GLP-1 agonist
Semaglutide
Semaglutide is FDA-approved as Ozempic, Wegovy and Rybelsus, with a prescription. The evidence grade is strong-human for blood sugar, weight and heart risk. Copies made by pharmacies or sold for research use are not approved, and FDA has not checked them.
This page has not been individually reviewed by a clinician.
Fact sheet · 6 facts
every row cites its source and its date| Fact | Value | Tier | Checked | Source |
|---|---|---|---|---|
| Also called | Ozempic, Wegovy, Rybelsus | primary | fda.gov | |
| Class | glp-1-agonist | primary | dailymed.nlm.nih.gov | |
| Regulatory status | fda-approved | primary | accessdata.fda.gov | |
| Status source read | 2026-10-23 | primary | accessdata.fda.gov | |
| Evidence grade | strong-human | our assessment | peptideindex.ai | |
| Label dosing | From the Wegovy label. Wegovy shot: once a week, starting at 0.25 mg for 4 weeks and going up every 4 weeks. The usual dose to stay on is 2.4 mg a week, and some adults may go up to 7.2 mg. Wegovy pill: once a day on an empty stomach, starting at 1.5 mg for 30 days and going up every 30 days to 25 mg. Ozempic and Rybelsus have their own schedules on their labels. The prescriber sets the dose. | primary | dailymed.nlm.nih.gov |
Short answer
Semaglutide is FDA-approved as Ozempic, Wegovy and Rybelsus, with a prescription. The evidence grade is strong-human for blood sugar, weight and heart risk. Copies made by pharmacies or sold for research use are not approved, and FDA has not checked them.
Our assessment, drawn from the sources below.
What it is
Semaglutide is a prescription drug. It copies GLP-1, a hormone the gut makes after you eat [4]. GLP-1 helps control blood sugar and makes you feel full. FDA first approved it in 2017 [4]. One company makes it and sells it under three brand names [1] [2] [3].
Ozempic is a weekly shot for type 2 diabetes. It now also comes as a daily pill [3] [4]. Wegovy is a weekly shot or a daily pill for weight loss and heart health [5]. Rybelsus is a daily pill for type 2 diabetes [6]. The body clears half of a dose in about a week [4]. That is why the shots are taken once a week.
Some pharmacies and online sellers offer their own copies of it. Those copies are not the approved drug [10].
Where it stands legally
Semaglutide is FDA-approved: FDA first approved it in 2017, and it is sold as Ozempic, Wegovy and Rybelsus [1] [2] [3] [4]. That covers the brand drugs, with a prescription, for the uses on their labels. It does not make copies from pharmacies or online sellers approved [10]. Checked 23 October 2026.
Ozempic is approved for type 2 diabetes, not for weight loss. Wegovy is the brand approved for weight loss [4] [5]. Many copies are sold for weight loss [12].
The shots were on FDA's drug shortage list until 2025 [7] [8]. During a shortage, pharmacies may make copies of a drug. FDA said the shortage was over on 21 February 2025 [7] [8]. Pharmacies had until 22 April 2025 to stop making copies. Larger outsourcing facilities had until 22 May 2025 [9] [16]. A court refused to block this in April 2025 [9].
Today a pharmacy may not make copies of the approved drug as a regular practice [9]. It may make a different version for one patient. The prescriber has to write down why that patient needs the change [16] [17]. FDA says it will not act on four or fewer copy prescriptions a month [9]. In April 2026, FDA proposed a rule to keep outsourcing facilities from making it from raw powder. The rule is not final [14] [17]. Selling it with a research-use label is illegal [15].
What the evidence shows
Evidence grade: strong-human · our assessment
The evidence grade is strong-human: several large trials in people agree that it lowers blood sugar, weight and heart risk [18] [19] [20]. In a two-year trial of 3,297 adults with type 2 diabetes, fewer people on it had a heart attack, a stroke or a heart death than people on a dummy shot [18]. In a 68-week trial of 1,961 adults with obesity and no diabetes, people on it lost about 15% of their weight. People on the dummy shot lost about 2% [19]. In a trial of 17,604 adults with heart disease and excess weight but no diabetes, it cut heart attacks, strokes and heart deaths by about a fifth [20]. A 2024 review of 38 studies found fewer hospital stays for heart failure and fewer deaths. It also found more stomach trouble [21].
These trials tested the approved drug from its maker, and the maker paid for them [18] [19] [20]. They tell us nothing about copies made by pharmacies or sold for research use. FDA has not checked those copies for quality [10].
