Half-Life.

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Compound

Semaglutide

GLP-1 receptor agonist (FDA-approved)

FDA-approvedBoxed warning (thyroid C-cell)Prescription only

What it is

Semaglutide is a GLP-1 receptor agonist FDA-approved for type 2 diabetes and, separately, for chronic weight management in adults meeting specified criteria.[1] It is available in injectable and oral formulations under different brand names.

Regulatory status

FDA-approved for the indications above. The weight-management brand additionally has an approved indication to reduce the risk of major adverse cardiovascular events in certain adults with cardiovascular disease and obesity.[1] The label carries a boxed warning regarding thyroid C-cell tumors. Compounded or 'research-use' semaglutide is not FDA-approved and has been the subject of FDA enforcement.[2]

State of the evidence

Large randomized trials support weight reduction and cardiovascular risk reduction in the approved populations.[1] Common adverse effects include nausea, vomiting, and diarrhea, particularly during dose escalation.

Sources

  1. [1]FDA, 'FDA approves first treatment to reduce risk of serious heart problems specifically in adults with obesity.'
  2. [2]FDA, 'FDA's concerns with unapproved GLP-1 drugs used for weight loss.'

Educational reference only. Not medical advice. No dosing or protocols are published here.

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