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
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 | 2017-12-05 | 4 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 |
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
489 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 | 21 | 70 | 32 | 62 | 231 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 43 | 23 | 72 | 23 | 62 | 219 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 26 | 25 | 45 | 21 | 33 | 145 |
| Overweight | D050177 | — | E66.3 | 16 | 9 | 23 | 6 | 9 | 63 |
| Healthy volunteers/patients | — | — | — | 44 | 3 | — | 2 | 2 | 51 |
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | 3 | 14 | 2 | 4 | 2 | 23 |
| Fatty liver | D005234 | EFO_0003934 | — | 3 | 12 | 1 | 4 | 3 | 22 |
| Weight loss | D015431 | — | — | 2 | 1 | 5 | 6 | 6 | 19 |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | 4 | 7 | 5 | 3 | 1 | 16 |
| Liver diseases | D008107 | EFO_0001421 | K70-K77 | 2 | 9 | — | 3 | 2 | 15 |
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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 |
| Heart failure | D006333 | EFO_0003144 | I50 | 1 | 3 | 4 | — | — | 6 |
| Nutrition disorders | D009748 | EFO_0001069 | — | 2 | 1 | 2 | — | — | 5 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | — | 1 | 3 | — | — | 4 |
| Renal insufficiency | D051437 | — | N19 | 2 | — | 1 | — | — | 3 |
| Body-weight trajectory | D000077962 | — | — | 1 | 1 | 1 | — | — | 3 |
| Ischemic stroke | D000083242 | — | — | — | 2 | 1 | — | — | 3 |
| Stroke | D020521 | EFO_0000712 | I63.9 | — | 2 | 1 | — | — | 3 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | 1 | — | 1 | — | — | 2 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | 1 | — | 1 | — | — | 2 |
Show 9 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 5 | — | — | — | 5 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 2 | — | — | 1 | 3 |
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | 2 | 1 | — | — | — | 3 |
| Alcohol drinking | D000428 | EFO_0004329 | — | — | 3 | — | — | — | 3 |
| Metabolic bone diseases | D001851 | — | — | 1 | 2 | — | — | — | 2 |
| Cognitive dysfunction | D060825 | — | G31.84 | — | 2 | — | — | — | 2 |
| Hypercholesterolemia | D006937 | — | — | 1 | 1 | — | — | — | 2 |
| Cigarette smoking | D000073865 | — | — | — | 2 | — | — | — | 2 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 2 | — | — | — | 2 |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | — | 2 | — | — | — | 2 |
Show 29 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 |
| Disease progression | D018450 | — | — | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
| Therapeutic equivalency | D013810 | — | — | 1 | — | — | — | — | 1 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastroparesis | D018589 | EFO_1000948 | K31.84 | — | — | — | — | 4 | 4 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 2 | 2 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | — | — | — | 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 |
| Schizophrenia spectrum and other psychotic disorders | D019967 | — | — | — | — | — | — | 1 | 1 |
| Abdominal obesity | D056128 | — | — | — | — | — | — | 1 | 1 |
Show 19 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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Ozempic – Novo Nordisk
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Rybelsus – Novo Nordisk
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Wegovy – Novo Nordisk
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Semaglutide
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Trends
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Safety
Black-box Warning
Black-box warning for: Ozempic, Rybelsus, Wegovy
Adverse Events
Top Adverse Reactions
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38,700 adverse events reported
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