Cagrilintide: Dosage, Side Effects and Legal Status

Cagrilintide is not a GLP-1 drug. It is constantly grouped with semaglutide, tirzepatide and retatrutide, but it is an amylin analogue, working on a different hormone system.

Dosing: what the studies used.

What is Cagrilintide? Not a GLP-1 drug - an amylin analogue

Amylin is a hormone the pancreas releases along with insulin. On its own pathway, separate from GLP-1, it signals fullness and slows stomach emptying. Cagrilintide is a long-acting synthetic version of human amylin. It uses the same fatty-acid chemistry (acylation) Novo Nordisk uses in semaglutide, so it can be dosed once a week.

Semaglutide acts on GLP-1 receptors, and tirzepatide on GLP-1 and GIP receptors. Cagrilintide acts on amylin receptors. The goal is the same, less appetite and slower stomach emptying, but the route is biologically separate.

That is why Novo Nordisk mostly develops cagrilintide combined with a GLP-1 drug rather than as a replacement for one. The bet is that two pathways add to each other’s effect rather than overlap.

Cagrilintide structure

Molecular formula

C₁₉₄H₃₁₂N₅₄O₅₉S₂

Molecular weight

4409.1 g/mol

Length

37 amino acids

Sequence

KCNTATCATQRLAEFLRHSSNNFGPILPPTNVGSNTP

Modifications

Lys1 is acylated on its N-terminus with a C20 fatty diacid via gamma-Glu; disulfide Cys2-Cys7; C-terminal prolinamide.

PubChem's record titled "Cagrilintide" (CID 171397054) draws several residues in the wrong (D) configuration. The only correctly configured record (CID 164618153) is titled as the acetate salt, so no diagram is shown.

Sequence checked against ChEMBL.

Cagrilintide benefits: what the research shows (as CagriSema)

Cagrilintide’s development is mostly the story of CagriSema: cagrilintide 2.4 mg and semaglutide 2.4 mg in a single once-weekly injection.

Its lead Phase 3 trial, REDEFINE 1, is randomised, double-blind and placebo-controlled. It compares CagriSema with cagrilintide alone, semaglutide alone and placebo in roughly 3,400 people with obesity or overweight. Its ClinicalTrials.gov registration names body weight change at 68 weeks as the main outcome.

The results were published in the New England Journal of Medicine in 2025 Garvey 2025 - Garvey WT, Blüher M, Osorto Contreras CK et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2025;393(7):635-647., in the references below. Among 3,417 adults without diabetes, weight fell by an average of 20.4% on CagriSema against 3.0% on placebo at 68 weeks, counting everyone randomised. Novo Nordisk’s press release, issued with its December 2025 FDA filing announcement, gives the same headline figure and adds the other two rows:

Cagrilintide dosage

There is no approved dose, because neither cagrilintide nor CagriSema has an approved product. Dosing guides describe weekly injections under the skin, starting at 0.25-0.6 mg and stepping up to a 2.4-4.5 mg maintenance dose. Sources disagree on the exact steps, so treat any single chart as one version of common practice.

A published Phase 2 trial tested cagrilintide alone at five weekly doses from 0.3 mg to 4.5 mg. Full detail and the trial table: Cagrilintide dosage.

Cagrilintide side effects

This section draws on one Phase 2 trial of cagrilintide, the REDEFINE 1 trial of CagriSema, and, for context only, the FDA label of a different approved amylin drug.

Reported in the cagrilintide trial

In a published Phase 2 trial Lau 2021 - Lau DCW, Erichsen L, Francisco AM et al. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lancet. 2021;398(10317):2160-2172., in the references below:

• Gut side effects (nausea, constipation and diarrhoea) affected 41-63% of people on cagrilintide, rising with dose, against 32% on placebo.
• Nausea alone ranged from 20% to 47%, against 18% on placebo.
• About 10% (73 of 906) stopped treatment permanently, most often because of a side effect.

