Data updated: Jun 28, 2026
SEMAGLUTIDE · Apotex
Approved 2017-12-05
SEMAGLUTIDE is FDA-approved to treat 3 conditions (same as WEGOVY).
Source: FDA Label
Details
- Status
- Prescription
- First Approved
- 2017-12-05
- PDUFA Date
- 2026-10-18 (99d)
- Routes
- SOLUTION
- Dosage Forms
- INJECTION
SEMAGLUTIDE Approval History
No approval records found
What SEMAGLUTIDE Treats
3 indicationsSEMAGLUTIDE is approved for 3 conditions . These indications span multiple therapeutic areas including oncology, immunology, and more.
- Obesity
- Overweight
- Metabolic Dysfunction-Associated Steatohepatitis
Same approved indications as WEGOVY (same active ingredient).
Source: FDA Label
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Clinical Trial Registry
258 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03884075 | 190072 19-DK-0072 | Ph 2 | recruiting | Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES) |
| NCT06745284 | 1404-0045 U1111-1309-3679 | Ph 1 | active not recruiting | A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity |
| NCT06015893 | 10001603 001603-DA | Ph 2 | recruiting | Semaglutide Therapy for Alcohol Reduction (STAR) |
| NCT06884293 | CIBI362B303 | Ph 3 | active not recruiting | A Study Comparing IBI362 vs Semaglutide in Chinese Overweight or Obese Adults With Metabolic Dysfunction-associated Fatty Liver Disease （MAFLD） |
| NCT07059377 GLP1-SC | HM74061 | Ph 3 | recruiting | Semaglutide for Smoking Cessation in Patients With Diabetes |
| NCT05514535 results posted | NN9535-4801 U1111-1267-0312, 2021-004392-13 | Ph 3 | completed | A Research Study to Look Into How Semaglutide, Together With a Lower Dose of Insulin Glargine, Compares to a Higher Dose of Insulin Glargine Alone in People With Type 2 Diabetes (SUSTAIN OPTIMIZE) |
| NCT05586802 KLIN-HEALTH | PZ00P3_202151 | Ph 3 | recruiting | Sex Steroids Balance for Metabolic and Reproductive Health in Klinefelter Syndrome |
| NCT06299098 COURAGE | R1033-OB-2288 | Ph 2 | active not recruiting | A Study to Test if Trevogrumab or Trevogrumab With Garetosmab When Taken With Semaglutide is Safe and How Well They Work in Adult Patients With Obesity for Weight Loss, Fat Loss, and Lean Mass Preservation |
| NCT07547878 RAPID-CKD | 026-271 | Ph 4 | not yet recruiting | Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD) |
| NCT07527195 RASMUS | NN9838-8411 U1111-1321-8655, 2025-522920-28 | Ph 1 | recruiting | Understanding the Effect of CagriSema, Cagrilintide, and Semaglutide on Muscle Health (Role of Amylin Signature in Muscle Health) |
| NCT07415954 | NN9662-8160 U1111-1324-0310, 2025-523260-20 | Ph 2 | recruiting | A Research Study Comparing How Well Different Doses of the Medicine NNC0662-0419 Lower Blood Sugar in People With Type 2 Diabetes |
| NCT06388187 | NN9838-7749 U1111-1298-3451, 2023-509273-24 | Ph 3 | completed | A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight |
| NCT05567796 REDEFINE 1 | NN9838-4608 Universal Trial Number (UTN), 2020-005435-75 | Ph 3 | active not recruiting | A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight |
| NCT06534411 REIMAGINE 5 | NN9388-7741 U1111-1300-2590, 2023-509600-15 | Ph 3 | active not recruiting | A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both |
| NCT07564414 | NN9838-7910 U1111-1323-0372, 2025-522488-14 | Ph 3 | recruiting | A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight |
| NCT07282769 | IRB25-1571 | Ph 2 | not yet recruiting | Semaglutide (Wegovy) Treatment for Trichotillomania |
| NCT06975111 | 25-0943 U1111-1322-1036 | Ph 2, Ph 3 | recruiting | Focusing on the Menopausal Transition to Improve Mid-Life Women's Health |
| NCT03811561 FOCUS | NN9535-4352 U1111-1201-6256, 2017-003619-20 | Ph 3 | active not recruiting | A Research Study to Look at How Semaglutide Compared to Placebo Affects Diabetic Eye Disease in People With Type 2 Diabetes |
| NCT07284979 | K9531-3107 2025-523511-11-00 | Ph 3 | recruiting | Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes |
| NCT07554417 | IRB-FY2026-226 | Ph 4 | not yet recruiting | Combatting Muscle Loss in Obese Adult Patients on GLP-1 Medications Through Dietary Counseling and Exercise During Treatment Evaluates Whether a 12-week Exercise and Individualized Nutrition Program Can Reduce Muscle and Bone Loss and Improve Strength, Fitness, and Function in Obese Adults on GLP-1 |
| NCT05649137 results posted | NN9536-7545 2022-002235-60, U1111-1279-0359 | Ph 3 | completed | A Research Study to See How Semaglutide Helps People With Excess Weight and Type 2 Diabetes Lose Weight |
| NCT05646706 STEP UP results posted | NN9536-4999 U1111-1274-4259, 2022-000790-94 | Ph 3 | completed | A Research Study to See How Semaglutide Helps People With Excess Weight, Lose Weight (STEP UP) |
| NCT05726227 STEP Young | NN9536-4512 U1111-1266-3808, 2022-502922-41 | Ph 3 | active not recruiting | A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight |
