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Semaglutide: A History and Overview
Semaglutide, a medication primarily used in the management of type 2 diabetes and obesity, has garnered significant attention in the medical community for its efficacy and versatility. Approved by various regulatory bodies, including the U.S. Food and Drug Administration (FDA), semaglutide represents a significant advancement in the pharmacological treatment of these conditions. This article aims to provide a comprehensive overview of semaglutide, discussing its mechanism of action, clinical applications, benefits, and potential side effects.
Semaglutide Chemical Composition
- Chemical Structure: Semaglutide is a synthetic peptide that mimics the human GLP-1 structure with slight modifications to enhance its stability and prolong its action. It contains a fatty acid side chain that allows for albumin binding, increasing its half-life.
- Synonyms: Sermaglutide; Semaglutide impurity; Sermaglutide USP/EP/BP;semaglutide;Sermaglutide CAS 910463 68 2;Ozempic, Rybelsus; Ozempic; Semaglutide (H-7894.0001)
- CAS No: 910463-68-2
- Molecular Formula: The molecular formula for Semaglutide reflects its peptide nature, composed of amino acids with the addition of a fatty acid moiety, leading to a complex structure that includes carbon, hydrogen, nitrogen, oxygen, and sulfur atoms.
- Stability: Semaglutide is stable under refrigerated conditions (2-8°C) when stored in its original container to protect it from light. It’s supplied either as a solution for injection or as a lyophilized powder for reconstitution.
- Solubility: It is soluble in water, making it suitable for subcutaneous administration.
- Mechanism of Action: Semaglutide works by mimicking the action of the endogenous hormone GLP-1, which increases insulin secretion, decreases glucagon secretion, and slows gastric emptying in a glucose-dependent manner. This leads to reduced blood glucose levels and weight loss.
- Therapeutic Use: Approved for the management of type 2 diabetes as it improves glycemic control. Additionally, it is approved for weight management in adults with obesity or overweight in the context of at least one weight-related condition such as hypertension, type 2 diabetes mellitus, or dyslipidemia.
- Efficacy: Clinical trials have demonstrated significant improvements in glycemic control in patients with type 2 diabetes and substantial weight loss in patients with obesity or overweight.
- Side Effects: Common side effects include gastrointestinal symptoms such as nausea, vomiting, diarrhea, abdominal pain, and constipation. Rare but more serious side effects can include pancreatitis, gallbladder disease, and renal impairment.
- Safety Profile: Semaglutide has been shown to be safe for long-term use in most patients when used as directed. However, it is not recommended for individuals with a personal or family history of medullary thyroid carcinoma or patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Legal Status and Availability: Semaglutide is approved by regulatory agencies such as the FDA (United States Food and Drug Administration) for the treatment of type 2 diabetes and for chronic weight management. It is available by prescription.
- Shelf Life: 36 months
- Appearance: White lipolyzed powder puck
Mechanism of Action
Semaglutide operates by mimicking the action of the incretin hormone glucagon-like peptide-1 (GLP-1). Incretins are a group of metabolic hormones that stimulate a decrease in blood glucose levels. Specifically, semaglutide binds to the GLP-1 receptor, enhancing the secretion of insulin (the hormone that lowers blood glucose levels) while simultaneously reducing the release of glucagon (a hormone that raises blood glucose levels) in a glucose-dependent manner. This dual action not only helps in controlling blood glucose levels but also slows gastric emptying, which can contribute to weight loss in patients.
Clinical Applications
Type 2 Diabetes
In the treatment of type 2 diabetes, semaglutide has been shown to improve glycemic control significantly. It is often prescribed as an adjunct to diet and exercise to lower blood sugar levels in adults with this condition. Clinical trials have demonstrated that semaglutide can reduce hemoglobin A1c—a measure of blood sugar control over time—more effectively than other diabetic medications and even insulin in some cases.
