Overview
Semaglutide is a glucagon-like peptide 1 (GLP-1) analog used to manage type 2 diabetes along with lifestyle changes, such as dietary restrictions and increased physical activity. Other members of this drug class include Exenatide and Liraglutide. Semaglutide was developed by Novo Nordisk and approved by the FDA for subcutaneous injection in December 2017. The tablet formulation was approved for oral administration in September 2019. Semaglutide works by binding to and activating the GLP-1 receptor, thereby stimulating insulin secretion and reducing blood glucose. The subcutaneous injection is administered once weekly and the tablet is administered once a day. Semaglutide offers a competitive advantage over other drugs used to manage diabetes, which may require several daily doses. Clinical trials have determined that this drug reduces glycosylated hemoglobin (HbA1c) levels and reduces body weight, proving to be effective for patients with type 2 diabetes. In June 2021, semaglutide was approved by the FDA for chronic weight management in adults with general obesity or overweight who have at least one weight-related condition, marking semaglutide as the first approved drug for such use since 2014. The use of semaglutide in weight management is also approved by Health Canada and the EMA. On May 31, 2023, the FDA issued a warning regarding the use of compounded semaglutide after receiving adverse event reports. The use of salt forms of semaglutide, including semaglutide sodium and semaglutide acetate, has not been proven to be safe or effective.
Background
Semaglutide is a glucagon-like peptide 1 (GLP-1) analog used to manage type 2 diabetes along with lifestyle changes, such as dietary restrictions and increased physical activity. Other members of this drug class include Exenatide and Liraglutide. Semaglutide was developed by Novo Nordisk and approved by the FDA for subcutaneous injection in December 2017. The tablet formulation was approved for oral administration in September 2019. Semaglutide works by binding to and activating the GLP-1 receptor, thereby stimulating insulin secretion and reducing blood glucose. The subcutaneous injection is administered once weekly and the tablet is administered once a day. Semaglutide offers a competitive advantage over other drugs used to manage diabetes, which may require several daily doses. Clinical trials have determined that this drug reduces glycosylated hemoglobin (HbA1c) levels and reduces body weight, proving to be effective for patients with type 2 diabetes. In June 2021, semaglutide was approved by the FDA for chronic weight management in adults with general obesity or overweight who have at least one weight-related condition, marking semaglutide as the first approved drug for such use since 2014. The use of semaglutide in weight management is also approved by Health Canada and the EMA. On May 31, 2023, the FDA issued a warning regarding the use of compounded semaglutide after receiving adverse event reports. The use of salt forms of semaglutide, including semaglutide sodium and semaglutide acetate, has not been proven to be safe or effective.
Indication
Semaglutide is indicated to improve glycemic control in adults diagnosed with type 2 diabetes mellitus, and is used as an adjunct to diet and exercise. However, semaglutide is not a suitable first-line drug for diabetes that has not been controlled by diet and exercise. In addition, it has not been studied in patients with pancreatitis. Semaglutide is not intended for use in patients with type 1 diabetes or to treat diabetic ketoacidosis. Semaglutide is indicated for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), for use in addition to a reduced-calorie diet and increased physical activity.. Semaglutide it is also indicated for chronic weight management in pediatric patients aged 12 years and older with an initial BMI at the 95th percentile or greater for age and sex.
Associated Conditions
- BMI >27 kg/m2
- Cardiovascular Events
- Obesity
- Type 2 Diabetes Mellitus
Research Report
Semaglutide: A Comprehensive Pharmacological and Clinical Review
1. Introduction to Semaglutide
1.1. Overview and Drug Class
Semaglutide is a prominent therapeutic agent classified as a glucagon-like peptide-1 (GLP-1) receptor agonist (GLP-1 RA).[1] It is a synthetic peptide analogue of human GLP-1, sharing 94% sequence homology with the native hormone, and has been engineered for an extended pharmacokinetic profile and enhanced therapeutic efficacy.[1] GLP-1 RAs mimic the action of the endogenous incretin hormone GLP-1, which plays a crucial role in glucose homeostasis and appetite regulation. This class of drugs has revolutionized the management of type 2 diabetes mellitus and, more recently, obesity and related cardiometabolic conditions.
