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: None *
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: Pancreatitis | Type 1 Diabetes | General Diabetes | Type 2 Diabetes | Hypertension | Pancreatitis | Pancreatitis, Chronic | Dyslipidemia | General Diabetes | Type 2 Diabetes | Obesity | Obesity, Morbid | Overweight | Weight Loss
Known Adverse Events: Abdominal Pain | Pain Unspecified | Constipation | Diarrhea | Dizziness | Headache | Enteritis | Gastroenteritis | Gastroesophageal Reflux | General Diabetes | Hypoglycemia | Type 2 Diabetes | Dyspepsia | Eructation | Flatulence
Company: Novo Nordisk
Company Location: BAGSVAERD DENMARK G7 00000
Company CEO: Lars Fruergaard Jorgensen
Additonal 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: 165
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|Intermittent Claudication|Kidney Diseases|Kidney Failure, Chronic|Non-alcoholic Steatohepatitis|Obesity|Obesity, Morbid|Osteoarthritis, Knee|Overweight|Peripheral Arterial Disease|Peripheral Vascular Diseases|Prediabetic State|Schizophrenia|Stomach Diseases|Stroke|Type 2 Diabetes|Weight Gain|Weight Loss
Phase 2: Body Weight Changes|Diabetic Nephropathy|Endometrial Hyperplasia|Inflammation|Mucositis|Prediabetes|Pregnancy Outcomes|Type 1 Diabetes
Phase 1: Healthy Volunteers|Hypercholesterolemia|Myocardial Infarction|Pain Unspecified|Polycystic Ovary Syndrome
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| NCT05829460 | P2 |
Not yet recruiting |
Endometrial Hyperplasia |
2029-12-31 |
|
| ESSENCE | P3 |
Active, not recruiting |
Hepatitis, Alcoholic|Non-alcoholic Steatohepatitis|Fatty Liver, Alcoholic |
2029-04-25 |
|
| NN9931-4553 | P3 |
Unknown Status |
Hepatitis, Alcoholic|Non-alcoholic Steatohepatitis |
2029-04-25 |
|
| ESSENCE | P3 |
Active, not recruiting |
Non-alcoholic Steatohepatitis|Hepatitis, Alcoholic |
2028-07-28 |