). Davunetide is derived from a naturally occurring neuroprotective brain protein known as activity dependent neuroprotective protein.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study to Evaluate the Safety and Efficacy of Davunetide for the Treatment of Progressive Supranuclear Palsy	2010/04/27	NCT01110720	Phase 2	Completed	Allon Therapeutics
Davunetide (AL-108) in Predicted Tauopathies - Pilot Study	2010/01/26	NCT01056965	Phase 1	Completed	University of California, San Francisco
A Multicenter Study of NAP (AL-108) in Schizophrenia	2007/07/23	NCT00505765	Phase 2	Completed	University of California, Los Angeles
Safety, Tolerability and Efficacy Study to Evaluate Subjects With Mild Cognitive Impairment	2007/01/17	NCT00422981	Phase 2	Completed	Allon Therapeutics
Study to Evaluate Safety, Tolerability, and Effect of AL208 on Mild Cognitive Impairment Following Coronary Artery Bypass Graft Surgery	2006/11/27	NCT00404014	Phase 2	Completed	Allon Therapeutics

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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