GLP-1ApprovedEvidence tier: Human RCT

Semaglutide

Last updated October 21, 2026. Approval line checked October 21, 2026. No compounding source date is assigned.

Quick answer

Semaglutide (Wegovy) is a GLP-1 medicine. In March 2024 the FDA also approved it to lower the risk of heart attack, stroke and cardiovascular death in adults with heart disease and obesity or overweight. The Wegovy pill was FDA-approved on December 22, 2025.

FDA status: Wegovy shots approved June 4, 2021, for chronic weight management. Source: FDA label .

Last reviewed November 1, 2026 by the PeptideX team. Educational info, not medical advice. PeptideX doesn't give dosing advice. Talk to a licensed clinician.

FDA status

Approved

Approved. FDA-approved drug products containing semaglutide include Wegovy (chronic weight management), Ozempic (type 2 diabetes), and Rybelsus (type 2 diabetes). Approval is specific to the product, indication, and route.

Drugs@FDA: Wegovy (NDA 215256)

Evidence tier

Human RCT. The tier is the highest indexed study type. It is not a safety rating and it is not an FDA approval. Confidence score 5/5. 8,400 PubMed citations indexed.

Products sold as "research use only" are not approved for human use. FDA warning.

Semaglutide in the literature

GLP-1 receptor agonist reducing appetite, slowing gastric emptying, and improving insulin secretion; acts centrally to modulate satiety signaling in the hypothalamus.

What the literature studies

GLP-1 Metabolic & Weight Management

Evidence tier

Human RCT

Compounding record

Status not verified

Confidence
5/5

Regulatory record

Status not verified. No product-specific FDA primary source is recorded for this entry. FDA approval and compounding eligibility are not verified. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route. Research information is not evidence of FDA approval. Approval, where applicable, is specific to a drug product, indication and route.

Regulatory source not verified; no checked date is assigned.

Regulatory context and verification limits are documented below.

Questions

Related peptides

Looking for a non-peptide GLP-1 pill? Orforglipron (Foundayo) is a small-molecule alternative to the Wegovy pill (oral semaglutide).

Educational only. Not medical advice. This page does not give doses or sourcing. See the medical and editorial disclaimer.

Short answer

Semaglutide is an FDA-approved GLP-1 agonist sold as Ozempic/Rybelsus for diabetes and Wegovy (injection and, since Dec 22 2025, a pill) for weight loss, with ~15% average weight loss in STEP 1 and a 20% cut in major heart events in SELECT.

What it is

A GLP-1 receptor agonist peptide made by Novo Nordisk, weekly injection or daily oral.

Legal / FDA status (as of Oct 27 2026)

  • Ozempic and Rybelsus are approved for type 2 diabetes; Wegovy injection is approved for chronic weight management [R3] and, since Mar 8 2024, to reduce risk of CV death, heart attack and stroke in adults with CVD and obesity/overweight [R4].
  • Wegovy pill (oral semaglutide 25 mg) approved Dec 22 2025 [R5].
  • FDA declared the semaglutide shortage resolved Feb 21 2025 [R6].

Human evidence

  • STEP 1 (68 wk): -14.9% vs -2.4% placebo [R1].
  • SELECT: 20% lower risk of major adverse CV events in people with CVD and overweight, no diabetes (6.5% vs 8.0%; HR 0.80, 95% CI 0.72-0.90) [R2].

Animal / lab evidence

In rodents, semaglutide caused thyroid C-cell tumors; Wegovy carries a boxed warning [R3].

Risks and unknowns

Wegovy label: boxed thyroid C-cell tumor warning; warnings include acute pancreatitis, acute gallbladder disease and hypoglycemia with insulin or secretagogues [R3].

What's coming

CagriSema (semaglutide + cagrilintide) FDA decision expected Q4 2026 per Novo [R7].

Sources

  1. [R1] Wilding JPH et al. Once-weekly semaglutide in adults with overweight or obesity. NEJM 2021;384:989-1002. doi:10.1056/NEJMoa2032183
  2. [R2] Lincoff AM et al. Semaglutide and cardiovascular outcomes in obesity without diabetes. NEJM 2023;389:2221-2232. doi:10.1056/NEJMoa2307563
  3. [R3] Wegovy prescribing information. https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=wegovy
  4. [R4] FDA. FDA approves first treatment to reduce risk of serious heart problems specifically in adults with obesity or overweight. Mar 8 2024. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-reduce-risk-serious-heart-problems-specifically-adults-obesity-or
  5. [R5] FDA approval letter NDA 218316 (Wegovy pill). https://www.accessdata.fda.gov/drugsatfda_docs/nda/2026/218316Orig1s000Approv.pdf ; Novo release Dec 22 2025
  6. [R6] FDA. Declaratory order: Resolution of shortages of semaglutide injection products. Feb 21 2025. https://www.fda.gov/media/185526/download
  7. [R7] Novo Nordisk. CagriSema NDA submission, Dec 18 2025. https://www.novonordisk-us.com/media/press-releases/novo-nordisk-cagrisema-fda-nda-submission.html

Last checked 2026-10-27

Education only. Not medical advice. No dosing guidance. peptidex.ai does not sell peptides or link to sellers.