Ozempic(semaglutide)
Ozempic, Rybelsus, Wegovy (semaglutide) is a protein pharmaceutical. Semaglutide was first approved as Ozempic on 2017-12-05. It has been approved in Europe to treat diabetes mellitus, obesity, overweight, and type 2 diabetes mellitus. The pharmaceutical is active against glucagon-like peptide 1 receptor.
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Commercial
Trade Name
FDA
EMA
Ozempic, Rybelsus, Wegovy (discontinued: Ozempic)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Semaglutide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OZEMPIC | Novo Nordisk | N-209637 RX | 2019-04-09 | 3 products, RLD, RS |
| RYBELSUS | Novo Nordisk | N-213051 RX | 2019-09-20 | 6 products, RLD, RS |
| WEGOVY | Novo Nordisk | N-215256 RX | 2021-06-04 | 5 products, RLD, RS |
Show 1 discontinued
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
SEMAGLUTIDE, WEGOVY, NOVO | |||
| 2025-12-23 | NPP | ||
| 2024-06-04 | NP | ||
SEMAGLUTIDE, OZEMPIC, NOVO | |||
| 2025-03-28 | D-185 | ||
| 2023-01-16 | I-822 | ||
SEMAGLUTIDE, RYBELSUS, NOVO | |||
| 2023-01-16 | M-252 | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Semaglutide, Wegovy, Novo | |||
| 11318191 | 2041-02-17 | DP | U-3162 |
| 10888605 | 2038-08-24 | DP | U-3162 |
| 9764003 | 2033-06-21 | U-3161 | |
| Semaglutide, Rybelsus, Novo | |||
| 10278923 | 2034-05-02 | U-2628 | |
| 10933120 | 2033-03-15 | DP | |
| 9278123 | 2031-12-16 | DP | U-2628 |
| 10086047 | 2031-12-16 | DP | |
| 10960052 | 2031-12-16 | DP | |
| 11382957 | 2031-12-16 | DP | |
| Semaglutide, Ozempic, Novo | |||
| 10335462 | 2033-06-21 | DP | U-2580 |
| 9132239 | 2032-02-01 | DP | |
| 8129343 | 2031-12-05 | DS, DP | U-2202, U-2628, U-3355, U-3469 |
| 9457154 | 2027-09-29 | DP | |
| 9687611 | 2027-02-27 | DP | |
| RE46363 | 2026-08-03 | DP | |
| 8920383 | 2026-07-17 | DP | |
| 9775953 | 2026-07-17 | DP | |
| 10220155 | 2026-07-17 | DP | |
| 11097063 | 2026-07-17 | DP | |
| 8536122 | 2026-03-20 | DS, DP | U-2202, U-2628, U-3355, U-3469 |
| 9108002 | 2026-01-20 | DP | |
| 9616180 | 2026-01-20 | DP | |
| 9861757 | 2026-01-20 | DP | |
| 10357616 | 2026-01-20 | DP | |
| 10376652 | 2026-01-20 | DP | |
| 11311679 | 2026-01-20 | DP | |
| 8684969 | 2025-10-20 | DP | |
| 11446443 | 2025-10-20 | DP | |
| 8114833 | 2025-08-13 | DP | |
| 7762994 | 2024-05-23 | DP | |
| 8579869 | 2023-06-30 | DP | |
HCPCS
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Clinical
Clinical Trials
594 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 48 | 27 | 72 | 36 | 73 | 254 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 32 | 35 | 50 | 26 | 54 | 189 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 44 | 18 | 58 | 22 | 48 | 185 |
| Overweight | D050177 | — | E66.3 | 18 | 10 | 25 | 8 | 22 | 81 |
| Healthy volunteers/patients | — | — | — | 44 | 3 | — | 2 | 2 | 51 |
| Weight loss | D015431 | — | — | 2 | 3 | 6 | 10 | 12 | 32 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 3 | 14 | 3 | 4 | 2 | 24 |
| Fatty liver | D005234 | EFO_0003934 | — | 3 | 12 | 2 | 4 | 4 | 24 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 5 | 7 | 7 | 3 | 1 | 19 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 2 | 9 | 1 | 3 | 3 | 17 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alcoholic fatty liver | D005235 | — | K70.0 | 2 | 5 | 1 | — | — | 7 |
| Nutrition disorders | D009748 | EFO_0001069 | — | 2 | 1 | 2 | — | — | 5 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 3 | 2 | — | — | 5 |
| Ischemic stroke | D000083242 | — | — | — | 2 | 2 | — | — | 4 |
| Renal insufficiency | D051437 | — | N19 | 2 | — | 1 | — | — | 3 |
| Body-weight trajectory | D000077962 | — | — | 1 | 1 | 1 | — | — | 3 |
