Cagrilintide
Also sold as: CagriSema, cagrilintide-semaglutide
Cagrilintide is not an FDA-approved drug. FDA has stated that 'Retatrutide and cagrilintide cannot be used in compounding under federal law' and that these 'are not components of FDA-approved drugs and have not been found safe and effective for any condition.' Cagrilintide is a long-acting amylin analogue in active Phase 3 development by Novo Nordisk, which submitted a New Drug Application to FDA on 18 December 2025 for CagriSema — a fixed-dose combination of cagrilintide and semaglutide, not cagrilintide on its own — and which states that 'CagriSema is not approved in the US or EU.' The published trial results belong to that combination: in REDEFINE 1 (N Engl J Med 2025), 302 of 3417 randomised participants were assigned to receive cagrilintide alone, but the trial's coprimary endpoints compared cagrilintide-semaglutide with placebo. The Phase 3 trial designed to test cagrilintide by itself, NCT07220642, has a primary completion date of 11 May 2027 and no posted results.
Which molecule this is. A long-acting amylin analogue — a different receptor system from the GLP-1 agonists it is sold alongside. The disambiguation that matters on this record is PRODUCT, not sequence. 'CagriSema' and 'cagrilintide-semaglutide' are listed above as aliases because that is what people search, NOT because they name the same substance: CagriSema is a fixed-dose combination of cagrilintide and semaglutide, so every CagriSema result is a result for two molecules given together, one of which is the most heavily evidenced peptide on this site. A number attributed to CagriSema is not a number attributed to cagrilintide. The trials cited below are read with that split kept intact.
FDA status
This is in active clinical development with an identifiable sponsor and registered trials. It is not approved, and being in trials is not evidence that it works.
In active clinical development with an identifiable sponsor and registered trials. Not approved. Being in trials is not evidence that it works, and being in someone else's combination trial is not evidence about the single molecule. WHAT WAS CHECKED, because the negative half is the harder half. Drugs@FDA was queried through the openFDA API on 2026-08-02 on THREE fields, not one — openfda.generic_name, products.active_ingredients.name and openfda.brand_name (CAGRISEMA). All three returned NOT_FOUND. Querying a single field is how a false 'not in Drugs@FDA' claim gets made in this library, so the check is recorded rather than asserted. FDA states independently, in its own words, that cagrilintide is not a component of an FDA-approved drug — recorded verbatim under FDA findings. SCOPE OF THE PENDING APPLICATION: the NDA Novo Nordisk submitted on 2025-12-18 is for CagriSema, the fixed-dose combination, not for cagrilintide as a single-agent product. Cagrilintide on its own is the subject of a separate Phase 3 trial that has not read out (NCT07220642, primary completion 2027-05-11). So even a CagriSema approval would not make cagrilintide an approved single-agent medicine. 'Investigational' is assigned on the active-development test the vocabulary sets: an identifiable sponsor (Novo Nordisk A/S) with registered, currently active Phase 3 trials — NCT07220642 and NCT05567796 both ACTIVE_NOT_RECRUITING, NCT07253285 and NCT07564414 both RECRUITING when ClinicalTrials.gov was queried on 2026-08-02. This is not a terminated programme being sold as a live one.
“Today, Novo Nordisk announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for once-weekly CagriSema … CagriSema is a fixed-dose combination of a long-acting amylin analogue, cagrilintide …, and the GLP-1 receptor agonist, semaglutide …. CagriSema is not approved in the US or EU.”Checked against the source on .
Evidence
There is human data, but efficacy is not established. This includes programmes that were tested and failed.
ADMINISTRATION CHECK RUN, NOT ASSUMED. The REDEFINE 1 report (N Engl J Med 2025;393:635-647, PMID 40544433) and the registration (NCT05567796) were both opened on 2026-08-02. Cagrilintide was ADMINISTERED: intervention type DRUG, given subcutaneously, with a dedicated monotherapy arm of 302 randomised participants. It was not measured as an endogenous biomarker, which is the trap that reduces MOTS-c and TB-500 from an apparent five human trials to an actual zero. Registration hygiene also checked — lead sponsor Novo Nordisk A/S, Phase 3, and the trial is reported in a peer-reviewed journal, so this is not a cloned or shell registration. WHY NOT A HIGHER TIER. The tier vocabulary reserves 'proven-in-humans' for efficacy established by adequate, well-controlled trials, and for cagrilintide AS A PRODUCT that does not exist yet. Read what REDEFINE 1 was designed to answer: its coprimary endpoints compare cagrilintide-semaglutide with placebo. The cagrilintide-alone arm is a reference arm, not the tested hypothesis, and the published abstract does not report a weight result for it — a genuine blank in the source cited here, recorded rather than filled. REDEFINE 2 (PMID 40544432) enrolled no cagrilintide-alone arm at all: 1206 patients randomised, cagrilintide-semaglutide versus placebo only. The single trial designed to test cagrilintide by itself, NCT07220642, has a primary completion date of 2027-05-11 and no posted results. SCOPE. Whatever this tier is worth, it attaches to the molecule Novo Nordisk administered under an IND in these trials. It does not travel to a vial sold under the same name, and FDA states cagrilintide is not a component of any FDA-approved drug, so no such vial comes from an approved supply.
