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
Known Adverse Events: None
Company: Novo Nordisk
Company Location: BAGSVAERD DENMARK G7 00000
Company CEO: Lars Fruergaard Jorgensen
Additional Commercial Interests: None
Clinical Description
Countries in Clinic: Algeria, Argentina, Australia, Austria, Bangladesh, Belgium, Brazil, Bulgaria, Canada, China, Colombia, Croatia, Czech Republic, Denmark, Estonia, 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: 164
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Novo Nordisk presented P3 Alzheimer Disease results on 2025-11-24 for Semaglutide
- Clinical Outcomes Reported - Novo Nordisk presented P3 Obesity|Weight Loss results on 2025-11-05 for Semaglutide
- Clinical Outcomes Reported - Novo Nordisk presented P2 Non-alcoholic Steatohepatitis results on 2025-11-09 for Semaglutide
Highest Development Phases
Phase 3: Albuminuria|Atherosclerosis|Diabetes, Gestational|Diabetic Retinopathy|Dyslipidemia|Fatty Liver, Alcoholic|Glucose Intolerance|Heart Failure|Heart Failure, Chronic|Heart Failure, Diastolic|Hepatitis, Alcoholic|Hypercholesterolemia|Hypertension|Ischemic Stroke|Kidney Diseases|Kidney Failure, Chronic|Non-alcoholic Steatohepatitis|Obesity|Osteoarthritis, Knee|Overweight|Peripheral Arterial Disease|Peripheral Vascular Diseases|Prediabetic State|Stomach Diseases|Stroke|Type 1 Diabetes|Type 2 Diabetes|Weight Loss
Phase 2: Diabetic Nephropathy|Endometrial Hyperplasia|Inflammation|Mucositis|Neuropathic Pain|Prediabetes|Schizophrenia|Weight Gain
Phase 1: Healthy Volunteers|Hyperglycemia|Myocardial Infarction|Obesity, Morbid|Pain Unspecified|Polycystic Ovary Syndrome|Sleep Apnea, Obstructive
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06222437 |
046.OBG.2023.D | P1 |
Not yet recruiting |
Polycystic Ovary Syndrome |
2026-01-01 |
2024-03-28 |
||
NCT07092605 |
ALRx010 | P1 |
Enrolling by invitation |
Inflammation |
2025-11-01 |
12% |
2025-07-31 |
Primary Endpoints|Treatments |
CTR20251083 |
CTR20251083 | P1 |
Completed |
Myocardial Infarction|Stroke|Type 2 Diabetes |
2025-06-30 |
2025-07-15 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
NCT05784402 |
NN9924-4891 | P1 |
Completed |
Healthy Volunteers|Pain Unspecified |
2024-02-23 |
50% |
2024-05-02 |
Patient Enrollment|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
NCT05829460 |
NCT05829460 | P2 |
Recruiting |
Endometrial Hyperplasia |
2030-04-30 |
50% |
2025-04-02 |
Primary Endpoints|Treatments|Trial Status |
NCT06449625 |
PROTECT | P2 |
Not yet recruiting |
Mucositis|Inflammation |
2026-12-31 |
12% |
2024-06-11 |
|
2023-503753-35-01 |
FIT-HF trial | P2 |
Recruiting |
Obesity|Heart Failure |
2026-12-31 |
2025-05-02 |
Treatments |
|
2023-509662-38-00 |
NN9388-7864 | P2 |
Recruiting |
Type 2 Diabetes|Neuropathic Pain |
2026-06-23 |
|||
NCT05822609 |
RT1D | P2 |
Recruiting |
Kidney Diseases|Diabetic Nephropathy|Type 1 Diabetes |
2026-06-01 |
2024-06-07 |
Primary Endpoints|Start Date|Treatments|Trial Status |
|
NCT05424003 |
HM20024306 | P2 |
Recruiting |
Weight Gain |
2026-02-01 |
50% |
2024-04-10 |
Primary Endpoints |
NCT06131372 |
NN9388-7700 | P2 |
Completed |
Type 2 Diabetes|Kidney Failure, Chronic|Obesity |
2025-09-24 |
50% |
2025-11-29 |
|
2020-004374-22 |
HISTORI - Home-based Intervention with Semaglutide Treatment Of | P2 |
Active, not recruiting |
Schizophrenia|Prediabetes |
2023-06-16 |
2022-03-13 |
Treatments |
|
NCT04822181 |
ESSENCE | P3 |
Active, not recruiting |
Non-alcoholic Steatohepatitis|Fatty Liver, Alcoholic|Hepatitis, Alcoholic |
2029-04-25 |
62% |
2025-03-04 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT05569772 |
SERENA | P3 |
Recruiting |
Diabetes, Gestational|Glucose Intolerance |
2028-07-01 |
2023-09-19 |
Primary Endpoints|Start Date |
|
2025-522326-13-00 |
2025-522326-13-00 | P3 |
Not yet recruiting |
Dyslipidemia|Hypercholesterolemia|Obesity|Ischemic Stroke|Hypertension|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 |
53% |
2025-10-23 |
Patient Enrollment|Primary Endpoints|Treatments |
NCT06633783 |
JY29-2-302 | P3 |
Not yet recruiting |
Weight Loss|Obesity |
2026-05-30 |
21% |
||
NCT06604624 |
HD1916-003 | P3 |
Active, not recruiting |
Obesity |
2026-02-01 |
40% |
2024-11-13 |
Patient Enrollment|Primary Endpoints|Start Date|Treatments|Trial Status |
NCT06065540 |
REIMAGINE 2 | P3 |
Active, not recruiting |
Type 2 Diabetes |
2025-11-17 |
45% |
2025-09-12 |
|
CTR20243491 |
CTR20243491 | P3 |
Completed |
Overweight |
2025-09-24 |
2025-11-23 |
Primary Completion Date|Study Completion Date|Treatments|Trial Status |
|
NCT04777409 |
EVOKE Plus | P3 |
Active, not recruiting |
Alzheimer Disease |
2025-09-15 |
47% |
2025-12-03 |
|
NCT04560998 |
STRIDE | P3 |
Completed |
Peripheral Vascular Diseases|Peripheral Arterial Disease|Type 2 Diabetes |
2024-06-05 |
98% |
2024-08-21 |
|
NCT04916470 |
STEP HFpEF DM | P3 |
Completed |
Type 2 Diabetes|Heart Failure, Diastolic|Heart Failure, Chronic |
2023-10-11 |
99% |
2023-11-01 |
|
NCT05064735 |
NN9536-4578 | P3 |
Completed |
Osteoarthritis, Knee|Obesity |
2023-07-24 |
27% |
2023-09-15 |
Primary Endpoints|Study Completion Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
12/11/2025 |
News Article |
Mazdutide Demonstrates Significant Weight Loss and Metabolic Benefits in Phase 1b Clinical Trial in Chinese Adolescents with Obesity |
|
12/11/2025 |
News Article |
Aligos Therapeutics Presents Positive Data at HEP-DART 2025 |
|
12/10/2025 |
News Article |
Lexicon Pharmaceuticals Announces Publication of Preclinical Data in the Journal of the Endocrine Society on Acyl-CoA Synthetase 5 (ACSL5) Reinforcing the Scientific Rationale for LX9851 |
|
12/10/2025 |
News Article |
Hims & Hers Brings Comprehensive Weight Loss Programme to the UK |