Semaglutide clinical trials
Semaglutide is named as an intervention in 133 current clinical trials in our USA, China, Canada, Denmark, Spain, Poland, Germany, Australia, Mexico, UK, Netherlands, South Korea, Italy, Belgium, India, Japan, Sweden, Portugal, France, Brazil, Austria, Turkey, Switzerland, Taiwan, Israel, Egypt, Czechia, Ireland, Norway and Singapore registers. 62 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Novo Nordisk A/S (30). The most-studied condition is Obesity. The EU clinical trials register (CTIS) separately lists 15 authorised or ongoing trials.
Where Semaglutide is approved
All regulators →Of the three regulators tracked here, the first to approve Semaglutide was the US, on 5 Dec 2017. It is approved in 3 of the 3 regulators tracked here.
- 5 EU safety letters (DHPC), latest: medication error for Rybelsus, 1 Aug 2025
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Semaglutide patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Semaglutide, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 30 listed patents; the last listed expires 17 Feb 2041 (US 11318191).
- Latest patent on the drug substance itself: 2 May 2034 (US 10278923).
- Exclusivity NS: New strength, until 19 Mar 2029.
- Exclusivity NP: New product, until 22 Dec 2028.
- Exclusivity I-976: New indication: to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction or non-fat…, until 17 Oct 2028.
- Exclusivity I-973: New indication: treatment of noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohep…, until 15 Aug 2028.
- Exclusivity I-961: New indication: to reduce the risk of sustained estimated glomerular filtration rate (EGFR) decline, end-stage kidney disease, and cardiova…, until 28 Jan 2028.
- Exclusivity I-935: New indication: in combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascul…, until 8 Mar 2027.
Reproduced from the FDA Orange Book and Purple Book (checked 8 Nov 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Semaglutide
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Semaglutide works
All drug targets →- Glucagon-like peptide 1 receptor agonist AgonistTarget: GLP1R glucagon like peptide 1 receptor✓ In ChEMBL and the Guide to Pharmacology
- Alzheimer diseasePhase 3
- HyperglycemiaPhase 3
- Increased body weightPhase 3
- Klinefelter syndromePhase 3
- AlbuminuriaPhase 3
- Atrial fibrillationPhase 3
- Chronic kidney diseasePhase 3
- Coronary atherosclerosisPhase 3
- DementiaPhase 3
- Diabetic retinopathyPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL2108724, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 9724, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Semaglutide
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 3 technology appraisals of Semaglutide. 3 are current, and 2 of these recommend it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Semaglutide for reducing the risk of major adverse cardiovascular events in people with cardiovascular disease and overweight or obesity NICE TA1152 | Recommended | 7 May 2026 | Current |
| Semaglutide for managing overweight and obesity in young people aged 12 to 17 years (terminated appraisal) NICE TA910 | Terminated (no company submission) | 13 Jul 2023 | Current |
| Semaglutide for managing overweight and obesity NICE TA875 | Optimised | 8 Mar 2023 Updated 4 Sep 2023 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Semaglutide
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 33 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EU
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Trials by status
Trials by phase
Clinical trials of Semaglutide
133 trialsRegisters list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Semaglutide in the EU trials register (CTIS)
15 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Semaglutide. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
Semaglutide across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
33 single-substance products containing Semaglutide on the HPRA medicines list.