Obesity
Beyond diabetes management, semaglutide has been approved for use in weight management for adults with obesity or overweight with at least one weight-related condition (such as hypertension, type 2 diabetes, or dyslipidemia). Studies have found that semaglutide, through its appetite-suppressing effects, can lead to significant weight loss by reducing hunger and increasing feelings of fullness.
Benefits
Semaglutide offers several benefits over traditional diabetes and weight management treatments. Its ability to significantly lower blood glucose levels and promote weight loss can lead to a reduction in the risk of cardiovascular events, which are common complications of diabetes and obesity. Additionally, semaglutide’s once-weekly injection makes it a convenient option, potentially improving adherence compared to medications requiring daily administration.
Potential Risks and Side Effects of Semaglutide
Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is used for the treatment of type 2 diabetes and as an intervention in weight management for obesity. While it offers significant benefits, including improved glycemic control and weight loss, semaglutide, like any medication, carries potential risks and side effects. It’s important to discuss these with a healthcare provider to understand how they might affect you. Here are the risks associated with semaglutide in detail:
Common Side Effects
- Gastrointestinal Issues: The most commonly reported side effects are gastrointestinal in nature, including nausea, vomiting, diarrhea, abdominal pain, and constipation. These symptoms are generally mild to moderate and tend to decrease over time.
- Appetite Changes: Semaglutide can lead to a decrease in appetite, which contributes to its effect on weight loss.
Serious Risks and Side Effects
- Pancreatitis: There is a risk of acute pancreatitis. Symptoms include severe abdominal pain that can radiate to the back, nausea, and vomiting. Immediate medical attention is required if pancreatitis is suspected.
- Gallbladder Problems: Use of semaglutide has been associated with gallbladder issues, including gallstones and cholecystitis.
- Hypoglycemia: When used with other diabetes medications like insulin or sulfonylureas, semaglutide can increase the risk of hypoglycemia (low blood sugar levels). Symptoms of hypoglycemia include dizziness, sweating, confusion, and shakiness.
- Kidney Damage: There have been reports of acute kidney injury, primarily through dehydration resulting from gastrointestinal side effects. Proper hydration is important while on this medication.
- Diabetic Retinopathy: In patients with type 2 diabetes, semaglutide has been linked to a worsening of diabetic retinopathy. Patients with a history of diabetic eye disease should be monitored closely.
- Thyroid C-cell Tumors: In rodent studies, semaglutide has been shown to cause thyroid C-cell tumors. It is unknown whether this risk applies to humans, but semaglutide is contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Allergic Reactions: As with any medication, there is a risk of allergic reactions. Symptoms can include rash, itching, swelling, dizziness, and difficulty breathing.
Considerations and Precautions
- Pregnancy and Breastfeedin: It’s important to discuss with a healthcare provider if planning to become pregnant or are breastfeeding, as the effects of semaglutide on pregnancy and breastfeeding are not fully known.
- Cardiovascular Diseas: While studies have suggested that GLP-1 receptor agonists may have cardiovascular benefits, patients with existing cardiovascular conditions should discuss the risks and benefits with their healthcare provider.
- Mental Health Effect: Changes in mood or behavior have been reported. Patients should be monitored for signs of depression or suicidal thoughts.
Monitoring and Management
Patients using semaglutide should be closely monitored by their healthcare provider for signs of side effects, particularly if they have pre-existing conditions that may be exacerbated by the medication. Regular follow-ups to assess the effectiveness and tolerability of the treatment are essential.
In conclusion, while semaglutide offers significant benefits for individuals with type 2 diabetes and those seeking weight management solutions, awareness and monitoring of its potential risks are crucial. A personalized approach, considering the individual’s health status and medical history, under the guidance of a healthcare professional, is essential to optimizing treatment outcomes with semaglutide.
