Peptide dossier, updated Nov 1, 2026

Semaglutide

An FDA-approved once-weekly GLP-1 receptor agonist injection and daily tablet, sold by Novo Nordisk as Ozempic, Wegovy and Rybelsus. This page is a record, not guidance on use. It covers the approvals, the label’s boxed warning, how the shortage and the compounding exemption ended, and what FDA says about compounded and counterfeit product.

See all 15 verified records for Semaglutide on the Records page

In plain terms

Approved for: Type 2 diabetes (Ozempic, Rybelsus) and chronic weight management and heart-risk reduction (Wegovy), per the current labels. The labels list further uses, including kidney disease and liver disease; see the label.

What it is: A lab-made copy of GLP-1, a gut hormone that raises insulin after meals, slows stomach emptying and reduces appetite. It is given as a weekly injection or taken daily as a tablet.

What it is said to do, and by whom:

FDA, through the labels: approved for the uses listed above, with a boxed warning about thyroid C-cell tumors seen in rodents.
Novo Nordisk and trial investigators: trials such as STEP 1 (weight), SUSTAIN-6 and SELECT (cardiovascular outcomes) reported benefits; see the papers linked below.
Sellers of compounded and “research” semaglutide: say it is equivalent to the approved drug. FDA says compounded versions are not FDA-approved and that it has received reports of adverse events and dosing errors.

How strong the evidence is: Strong, for the approved products: large randomized trials published in major journals. Not applicable to compounded or gray-market product, which FDA has not reviewed.

FDA approval

Approved

Ozempic, Dec 5, 2017; Rybelsus, Sep 20, 2019; Wegovy, Jun 4, 2021 (original approvals per Drugs@FDA).

Label boxed warning

Thyroid C-cell tumors

The Ozempic label’s boxed warning says semaglutide causes dose- and duration-dependent thyroid C-cell tumors in rodents, and that it is unknown whether it does in humans.

Shortage and compounding

Resolved Feb 21, 2025

FDA declared the shortage resolved. Enforcement discretion for compounding copies ended Apr 22, 2025 (503A) and May 22, 2025 (503B).

FDA on compounded product

990 adverse event reports

FDA says it had received 990 adverse event reports for compounded semaglutide as of May 31, 2026, and notes underreporting is likely.

HHS enforcement, Oct 30

Not covered

The draft policy’s appendix names six covered peptides: BPC-157, epitalon, KPV, MOTS-c, Semax and TB-500. Semaglutide is not one of them.

WADA prohibited list

Not named

The 2026 list we read does not name semaglutide. We read a copy of the list, not WADA’s own file.

FDA approvals

Original approval dates are from Drugs@FDA through the openFDA API. Current uses are paraphrased from the DailyMed labels we read; the labels govern.

Brand	Application	Original approval	Current use, per the label
Ozempic	Drugs@FDA NDA209637	Dec 5, 2017	Type 2 diabetes; reduce cardiovascular and kidney risk in adults with type 2 diabetes. DailyMed label
Rybelsus	Drugs@FDA NDA213051	Sep 20, 2019	Type 2 diabetes tablets. DailyMed label
Wegovy	Drugs@FDA NDA215256	Jun 4, 2021	Weight management, cardiovascular risk reduction, and (injection) MASH with fibrosis under accelerated approval. DailyMed label

Shortage and compounding timeline

The dates below are from FDA’s page “FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize” (content current Apr 1, 2026).

Date	Event
2022	FDA says semaglutide injection has been in shortage since 2022 due to increased demand.
Feb 21, 2025	FDA determines the shortage of semaglutide injection products is resolved.
Apr 22, 2025	End of FDA’s stated enforcement discretion for state-licensed pharmacies compounding essentially copies of the approved product (503A), or the court’s ruling on the preliminary injunction if later.
May 22, 2025	End of the stated discretion for outsourcing facilities (503B).

The page also says semaglutide does not appear on the 503B bulks list or the drug shortage list as of its date. FDA page

FDA statements on compounded and counterfeit product

FDA’s page “FDA’s Concerns with Unapproved GLP-1 Drugs Used for Weight Loss” (content current Oct 1, 2026) and two warning letters.