- Kayshild 0.25 mg solution for injection in pre-filled penNovo Nordisk A/S · EU/1/26/2019/001
- Kayshild 0.5 mg solution for injection in pre-filled penNovo Nordisk A/S · EU/1/26/2019/002
- Kayshild 1 mg solution for injection in pre-filled penNovo Nordisk A/S · EU/1/26/2019/003
- Kayshild 1.7 mg solution for injection in pre-filled penNovo Nordisk A/S · EU/1/26/2019/004
- Kayshild 2.4 mg solution for injection in pre-filled penNovo Nordisk A/S · EU/1/26/2019/005
Supply shortages
Recent approvals
Conditions studied with Semaglutide
140 conditionsAll 140 conditions
| Condition (as registered) | Trials |
|---|---|
| Obesity | 44 |
| Overweight | 13 |
| Type 2 Diabetes | 9 |
| Diabetes Mellitus, Type 2 | 8 |
| Obesity & Overweight | 7 |
| Type 2 Diabetes Mellitus (T2DM) | 5 |
| Morbid Obesity | 5 |
| Chronic Kidney Disease | 4 |
| Weight Loss | 4 |
| Acute Ischemic Stroke | 3 |
| Caloric Restriction | 3 |
| Type 1 Diabetes | 3 |
| Type 2 Diabetes Mellitus | 2 |
| Weight Management | 2 |
| Overweight and/or Obesity | 2 |
| Chronic Kidney Diseases | 2 |
| Type 2 Diabetes (T2DM) | 2 |
| Diabetes Mellitus | 2 |
| Cardiovascular Diseases | 2 |
| T2DM | 2 |
| Body Composition | 2 |
| Performance | 2 |
| Diabetes | 2 |
| PreDiabetes | 2 |
| Obesity (Disorder) | 2 |
| Metabolic Syndrome | 2 |
| Non-alcoholic Steatohepatitis | 1 |
| Metabolic Disease | 1 |
| Cardiovascular Disease | 1 |
| Hypertension | 1 |
| Facial Skin Aging | 1 |
| Facial Volume Loss | 1 |
| Wrinkle Appearance | 1 |
| Preventative Health | 1 |
| Body Weight | 1 |
| Adult Obesity | 1 |
| Longevity | 1 |
| Quality of Life | 1 |
| Mood | 1 |
| Inflammation | 1 |
| Treatment Of Obesity | 1 |
| MAFLD | 1 |
| Metabolic Dysfunction-associated Fatty Liver Disease (MAFLD) | 1 |
| Hypertriglyceridemia Induced Acute Pancreatitis | 1 |
| Recurrent Acute Pancreatitis | 1 |
| Pancreatitis Relapsing | 1 |
| Hypertriglyceridemia | 1 |
| Cerebrovascular Disease | 1 |
| Large Vessel Occlusion | 1 |
| Neuroprotective Drugs | 1 |
| Endovascular Treatment | 1 |
| Metabolic Dysfunction-associated Steatohepatitis (MASH) | 1 |
| Intracerebral Hemorrhage | 1 |
| Adults With Simple Obesity | 1 |
| Obesity/Overweight in Adult | 1 |
| Semaglutide | 1 |
| Osteoporosis | 1 |
| Osteoporosis Fracture | 1 |
| Protein Supplementation | 1 |
| Obesity Type 2 Diabetes Mellitus | 1 |
| Cardiovascular Risk | 1 |
| Non-diabetic Obesity | 1 |
| Homeostasis | 1 |
| Probiotic Intervention | 1 |
| Diabetes With Diabetic Autonomic Neuropathy (Diagnosis) | 1 |
| Insulin Sensitivity | 1 |
| Chronic Kidney Disease(CKD) | 1 |
| Severe Mental Illness | 1 |
| Depression / Major Depressive Disorder | 1 |
| Bipolar Disorder (BD) | 1 |
| Schizophrenia | 1 |
| Diabetes Mellitus, Type 1 | 1 |
| Monogenic Obesity | 1 |
| Chronic Kidney Disease stage3 | 1 |
| Chronic Kidney Disease stage4 | 1 |
| Chronic Kidney Disease Stage 1 | 1 |
| Chronic Kidney Disease Stage 2 | 1 |
| Infertility | 1 |
| T2DM (Type 2 Diabetes Mellitus) | 1 |
| Atrial Fibrillation | 1 |
| Type2 Diabetes | 1 |
| Childhood Obesity | 1 |
| Treatment Adherence | 1 |
| Atrial Fibrillation (AF) | 1 |
| Foot Ulcer Due to Type 2 Diabetes Mellitus | 1 |
| Obesity in Diabetes | 1 |
| Obesity/Therapy | 1 |
| Type 1 Diabetes Mellitus (T1DM) | 1 |
| Insulin Sensitivity/Resistance | 1 |
| Heart Failure | 1 |
| Kidney Failure | 1 |
| Primary Open Angle Glaucoma (POAG) | 1 |
| Open-Angle Glaucoma | 1 |
| Glaucoma | 1 |
| Type 2 DM | 1 |
| Type 2 DM /Diabetic Nephropathy | 1 |
| Albuminuria | 1 |
| Breast Cancer (Early Breast Cancer) | 1 |
| Hyperglycemia | 1 |
| Renal Transplant Complication Primary Non-Function | 1 |
| Cannabis Use Disorder | 1 |
| Cannabis Use Disorders | 1 |
| Cannabis Abuse | 1 |
| Cannabis Dependence | 1 |
| Coronary Artery Disease | 1 |
| Menopause | 1 |