What is Compounded Semaglutide
Compounded semaglutide is a customized formulation of the standard semaglutide medication, which is tailored to meet individual healthcare needs, particularly in weight management and diabetes treatment. Semaglutide itself is a glucagon-like peptide-1 (GLP-1) receptor agonist, a class of medications that mimics the GLP-1 hormone. This hormone is released in response to food intake and helps to regulate blood sugar levels by increasing insulin secretion, decreasing glucagon secretion when glucose levels are high, and slowing gastric emptying to help control appetite and food intake.
The “compounded” aspect refers to the practice of pharmacists or other qualified practitioners preparing medications in new forms or doses, or by combining specific ingredients to meet the specific needs of a patient, as prescribed by a healthcare provider. This can include adding ingredients such as vitamins or other supplements to the base semaglutide formula with the aim of enhancing the medication’s effectiveness or reducing side effects. However, it’s important to note that such compounded medications might not have been specifically approved by regulatory agencies like the FDA in the same way that commercially available versions of semaglutide, such as Ozempic, Rybelsus, and Wegovy, have been. These commercial products undergo rigorous testing for safety and efficacy before receiving approval.
Compounded semaglutide may be sought after due to various reasons, including drug shortages, the need for specific dosages not available in commercial forms, or the addition of components believed to enhance the drug’s action or mitigate side effects. However, patients and healthcare providers should exercise caution with compounded medications. The safety, efficacy, and quality of compounded medications can vary and may not be guaranteed in the same manner as FDA-approved products. The FDA and other healthcare authorities often issue guidelines and warnings about the use of compounded medications, advising on the importance of obtaining them from reputable and certified compounding pharmacies to ensure safety and efficacy.
Conclusion
Semaglutide represents a significant breakthrough in the treatment of type 2 diabetes and obesity. Its efficacy in lowering blood glucose levels and facilitating weight loss, combined with a favorable safety profile, makes it a valuable tool in managing these conditions. However, like any medication, it’s essential for individuals to discuss with their healthcare provider to determine if semaglutide is the right choice for them, considering their specific health profile and treatment goals.
Referenced Citations
- FDA and Semaglutide (https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/215256s000lbl.pdf)
- Two-year effects of semaglutide in adults with overweight or obesity: the STEP 5 trial – This study evaluated the long-term effect of once-weekly subcutaneous semaglutide compared with placebo, highlighting significant weight loss and improvements in various health parameters over a two-year period. (https://www.nature.com/articles/s41591-022-01688-0)
- Once-Weekly Semaglutide in Adults with Overweight or Obesity – This research discusses the sustained, clinically relevant reduction in body weight among participants with overweight or obesity when treated with 2.4 mg of semaglutide once weekly plus lifestyle intervention. (https://pubmed.ncbi.nlm.nih.gov/33567175/)
- Weight loss and cardiovascular disease risk outcomes of semaglutide: a one-year multicentered study – This multicenter study focuses on the weight loss and cardiovascular risk outcomes associated with semaglutide use, offering insights into its benefits beyond glucose control. (https://www.nature.com/articles/s41366-021-00859-4)
- Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes – This study examines the cardiovascular effects of semaglutide in patients with type 2 diabetes, showing a reduction in the risk of adverse cardiovascular events. (https://www.nejm.org/doi/full/10.1056/NEJMoa1607141)
- Oral semaglutide and cardiovascular outcomes in patients with type 2 diabetes – Investigates the cardiovascular outcomes associated with oral semaglutide in patients with type 2 diabetes, reinforcing its cardiovascular safety profile. (https://www.nejm.org/doi/full/10.1056/NEJMoa1901118)
- Efficacy and Safety of Semaglutide for Weight Loss in Obesity Without Diabetes – This study explores the efficacy and safety of subcutaneous semaglutide in patients with obesity without diabetes, emphasizing its potential for weight management. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7989594/)
- A Review on the Efficacy and Safety of Oral Semaglutide – Offers a comprehensive review of the efficacy and safety profile of oral semaglutide, detailing its impact on glycemic control and weight management. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322438/)
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