1.2. Therapeutic Significance and Key Indications
Semaglutide was initially developed and approved for the treatment of type 2 diabetes mellitus (T2DM) as an adjunct to diet and exercise to improve glycemic control.[1] Its therapeutic applications have since expanded significantly. It is now also indicated for chronic weight management in adults and adolescents (aged 12 years and older) with obesity or those who are overweight and have at least one weight-related comorbidity.[1]
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
---|---|---|---|---|---|
2025/07/01 | Not Applicable | Not yet recruiting | |||
2025/06/29 | N/A | Completed | |||
2025/06/27 | Not Applicable | Not yet recruiting | |||
2025/06/22 | Phase 3 | Not yet recruiting | |||
2025/06/12 | Phase 4 | Not yet recruiting | |||
2025/06/08 | Phase 1 | Not yet recruiting | |||
2025/05/25 | Not Applicable | Not yet recruiting | |||
2025/05/25 | Not Applicable | Not yet recruiting | |||
2025/05/23 | Phase 4 | Recruiting | |||
2025/05/21 | Phase 1 | Not yet recruiting |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
---|---|---|---|---|---|
Novo Nordisk | 0169-4525 | SUBCUTANEOUS | 0.25 mg in 0.5 mL | 6/4/2021 | |
A-S Medication Solutions | 50090-6051 | SUBCUTANEOUS | 2.68 mg in 1 mL | 9/22/2023 | |
Novo Nordisk | 0169-4505 | SUBCUTANEOUS | 0.5 mg in 0.5 mL | 6/4/2021 | |
Novo Nordisk | 0169-4517 | SUBCUTANEOUS | 1.7 mg in 0.75 mL | 6/4/2021 | |
Novo Nordisk | 0169-4314 | ORAL | 14 mg in 1 1 | 9/30/2021 | |
Novo Nordisk | 0169-4307 | ORAL | 7 mg in 1 1 | 9/30/2021 | |
Novo Nordisk | 0169-4136 | SUBCUTANEOUS | 1.34 mg in 1 mL | 9/22/2023 | |
Novo Nordisk | 0169-4772 | SUBCUTANEOUS | 2.68 mg in 1 mL | 9/22/2023 | |
Novo Nordisk | 0169-4501 | SUBCUTANEOUS | 1.0 mg in 0.5 mL | 6/4/2021 | |
A-S Medication Solutions | 50090-5138 | SUBCUTANEOUS | 1.34 mg in 1 mL | 1/16/2020 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
---|---|---|---|
Authorised | 2/8/2018 | ||
Authorised | 4/3/2020 | ||
Authorised | 1/6/2022 | ||
Authorised | 2/8/2018 | ||
Authorised | 4/3/2020 | ||
Authorised | 1/6/2022 |
HSA Drug Approvals
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
---|---|---|---|---|---|
Semaglutide Tablet | 国药准字SJ20240004 | 生物制品 | 片剂 | 4/9/2024 | |
Semaglutide Tablet | 国药准字SJ20240005 | 生物制品 | 片剂 | 4/9/2024 | |
Semaglutide Tablet | 国药准字SJ20240006 | 生物制品 | 片剂 | 4/9/2024 | |
Semaglutide Injection | 国药准字SJ20240020 | 生物制品 | 注射剂 | 6/18/2024 | |
Semaglutide Injection | 国药准字SJ20240023 | 生物制品 | 注射剂 | 6/18/2024 | |
Semaglutide Injection | 国药准字SJ20240022 | 生物制品 | 注射剂 | 6/18/2024 | |
Semaglutide Injection | 国药准字SJ20240021 | 生物制品 | 注射剂 | 6/18/2024 | |
Semaglutide Injection | 国药准字SJ20240024 | 生物制品 | 注射剂 | 6/18/2024 | |
Semaglutide Injection | 诺和诺德制药有限公司 | 国药准字SJ20210015 | 生物制品 | 注射剂 | 4/27/2021 |
Semaglutide Injection | 诺和诺德制药有限公司 | 国药准字SJ20210014 | 生物制品 | 注射剂 | 4/27/2021 |
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
---|---|---|---|---|---|
OZEMPIC SOLUTION FOR INJECTION IN 3.0 ML PRE-FILLED PEN 1MG/DOSE | N/A | novo nordisk hong kong ltd. | N/A | N/A | 12/16/2019 |