Semaglutide
Highest phase reached
Approved
Drug type
Protein
First approval year
2017
- First approval year
- 2017
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Semaglutide
- ozempic
- Ozempic
- rybelsus
- Rybelsus
- semaglutide component of cagrisema
- Semaglutide component of cagrisema
- semaglutide component of nn1535 icosema
- Semaglutide component of nn1535 icosema
- semaglutide component of nn1535 laisema
- Semaglutide component of nn1535 laisema
- wegovy
- Wegovy
- 14mg rybelsus
- Arm 4 - Rybelsus medication (semaglutide) alone
- arm 4 rybelsus medication semaglutide alone
- cagrisema component semaglutide
- CagriSema component semaglutide
- GLP1-RA (semaglutide)
- nn 9535
- NN-9535
- nn1535 icosema component semaglutide
- NN1535 ICOSEMA COMPONENT SEMAGLUTIDE
- nn1535 laisema component semaglutide
- NN1535 LAISEMA COMPONENT SEMAGLUTIDE
- nn9535
- Nn9535
- NN9535
- nnc 0113 0217
- NNC 0113-0217
- NNC-0113-0217
- oral semaglutide
- Oral semaglutide
- Oral Semaglutide
- ozempic
- Ozempic
- Ozempic®
- Rybelsus
And 62 more, listed on the interactive page.
- ATC classification codes
- A10BJ06
Sources for recorded values
- CAS registry numbers
- 910463-68-2
- ChEMBL ID
- CHEMBL2108724
- PubChem compound IDs
- 56843331
- RxNorm IDs (RxCUI)
- 1991302
- FDA ingredient codes (UNII)
- 53AXN4NNHX
- Applicant
- NOVO
- Approval date
- 20 Sept 2019
- Application number
- NDA213051
- Status
- Authorised
- Status date
- 8 Feb 2018
- Authorisation date
- 8 Feb 2018
- Approved indications
- Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise: as monotherapy when metformin is considered inappropriate due to intolerance or contraindications; in addition to other medicinal products for the treatment of diabetes. For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
- Product number
- EMEA/H/C/004174
- Authorisation holder
- Novo Nordisk A/S
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Diabetes Mellitus
European medicines record
- Patents
- 53
- Designations
- 1
- Earliest recorded loss of exclusivity
- 17 Feb 2041
- First in class
- No
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Boxed warning
- Yes
- Pharmacology name
- semaglutide
- Type
- Peptide
- Drug name stem
- -tide
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Oral
- Parenteral
- Action
- Agonist
- Action type
- Agonist
- Target
- GLP-1 receptor
- Gene symbol
- GLP1R
- Protein identifier
- P43220
- Median affinity
- 11.21
- Affinity units
- pEC50
- Primary target
- Yes
- Mechanism
- Glucagon-like peptide 1 receptor agonist
- Action type
- Agonist
- Target
- Glucagon-like peptide 1 receptor
- Protein identifier
- P43220
Open Targets mechanisms
- Mechanism
- Glucagon-like peptide 1 receptor agonist
- Action type
- Agonist
- Target
- Glucagon-like peptide 1 receptor
DrugCentral mechanisms
- Action type
- Agonist
- Gene symbol
- GLP1R
- Protein identifier
- P43220
- Organism
- Homo sapiens
- Target development level
- Clinical
- Condition
- Cardiovascular Diseases
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000319
- Subject identifier
- D002318
- Condition
- Diabetes Mellitus
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000400
- Subject identifier
- D003920
- Condition
- Diabetic Nephropathies
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000401
- Subject identifier
- D003928
- Condition
- Polycystic Ovary Syndrome
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000660
- Subject identifier
- D011085
- Condition
- Nutrition Disorders
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001069
- Subject identifier
- D009748
- Condition
- Obesity
- Highest recorded phase
- 4
- Condition identifier
- EFO:0001073
- Subject identifier
- D009765
- Condition
- Liver Diseases
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001421
- Subject identifier
- D008107
- Condition
- Coronary Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0001645
- Subject identifier
- D003327
- Condition
- Non-alcoholic Fatty Liver Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003095
- Subject identifier
- D065626
- Condition
- Tobacco Use Disorder
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003768
- Subject identifier
- D014029
- Condition
- Substance-Related Disorders
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003890
- Subject identifier
- D019966
- Condition
- Overweight
- Highest recorded phase
- 4
- Condition identifier
- EFO:0005935
- Subject identifier
- D050177
- Condition
- Klinefelter Syndrome
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001006
- Subject identifier
- D007713
- Condition
- Pseudotumor Cerebri
