GLP1Base
Menu

Side-by-side comparison

CagriSema vs Tirzepatide

CagriSema combines two molecules in one weekly injection: cagrilintide, which copies the hormone amylin, and semaglutide. Tirzepatide is a single molecule that acts on the GIP and GLP-1 receptors. Tirzepatide is approved; CagriSema is not yet approved anywhere.

CagriSema is Novo Nordisk's fixed-dose combination of cagrilintide with semaglutide. It is investigational. Facts shown are for the combination where our sources report them.

Last verified 2026-09-29 · how we verify

In plain English

The real difference

  • CagriSema acts on the amylin receptors (AMY1R, AMY2R, AMY3R), calcitonin receptor and GLP-1 receptor (across its two components). Tirzepatide acts on the GIP receptor and GLP-1 receptor.[src][src][src]
  • CagriSema is not approved by any regulator yet; the strongest evidence so far is from phase 3 trials.[src]
  • Tirzepatide is an approved medicine.[src]
  • CagriSema is made by Novo Nordisk; tirzepatide by Eli Lilly.
  • CagriSema is taken as a once-weekly injection (in clinical trials); tirzepatide as a once-weekly injection.
  • Half-life (how long until half the drug has left the blood): cagrilintide (in CagriSema), about 159-195 hours (roughly 6.5-8 days) in a phase 1b trial where cagrilintide was given together with semaglutide; tirzepatide, about 5 days (5 to 6 days in adults with obesity).[src][src]
  • Our sources include no head-to-head trial between them. Their results come from different trials, with different people, durations and methods, so the numbers below are not directly comparable.

Which one suits a person is a decision for them and their clinician.

