CagriSema (Cagrilintide/Semaglutide)

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  • Product Details

    Description

    CagriSema is an investigational once-weekly injectable medication being studied for weight loss in adults with obesity or overweight, including some people with type 2 diabetes. It combines cagrilintide, which acts like the natural hormone amylin to control hunger, and semaglutide, a GLP-1 agonist. Taking this medication may help promote satiety, slow stomach emptying, and improve blood sugar control. CagriSema has not yet been approved by the FDA, Health Canada, or other regulators, so current information may change if an official approval and label are released.

    Fact Table

    Formula

    Cagrilintide: C194H312N54O59S2; Semaglutide: C187H291N45O59

    License

    None; NDA submitted to US FDA, not approved

    Bioavailability

    Not established for combination; semaglutide SC: 89%

    Legal status

    Investigational; not approved in US or EU

    Chemical Name

    Cagrilintide/semaglutide

    Elimination half-life

    Cagrilintide: 159-195 hours; semaglutide: about 1 week

    Dosage (Strength)

    No approved dosage; studied as cagrilintide 2.4mg/semaglutide 2.4mg once weekly

    Pregnancy

    No approved pregnancy labeling; not recommended during pregnancy

    Brands

    CagriSema; not marketed

    Protein binding

    Semaglutide: >99% albumin; cagrilintide: albumin-binding lipidated peptide, exact % not established

    PubChem CID

    Cagrilintide: 171397054; Semaglutide: 56843331

    MedlinePlus

    Not listed for combination; semaglutide injection: a618008

    ChEBI

    Not assigned for combination; semaglutide: 167574

    ATC code

    Not assigned for combination; semaglutide: A10BJ06

    DrugBank

    Cagrilintide: DB18887; Semaglutide: DB13928

    KEGG

    Not assigned for combination; semaglutide: D10025

    Routes of administration

    Subcutaneous injection

    Directions

    CagriSema is still being studied and does not have an approved dosing schedule. It should only be used in an approved clinical trial or exactly as directed by a healthcare provider. In phase 3 studies, CagriSema was taken as a once-weekly injection under the skin, usually in the stomach area, thigh, or upper arm. The dose was started low and slowly increased over several weeks to help the body adjust and reduce side effects like nausea.

    If a dose is missed, it may be taken as soon as possible within a set number of days. Otherwise, skip it. Do not take two doses at once to make up for a missed dose. CagriSema is meant to be used with a lower-calorie diet and increased physical activity.

    Ingredients

    The active ingredients are cagrilintide and semaglutide.

    Cautions

    Before using this medication, you may want to consult a healthcare provider about the following:

    • Any existing health conditions
    • Any allergies
    • A list of all medications currently being taken

    CagriSema is an investigational medicine that should only be used under medical supervision, and its long-term safety is not yet fully known.

    Semaglutide has been linked to thyroid tumors, including medullary thyroid carcinoma, in animal studies. It is not known whether this happens in people.

    Stomach-related side effects such as nausea, vomiting, and diarrhea may be common, particularly when starting or increasing the dose. Severe or lasting vomiting or diarrhea can lead to dehydration, which may affect the kidneys.

    Inflammation of the pancreas, also called pancreatitis, and gallbladder problems have been linked to GLP-1 receptor agonists like semaglutide. Seek medical care for severe, ongoing stomach pain that may spread to the back, fever, or yellowing of the skin or eyes.

    When used in people with type 2 diabetes alongside insulin or medicines that increase insulin release, such as sulfonylureas, there may be a higher risk of low blood sugar, also called hypoglycemia. The dose of those other medicines may need to be lowered.

    If you have a history of diabetic eye disease, also called diabetic retinopathy, your healthcare provider may monitor your eyes, as rapid changes in blood sugar can affect this condition.

    Because CagriSema slows stomach emptying, it can affect how food and other oral medications are absorbed. Tell your healthcare providers, including any surgeon or anesthesiologist, that you use it before a planned surgery or procedure.