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001132
- Subject identifier
- D011559
- Condition
- Non-alcoholic Fatty Liver Disease
- Highest recorded phase
- 3
- Condition identifier
- EFO:1001249
- Subject identifier
- D065626
- Condition
- Bone Diseases, Metabolic
- Highest recorded phase
- 1
- Condition identifier
- HP:0000938
- Subject identifier
- D001851
- Condition
- Ischemic Stroke
- Highest recorded phase
- 2
- Condition identifier
- HP:0002140
- Subject identifier
- D000083242
- Condition
- Depressive Disorder, Major
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002009
- Subject identifier
- D003865
- Condition
- Alzheimer Disease
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0004975
- Subject identifier
- D000544
- Condition
- Asthma
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0004979
- Subject identifier
- D001249
- Condition
- Diabetes Mellitus, Type 1
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0005147
- Subject identifier
- D003922
- Condition
- Diabetes Mellitus, Type 2
- Highest recorded phase
- 4
- Condition identifier
- MONDO:0005148
- Subject identifier
- D003924
- Condition
- Parkinson Disease
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005180
- Subject identifier
- D010300
- Condition
- Alcoholism
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0007079
- Subject identifier
- D000437
- Condition identifier
- EFO_0000195
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000195
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000319
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000400
- Condition identifier
- EFO_0000401
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000537
- Condition identifier
- EFO_0000589
- Condition identifier
- EFO_0000660
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001069
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001073
- Condition identifier
- EFO_0001421
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001422
- Condition identifier
- EFO_0001645
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003095
- Condition identifier
- EFO_0003768
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003827
- Condition identifier
- EFO_0003890
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004285
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004319
- Highest recorded phase
- 3
- Condition identifier
- EFO_0004338
- Condition identifier
- EFO_0004701
- Highest recorded phase
- 2
- Condition identifier
- EFO_0005935
- Condition identifier
- EFO_0008008
- Condition identifier
- EFO_0009523
- Condition identifier
- EFO_0010445
- Highest recorded phase
- 2
And 83 more, listed on the interactive page.
Warnings
- Warning
- Black Box Warning
- Effect
- carcinogenicity
Open Targets warnings
- Warning
- Black Box Warning
- Effect
- carcinogenicity
- Country
- United States
- Event
- abdominal pain
- Reports
- 155
- Reporting signal score
- 75.7023
- Event
- acute kidney injury
- Reports
- 103
- Reporting signal score
- 44.9032
- Event
- blood glucose increased
- Reports
- 71
- Reporting signal score
- 51.9654
- Event
- decreased appetite
- Reports
- 106
- Reporting signal score
- 48.6178
- Event
- dehydration
- Reports
- 101
- Reporting signal score
- 56.9194
- Event
- diabetic ketoacidosis
- Reports
- 83
- Reporting signal score
- 129.303
- Event
- diabetic retinopathy
- Reports
- 29
- Reporting signal score
- 85.5215
- Event
- diarrhoea
- Reports
- 289
- Reporting signal score
- 94.9216
- Event
- eructation
- Reports
- 36
- Reporting signal score
- 79.1515
- Event
- euglycaemic diabetic ketoacidosis
- Reports
- 43
- Reporting signal score
- 115.643
- Event
- gastrointestinal disorder
- Reports
- 73
- Reporting signal score
- 67.9953
- Event
- glycosylated haemoglobin increased
- Reports
- 46
- Reporting signal score
- 77.8225
- Event
- lipase increased
- Reports
- 31
- Reporting signal score
- 49.0872
- Event
- nausea
- Reports
- 556
- Reporting signal score
- 372.48
- Event
- pancreatic carcinoma
- Reports
- 22
- Reporting signal score
- 36.8989
- Event
- pancreatitis
- Reports
- 277
- Reporting signal score
- 594.599
- Event
- pancreatitis acute
- Reports
- 53
- Reporting signal score
- 60.1721
- Event
- retinopathy
- Reports
- 37
- Reporting signal score
- 94.9325
- Event
- vomiting
- Reports
- 423
- Reporting signal score
- 329.03
- Event
- weight decreased
- Reports
- 173
- Reporting signal score
- 126.346
- NCT00696657
- NCT00813020
- NCT01272973
- NCT01324505
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- NCT02207374
- NCT02212067
- NCT02254291
- NCT02305381
- NCT02461589
- NCT02607865
And 177 more, listed on the interactive page.