| Tobacco use disorder | D014029 | — | F17 | — | 1 | 1 | — | 1 | 3 |
| Hypersensitivity | D006967 | EFO_0003785 | T78.40 | — | — | 1 | — | 2 | 3 |
| Disease | D004194 | EFO_0000408 | R69 | — | — | 2 | — | — | 2 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 1 | — | 1 | — | — | 2 |
Show 16 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | 2 | 1 | — | — | 1 | 4 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 2 | — | — | 1 | 3 |
| Alcohol drinking | D000428 | EFO_0004329 | — | — | 2 | — | — | 1 | 3 |
| Metabolic bone diseases | D001851 | — | — | 1 | 2 | — | — | — | 2 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | 2 | — | — | — | 2 |
| Hypercholesterolemia | D006937 | — | — | 1 | 1 | — | — | — | 2 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 2 | — | — | — | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | 1 | — | — | — | 1 |
| Wounds and injuries | D014947 | — | T14.8 | — | 1 | — | — | — | 1 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 1 | — | — | — | 1 |
Show 23 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bariatric surgery | D050110 | — | — | 1 | — | — | — | 1 | 2 |
| Gastrointestinal diseases | D005767 | — | — | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | 1 | — | — | — | — | 1 |
| Localized scleroderma | D012594 | EFO_1001361 | L94.0 | 1 | — | — | — | — | 1 |
| Diffuse scleroderma | D045743 | EFO_0000404 | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | — | — | — | — | 1 |
| Pain management | D059408 | — | — | 1 | — | — | — | — | 1 |
Show 1 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 2 | 2 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | — | — | — | 2 | 2 |
| Feeding and eating disorders | D001068 | — | F50 | — | — | — | — | 2 | 2 |
| Binge-eating disorder | D056912 | — | F50.2 | — | — | — | — | 2 | 2 |
| Heart disease risk factors | D000082742 | — | — | — | — | — | — | 2 | 2 |
| Carcinoma | D002277 | — | C80.0 | — | — | — | — | 1 | 1 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | — | — | — | 1 | 1 |
| Neuroendocrine carcinoma | D018278 | — | — | — | — | — | — | 1 | 1 |
| Papillary thyroid cancer | D000077273 | — | — | — | — | — | — | 1 | 1 |
| Thyroid diseases | D013959 | — | E00-E07 | — | — | — | — | 1 | 1 |
Show 25 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Semaglutide |
| INN | semaglutide |
| Description | Semaglutide is a polypeptide that contains a linear sequence of 31 amino acids joined together by peptide linkages. It is an agonist of glucagon-like peptide-1 receptors (GLP-1 AR) and used for the treatment of type 2 diabetes. It has a role as a hypoglycemic agent, a glucagon-like peptide-1 receptor agonist, an anti-obesity agent, a neuroprotective agent and an appetite depressant. It is a polypeptide and a lipopeptide. |
| Classification | Protein |
| Drug class | peptides: glucagon-like peptide (GLP) analogs |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 910463-68-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2108724 |
| ChEBI ID | — |
| PubChem CID | 56843331 |
| DrugBank | DB13928 |
| UNII ID | 53AXN4NNHX (ChemIDplus, GSRS) |
Target
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Rybelsus – Novo Nordisk
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Wegovy – Novo Nordisk
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Ozempic – Novo Nordisk
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Estimated US medical usage
Semaglutide
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Ozempic, Rybelsus, Wegovy
Adverse Events
Top Adverse Reactions
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47,853 adverse events reported
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