“The coprimary end points were the relative change in body weight and a reduction of 5% or more in body weight from baseline to week 68 with cagrilintide-semaglutide as compared with placebo. … A total of 3417 participants underwent randomization, with 2108 assigned to receive cagrilintide-semaglutide, 302 to receive semaglutide, 302 to receive cagrilintide, and 705 to receive placebo.”Checked against the source on .
What FDA found
FDA’s own words. These are the most citable thing on this site, and the least likely to appear anywhere funded by someone selling the compound.
FDA has stated that retatrutide and cagrilintide cannot be used in compounding under federal law, that they are not components of FDA-approved drugs, and that they have not been found safe and effective for any condition.
The only FDA-authored sentence on this record that names cagrilintide, and it does three separate jobs: it forecloses compounding, it establishes that cagrilintide is in no approved product, and it states that FDA has made no finding of safety or effectiveness for it in any condition. That third clause is the one to hold onto while reading the Phase 3 results below — a completed trial with a published result is not an agency finding, and FDA's position is unchanged by REDEFINE 1. READ THE SCOPE PRECISELY, because this page invites an overreach. Immediately beneath this sentence FDA lists parties it has warned — telehealth companies, API distributors, outsourcing facilities — and every one of those bullets names RETATRUTIDE, not cagrilintide. Do not carry the enforcement examples across to cagrilintide; the shared heading does not make them shared actions. What is shared is the legal conclusion in the quoted sentence.
FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss — FDA, 15 June 2026“Retatrutide and cagrilintide cannot be used in compounding under federal law. Additionally, these are not components of FDA-approved drugs and have not been found safe and effective for any condition.”
Checked against the source on .Cagrilintide appears in none of Categories 1, 2 or 3 of FDA's 503A bulk drug substances list updated 2026-05-14, and does not appear on FDA's companion page listing bulk drug substances nominated but withdrawn.
Verified by downloading the PDF with a browser user-agent and text-extracting it locally on 2026-08-02: 'cagrilintide' returns zero hits across all seven pages. The companion safety-risks page, which carries the table headed 'Bulk drug substances nominated but withdrawn', likewise returns zero hits. Recorded to close a misreading, not to assert a status — which is why this record carries no 503A badge at all. Cagrilintide's absence means something different from BPC-157's. BPC-157 was nominated and left Category 2 when its nominators withdrew; cagrilintide was never in the nomination system, so there is no category, no withdrawal and no proceeding to describe. Categorical silence is neither permission nor a safety finding, and it is not what makes cagrilintide non-compoundable — FDA's own statement above is.
Bulk Drug Substances Nominated for Use in Compounding Under Section 503A of the Federal Food, Drug, and Cosmetic Act — FDA, 14 May 2026Checked against the source on .
Documented safety signals
In the REDEFINE 1 Phase 3 trial, gastrointestinal adverse events were reported in 79.6% of the cagrilintide-semaglutide group and 39.9% of the placebo group; the investigators reported them as mainly transient and mild-to-moderate in severity.
Read the group label. This rate is for the COMBINATION arm, not for cagrilintide alone. REDEFINE 1 randomised a cagrilintide-alone arm of 302 participants, and the published abstract cited here does not report an adverse-event rate for it — so this record does not state one. That is a blank in the source, and filling it by assuming the combination figure describes the single agent would be exactly the attribution error this record exists to prevent, run in the direction of harm instead of benefit.
Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (Garvey WT et al., REDEFINE 1 Study Group) — PubMed, 14 August 2025“Gastrointestinal adverse events (affecting 79.6% in the cagrilintide-semaglutide group and 39.9% in the placebo group), including nausea, vomiting, diarrhea, constipation, or abdominal pain, were mainly transient and mild-to-moderate in severity.”
Checked against the source on .In the REDEFINE 2 Phase 3 trial in adults with type 2 diabetes, gastrointestinal adverse events were reported by 72.5% of patients in the cagrilintide-semaglutide group and 34.4% in the placebo group; the investigators reported most as transient and mild or moderate in severity.