Known risks
- In rats and mice, semaglutide caused thyroid tumors. The labels warn people with a rare thyroid cancer in the family not to use it [4] [5].
- The most common problems are nausea, vomiting, diarrhea, belly pain and constipation [4]. More people on it than on a dummy shot quit for stomach trouble [19].
- The labels warn of a swollen pancreas and gallbladder disease. They also warn of kidney harm from losing fluids, and of bad allergic reactions [4] [5].
- Taken with insulin or some other diabetes drugs, it can push blood sugar too low [4].
- In a diabetes trial, eye damage from diabetes got worse more often in people on semaglutide [18].
- FDA has reports of people who took 5 to 20 times the intended amount of compounded semaglutide. Some went to the hospital [12].
What nobody knows yet
- Nobody knows if it can cause thyroid cancer in people. The rat and mouse studies do not tell us [4].
- A 2025 review linked it to a rare eye nerve problem that can take away sight. The evidence is too thin to say it is the cause [22].
- The main weight trial lasted 68 weeks, so it does not show what years of use do [19].
- Nobody knows if the salt forms some pharmacies use act like the approved drug [10].
Legitimate ways to get it
The legal way to get semaglutide is a prescription for one of the approved brands, filled at a state-licensed pharmacy [1] [10]. Ozempic, Wegovy and Rybelsus are each approved by FDA [1] [2] [3]. Each label says who it is for and how it is taken [4] [5] [6].
A copy made by a pharmacy is lawful only in narrow cases. The prescriber has to write down why one patient needs a change from the approved drug, such as an allergy to one of its parts [16] [17]. A lower price or a wish for a different form is not enough [17]. FDA says pharmacy copies should be used only when an approved drug cannot meet a patient's needs [10]. FDA does not check pharmacy copies for safety, quality or whether they work [10].
Open trials are listed in the trials block below, with the date the official registry was last checked.
Approved product
Approved by FDA and sold with a prescription as weekly shots and daily pills. Ozempic and Rybelsus are for type 2 diabetes. Wegovy is for weight loss and heart risk.
Brand names: Ozempic, Wegovy, Rybelsus
Manufacturer: Novo Nordisk
Indication: Type 2 diabetes, and lower heart and kidney risk in some adults with it (Ozempic, Rybelsus). Weight loss, lower heart risk, and a fatty liver disease called MASH (Wegovy).
Lawful compounding
FDA said the shortage ended on 21 February 2025. A pharmacy may make a version for one patient only when the prescriber writes down why that patient needs a change from the approved drug. Regular copies of the approved drug are not allowed.
Recruiting trials
A listing is not a recommendation. Trials have strict eligibility rules. Talk to your doctor and read the official record.
Snapshot of .clinicaltrials.gov
NCT07586150
Personalized Pharmaco-Lifestyle Interventions for Severe Mental Illnesses (LIFETRAIN)
Phase: Not applicable · Sponsor: Ludwig-Maximilians - University of Munich · Status: Not yet recruiting
Countries: Austria, Germany, Netherlands
US states: none listed
NCT07430332
GLP-1 RA for Stage 1 Type 1 Diabetes
Phase: Phase 2 · Sponsor: Children's Hospital Medical Center, Cincinnati · Status: Not yet recruiting
Countries: United States
US states: Ohio
NCT07797036
Postpartum Semaglutide to Reduce Cardiometabolic Risk After Gestational Diabetes Mellitus
Phase: Phase 2/Phase 3 · Sponsor: University of Massachusetts, Worcester · Status: Not yet recruiting
Countries: United States
US states: Massachusetts
NCT07711548
Can Two Dietary Interventions Maintain Weight Loss for 12 Months After GLP-1 Therapy in Adults With Overweight/Obesity?
Phase: Not applicable · Sponsor: Knut Mai · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07754045
Evaluating the Efficacy and Safety of LUM-201 Plus Semaglutide Versus Semaglutide Plus Placebo in Older Obese Adults
Phase: Phase 2 · Sponsor: Lumos Pharma · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07731256
Semaglutide for Low Back Pain
Phase: Phase 2 · Sponsor: Washington University School of Medicine · Status: Not yet recruiting
Countries: United States
US states: Alabama, Missouri
NCT05714683
Regulatory Post Marketing Surveillance (rPMS) Study of Rybelsus (Oral Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea
Phase: Not stated · Sponsor: Novo Nordisk A/S · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07879612
Semaglutide for the Treatment of Cannabis Use Disorder
Phase: Phase 2 · Sponsor: Massachusetts General Hospital · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07462663
SHAPE-ENDO: Pilot Randomized Trial of Multimodal Pre-Surgical Optimization Versus Standard Surgery in Patients With Obesity and Early-Stage Endometrial Cancer
Phase: Phase 4 · Sponsor: Hospital Universitari de Bellvitge · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07614412
SHIELD-T1D: Shingrix and GLP-1 Agonist for Beta-Cell Preservation in Recent-Onset Type 1 Diabetes.