- Dose
- 0.25 mg
- Route
- Subcutaneous
- How often
- Once weekly
Conditions of use
- Administer in the abdomen, thigh, or upper arm
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Sequences
- Component
- Sequence
- Type
- Protein
- Sequence
- HEGTFTSDVSESYLEGQAAKEFIAWLVRGRG
- 0169-1704
- 0169-1709
- 0169-1715
- 0169-4303
- 0169-4307
- 0169-4314
- 50090-5824
- 50090-5949
- 50090-6051
- 50090-8027
- Recorded assays
- 1
- Active assays
- 1
Active assay types
- Other
Oral bioavailability
- Median
- 94
- Mean
- 94
- Minimum
- 94
- Maximum
- 94
- Unit
- %
- Assays
- 1
- Standard deviation
- 0
- Summary method
- median
- Censored results excluded
- 0
- Other units excluded
- 0
- Unknown units excluded
- 0
Measurement types
- F
Related records
Trials (585)
- "Efficacy of Once Weekly GLP 1 Analogue: Semaglutide. A Multicenter Experience From Pakistan."
- 16-week Flexible vs. 8-week Semaglutide Titration
- A Biomarker-targeted Clinical Trial to Optimize Treatment for Patients With Chronic Kidney Disease
- A Clinical Study Comparing Semaglutide Injection and Wegovy® for Weight Management in Obese Subjects
- A Clinical Study of Efinopegdutide in Participants With Precirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-6024-013)
- A Clinical Study of Semaglutide Nasal Spray in Overweight or Obese Adults
- A Clinical Trial Comparing Semaglutide in Healthy People Who Eat and Take the Medicine at Different Times
- A Clinical Trial Investigating the Comparison of Three Different Concentrations of NN9535 in Healthy Male Subjects
- A Clinical Trial Looking at the Comparability of 2 Different Forms of Semaglutide
- A Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adults Living With Type 1 Diabetes
- A First-in-human Research Study on How NNC0721-8060 Works in People Living With Overweight or Obesity
- A Heart Disease Study of Semaglutide in Patients With Type 2 Diabetes
- A Non-interventional Study Investigating Semaglutide in Combination With Lifestyle-based Modifications for the Management of Obesity in Real-World Clinical Practice in Germany (WeGo Real Germany).
- A Ph2 Study to Evaluate the Safety, Efficacy and Tolerability of HT-6184 and Semaglutide in Obese Participants With T2DM
- A Phase III Clinical Study to Evaluate the Efficacy and Safety of GZR18 Injection in Adult Type 2 Diabetes Mellitus
- A Phase III Study Comparing the Weight Loss Effects of Semaglutide Injection and Wegovy®
- A Proof-of-Concept Study to Evaluate Topical-Lingual Semaglutide in Adults With Obesity
- A Randomised Controlled Clinical Trial in Type 2 Diabetes Comparing Semaglutide to Placebo and Liraglutide
- A Randomised, Single Centre, Double-blind, Two-period, Cross-over Trial in Healthy Subjects Investigating the Bioequivalence Between Subcutaneous Injections of Semaglutide Produced by Two Manufacturing Processes
- A Randomized Controlled Study of Dose-tapering Regimen of Semaglutide for Weight-Loss Maintenance in Adults With Overweight or Obesity
Approved for (3)
In development for (22)
- Alcohol abuse Phase 3
- Alcohol dependence Phase 2
- Alzheimer disease Phase 3
- Asthma Phase 2
- Cardiovascular disorder Phase 3
- Coronary artery disorder Phase 3
- Diabetic kidney disease Phase 2
- Drug dependence Phase 2
- Ischemic stroke Phase 2
- Klinefelter syndrome Phase 3
- Liver disorder Phase 2
- Major depressive disorder Phase 2
- Metabolic bone disorder Phase 1
- Metabolic dysfunction-associated steatohepatitis Phase 3
- Metabolic dysfunction-associated steatotic liver disease Phase 3
- Methamphetamine dependence Phase 2
- Nicotine dependence Phase 2
- Nutritional disorder Phase 3
- Parkinson disease Phase 2
- Polycystic ovary syndrome Phase 2
Other linked conditions (6)
- Cirrhosis of liver
- Hyperlipidemia
- Hypertensive disorder
- Inherited obesity
- Metabolic disease
- Pulmonary embolism
Targets (1)
- GLP1R Glucagon-like peptide 1 receptor agonist