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Semaglutide

Generic Name
Semaglutide
Brand Names
Ozempic, Rybelsus, Wegovy
Drug Type
Small Molecule
Chemical Formula
C187H291N45O59
CAS Number
910463-68-2
Unique Ingredient Identifier
53AXN4NNHX

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

Published: May 23, 2025

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]

Continue reading the full research report

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

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
OZEMPIC 0.25MG, 0.5MG/DOSE SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34MG/ML
SIN16165P
INJECTION, SOLUTION
1.34mg/ml
4/21/2021
WEGOVY 1.7 MG/DOSE FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 2.27 MG/ML
SIN16747P
INJECTION, SOLUTION
2.27mg/ml
3/24/2023
OZEMPIC 1MG/DOSE SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34MG/ML
SIN16164P
INJECTION, SOLUTION
1.34mg/ml
4/21/2021
WEGOVY 1 MG/DOSE FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.34 MG/ML
SIN16746P
INJECTION, SOLUTION
1.34mg/ml
3/24/2023
WEGOVY 0.25 MG/DOSE FLEXTOUCH SOLUTION FOR INJECTION IN PRE-FILLED PEN 0.68 MG/ML
SIN16744P
INJECTION, SOLUTION
0.68mg/mL
3/24/2023
WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 1.7MG/0.75ML
SIN16707P
INJECTION, SOLUTION
1.7mg/ 0.75ml
2/22/2023
WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 1MG/0.5ML
SIN16704P
INJECTION, SOLUTION
1.0mg/0.5ml
2/22/2023
RYBELSUS® TABLET 7MG
SIN16216P
TABLET
7mg
6/1/2021
WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 2.4MG/0.75ML
SIN16708P
INJECTION, SOLUTION
2.4mg/ 0.75ml
2/22/2023
WEGOVY SOLUTION FOR INJECTION IN PRE-FILLED PEN 0.25MG/0.5ML
SIN16706P
INJECTION, SOLUTION
0.25mg/0.5ml
2/22/2023

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

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
Wegovy FlexTouch 1.7 mg semaglutide 2.27 mg/mL solution for injection pre-filled pen
424393
Medicine
A
5/30/2024
OZEMPIC 0.25/0.5 mg semaglutide (rys) 1.34 mg/mL solution for injection pre-filled pen
308324
Medicine
A
8/28/2019
WEGOVY 0.25 mg semaglutide 0.5 mg/mL solution for injection pre-filled pen with pre-assembled needle
356270
Medicine
A
9/1/2022
WEGOVY 1.7 mg semaglutide 2.27 mg/mL solution for injection pre-filled pen with pre-assembled needle
356287
Medicine
A
9/1/2022
WEGOVY 1 mg semaglutide 2.0 mg/mL solution for injection pre-filled pen with pre-assembled needle
356286
Medicine
A
9/1/2022
Wegovy FlexTouch 2.4 mg semaglutide 3.2 mg/mL solution for injection pre-filled pen
424394
Medicine
A
5/30/2024
OZEMPIC 1 mg semaglutide (rys) 1.34 mg/mL solution for injection pre-filled pen
315107
Medicine
A
8/28/2019
Wegovy FlexTouch 1 mg semaglutide 1.34 mg/mL solution for injection pre-filled pen
424392
Medicine
A
5/30/2024
RYBELSUS semaglutide 7 mg tablet blister pack
346199
Medicine
A
2/7/2022
WEGOVY 0.5 mg semaglutide 1.0 mg/mL solution for injection pre-filled pen with pre-assembled needle
356285
Medicine
A
9/1/2022
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