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: 152
Recent & Upcoming Milestones
- Clinical Outcomes Reported - Novo Nordisk presented P3 Obesity results on 2025-01-17 for Semaglutide
- Clinical Outcomes Reported - Novo Nordisk presented P3 Non-alcoholic Steatohepatitis results on 2024-11-01 for Semaglutide
- Clinical Outcomes Reported - Novo Nordisk presented P3 Obesity|Kidney Diseases results on 2024-09-09 for Semaglutide
Highest Development Phases
Phase 3: Albuminuria|Alzheimer Disease|Diabetes, Gestational|Diabetic Retinopathy|Fatty Liver, Alcoholic|Glucose Intolerance|Heart Failure|Heart Failure, Chronic|Heart Failure, Diastolic|Hepatitis, Alcoholic|Kidney Diseases|Kidney Failure, Chronic|Non-alcoholic Steatohepatitis|Obesity|Osteoarthritis, Knee|Overweight|Peripheral Arterial Disease|Peripheral Vascular Diseases|Prediabetic State|Stomach Diseases|Stroke|Type 2 Diabetes|Weight Loss
Phase 2: Diabetic Nephropathy|Endometrial Hyperplasia|Inflammation|Mucositis|Peripheral Nervous System Diseases|Prediabetes|Schizophrenia|Type 1 Diabetes|Weight Gain
Phase 1: Healthy Volunteers|Hypercholesterolemia|Myocardial Infarction|Pain Unspecified|Polycystic Ovary Syndrome
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|
| SMART | P3 |
Completed |
Kidney Diseases|Overweight |
2023-05-28 |
5% |
2025-07-07 |
Treatments |
| 2022-000790-94 | P3 |
Completed |
Obesity |
2024-11-26 |
51% |
2025-07-06 |
Treatments |
| COMBINE 2 | P3 |
Completed |
Type 2 Diabetes |
2024-01-16 |
2025-07-09 |
Treatments |
|
| STEP HFpEF DM | P3 |
Completed |
Type 2 Diabetes|Heart Failure, Diastolic|Heart Failure, Chronic |
2023-10-11 |
99% |
2025-07-07 |
Treatments |
| NN9388-7864 | P2 |
Recruiting |
Type 2 Diabetes|Peripheral Nervous System Diseases |
2026-08-21 |
50% |
2025-02-26 |
|
| RT1D | P2 |
Recruiting |
Kidney Diseases|Type 1 Diabetes|Diabetic Nephropathy |
2026-06-01 |
2024-06-07 |
Primary Endpoints|Start Date|Treatments|Trial Status |
|
| NN9931-4553 | P3 |
Recruiting |
Hepatitis, Alcoholic|Non-alcoholic Steatohepatitis |
2029-04-25 |
2025-05-02 |
Treatments |
|
| ESSENCE | P3 |
Active, not recruiting |
Non-alcoholic Steatohepatitis|Fatty Liver, Alcoholic|Hepatitis, Alcoholic |
2029-04-25 |
84% |
2025-03-04 |
Patient Enrollment|Primary Endpoints|Treatments |
| NN9838-7859 | P3 |
Recruiting |
Obesity |
2028-11-17 |
2025-05-02 |
Treatments |
|
| NN9838-7859 | P3 |
Recruiting |
Obesity |
2028-08-28 |
29% |
2025-02-14 |
|
| SERENA | P3 |
Recruiting |
Diabetes, Gestational|Glucose Intolerance |
2028-07-01 |
2023-09-19 |
Primary Endpoints|Start Date |
|
| jRCT2031210033 | P3 |
Recruiting |
Hepatitis, Alcoholic|Non-alcoholic Steatohepatitis |
2028-05-26 |
84% |
||
| NN9535-4352 | P3 |
Active, not recruiting |
Type 2 Diabetes|Diabetic Retinopathy |
2027-11-07 |
2025-05-02 |
Treatments |
|
| REDEFINE 3 | P3 |
Active, not recruiting |
Stroke|Stomach Diseases |
2027-09-01 |
76% |
2025-03-22 |
|
| NN9536-4512 | P3 |
Active, not recruiting |
Overweight|Obesity |
2027-01-15 |
2025-05-02 |
Treatments |
|
| FOCUS | P3 |
Active, not recruiting |
Type 2 Diabetes |
2026-12-25 |
98% |
2023-07-12 |
|
| NN9838-8484 | P3 |
Recruiting |
Obesity |
2026-12-15 |
24% |
2025-06-12 |
|
| NN6535-4725 | P3 |
Active, not recruiting |
Alzheimer Disease |
2026-10-23 |
2025-05-02 |
Treatments |
|
| NN6535-4730 | P3 |
Active, not recruiting |
Alzheimer Disease |
2026-10-23 |
2025-05-02 |
Treatments |
|
| TQF3510-III-02 | P3 |
Not yet recruiting |
Obesity |
2026-07-01 |
31% |
2024-12-19 |
Primary Endpoints|Treatments |
| NCT05829460 | P2 |
Recruiting |
Endometrial Hyperplasia |
2030-04-30 |
50% |
2025-04-02 |
Primary Endpoints|Treatments|Trial Status |
| JY29-2-302 | P3 |
Not yet recruiting |
Obesity|Weight Loss |
2026-05-30 |
21% |
||
| 1R01DK134398-01A1 | P2 |
Recruiting |
Type 1 Diabetes|Obesity |
2028-04-30 |
14% |
2024-07-24 |
Primary Endpoints|Start Date|Treatments|Trial Status |
| FIT-HF trial | P2 |
Recruiting |
Obesity|Heart Failure |
2026-12-31 |
2025-05-02 |
Treatments |
|
| PROTECT | P2 |
Not yet recruiting |
Inflammation|Mucositis |
2026-12-31 |
12% |
2024-06-11 |