Beinaglutide

Summary

Beinaglutide (also known as rhGLP-1) is a native human GLP-1 analogue approved in China for the treatment of type 2 diabetes mellitus and obesity. It is administered as a subcutaneous injection three times daily due to its short half-life, as it lacks the fatty acid modifications present in longer-acting GLP-1 analogues such as semaglutide or liraglutide.

Mechanism of Action

Beinaglutide is a recombinant human GLP-1 (7-36) amide that acts as a full agonist at the glucagon-like peptide-1 receptor (GLP-1R), stimulating glucose-dependent insulin secretion, suppressing glucagon release, slowing gastric emptying, and reducing appetite via central and peripheral mechanisms.

Routes of Administration

Goals & Uses

• Cardiovascular risk reductionCardiovascularLow
• Weight reduction / anti-obesityMetabolicHigh
• Glycemic control in type 2 diabetesMetabolicHigh
• Beta-cell preservationMetabolicModerate

Contraindications

• Personal or family history of medullary thyroid carcinomaOncologicHigh
• Severe gastrointestinal diseaseGastrointestinalModerate
• Multiple endocrine neoplasia syndrome type 2 (MEN2)OncologicHigh
• Severe renal impairmentOrganModerateKidney function concerns
• Type 1 diabetes mellitusEndocrineModerate

Adverse Effects

• PancreatitisGastrointestinalRareInflammation of the pancreas
• HypoglycemiaMetabolicUncommonAbnormally low blood glucose
• Injection site reactionsLocalCommon
• NauseaGastrointestinalCommonFeeling of sickness or urge to vomit
• VomitingGastrointestinalCommonForceful expulsion of stomach contents
• DiarrheaGastrointestinalCommonLoose or frequent stools

Drug Interactions

• InsulinModerateMay increase risk of low blood sugar
• Oral medications (general)Low
• WarfarinModerate
• SulfonylureasModerateMay increase risk of low blood sugar

Population Constraints

• PregnancyReproductive SafetyAbsolute
• Pediatric patients (<18 years)AgeRelative
• LactationReproductiveRelative
• Elderly patients (>75 years)AgeRelative
• Severe hepatic impairmentOrgan ImpairmentRelative

Regulatory Status

• European UnionUnapprovedNot approved by the EMA; no marketing authorization application on record.
• United StatesUnapprovedNot approved by the FDA; no NDA or BLA on record as of 2024.
• United KingdomUnapprovedNot approved by the MHRA.

Approved by the National Medical Products Administration (NMPA) of China. Not approved by the US FDA or EMA. Developed primarily by Chengdu Beite Pharmaceutical Co., Ltd.

Evidence & Sources

No sources recorded yet.