Product Description
The glucagon-like peptide-1 receptor agonist (GLP-1RA) semaglutide is the most recently approved agent of this drug class, and the only GLP-1RA currently available as both subcutaneous and oral formulation. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/34305810/)
Mechanisms of Action: GLP-1 Agonist
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Oral, Subcutaneous
FDA Designation: Priority Review - Non-alcoholic Steatohepatitis *
Approval Status: Approved
Approved Countries: Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Canada | Chile | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Japan | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Mexico | Netherlands | New Zealand | Norway | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | Spain | Sweden | Switzerland | Taiwan | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States
Approved Indications: None
Company: Novo Nordisk
Company Location: Europe
Company Founding Year: 1923
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Korea, Latvia, Lebanon, Malaysia, Mexico, Morocco, Netherlands, New Zealand, North Macedonia, Norway, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States, Unknown Location
Active Clinical Trial Count: 168
Recent & Upcoming Milestones
- Clinical Outcomes Expected - Veru announced they will present P2 Obesity results in 4Q27 for Semaglutide
- Clinical Outcomes Expected - Veru announced they will present P2 Obesity results in 1Q27 for Semaglutide
- Clinical Outcomes Reported - Regeneron presented P2 Obesity results on 2026-06-07 for Semaglutide
Highest Development Phases
Phase 3: Albuminuria|Atherosclerosis|Diabetes, Gestational|Diabetic Retinopathy|Dyslipidemia|Early Alzheimer Disease|Fatty Liver|Fatty Liver, Alcoholic|Glucose Intolerance|Heart Failure, Chronic|Heart Failure, Diastolic|Hepatitis, Alcoholic|Hypercholesterolemia|Hypertension|Ischemic Stroke|Kidney Diseases|Kidney Failure, Chronic|Metabolic Dysfunction-Associated Steatohepatitis|Obesity|Other|Overweight|Peripheral Arterial Disease|Peripheral Vascular Diseases|Stomach Diseases|Stroke|Type 1 Diabetes|Type 2 Diabetes|Weight Loss
Phase 2: Chronic Pain|Diabetic Nephropathy|Heart Failure|Hypogonadism|Infertility|Inflammation|Low Back Pain|Marijuana Abuse|Mucositis|Muscular Atrophy|Neuropathic Pain|Non-alcoholic Fatty Liver Disease|Opioid-Related Disorders|Prediabetes|Schizophrenia
Phase 1: Healthy Volunteers|Hyperglycemia|Myocardial Infarction|Pain Unspecified|Sleep Apnea, Obstructive
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT07430059 |
SLIM-1 | P1 |
Not yet recruiting |
Overweight|Obesity |
2026-12-01 |
33% |
2026-07-01 |
Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments |
CTR20253659 |
CTR20253659 | P1 |
Completed |
Overweight|Hyperglycemia|Dyslipidemia|Hypertension|Sleep Apnea, Obstructive |
2026-04-21 |
2026-07-12 |
Primary Completion Date|Start Date|Study Completion Date|Treatments|Trial Status |
|
NCT07731256 |
U1111-1323-5378 | P2 |
Not yet recruiting |
Low Back Pain|Obesity|Chronic Pain |
2031-01-01 |
2026-07-29 |
Primary Endpoints|Treatments |
|
2026-527373-11-00 |
2026-527373-11-00 | P2 |
Not yet recruiting |
Hypogonadism |
2029-10-31 |
|||
2026-527538-29-00 |
2026-527538-29-00 | P2 |
Not yet recruiting |
Infertility|Overweight |
2029-10-30 |
|||
NCT06449625 |
PROTECT | P2 |
Not yet recruiting |
Mucositis|Inflammation |
2026-12-31 |
36% |
2024-06-11 |
|
2025-524163-21-00 |