CagriSema and Tirzepatide, side by side

CagriSema compared with Tirzepatide
CagriSemacagrilintide + semaglutide · Novo NordiskTirzepatideEli Lilly
The basics
MoleculeCagrilintide + SemaglutideTirzepatide
Brand namesCagriSema (investigational name)Mounjaro, Zepbound
MakerNovo NordiskEli Lilly
Acts onThe hormone receptors the drug switches on
  • Cagrilintide: Amylin receptors (AMY1R, AMY2R, AMY3R), Calcitonin receptor
  • Semaglutide: GLP-1 receptor
GIP receptor, GLP-1 receptor
Approved to treatNone: not an approved medicine
  • Mounjaro: Type 2 diabetes (adults and children 10 and older); reducing major cardiovascular events in adults with type 2 diabetes at high risk (US label)
  • Zepbound: Chronic weight management in adults with obesity, or overweight with a weight-related condition; moderate-to-severe obstructive sleep apnea in adults with obesity (US label)
How it is takenInvestigational once-weekly subcutaneous injection in clinical trials, alone or as a fixed-dose combination with semaglutide (CagriSema). There is no approved route because there is no approved product.Subcutaneous injection, given once a week, supplied as prefilled pens or vials
Half-lifeHow long until half the drug has left the bloodAbout 159-195 hours (roughly 6.5-8 days) in a phase 1b trial where cagrilintide was given together with semaglutide[src]About 5 days (5 to 6 days in adults with obesity)[src]
Evidence and safety
Evidence level
Phase 3. Large trials comparing it with placebo or other drugs.
Approved. Approved by a major regulator after large trials.
Approvals and filings
  • Regulatory status. No approval by any regulator found as of 2026-09-29. FDA states that cagrilintide is not a component of FDA-approved drugs and has not been found safe and effective for any condition.[src]
  • CagriSema filing. Novo Nordisk announced on 2025-12-18 that it had filed a US New Drug Application for the once-weekly cagrilintide-semaglutide combination for adult weight management, with FDA review expected in 2026.[src]
  • FDA approval for type 2 diabetes. Approved on 13 May 2022 as Mounjaro, to improve blood sugar control in adults with type 2 diabetes as an addition to diet and exercise.[src]
  • FDA approval for weight management. Approved on 8 November 2023 as Zepbound for chronic weight management in adults with obesity, or overweight with a weight-related condition.[src]
  • FDA approval for sleep apnea. Zepbound approved on 20 December 2024 for moderate-to-severe obstructive sleep apnea in adults with obesity.[src]
  • EU authorisation. Marketing authorisation for Mounjaro granted on 15 September 2022; the EU indications cover type 2 diabetes (adults and children 10 and older) and weight management in adults. Sleep apnea is not a separate EU indication.[src]
Key trial resultsTrials test the molecule, not a brand; each result names its population
  • REDEFINE 1 (68 weeks, adults without diabetes). Cagrilintide-semaglutide: -20.4% body weight versus -3.0% with placebo (estimated difference -17.3 percentage points; treatment-policy estimand; 3,417 participants).[src]
  • SURMOUNT-1 weight change at 72 weeks. -20.9% at the highest of three maintenance doses versus -3.1% with placebo (2,539 adults with obesity, or overweight with a weight-related condition, and without diabetes).[src]
  • SURMOUNT-5 versus semaglutide. -20.2% with tirzepatide versus -13.7% with semaglutide at 72 weeks (751 adults, open-label).[src]
Known safety signals
  • REDEFINE 1: gastrointestinal adverse events affected 79.6% of people on cagrilintide-semaglutide versus 39.9% on placebo, mainly transient and mild to moderate.[src]
  • Cagrilintide is not approved by FDA and, per FDA, cannot be used in compounding under federal law; it has not been found safe and effective for any condition.[src]
  • Unregulated products: US Customs stated that overseas-made unapproved peptides, with cagrilintide listed among those seized in one 2026 case, could be contaminated with other substances or impurities, and that their authenticity and safety cannot be determined.[src]
  • Boxed warning: in rats, tirzepatide caused thyroid C-cell tumours at clinically relevant exposures. It is unknown whether it causes these tumours, including medullary thyroid carcinoma, in humans. It is contraindicated in people with a personal or family history of medullary thyroid carcinoma or with Multiple Endocrine Neoplasia syndrome type 2.[src]
  • In SURPASS-2, the most common adverse events with tirzepatide were gastrointestinal and mostly mild to moderate: nausea in 17 to 22%, diarrhoea in 13 to 16% and vomiting in 6 to 10% of the three tirzepatide groups. Serious adverse events were reported in 5 to 7% of tirzepatide patients and 3% of semaglutide patients.[src]
  • US labels list nausea, diarrhoea, vomiting, constipation, abdominal pain and dyspepsia among the most common adverse reactions (5% or more of patients), and warn of serious gastrointestinal reactions (not recommended in severe gastroparesis), acute kidney injury from dehydration, acute gallbladder disease and acute pancreatitis.[src]
  • The label states that the risk of hypoglycaemia, including severe hypoglycaemia, is increased when tirzepatide is used with insulin or an insulin secretagogue such as a sulfonylurea.[src]
  • Because it delays gastric emptying, tirzepatide can affect the absorption of oral medicines, and there are rare postmarketing reports of pulmonary aspiration in people taking GLP-1 receptor agonists who had elective procedures under general anaesthesia or deep sedation.[src]
  • Other label warnings include serious hypersensitivity reactions (anaphylaxis, angioedema) reported after marketing, monitoring for diabetic retinopathy complications in people with type 2 diabetes and a history of retinopathy, and possible fetal harm in pregnancy.[src]
Legal status
United States
Under review

Not approved alone; Novo Nordisk's CagriSema (cagrilintide plus semaglutide) is under FDA review for obesity, and cagrilintide cannot be compounded[src]

Full detail →
Approved

FDA-approved as Mounjaro (type 2 diabetes) and Zepbound (weight management, sleep apnea); shortage over since December 2024[src]

Full detail →
United Kingdom
Not approved

No UK licence for cagrilintide or the cagrilintide-semaglutide combination (CagriSema)[src]

Full detail →
Approved

Licensed in the UK as Mounjaro for type 2 diabetes and for weight management; NHS access is being phased in[src]

Full detail →
European Union
Not approved

No EU marketing authorisation; no application on EMA's September 2026 evaluation list[src]