Reported in the CagriSema trial (REDEFINE 1)

Gut side effects (nausea, vomiting, diarrhoea, constipation or abdominal pain) affected 79.6% of people on CagriSema against 39.9% on placebo. They were mostly passing and mild to moderate Garvey 2025 - Garvey WT, Blüher M, Osorto Contreras CK et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2025;393(7):635-647., in the references below. That is cagrilintide combined with semaglutide, not cagrilintide alone.

Reported for pramlintide, a different drug

Neither cagrilintide nor CagriSema has FDA-reviewed side-effect data yet. The closest verifiable comparison is pramlintide (Symlin), the only FDA-approved amylin analogue.

Its label lists nausea as the most common side effect: up to 48% in type 1 diabetes and 28% in type 2 diabetes in placebo-controlled trials, against 17% and 12% on placebo. It also lists reduced appetite, vomiting, headache and fatigue. A boxed warning covers severe low blood sugar when it is combined with mealtime insulin, a combination CagriSema doesn’t involve.

For redness, itching or swelling at the injection site, see injection-site reactions. There are no long-term safety data beyond the trials above, and no regulator checks that a vial sold outside the trial system matches its label.

The FDA filing, and what it does and doesn’t mean

Novo Nordisk announced on 18 December 2025 that it had submitted a New Drug Application to FDA for CagriSema. It expects a decision in late 2026. FDA doesn’t publish updates on pending applications, so that timeline is the company’s statement, not a confirmed FDA date.

A filing is a request for approval. It doesn’t make approval likely on any timeline, and it doesn’t change cagrilintide’s legal status. As of this writing it is unapproved, with no FDA-reviewed label for dosing, side-effect rates or contraindications.

Is Cagrilintide legal?

FDA’s published statement on unapproved GLP-1-related drugs names cagrilintide. It cannot be used in compounding under federal law, because it is not a component of an FDA-approved drug and has not been found safe and effective for any condition. FDA has also warned sellers who market peptides, including cagrilintide, as “research use only” while selling them for human use with dosing instructions.

Related

• Semaglutide (Ozempic, Wegovy)
• Tirzepatide (Mounjaro, Zepbound)
• Retatrutide - the triple agonist developed separately
• Best GLP-1 for weight loss: the approved options compared
• Are peptides safe?

Regulatory changes for this compound and others, as they happen: US peptide regulation tracker.

How Cagrilintide compares

GLP-1 and related medicines. Doses for unapproved compounds are common practice, not trial-established. All weight loss and metabolism peptides →

Compound	Main use	Evidence	Usual dose	US status
Cagrilintide	Investigational amylin analogue studied alone and, more prominently, combined with semaglutide as the fixed-dose combination CagriSema, for chronic weight management. Not approved for any indication in the US; the combination is under FDA review following the sponsor's New Drug Application.	Moderate human evidence	0.25-4.5 mg, once weekly, titrating from a 0.25-0.6 mg starting dose up to a 2.4-4.5 mg maintenance dose	Research use only
Semaglutide	FDA-approved for type 2 diabetes in adults (Ozempic injection and tablets, Rybelsus), including cardiovascular risk reduction and, for the Ozempic injection, kidney-disease progression; and as Wegovy injection and tablets for chronic weight management and cardiovascular risk reduction in adults with obesity or overweight. The Wegovy injection is also approved for weight management from age 12 and for MASH with moderate to advanced liver fibrosis in adults.	Strong human evidence	FDA label	FDA-approved · prescription only
Tirzepatide	FDA-approved to improve glycemic control in type 2 diabetes in adults and children 10 years and older, and to reduce cardiovascular risk in adults with type 2 diabetes (Mounjaro), and for chronic weight management and moderate-to-severe obstructive sleep apnoea in adults with obesity (Zepbound).	Strong human evidence	FDA label	FDA-approved · prescription only
Liraglutide	FDA-approved as a once-daily injection under two brands: Saxenda, for chronic weight management alongside diet and exercise in adults and in children 12 years and older with obesity who weigh more than 60 kg, and Victoza, for glycemic control in type 2 diabetes in adults and children 10 years and older, and for reducing major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.	Strong human evidence	FDA label	FDA-approved · prescription only
Orforglipron	FDA-approved as Foundayo, in combination with a reduced-calorie diet and increased physical activity, to reduce excess body weight and maintain weight reduction long term in adults with obesity, or adults with overweight who have at least one weight-related condition.	Strong human evidence	FDA label	FDA-approved · prescription only
Retatrutide	Investigational in Phase 3 trials for obesity, type 2 diabetes and related conditions. Not approved for any indication in the US. Sold outside the trial system as an unapproved research chemical, often alongside semaglutide and tirzepatide.	Moderate human evidence	2-12 mg, once weekly, starting at 2 mg and titrating up every 4 weeks to a 4-12 mg maintenance dose	Research use only
Survodutide	An investigational injectable peptide, not approved for any use. Its sponsor, Boehringer Ingelheim, is studying it in Phase 3 trials for chronic weight management and, in a separate programme, for MASH (metabolic dysfunction-associated steatohepatitis). It is also sold directly to consumers as a research chemical outside those trials.	Moderate human evidence	0.6-6 mg, once weekly, starting around 0.6 mg; the phase 2 trial titrated over about 20 weeks to a 2.4-4.8 mg maintenance dose, while the published phase 3 SYNCHRONIZE-1 trial randomizes to a higher 3.6 or 6.0 mg maintenance target using a slower, flexible up-titration	Research use only
Mazdutide	Approved in China for chronic weight management and for glycemic control in type 2 diabetes. Not FDA-approved in the United States, where it is sold to consumers as a research-chemical vial.	Moderate human evidence	3-9 mg, once weekly, titrated upward from a lower starting dose	Research use only