| NCT06221969 | NN9388-4894 U1111-1282-5561, 2023-503789-21-00 | Ph 3 | completed | A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor |
| NCT07511543 LEAST | LEAST | Ph 2 | not yet recruiting | Glucagon-like Peptide-1 Receptor Agonists for Endovascular Stroke Thrombectomy |
| NCT04822181 ESSENCE | NN9931-4553 U1111-1244-3678, 2019-004594-44 | Ph 3 | active not recruiting | Research Study on Whether Semaglutide Works in People With Non-alcoholic Steatohepatitis (NASH) |
| NCT07218354 CRAVE | 2041 | Ph 3 | not yet recruiting | Cessation or Reduction of Alcohol Consumption in Veterans: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of a GLP-1 Receptor Agonist Semaglutide in U.S. Veterans With Alcohol Use Disorder |
| NCT05202353 | 1404-0047 2021-000363-76, 2024-515417-17-00 | Ph 1 | recruiting | A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver |
| NCT07523633 HASHTAG | The HASHTAG Study U1111-1327-8749, 2025-524163-21 | Ph 2 | recruiting | Effect of Semaglutide on Cannabis Use in Adults With Cannabis Use Disorder |
| NCT06260722 | 18805 J1I-MC-GZBZ | Ph 3 | active not recruiting | Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2) |
| NCT07466017 | CS060380-MASH-CN-II-03 2024LP01824, CS060380-MASH-CN-II-03 | Ph 2 | recruiting | A Study of CS060380 Tablets in Patients With MASH and Obesity |
| NCT05813912 results posted | NN1436-4910 2022-002847-24, U1111-1281-4752 | Ph 3 | completed | A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes |
| NCT05144984 results posted | NN9389-4606 U1111-1259-2741, 2020-004863-14 | Ph 2 | completed | A Research Study Looking at How Well a Combination of the Medicines Semaglutide and NNC0480-0389 Works in People With Type 2 Diabetes |
| NCT07112872 | BP45703 2024-520322-11-00 | Ph 2 | active not recruiting | A Study to Compare Different Doses of RO7795081 With a Placebo or Semaglutide in People With Type 2 Diabetes |
| NCT06604624 | HD1916-003 | Ph 3 | completed | Semaglutide in Treatment of Obesity |
| NCT07087795 | NN6497-8316 U1111-1315-5122, 2024-519533-38 | Ph 1 | active not recruiting | A Study to See the Effect of NNC0194-0499 Alone or in Combination With Semaglutide on Blood Sugar Control in People Living With Type 1 Diabetes |
| NCT06323174 REIMAGINE 1 | NN9388-4895 2022-502677-42, U1111-1283-0404 | Ph 3 | completed | A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise |
| NCT07253285 | NN9838-4968 U1111-1299-4751, 2023-509176-42 | Ph 3 | recruiting | A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight |
| NCT07272343 | 2022efyA04 | Ph 4 | recruiting | The Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes |
| NCT06803888 | 24-915 | Ph 4 | active not recruiting | Bariatric Surgery vs. Semaglutide vs. Tirzepatide |
| NCT06131372 | NN9388-7700 U1111-1291-5907, 2023-505857-42 | Ph 2 | completed | A Research Study to See if Kidney Damage in People With Chronic Kidney Disease and Type 2 Diabetes Living With Overweight or Obesity Can be Reduced by CagriSema Compared to Semaglutide, Cagrilintide and Placebo |
| NCT07505303 | EC0011 | Ph 2 | active not recruiting | MIST (Metabolic Intervention With Semaglutide and THR-β Therapy) Trial |
| NCT04777409 EVOKE Plus | NN6535-4725 U1111-1259-2920, 2023-506918-45 | Ph 3 | completed | A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus) |
| NCT07040592 HARP | 2000033919_c 1P01AA029545-01 | Ph 2 | recruiting | Off-Label Medications for Alcohol Use Disorder Among Patients With HIV: Pilot Study 3 Semaglutide |
| NCT06222437 | 046.OBG.2023.D | Ph 1 | withdrawn | Semaglutide and Polycystic Ovarian Syndrome: an Emerging Treatment Strategy |
| NCT07485062 MOTIVATE | 128008 528313 | Ph 4 | not yet recruiting | Exercise and Diabetes Interventions to Improve Brain Health in Older Adults With Type 2 Diabetes |
| NCT07227948 | HSC-MS-25-0412 R01DA062720-01 | Ph 2 | recruiting | Repurposing Semaglutide for the Treatment of Cocaine Use Disorder |
| NCT07483801 DECODE | DECODE (A097165) | Ph 4 | not yet recruiting | DECODE - Haemodynamic Effects Of Semaglutide and Tirzepatide - a Series of Pilot Studies |
| NCT05119179 | HSC-MS-21-0297 5R01DK127084 | Ph 4 | recruiting | Pharmacogenetics of the Response to GLP-1 in Mexican-Americans With Prediabetes |
| NCT06762314 | Tanta 145 | Ph 2 | recruiting | Efficacy and Safety of Empagliflozin or Semaglutide in Overweight/Obese Patients With Type 1 Diabetes |
Showing 50 of 258 trials
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SEMAGLUTIDE FDA Label Details
Indications & Usage
SEMAGLUTIDE is FDA-approved to treat 3 conditions — same approved indications as WEGOVY.
Looking for the branded version?
WEGOVY
Full clinical data, patents, trials, and competitive landscape for semaglutide.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.