A second, independent trial reporting the same shape of signal, in a different population (1206 patients with type 2 diabetes and obesity or overweight). REDEFINE 2 had no cagrilintide-alone arm — it randomised the combination against placebo only — so it says nothing at all about cagrilintide as a single agent, and is recorded here for the combination in which cagrilintide's human exposure has overwhelmingly occurred.
Cagrilintide-Semaglutide in Adults with Overweight or Obesity and Type 2 Diabetes (Davies MJ et al., REDEFINE 2 Study Group) — PubMed, 14 August 2025“Gastrointestinal adverse events were reported by 72.5% of the patients in the cagrilintide-semaglutide group and 34.4% in the placebo group, most of which were transient and mild or moderate in severity.”
Checked against the source on .Novo Nordisk reported discontinuation rates due to adverse events of 5.9% for CagriSema versus 3.5% for placebo in REDEFINE 1, and 8.4% versus 3% in REDEFINE 2.
The figures are the sponsor's; so is the word 'low', which is a characterisation and not a finding, and it is left inside the quotation marks rather than repeated as this site's own assessment. What the numbers themselves show is a discontinuation rate roughly one and a half to nearly three times the placebo rate across the two trials. Again this is the combination, not cagrilintide alone.
Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management — Novo Nordisk, 18 December 2025“Overall, discontinuation rates due to adverse events were low, with 5.9% for CagriSema versus 3.5% for placebo in REDEFINE 1 and 8.4% with CagriSema versus 3% with placebo in REDEFINE 2.”
Checked against the source on .
Questions people actually ask
Every answer cites the document behind it. Where the honest answer is “nobody knows”, that is the answer you will get.
- Is cagrilintide FDA-approved in 2026?
No. Cagrilintide is not an FDA-approved drug and is not an ingredient in one. FDA states that retatrutide and cagrilintide 'are not components of FDA-approved drugs and have not been found safe and effective for any condition.' Novo Nordisk submitted a New Drug Application to FDA on 18 December 2025 for CagriSema, a fixed-dose combination of cagrilintide and semaglutide, and states in its own announcement that 'CagriSema is not approved in the US or EU.' Two things follow that are easy to miss. First, an application under review is not an approval — a Drugs@FDA query through the openFDA API on 2 August 2026 returned no matching application for cagrilintide on generic name, active ingredient name or the brand name CagriSema. Second, the pending application is for the combination product, so even an approval of CagriSema would not make cagrilintide an approved single-agent medicine.
FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss — FDA, 15 June 2026“Retatrutide and cagrilintide cannot be used in compounding under federal law. Additionally, these are not components of FDA-approved drugs and have not been found safe and effective for any condition.”
Checked against the source on .- Can I get cagrilintide from a compounding pharmacy?
Not lawfully. FDA states plainly that 'Retatrutide and cagrilintide cannot be used in compounding under federal law.' The mechanism is worth understanding rather than taking on faith: a bulk drug substance that is neither the subject of an applicable USP or NF monograph nor a component of an FDA-approved drug product must appear on FDA's 503A bulks list to be used in compounding under section 503A. FDA states cagrilintide is not a component of an FDA-approved drug, and cagrilintide returns zero hits in the 503A bulks list document updated 14 May 2026 — verified on 2 August 2026 by downloading the PDF and extracting its text. Note what that absence is not: cagrilintide is not in Category 1, 2 or 3, and it does not appear on FDA's list of substances nominated but withdrawn either. It was never in the nomination system at all, which is why this record carries no 503A category. The absence is not permission and it is not a safety finding.
FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss — FDA, 15 June 2026“Retatrutide and cagrilintide cannot be used in compounding under federal law.”
Checked against the source on .- How much weight did people lose on cagrilintide in the REDEFINE 1 trial?
The published REDEFINE 1 abstract does not report a weight result for the cagrilintide-alone group, and this is the single most misquoted point about this compound. What the trial reported is the combination: of 3417 participants randomised, 2108 were assigned to receive cagrilintide-semaglutide, 302 to semaglutide alone, 302 to cagrilintide alone and 705 to placebo, and the investigators reported an estimated mean change in body weight from baseline to week 68 of -20.4% with cagrilintide-semaglutide compared with -3.0% with placebo (estimated difference -17.3 percentage points, 95% confidence interval -18.1 to -16.6). Those coprimary endpoints compared the combination with placebo. Semaglutide is separately an FDA-approved active ingredient with its own large trial record, so attributing the combination's result to cagrilintide credits one molecule with a result produced by two.
Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (Garvey WT et al., REDEFINE 1 Study Group) — PubMed, 14 August 2025“A total of 3417 participants underwent randomization, with 2108 assigned to receive cagrilintide-semaglutide, 302 to receive semaglutide, 302 to receive cagrilintide, and 705 to receive placebo. The estimated mean percent change in body weight from baseline to week 68 was -20.4% with cagrilintide-semaglutide as compared with -3.0% with placebo (estimated difference, -17.3 percentage points; 95% confidence interval, -18.1 to -16.6; P<0.001).”
Checked against the source on .- Did CagriSema beat tirzepatide?
No. Novo Nordisk announced on 23 February 2026 that REDEFINE 4, an open-label head-to-head Phase 3 trial in 809 randomised people with obesity and one or more comorbidities, 'did not achieve its primary endpoint of demonstrating non-inferiority on weight loss for CagriSema compared to tirzepatide after 84 weeks.' The sponsor reported weight loss of 23.0% with CagriSema versus 25.5% with tirzepatide after 84 weeks when evaluating the effects of treatment if all people adhered to treatment, and 20.2% versus 23.6% under the treatment-regimen estimand. Read the design limits with the result: the trial was open-label, meaning investigators and participants knew which drug was given, and it tested the CagriSema combination, not cagrilintide on its own. This is a sponsor announcement of headline results, reported by the sponsor against its own product.
Novo Nordisk A/S: CagriSema demonstrated 23% weight loss in an open-label head-to-head REDEFINE 4 trial in people with obesity, the primary endpoint was not achieved — Novo Nordisk, 23 February 2026“The trial did not achieve its primary endpoint of demonstrating non-inferiority on weight loss for CagriSema compared to tirzepatide after 84 weeks.”
Checked against the source on .- Is cagrilintide being studied on its own, without semaglutide?
Yes, and it has not reported. Novo Nordisk A/S is the lead sponsor of NCT07220642, a Phase 3 trial titled 'Efficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity', which randomises participants to cagrilintide or to matching placebo administered subcutaneously, with relative change in body weight as its primary outcome measure. Checked on 2 August 2026: status ACTIVE_NOT_RECRUITING, estimated enrolment 300, primary completion date 11 May 2027, and no results posted. So the trial that would establish what cagrilintide does as a standalone product is running and unread. Until it reports, every published Phase 3 efficacy result for cagrilintide comes from a trial of the combination with semaglutide.
NCT07220642 — Efficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity — ClinicalTrials.gov, 26 June 2026Checked against the source on .- When will FDA decide on CagriSema?
Novo Nordisk stated on 23 February 2026 that 'CagriSema for weight management was submitted to the US FDA in December 2025 based on the REDEFINE 1 and REDEFINE 2 pivotal trials, and an FDA decision is anticipated by late 2026.' That is the sponsor's expectation, not an FDA commitment, and FDA has published no approval: a Drugs@FDA query through the openFDA API on 2 August 2026 returned no application matching cagrilintide by generic name, by active ingredient name, or by the brand name CagriSema. An anticipated decision date is not an outcome — FDA can approve, refuse, or issue a complete response letter — and a pending application confers no legal status on cagrilintide in the meantime.
Novo Nordisk A/S: CagriSema demonstrated 23% weight loss in an open-label head-to-head REDEFINE 4 trial in people with obesity, the primary endpoint was not achieved — Novo Nordisk, 23 February 2026“CagriSema for weight management was submitted to the US FDA in December 2025 based on the REDEFINE 1 and REDEFINE 2 pivotal trials, and an FDA decision is anticipated by late 2026.”
Checked against the source on .- Is cagrilintide sold as a research peptide the same thing Novo Nordisk is testing?
Nothing verifies that it is. FDA states that cagrilintide is not a component of an FDA-approved drug, which means no vial of it originates from an approved supply chain, and that it 'ha[s] not been found safe and effective for any condition.' The trial results on this page were generated with material manufactured and administered by Novo Nordisk under its own investigational programme; they describe that material and nothing else. One point of precision, because the FDA page invites an overreach: the enforcement examples listed immediately below FDA's cagrilintide sentence — warnings to telehealth companies, to active pharmaceutical ingredient distributors, and to outsourcing facilities — all name retatrutide, not cagrilintide. This record does not carry them across. What FDA has stated about cagrilintide is the legal conclusion quoted here.
FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss — FDA, 15 June 2026“Retatrutide and cagrilintide cannot be used in compounding under federal law. Additionally, these are not components of FDA-approved drugs and have not been found safe and effective for any condition.”
Checked against the source on .