2025-524163-21-00 | P2 |
Not yet recruiting |
Marijuana Abuse |
2028-03-01 |
|||
NCT05822609 |
RT1D | P2 |
Recruiting |
Type 1 Diabetes|Kidney Diseases|Diabetic Nephropathy |
2027-06-01 |
2026-06-04 |
Primary Completion Date|Primary Endpoints|Study Completion Date |
|
NCT06548490 |
STUDY00024676 | P2 |
Recruiting |
Opioid-Related Disorders |
2027-04-30 |
2026-08-29 |
||
NCT07101939 |
PROACT | P2 |
Recruiting |
Obesity|Muscular Atrophy |
2027-03-01 |
47% |
2025-12-20 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2023-503753-35-01 |
FIT-HF trial | P2 |
Recruiting |
Obesity|Heart Failure |
2026-12-31 |
2025-05-02 |
Treatments |
|
NCT07505303 |
EC0011 | P2 |
Active, not recruiting |
Obesity |
2026-10-15 |
24% |
2026-06-26 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Start Date|Study Completion Date|Treatments|Trial Status |
NCT05424003 |
HM20024306 | P2 |
Recruiting |
Non-alcoholic Fatty Liver Disease|Fatty Liver, Alcoholic |
2026-08-01 |
40% |
2026-06-05 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
2023-509662-38-00 |
NN9388-7864 | P2 |
Recruiting |
Type 2 Diabetes|Neuropathic Pain |
2026-06-23 |
|||
NCT06131372 |
NN9388-7700 | P2 |
Completed |
Kidney Failure, Chronic|Obesity|Type 2 Diabetes |
2025-09-24 |
47% |
2025-11-29 |
|
NCT05569772 |
SERENA | P3 |
Recruiting |
Glucose Intolerance|Type 2 Diabetes|Diabetes, Gestational |
2030-03-01 |
2026-09-16 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
|
NCT04822181 |
ESSENCE | P3 |
Active, not recruiting |
Fatty Liver, Alcoholic|Hepatitis, Alcoholic|Metabolic Dysfunction-Associated Steatohepatitis |
2029-04-25 |
94% |
2025-03-04 |
Patient Enrollment|Primary Endpoints|Treatments |
2025-522326-13-00 |
2025-522326-13-00 | P3 |
Not yet recruiting |
Obesity|Dyslipidemia|Ischemic Stroke|Hypertension|Hypercholesterolemia|Atherosclerosis|Type 1 Diabetes|Albuminuria |
2028-06-01 |
|||
2023-506827-26-00 |
NN9535-4352 | P3 |
Active, not recruiting |
Diabetic Retinopathy|Type 2 Diabetes |
2027-11-07 |
2025-05-02 |
Treatments |
|
NCT05669755 |
REDEFINE 3 | P3 |
Active, not recruiting |
Stroke|Stomach Diseases |
2027-09-01 |
66% |
2025-10-23 |
Patient Enrollment|Primary Endpoints|Treatments |
2023-506918-45-00 |
NN6535-4725 | P3 |
Active, not recruiting |
Alzheimer Disease |
2026-10-23 |
2025-05-02 |
Treatments |
|
NCT07271251 |
NN9924-8485 | P3 |
Completed |
Type 2 Diabetes |
2026-06-29 |
68% |
2026-08-14 |
Primary Endpoints |
CTR20244777 |
CTR20244777 | P3 |
Completed |
Weight Loss |
2026-05-29 |
2026-06-17 |
Patient Enrollment|Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
CTR20243356 |
CTR20243356 | P3 |
Completed |
Other |
2025-10-09 |
2026-05-17 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
NCT04777409 |
EVOKE Plus | P3 |
Completed |
Early Alzheimer Disease|Alzheimer Disease |
2025-09-15 |
78% |
2026-03-27 |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
04/23/2026 |
News Article |
Novo Nordisk's oral semaglutide demonstrates potential to be the first oral GLP-1 RA therapy for children and adolescents with type 2 diabetes |
|
04/23/2026 |
News Article |
Lexaria Launches New Study to Examine Next-Generation GLP-1 Drugs |
|
04/23/2026 |
News Article |
Exert BodySculpt Addresses Rise in Buffalo Hump Cases Linked to GLP-1 Weight Loss Drugs |
|
04/23/2026 |
News Article |
The Longevity Trade Is No Longer a Buzzword — It's a $120 Billion Market, and the FDA Just Cleared the First Cellular Rejuvenation Trial |