Phase: Phase 2 · Sponsor: Ministry of Health, Saudi Arabia · Status: Not yet recruiting
Countries: Saudi Arabia
US states: none listed
NCT07820358
Semaglutide, Weight Loss, and LNG-IUD for Conservative Treatment of Endometrial Atypical Hyperplasia and Grade 1 Endometrial Cancer
Phase: Phase 2 · Sponsor: The Methodist Hospital Research Institute · Status: Not yet recruiting
Countries: United States
US states: Texas
NCT07787936
GLP-1/GIP Receptor Agonists in Obesity-Related HFpEF: The GLIDE-HF Registry
Phase: Not stated · Sponsor: Miedziowe Centrum Zdrowia SA · Status: Not yet recruiting
Countries: Poland
US states: none listed
NCT07858331
Patient-centred Intervention With Virtual Support for Obesity and Kidney Transplant Access
Phase: Phase 4 · Sponsor: Kristin Clemens · Status: Not yet recruiting
Countries: Canada
US states: none listed
NCT07760948
HMB Plus Vitamin D to Preserve Muscle in Older Adults Starting Semaglutide
Phase: Phase 2 · Sponsor: Vanderbilt University Medical Center · Status: Not yet recruiting
Countries: United States
US states: Tennessee
NCT07770282
Efficacy and Safety of Semaglutide Versus Placebo on Cardiometabolic Profile in Patients With Schizophrenia With Metabolic Syndrome
Phase: Phase 3 · Sponsor: All India Institute of Medical Sciences, Bhubaneswar · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT06977438
GLP-1 Plus Lifestyle for Overall Wellness: Find Your Way Forward
Phase: Phase 4 · Sponsor: University of Minnesota · Status: Not yet recruiting
Countries: United States
US states: Minnesota
NCT07855900
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Phase: Phase 3 · Sponsor: Boehringer Ingelheim · Status: Not yet recruiting
Countries: United States
US states: Florida
NCT07866066
Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes
Phase: Phase 3 · Sponsor: Amgen · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07249554
Combination Therapy for Alcohol Use Disorder
Phase: Phase 2 · Sponsor: Johns Hopkins University · Status: Not yet recruiting
Countries: United States
US states: Maryland
NCT07878494
Dietary, Medication, and Endoscopic Interventions for Post-Bariatric Hypoglycemia
Phase: Not applicable · Sponsor: Stanford University · Status: Not yet recruiting
Countries: United States
US states: California
NCT06546384
GLP-1 RA on Alcohol Consumption, Metabolism and Liver Parameters in Patients With Obesity and Fatty Liver Disease
Phase: Not applicable · Sponsor: Insel Gruppe AG, University Hospital Bern · Status: Not yet recruiting
Countries: Switzerland
US states: none listed
NCT07832084
Comparing Different Medication Regimens to Maintaining Weight Loss Among Adults With Obesity Using GLP-1s
Phase: Phase 4 · Sponsor: Jing Luo · Status: Not yet recruiting
Countries: United States
US states: Pennsylvania
NCT07027969
Metabolic Surgery for Atrial Fibrillation Elimination
Phase: Phase 4 · Sponsor: Ali Aminian · Status: Not yet recruiting
Countries: United States
US states: Ohio
NCT07845994
SEMAFORCRANIO : Multicenter, Double-blind, Parallel, Randomized Controlled Trial of the Efficacy of Semaglutide in Hypothalamic Obesity Secondary to Craniopharyngioma in Children Aged 12 to 17 Years
Phase: Phase 3 · Sponsor: University Hospital, Angers · Status: Not yet recruiting
Countries: France
US states: none listed
NCT07511543
Glucagon-like Peptide-1 Receptor Agonists for Endovascular Stroke Thrombectomy
Phase: Phase 2 · Sponsor: Population Health Research Institute · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07881783
A Real-world Study of Treatment Retention and Adherence to Secukinumab in Patients With Plaque Psoriasis (PsO) With or Without Glucagon-like Peptide-1 Receptor Agonist (GLP-1 RA) Co-therapy
Phase: Not stated · Sponsor: Novartis Pharmaceuticals · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07840729
Evaluate the Safety and Tolerability of Multiple Doses of JMT206 Injection in Obese Participants
Phase: Phase 1 · Sponsor: Shanghai JMT-Bio Inc. · Status: Not yet recruiting
Countries: China
US states: none listed
NCT07874971
Short Term Effects of Semaglutide on Body Composition and Performance
Phase: Not applicable · Sponsor: Morten Hostrup, PhD · Status: Not yet recruiting
Countries: Denmark
US states: none listed
NCT07874932
Long-Term Effects of Semaglutide on Body Composition and Performance in Running
Phase: Not applicable · Sponsor: Morten Hostrup, PhD · Status: Not yet recruiting
Countries: Denmark
US states: none listed
NCT07891156
Lean Mass Changes With Semaglutide in Adults With Type 1 Diabetes and Overweight/Obesity.