Where to buy Cagrilintide for research

Each vendor is checked against my vendor checklist.

1. 1.Next Level PharmFeatured

   5 mg vial

   • No FDA warning letter found
   • Names its testing lab
   • Batch COAs published
   • Takes card payment

   $64.99as of 3 October 2026

   View product →My Next Level Pharm review

2. 2.BioEdge Research Labs

   5 mg vial

   • No FDA warning letter found
   • Names its testing lab
   • Batch COAs published

   $59.00as of 3 October 2026

   View product →My BioEdge Research Labs review

Compare every checked vendor for Cagrilintide →

See all vendors and how they compare →

Common questions

Is cagrilintide the same thing as semaglutide?

No. Semaglutide acts on the GLP-1 receptor; cagrilintide acts on the amylin receptor, a different hormone system. Both slow stomach emptying and reduce appetite. They are combined in one injection, CagriSema, because they work through different receptors and their effects were found to add up.

Is CagriSema FDA-approved?

No. Novo Nordisk said it submitted a New Drug Application for CagriSema to FDA in December 2025 and expects a decision in late 2026. As of this writing, no decision has been made public. A filing is a request for approval, not approval.

What do the CagriSema trials show?

REDEFINE 1, a 68-week Phase 3 trial of 3,417 adults with overweight or obesity and no diabetes, was published in the New England Journal of Medicine in 2025. Weight fell 20.4% on CagriSema versus 3.0% on placebo, counting everyone randomised; Novo Nordisk adds 22.7% versus 2.3% among those who stayed on treatment. Gut side effects affected 79.6% versus 39.9%. These results are not FDA-reviewed and are not posted to the public trial registry.

Can cagrilintide be prescribed or compounded on its own right now?

No. FDA says cagrilintide cannot legally be used in compounding, because it is not a component of an FDA-approved drug and has not been found safe and effective for any condition. There is no standalone prescription product in the US.

Why is cagrilintide developed together with semaglutide instead of on its own?

Because it works through a different receptor. The amylin and GLP-1 pathways both reduce appetite and slow stomach emptying, by separate mechanisms. The combination is a bet that the two effects add together rather than overlap, which is what the CagriSema trials were built to test.

What is the difference between cagrilintide and tirzepatide?