    Because semaglutide stays in the body for a long time, it should be stopped well before a planned pregnancy.

    Contraindications

    CagriSema does not currently have an approved drug label with contraindications. However, based on its ingredients and the eligibility rules used in clinical studies, it should be avoided if any of the following apply:

    • A known serious allergic, or hypersensitivity, reaction to cagrilintide, semaglutide, or any of the ingredients.
    • A personal or family history of medullary thyroid carcinoma, or MTC, or Multiple Endocrine Neoplasia syndrome type 2, or MEN 2.
    • Pregnancy or breastfeeding, as CagriSema has not been studied in these groups.

    Side Effects

    The most common side effects of CagriSema reported in clinical trials were gastrointestinal. They were usually mild to moderate, tended to occur when starting treatment or raising the dose, and were temporary. They include:

    • Nausea
    • Vomiting
    • Diarrhea
    • Constipation
    • Abdominal, or stomach, pain
    • Decreased appetite

    More serious effects are possible. Get medical help for signs of a serious allergic reaction, such as trouble breathing, a severe rash, or swelling of the face, lips, tongue, or throat. Report any severe or lasting stomach pain that may spread to the back, symptoms of gallbladder problems, or signs of low blood sugar, such as shakiness, sweating, confusion, or a fast heartbeat. You should also seek medical advice for any severe or persistent vomiting, diarrhea, any new lump or swelling in the neck, hoarseness, or trouble swallowing.

    Frequently Asked Questions about CagriSema


    What is CagriSema?

    CagriSema is an investigational once-weekly injectable medicine that combines cagrilintide and semaglutide. It is being developed by Novo Nordisk for weight management and type 2 diabetes.


    What are cagrilintide and semaglutide?

    Cagrilintide is a long-acting amylin analogue, while semaglutide is a GLP-1 receptor agonist. Together, they are designed to reduce appetite, increase fullness, and improve metabolic control.


    Is CagriSema FDA-approved?

    No. CagriSema is not FDA-approved. Novo Nordisk submitted a New Drug Application to the FDA in December 2025 for weight management, and a decision is expected in Q4 2026.


    How is CagriSema taken?

    CagriSema is being studied as a once-weekly subcutaneous injection, meaning it is injected under the skin once per week.


    How much weight loss has CagriSema shown?

    In the REDEFINE 1 Phase 3 trial, adults with obesity or overweight without type 2 diabetes lost an average of 22.7% of body weight at 68 weeks under the main efficacy analysis, compared with 2.3% for placebo.


    How did CagriSema compare with semaglutide alone?

    In REDEFINE 1, CagriSema showed greater weight loss than semaglutide 2.4 mg alone in trial results reported by Drugs.com/Novo Nordisk: 22.7% with CagriSema versus 16.1% with semaglutide.


    Is CagriSema being studied for type 2 diabetes?

    Yes. In the REIMAGINE program, CagriSema was studied in adults with type 2 diabetes at different stages of treatment. In REIMAGINE 2, the 2.4 mg/2.4 mg dose reduced HbA1c by 1.91 percentage points and body weight by 14.2% at 68 weeks.


    What side effects have been reported?

    The most commonly reported side effects in trials were gastrointestinal, such as nausea, vomiting, diarrhea, or similar GI issues. In REIMAGINE 2, GI-related adverse events were reported in 67.2% of people on CagriSema 2.4 mg/2.4 mg.


    Is CagriSema better than Zepbound/tirzepatide?

    Not clearly. In the REDEFINE 4 head-to-head trial, CagriSema produced about 23% weight loss after 84 weeks, compared with 25.5% for tirzepatide, and it did not meet the primary endpoint of showing non-inferiority to tirzepatide.


    Can people buy CagriSema now?

    No approved commercial CagriSema product is available in the U.S. at this time. Because it is still investigational, products marketed online as “CagriSema” may not be verified for quality, dose, safety, or authenticity.




    IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

    Product Code : 14029

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