Phase: Phase 2/Phase 3 · Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Status: Recruiting
Countries: Canada
US states: none listed
NCT07881770
Semaglutide Health Outcomes and Patient Adherence in Australia
Phase: Not stated · Sponsor: Novo Nordisk A/S · Status: Not yet recruiting
Countries: Australia
US states: none listed
NCT07812597
A Study Evaluating Safety and Tolerability of Switching From Semaglutide to Zovaglutide in Adults With Obesity (HORIZON-SWITCH-SZ)
Phase: Phase 2 · Sponsor: Beijing QL Biopharmaceutical Co.,Ltd · Status: Not yet recruiting
Countries: China
US states: none listed
NCT07627191
GLP-1 RA Plus SOC Treatment in First-line, Metastatic Pancreatic, Colorectal, or Hepatocellular Cancer
Phase: Early phase 1 · Sponsor: University of Arizona · Status: Recruiting
Countries: United States
US states: Arizona
NCT07855133
A Research Study Investigating How Adults With Overweight or Obesity, With or Without Type 2 Diabetes, Tolerate Switching to a New Treatment (Zenagamtide) From Their Current Semaglutide Medication
Phase: Phase 1 · Sponsor: Novo Nordisk A/S · Status: Recruiting
Countries: United States
US states: California, Maryland
NCT07816744
Danish Trial of Weight Loss to Reduce Atrial Fibrillation Progression
Phase: Not applicable · Sponsor: Axel Brandes · Status: Not yet recruiting
Countries: Denmark
US states: none listed
NCT07859137
Semaglutide Before Primary Metabolic and Bariatric Surgery in Patients With BMI 60 kg/m² or Higher
Phase: Phase 4 · Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt · Status: Not yet recruiting
Countries: Egypt
US states: none listed
NCT07423481
Weight Trajectories and Predictive Factors After Semaglutide in Patients With Grade 3 and Complicated Obesity
Phase: Not stated · Sponsor: Nantes University Hospital · Status: Not yet recruiting
Countries: France
US states: none listed
NCT07859150
Semaglutide 2.4 mg Once Weekly for Recurrent Weight Gain After Metabolic and Bariatric Surgery (RESURGE)
Phase: Phase 4 · Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt · Status: Not yet recruiting
Countries: Egypt
US states: none listed
NCT07872904
FutureShape Family
Phase: Phase 4 · Sponsor: Signe Torekov · Status: Not yet recruiting
Countries: Denmark
US states: none listed
NCT07859189
Immediate Versus Criterion-triggered Semaglutide for Suboptimal Clinical Response One Year After Primary Metabolic and Bariatric Surgery
Phase: Phase 4 · Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt · Status: Not yet recruiting
Countries: Egypt
US states: none listed
NCT07389941
Semaglutide PrIor to CathEeter Ablation in Patients With Atrial Fibrillation
Phase: Phase 4 · Sponsor: University of Luebeck · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07737522
Myocardial Metabolic Flux in Pulmonary Arterial Hypertension
Phase: Phase 2 · Sponsor: Imperial College London · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07859176
Tapered Versus Abrupt Discontinuation of Semaglutide After Treatment of Recurrent Weight Gain or Suboptimal Response Following Metabolic and Bariatric Surgery
Phase: Phase 4 · Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt · Status: Not yet recruiting
Countries: Egypt
US states: none listed
NCT07755085
GLP-1s in Hip and Knee Arthroplasty
Phase: Phase 4 · Sponsor: Nova Scotia Health Authority · Status: Not yet recruiting
Countries: Canada
US states: none listed
NCT07820722
Assessing Heart and Brain Metabolism in Type II Diabetes Mellitus Patients Using Carbon-13 MRI
Phase: Early phase 1 · Sponsor: Sunnybrook Health Sciences Centre · Status: Not yet recruiting
Countries: none listed
US states: none listed
NCT07772960
Semaglutide Dose Effects on Metabolic and Stress Hormone, Craving and Alcohol Use Outcomes
Phase: Phase 1 · Sponsor: Yale University · Status: Not yet recruiting
Countries: United States
US states: Connecticut
NCT07859163
Semaglutide Given Before and After Conversion of Sleeve Gastrectomy to Roux-en-Y Gastric Bypass for Recurrent Weight Gain
Phase: Phase 4 · Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt · Status: Not yet recruiting
