Efpeglenatide
/ Long-acting GLP-1 receptor agonist with glucagon receptor selectivity (Hanmi/Sanofi)ALIAS · LongGLP · GS-1428 · HM-11260C · Efpeglenatide
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Tier 2. AMPLITUDE-O Phase 3 cardiovascular outcomes trial (Gerstein and colleagues, NEJM 2021) demonstrated CV benefit in type 2 diabetes. Despite positive Phase 3 data, Hanmi/Sanofi did not file for FDA approval; Hanmi reacquired global rights from Sanofi in 2020 and the molecule's commercial path has been ambiguous since.
Efpeglenatide is a synthetic exendin-4-derived GLP-1 receptor agonist conjugated to a non-glycosylated immunoglobulin Fc fragment via a flexible linker (Hanmi's LAPSCOVERY long-acting protein technology). The Fc conjugation extends plasma half-life sufficient to support once-weekly or longer-interval subcutaneous dosing. Receptor activity is selective for the GLP-1 receptor; despite the alias 'LongGLP', the molecule is not a glucagon receptor co-agonist in the survodutide/mazdutide sense.
Tier 2. The AMPLITUDE-O Phase 3 cardiovascular outcomes trial (Gerstein and colleagues, NEJM 2021) randomised 4,076 participants with T2D and either established CV disease or CKD with at least one CV risk factor to efpeglenatide or placebo; efpeglenatide reduced major adverse cardiovascular events versus placebo (HR 0.73). Earlier Phase 2 trials in T2D demonstrated dose-dependent HbA1c and weight reduction.
Class GLP-1 receptor agonist adverse events (nausea, vomiting, diarrhoea) at expected frequencies. AMPLITUDE-O reported acceptable safety with no unexpected signals. Class C-cell tumour and pancreatitis concerns apply.
Regulatory status
- FDA status:
- Not FDA-approved
- Compounding:
- Compounding eligibility ambiguous
The disconnect between positive Phase 3 CVOT data and lack of regulatory filing is the dominant fact about efpeglenatide. Hanmi reacquired global rights from Sanofi in 2020; subsequent commercial path has been unclear. The molecule serves as a regulatory-history reference and as evidence that Phase 3 CV benefit is not, by itself, sufficient to drive an approval filing in a competitive class. Vendor research-grade material is not equivalent to clinical-grade efpeglenatide.