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Disodium edetate (minimal amount in March B12 injection) Disodium edetate is used in B12 injections as a chelating agent to help stabilize the formulation and enhance the absorption of trace minerals like zinc, manganese, and copper, which are often included alongside vitamin B12 for supplementation
These treatments vary significantly in terms of injection depth , needle type , and session frequency , which can ultimately affect patient experience and outcomes
RELATED STORY | FDA says shortage of popular diabetes, weight-loss drugs resolved For now though, according to the recent court filing, the FDA said it will not take action against the pharmacies making the drug while it looks into potentially adding it back to its shortage list
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Heres the realistic timeline: Phase 3 trials (AMAZE program): - AMAZE 1 (obesity) started February 2026, enrolling ~1,150 participants - Primary completion estimated: June 2029 - Phase 3 in T2D also being planned following the ADA 2026 data US FDA approval (projected): Q4 2030 at the earliest (GlobalData estimate) EU EMA approval (projected): Q1 2031 at the earliest Bulgaria and Eastern Europe: Typically 612 months after EMA approval for market access, depending on national reimbursement negotiations
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