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GA Depot
- Development stage
- Unknown
- Lead developer
- Mapi Pharma
- Modality
- Peptides
- Administration
- Intramuscular
01
Overview
GA Depot is a long-acting, extended-release depot formulation of glatiramer acetate (the active ingredient in Copaxone) developed by Mapi Pharma in collaboration with Viatris. It consists of extended-release microspheres designed for once-monthly intramuscular injection, offering a more convenient dosing schedule compared to the daily or thrice-weekly subcutaneous injections of conventional glatiramer acetate formulations. Glatiramer acetate is an immunomodulatory agent that binds to major histocompatibility complex (MHC) class II molecules and acts as a T-cell receptor antagonist, shifting the immune response from pro-inflammatory Th1 cells to anti-inflammatory Th2 cells. GA Depot has been investigated for relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). Although a Phase III trial in RMS demonstrated a significant reduction in the annualized relapse rate, the FDA issued a Complete Response Letter in March 2024 declining to approve the NDA.
- Brand names
- GA Depot
- Other names
- Glatiramer Acetate Depotlong-acting glatiramer acetatelong-acting intramuscular glatiramer acetate
02
Targets
MHC II (Major histocompatibility complex class II receptor)γδ TCR (T-cell receptor)
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