They work on different pathways and have different legal status. Tirzepatide is FDA-approved: a dual GIP and GLP-1 receptor agonist, sold as Mounjaro for type 2 diabetes and Zepbound for weight management. Cagrilintide is an unapproved amylin receptor agonist, developed mainly with semaglutide, not tirzepatide. They are not interchangeable and haven't been studied together.

How long can you take cagrilintide?

There is no established answer, because neither cagrilintide nor CagriSema has an FDA-approved label. The longest data Novo Nordisk has reported is from REDEFINE 1, at 68 weeks. No FDA-reviewed source covers longer use or what happens after stopping.

How does cagrilintide make you feel?

There are no FDA-reviewed data. In REDEFINE 1, gut side effects (nausea, vomiting, diarrhoea, constipation or abdominal pain) affected 79.6% on CagriSema versus 39.9% on placebo, mostly passing and mild to moderate. A Phase 2 trial of cagrilintide alone reported nausea, constipation and diarrhoea in 41-63% across doses, versus 32% on placebo. The approved amylin drug pramlintide (Symlin) lists nausea, reduced appetite, vomiting, headache and fatigue, but it is a different drug.

What is cagrilintide?

An investigational, long-acting synthetic version of the hormone amylin, built with the same fatty-acid chemistry Novo Nordisk uses in semaglutide. It is not FDA-approved. It is mostly developed combined with semaglutide as CagriSema, not as a standalone drug.

What is the usual cagrilintide dose?

There is no approved dose. Dosing guides describe weekly injections under the skin, starting at 0.25-0.6 mg and stepping up to 2.4-4.5 mg. That is common practice, not an established dose. A Phase 2 trial tested five weekly doses from 0.3 mg to 4.5 mg; the dosage page has the table.

What are the side effects of cagrilintide?

In a Phase 2 trial, nausea, constipation and diarrhoea affected 41-63% of people on cagrilintide, rising with dose, versus 32% on placebo; about 10% stopped treatment, most often because of a side effect. As CagriSema in REDEFINE 1, gut side effects affected 79.6% versus 39.9% on placebo, mostly passing and mild to moderate. With no FDA-reviewed label, there is no regulator-confirmed full list.

Is cagrilintide better than semaglutide?

I can't say, and no trial cited here compared them head to head for that purpose. Semaglutide is FDA-approved and cagrilintide is not, and cagrilintide is mainly developed to be taken with semaglutide, not instead of it. In REDEFINE 1, the combination produced more weight loss on average than either drug alone.

What is cagrilintide peptide used for?

It has no approved use. It is being developed for weight management, mostly combined with semaglutide as CagriSema, which has also been trialled in adults with type 2 diabetes. In the US it is sold only as a "research use only" peptide, and FDA says it cannot legally be compounded.

Is cagrilintide safe?

No regulator has established that: FDA says it has not been found safe and effective for any condition. In trials, nausea, constipation and diarrhoea were common and mostly mild to moderate, but those were monitored participants on the developer's drug. No regulator checks that a research-sold vial matches its label.

References (5 sources)

Show

Bibliographic detail is fetched from PubMed, not written by me - so a citation here cannot drift from the paper it names. Study design comes from PubMed's own tags rather than my judgement.

1. 1.Lau DCW, Erichsen L, Francisco AM et al. Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. Lancet. 2021;398(10317):2160-2172.Randomised trialPMID 34798060
2. 2.Garvey WT, Blüher M, Osorto Contreras CK et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2025;393(7):635-647.Randomised trialPMID 40544433
3. 3.FDA - retatrutide and cagrilintide cannot be used in compounding under federal law; not components of FDA-approved drugs and not found safe and effective for any condition; enforcement against sellers of unapproved peptides marketed as research-use-only.- US Food and Drug Administrationregulatory
4. 4.ZEPBOUND (tirzepatide) - FDA-approved indications: weight reduction and obstructive sleep apnoea, as a dual GIP/GLP-1 receptor agonist.- DailyMed, National Library of Medicinelabel
5. 5.SYMLIN (pramlintide) - the only FDA-approved amylin analogue; full prescribing information including adverse reaction rates and boxed warning.- DailyMed, National Library of Medicinelabel

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