Countries: Egypt
US states: none listed
NCT07845500
A Study to Learn About Switching to a Monthly Study Medicine Called Berobenatide (PF-08653944) to Help Keep Weight Off in People With Overweight or Obesity
Phase: Phase 3 · Sponsor: Pfizer · Status: Recruiting
Countries: United States
US states: Alabama, California, Florida, Kentucky, Michigan, Mississippi, Missouri, Montana, North Carolina, Ohio, South Carolina
NCT07845578
A Research Study Looking Into How a High Dose of s.c. Semaglutide Works With Emptying of the Stomach in People With Excess Body Weight
Phase: Phase 1 · Sponsor: Novo Nordisk A/S · Status: Not yet recruiting
Countries: Austria
US states: none listed
NCT07668414
A Research Study Investigating How Well the Medicine Zenagamtide Helps People With Excess Body Weight Lose Weight Compared to Semaglutide
Phase: Phase 3 · Sponsor: Novo Nordisk A/S · Status: Recruiting
Countries: United States
US states: California, District of Columbia, Florida, Georgia, Illinois, Indiana, Louisiana, Missouri, New York, North Carolina, North Dakota, Pennsylvania, South Carolina, Texas, Virginia, Washington
How people are getting it anyway
This section describes what happens and is not a recommendation.
Semaglutide reaches people outside the approved brands in four main ways [10]. The first is pharmacies that kept making copies after the shortage ended [9] [13]. FDA has received reports of harm tied to pharmacy copies and says many more likely go unreported [10]. The second is online prescribers that sell these copies. FDA has told companies they may not call a copy generic or the same as the approved drug [13]. The third is fake Ozempic pens. FDA has seized fake pens from the US drug supply three times since 2023 [11]. The fourth is online sellers that label it for research use. FDA has warned such a seller that the label does not make the sale legal [15].
In each case, FDA cannot vouch for what is in the product [10]. Some pharmacy copies use salt forms, which are a different ingredient from the approved drug [10] [12]. Some carry the name of a pharmacy that does not exist or did not make them [10]. People have taken many times the intended amount by mistake [12].
Compounding outside the rules
Copies of the approved shots made by pharmacies and outsourcing facilities, often sent in vials that hold several doses.
The lawSince the shortage ended in 2025, a pharmacy may not make copies of the approved drug as a regular practice. FDA knows of no lawful basis for making it from salt forms such as semaglutide sodium.fda.gov
Documented riskFDA has reports of people who took 5 to 20 times the intended amount from multi-dose vials. Some went to the hospital with vomiting, fainting, a swollen pancreas or gallstones.fda.gov
Documented riskFDA has received reports of harm tied to compounded semaglutide and says many more likely go unreported.fda.gov
Documented riskFDA has found fake compounded semaglutide with labels naming pharmacies that do not exist or did not make it.fda.gov
Enforcement FDA said it would restrict the raw ingredient used for mass-marketed copies, and warned that seizure and court orders may follow.fda.gov
Enforcement FDA proposed keeping semaglutide off the list of bulk ingredients outsourcing facilities may use. The proposal is not final.fda.gov
Telehealth
Online prescribers that sell compounded semaglutide after a short online visit, often by monthly plan.
The lawFDA says a company may not claim a compounded copy is a generic, is the same as the approved drug, or is proven to work.fda.gov
Documented riskFDA reviewed a case where a patient could not get clear instructions from an online prescriber and took five times the intended amount.fda.gov
Documented riskFDA has complaints that compounded GLP-1 drugs arrived warm, which can harm their quality.fda.gov
Enforcement FDA said it would act against misleading marketing of compounded GLP-1 drugs, after warning letters sent in the fall of 2025.fda.gov
Counterfeit or diverted
Fake Ozempic pens sold outside the maker's own supply chain. Some reached the regular US drug supply.