| Adiposity | 1 |
| Fatty Liver | 1 |
| Alcohol Use Disorder | 1 |
| Klinefelter Syndrome | 1 |
| Kidney Transplant Recipient | 1 |
| Nicotine Addiction | 1 |
| Tobacco Dependence | 1 |
| Chronic Renal Disease | 1 |
| CKD | 1 |
| Kidney Disease, Chronic | 1 |
| Dialysis | 1 |
| End Stage Kidney Disease (ESRD) | 1 |
| Class I/II Obesity | 1 |
| Schizophrenia Spectrum Disorders | 1 |
| Diabetic Kidney Disease | 1 |
| Cognitive Decline in Older Adults | 1 |
| Kidney Transplant Recipients | 1 |
| Overweight , Obesity | 1 |
| Metabolic Associated Fatty Liver Disease | 1 |
| Metabolic Associated-dysfunction Steatohepatitis (MASH) | 1 |
| Endometrial Cancer | 1 |
| Atypical Hyperplasia | 1 |
| Fertility Perservation | 1 |
| STEMI - ST Elevation Myocardial Infarction | 1 |
| Epicardial Fat | 1 |
| Psoriasis (PsO) | 1 |
| Diabetes Mellitus - Type 2 | 1 |
| Brown Adipose Tissue | 1 |
| Food Addiction Tendency | 1 |
| Glucagon-Like Peptide-1 Receptor Agonists | 1 |
| Coronary Arterial Disease (CAD) | 1 |
| Alzheimer Disease | 1 |
| Mild Cognitive Impairment | 1 |
| Prediabetic State | 1 |
Sponsors
lead sponsor per trial+ 74 more sponsors in the trial list above.
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Semaglutide trials
How many clinical trials are testing Semaglutide?
133 current trials in our USA, China, Canada, Denmark, Spain, Poland, Germany, Australia, Mexico, UK, Netherlands, South Korea, Italy, Belgium, India, Japan, Sweden, Portugal, France, Brazil, Austria, Turkey, Switzerland, Taiwan, Israel, Egypt, Czechia, Ireland, Norway and Singapore registers name Semaglutide (also registered as GLP-1RA) as a drug or biological intervention, as of the registry sync on 9 November 2026. Completed and withdrawn studies are not counted.
Are Semaglutide trials recruiting patients?
Yes. 62 of the 133 trials are recruiting: 15 with sites in USA, 13 with sites in China, 13 with sites in Canada, 12 with sites in Denmark, 11 with sites in Spain, 9 with sites in Poland, 4 with sites in Germany, 7 with sites in Australia, 3 with sites in Mexico, 2 with sites in UK, 4 with sites in Netherlands, 5 with sites in South Korea, 5 with sites in Italy, 4 with sites in Belgium, 3 with sites in India, 3 with sites in Japan, 6 with sites in Sweden, 3 with sites in Portugal, 3 with sites in France, 2 with sites in Brazil, 2 with sites in Austria, 1 with sites in Turkey, 1 with sites in Switzerland, 2 with sites in Taiwan, 2 with sites in Israel and 2 with sites in Czechia. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Semaglutide clinical trials?
Novo Nordisk A/S (30), General Committee of Teaching Hospitals and Institutes, Egypt (5), Eli Lilly and Company (2) and Boehringer Ingelheim (2), among 89 lead sponsors in total. The number in brackets is how many trials each organisation leads.
Are there Semaglutide clinical trials in Ireland?
Yes. 3 trials in our Ireland register (ClinicalTrials.gov). Some may be the same study registered in both. See the Irish clinical trials register for sites and contacts.
Is Semaglutide licensed in Ireland?
Yes. The HPRA medicines list includes 33 single-substance products containing Semaglutide, for example Kayshild 0.25 mg solution for injection in pre-filled pen (Novo Nordisk A/S). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Semaglutide shortage?
The registers we track list 3 entries for Semaglutide: Rybelsus (EU: shortage resolved); Ozempic (EU: shortage resolved); US FDA: resolved. Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Semaglutide works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Semaglutide works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Semaglutide (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 9 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.