Full detail →
Approved

Authorised EU-wide as Mounjaro for type 2 diabetes and for weight management in adults[src]

Full detail →
Australia
Not approved

Not approved and not shown as under TGA evaluation. No cagrilintide product is on the ARTG.[src]

Full detail →
Approved

Approved as Mounjaro for type 2 diabetes (Dec 2022) and weight management (Sep 2024). Not PBS-listed: the sponsor is not proceeding for now. Compounding barred since Oct 2024.[src]

Full detail →
Canada
Under review

Cagrilintide with semaglutide (CagriSema) under review since March 2026; no cagrilintide product is authorised[src]

Full detail →
Approved

Approved as Mounjaro (type 2 diabetes) and Zepbound (weight management, sleep apnea); no generic submissions[src]

Full detail →

Trial results come from separate studies unless a row says it is a head-to-head trial. Populations, durations and methods differ, so compare numbers across columns with care.

Go deeper

Molecule

Cagrilintide (and CagriSema) explained →Watch the 3D body journey →

Molecule

Semaglutide explained →Watch the 3D body journey →

Molecule

Tirzepatide explained →Watch the 3D body journey →

Educational information only. Not medical advice, not a recommendation to use any substance, and not an offer to supply. Talk to a licensed clinician about your own care.

Sources (72)