The lawCounterfeit drugs are illegal, FDA says.fda.gov
Documented riskA fake drug may hold the wrong ingredient, too much or too little drug, or none at all, FDA warns.fda.gov
Documented riskIn fake pens seized in 2023, the needles were also fake, so nobody could confirm they were germ-free.fda.gov
Enforcement FDA said it had seized thousands of fake Ozempic pens from the US drug supply.fda.gov
Enforcement FDA said it had seized several hundred fake Ozempic pens on 9 April 2025.fda.gov
Enforcement FDA said it had found more fake Ozempic pens in the US drug supply.fda.gov
Research use seller
Sold online as a powder with a label saying it is for research use or not for people.
The lawFDA treats these as unapproved new drugs when the seller's site shows they are meant for people, whatever the label says.fda.gov
Documented riskFDA says these products are of unknown quality and may harm health.fda.gov
Documented riskFDA warns that injected products skip some of the body's defenses, so toxins or germs in them can cause life-threatening illness.fda.gov
Enforcement FDA warning letter to an online seller of research-use peptides, including semaglutide.fda.gov
Sources
- [1]Drugs@FDA: Ozempic injection, application 209637Regulatory · primary
- [2]Drugs@FDA: Wegovy injection, application 215256Regulatory · primary
- [3]Drugs@FDA: Rybelsus and Ozempic tablets, application 213051Regulatory · primary
- [4]DailyMed: Ozempic injection prescribing information, revised May 2026Label · primary
- [5]DailyMed: Wegovy injection and tablets prescribing information, revised June 2026Label · primary
- [6]DailyMed: Rybelsus and Ozempic tablets prescribing information, revised January 2026Label · primary
- [7]FDA drug shortages: semaglutide injection, resolvedRegulatory · primary
- [8]FDA order: the semaglutide injection shortage is resolved, 21 February 2025Regulatory · primary
- [9]FDA: policies for compounders as GLP-1 supply stabilizes, updated 1 April 2026Regulatory · primary
- [10]FDA: concerns with unapproved GLP-1 drugs used for weight loss, updated 1 October 2026Regulatory · primary
- [11]FDA: warnings on counterfeit Ozempic in the US drug supply, 2023 to 2025Regulatory · primary
- [12]FDA: dosing errors with compounded semaglutide injections, 2024Regulatory · primary
- [13]FDA statement: action against non-approved GLP-1 drugs, 6 February 2026Regulatory · primary
- [14]FDA: proposal to exclude semaglutide from the 503B bulks list, 30 April 2026Regulatory · primary
- [15]FDA warning letter to an online seller of research-use peptides, 24 August 2026Regulatory · primary
- [16]McDermott Will & Schulte: what the end of the semaglutide shortage meansLegal analysis · legal-analysis
- [17]Orrick: FDA moves to end large-scale compounding of GLP-1 drugsLegal analysis · legal-analysis
- [18]SUSTAIN-6: semaglutide and heart outcomes in type 2 diabetes, 2016Rct · peer-reviewed
- [19]STEP 1: weekly semaglutide in adults with overweight or obesity, 2021Rct · peer-reviewed
- [20]SELECT: semaglutide and heart outcomes in obesity without diabetes, 2023Rct · peer-reviewed
- [21]Review of heart outcomes and harms of semaglutide in overweight or obesity, 2024Systematic review · peer-reviewed
- [22]Review of eye disorders, including an optic nerve problem, with semaglutide, 2025Systematic review · peer-reviewed
- [23]STAT: FDA proposes a rule that would end bulk compounding of GLP-1 drugsReference · established-news
- [24]NBC News: FDA proposes keeping weight-loss drugs off a key compounding listReference · established-news
Last verified · 6 facts · 10 sources
- clinicaltrials.gov
- dailymed.nlm.nih.gov
- dailymed.nlm.nih.gov
- peptideindex.ai
- peptideindex.ai
- pubmed.ncbi.nlm.nih.gov
- accessdata.fda.gov
- accessdata.fda.gov
- fda.gov
- fda.gov
Primary source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=215256
Machine readers: JSON · Markdown · Status history: Change log
Information, not medical advice.
Status alerts
Get status alerts for Semaglutide
No alert has been sent yet. Until alerts begin, the confirmation is the only email you will get.