Regulatory and anti-doping status

FDA-approved use

Yes. Wegovy for chronic weight management (2021), with a cardiovascular risk-reduction indication added in 2024 and a MASH indication under accelerated approval. Ozempic (2017) and Rybelsus (2019) for type 2 diabetes. Novo Nordisk.

Classification here

Approved

Compounding status

FDA declared the semaglutide shortage resolved in February 2025, ending the basis on which compounded versions were widely available. FDA proposed in May 2026 not to include it on the 503B Bulks List. FDA also states that semaglutide sodium and semaglutide acetate are different active ingredients from the approved drug, and that it is not aware of a lawful basis for their use in compounding.

Anti-doping status

Not prohibited. Semaglutide appears nowhere on the WADA 2026 Prohibited List. It sits on WADA’s separate Monitoring Program, which by WADA’s own definition covers substances that are not on the Prohibited List.

Every line above is re-verified against the primary agency source before each update. What the July 2026 FDA vote did and did not do →

What semaglutide is

Semaglutide is a synthetic analogue of the gut hormone GLP-1. It slows gastric emptying, increases glucose-dependent insulin release, and acts on appetite-regulating centres in the brain to reduce food intake. It is long-acting: weekly by injection, or daily by mouth.

What the trials actually showed

STEP 1 randomised 1,961 adults with obesity or overweight without diabetes over 68 weeks and reported a mean body-weight change of −14.9% against −2.4% on placebo. SELECT went further and asked whether that translated into hard outcomes: 17,604 adults with overweight or obesity and established cardiovascular disease, no diabetes, with roughly a fifth fewer major adverse cardiovascular events. That second trial is why the cardiovascular indication exists, and it is the kind of evidence almost nothing else in this catalogue has.

What the label warns about

The approved label carries a boxed warning: in rodents, semaglutide causes thyroid C-cell tumours at clinically relevant exposures, and FDA states it is unknown whether it does so in humans. It is contraindicated with a personal or family history of medullary thyroid carcinoma or MEN 2. Warnings also cover pancreatitis, gallbladder disease, kidney injury from volume depletion, severe gastrointestinal reactions and pulmonary aspiration under anaesthesia. Common adverse reactions are predominantly gastrointestinal.

Why the liver indication is worded carefully here

The MASH indication rests on accelerated approval, granted on histologic improvement — a surrogate endpoint — with confirmatory outcome data still pending. That is a real approval and a meaningful signal, but it is not the same standard as the cardiovascular indication, and this guide does not present the two as equivalent.

How far up the evidence hierarchy this reaches

The strongest evidence base of any substance in this catalogue: an FDA-approved label, plus a 17,604-participant cardiovascular outcomes trial. Where a substance has a label, that document is the authoritative source on its risks.

FDA-approved label This substance reaches here

Adverse reactions observed in trials of known size, in a defined population.

Registered human trials

Useful — but read the size. A few dozen participants cannot detect an uncommon harm.

Animal and in-vitro work

Where the literature for most marketed peptides actually sits. Not evidence of human benefit.

Testimonials and forums

Not evidence. Systematically under-reports harm.

Where a substance's best available evidence sits matters more than any claim made about it.

Where it sits on the compounding pathway

Nominated

Someone proposes the substance for compounding use.

Category 2

FDA flags significant safety risks pending evaluation.

Nomination withdrawn

The nominator pulls it. FDA still publishes its risk language.

Advisory committee

A non-binding recommendation. Not a decision.

05 Here

On the 503A Bulks List

The only stage that confers authority. Reached by rulemaking.

As of August 2026 no peptide has reached stage 05. Coverage routinely reports stage 04 as though it were stage 05.

What it is sold for, against what the evidence shows

Marketing claims on the left, in the terms sellers use. What the human literature actually supports on the right.

Marketed for	What the evidence shows	Verdict
Substantial, sustained weight loss	STEP 1, 1,961 participants, 68 weeks: −14.9% against −2.4% on placebo.	Supported
Cardiovascular risk reduction	SELECT, 17,604 participants: roughly 20% fewer major adverse cardiovascular events.	Supported
Blood-sugar control in type 2 diabetes	Approved indication on a dedicated phase 3 programme.	Supported
Liver benefit in fatty liver disease	Accelerated approval on a histologic surrogate; confirmatory outcome data still pending.	Partly supported
"Safe because it is just a gut hormone"	The label carries a boxed warning, contraindications, and warnings including pancreatitis, gallbladder disease and aspiration under anaesthesia.	Contradicted
Performance enhancement in sport	Not prohibited by WADA and not studied for performance. Monitoring is not a performance finding.	No human evidence

Where to go next

GLP-1 receptor agonists

Tirzepatide

The other approved incretin drug, activating two receptors instead of one. The comparison people actually want, and the one both labels decline to make.

GLP-1 receptor agonists

Retatrutide

The three-receptor successor, with larger reported weight loss and no approval at all — the contrast that explains why approval status matters.

What this guide deliberately omits

No dosing, cycling, stacking, reconstitution or administration instructions appear anywhere on this site, and this page links to no page selling an unapproved injectable. Questions about how a substance would be used belong with a licensed clinician who has evaluated you.

Semaglutide: What the Trials Established, and What the Label Still Warns About