What FDA says

As of May 31, 2026, FDA had received 990 reports of adverse events associated with compounded semaglutide. It says some events appear consistent with events from approved products and that underreporting is likely.
Warning letters, Sep 9, 2025 (SemaBio, SimpleRx): say website claims such as “generic semaglutide” (SemaBio) and “Semaglutide (Ozempic)” (SimpleRx) are false or misleading because they imply compounded products are the same as the approved drug, which they are not. SemaBio 715866 SimpleRx 715874

Read with care

A warning letter is FDA’s statement about one firm’s conduct on one date.
FDA’s count is of reports, which do not prove the product caused the event.
FDA also addresses dosing errors, fraudulent labeling and salt forms on its page; we did not summarize all of it.

Sources: FDA: concerns with unapproved GLP-1 drugs

Key trial papers

PubMed returns 6,006 results for semaglutide and ClinicalTrials.gov lists 793 studies as of Nov 1, 2026. The papers below are examples of large published trials, not a complete list.

Papers

SUSTAIN-6, 2016. Semaglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med PubMed
STEP 1, 2021. Once-weekly semaglutide in adults with overweight or obesity. N Engl J Med PubMed NCT03548935
SELECT, 2023. Semaglutide and cardiovascular outcomes in obesity without diabetes. N Engl J Med PubMed
FLOW, 2024. Effects of semaglutide on chronic kidney disease in type 2 diabetes. N Engl J Med PubMed
MASH, 2025. Phase 3 trial of semaglutide in metabolic dysfunction-associated steatohepatitis. N Engl J Med PubMed

Read with care

Trial names are from the paper titles or our reading of the title; we did not read full text.
Results describe the approved products used under medical supervision.

Timeline

Newest first. Every entry links to the document it comes from.

Government or registry record
Journal

Oct 30, 2026Regulatory
HHS publishes draft policy pausing enforcement on six peptides; semaglutide is not one of them
The draft policy’s appendix names six peptides: BPC-157, TB-500, epitalon, Semax, KPV and MOTS-c. We read the appendix through a text extraction.
Federal Register HHS policy appendix BakerHostetler summary
Oct 1, 2026Regulatory
FDA page on unapproved GLP-1 drugs reports 990 adverse event reports for compounded semaglutide
Count as of May 31, 2026.
FDA page
Sep 9, 2025Enforcement
FDA warning letters to SemaBio and SimpleRx over “generic semaglutide” claims
The letters say compounded drugs are not FDA-approved.
SemaBio SimpleRx
May 22, 2025Regulatory
End of stated FDA enforcement discretion for 503B outsourcing facilities compounding semaglutide copies
503A discretion ended Apr 22, 2025.
FDA page
Feb 21, 2025Regulatory
FDA determines the semaglutide injection shortage is resolved
FDA says the shortage had run since 2022.
FDA page
Jun 4, 2021Approval
FDA approves Wegovy (NDA 215256)
Original approval date per Drugs@FDA.
Drugs@FDA NDA215256
Sep 20, 2019Approval
FDA approves Rybelsus tablets (NDA 213051)
Original approval date per Drugs@FDA.
Drugs@FDA NDA213051
Dec 5, 2017Approval
FDA approves Ozempic (NDA 209637)
Original approval date per Drugs@FDA.
Drugs@FDA NDA209637

Still not covered

Left off rather than guessed:

Counterfeit product: FDA issued a MedWatch bulletin in April 2025 on counterfeit Ozempic. We read the bulletin through a secondary summary and did not open FDA’s alert page.
Shortage status today: we did not extract the current status from FDA’s drug shortage database.
Wegovy tablets: they appear in the current Wegovy label; we did not find or open FDA’s approval document for the tablet, so no tablet approval date is stated.
Safety beyond the boxed warning: this dossier does not summarize adverse reactions. See the labels.
HHS policy: we read the draft policy appendix through a text extraction, not the original PDF layout. It names six covered peptides and not this drug.
Patents, SEC filings and sponsor results releases: not researched for this dossier, except where cited.
Seller claims and independent lab reports: how gray-market product is marketed versus what testing finds. We have not collected testing data.
Unread items: full text of every paper; EU and other non-US regulators; WADA’s own file for the 2026 list; FDA warning letters other than those listed.