  1. 01Once-weekly cagrilintide for weight management in people with overweight and obesity: a dose-finding phase 2 trialThe Lancet (via PubMed) · 2021-11-16 · accessed 2026-09-29
  2. 02Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity (REDEFINE 1)New England Journal of Medicine (via PubMed) · 2025-06-22 · accessed 2026-09-29
  3. 03Novo Nordisk presents phase 3 data for next-generation amylin cagrilintide, leading to advancement into dedicated clinical programmeNovo Nordisk press release (reprinted by BioSpace) · 2025-09-16 · accessed 2026-09-29
  4. 04RENEW 1: Efficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity (NCT07220642)ClinicalTrials.gov · 2025-10-24 · accessed 2026-09-29
  5. 05Novo's CagriSema delivers superior weight loss versus tirzepatide in REIMAGINE 5 trialNovo Nordisk (company announcement) · 2026-09-21 · accessed 2026-09-29
  6. 06Safety, tolerability, pharmacokinetics, and pharmacodynamics of concomitant administration of multiple doses of cagrilintide with semaglutide for weight management: a randomised, controlled, phase 1b trialThe Lancet (via PubMed) · 2021-04-22 · accessed 2026-09-29
  7. 07FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight LossU.S. Food and Drug Administration · 2026-09-01 · accessed 2026-09-29
  8. 08Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight managementNovo Nordisk (press release) · 2025-12-18 · accessed 2026-09-29
  9. 09Cincinnati CBP foils scheme to smuggle over 5,000 unapproved peptides into the U.S.U.S. Customs and Border Protection · 2026-03-31 · accessed 2026-09-29
  10. 10Novo Nordisk financial report for 2025 (Form 6-K, company announcement)Novo Nordisk A/S (SEC filing) · 2026-02-03 · accessed 2026-09-29
  11. 11Novo Nordisk financial report for the period 1 January to 30 June 2026 (Form 6-K)Novo Nordisk A/S (SEC filing) · 2026-08-04 · accessed 2026-09-29
  12. 12Find product information about medicines (MHRA Products register)Medicines and Healthcare products Regulatory Agency (MHRA) · 2026-09-25 · accessed 2026-09-29
  13. 13The Human Medicines Regulations 2012, regulation 46 (prohibition on sale or supply of unauthorised medicinal products)UK Government (legislation.gov.uk) · 2012 · accessed 2026-09-29
  14. 14Borderline products: how to tell if your product is a medicineMedicines and Healthcare products Regulatory Agency (MHRA) · 2026-07-02 · accessed 2026-09-29
  15. 15Union Register of medicinal products for human useEuropean Commission · 2026-09-29 · accessed 2026-09-29
  16. 16Applications for new human medicines under evaluation by the CHMP (September 2026)European Medicines Agency · 2026-09-04 · accessed 2026-09-29
  17. 17Directive 2001/83/EC on the Community code relating to medicinal products for human use (consolidated text, 1 January 2025)European Union (EUR-Lex) · 2025-01-01 · accessed 2026-09-29
  18. 18ARTG keyword search for 'cagrilintide' (no matching results)Therapeutic Goods Administration (TGA) · 2026-09-29 · accessed 2026-09-29
  19. 19Prescription medicines under evaluation (last updated 21 September 2026)Therapeutic Goods Administration (TGA) · 2026-09-21 · accessed 2026-09-29
  20. 20Access pathways for unapproved therapeutic goodsTherapeutic Goods Administration (TGA) · 2025-10 · accessed 2026-09-29
  21. 21Drug and Health Product Submissions Under Review: New drug submissions under review (list current as of 2026-08-31)Health Canada · 2026-08-31 · accessed 2026-09-29
  22. 22Drug Product Database API: active-ingredient search for cagrilintideHealth Canada (Drug Product Database) · 2026-09-29 · accessed 2026-09-29
  23. 23Once-Weekly Semaglutide in Adults with Overweight or Obesity (STEP 1)New England Journal of Medicine (via PubMed) · 2021-03-18 · accessed 2026-09-29
  24. 24Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes (SUSTAIN-6)New England Journal of Medicine (via PubMed) · 2016-11-10 · accessed 2026-09-29
  25. 25Semaglutide and Cardiovascular Outcomes in Obesity without Diabetes (SELECT)New England Journal of Medicine (via PubMed) · 2023-12-14 · accessed 2026-09-29
  26. 26Effects of Semaglutide on Chronic Kidney Disease in Patients with Type 2 Diabetes (FLOW)New England Journal of Medicine (via PubMed) · 2024-07-11 · accessed 2026-09-29
  27. 27Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis (ESSENCE)New England Journal of Medicine (via PubMed) · 2025-06-05 · accessed 2026-09-29
  28. 28Drugs@FDA record, NDA 209637 (Ozempic): original approval 2017-12-05U.S. Food and Drug Administration (openFDA Drugs@FDA) · 2017-12-05 · accessed 2026-09-29
  29. 29Drugs@FDA record, NDA 213051 (Rybelsus): original approval 2019-09-20U.S. Food and Drug Administration (openFDA Drugs@FDA) · 2019-09-20 · accessed 2026-09-29
  30. 30Drugs@FDA record, NDA 215256 (Wegovy): original approval 2021-06-04U.S. Food and Drug Administration (openFDA Drugs@FDA) · 2021-06-04 · accessed 2026-09-29
  31. 31Drugs@FDA record, NDA 218316 (Wegovy tablets): original approval 2025-12-22U.S. Food and Drug Administration (openFDA Drugs@FDA) · 2025-12-22 · accessed 2026-09-29
  32. 32Wegovy approved by FDA for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosisNovo Nordisk (PR Newswire) · 2025-08-15 · accessed 2026-09-29
  33. 33Ozempic: EPAR (European public assessment report)European Medicines Agency · 2026-08 · accessed 2026-09-29
  34. 34Rybelsus: EPAR (European public assessment report)European Medicines Agency · 2026-04 · accessed 2026-09-29
  35. 35Wegovy: EPAR (European public assessment report)European Medicines Agency · 2026-09 · accessed 2026-09-29
  36. 36RYBELSUS and OZEMPIC (semaglutide) tablets: prescribing informationDailyMed (U.S. National Library of Medicine) / Novo Nordisk · 2026-01 · accessed 2026-09-29
  37. 37Tirzepatide Once Weekly for the Treatment of Obesity (SURMOUNT-1)New England Journal of Medicine · 2022-07-21 · accessed 2026-09-29
  38. 38Tirzepatide versus Semaglutide Once Weekly in Patients with Type 2 Diabetes (SURPASS-2)New England Journal of Medicine · 2021-08-05 · accessed 2026-09-29
  39. 39Tirzepatide as Compared with Semaglutide for the Treatment of Obesity (SURMOUNT-5)New England Journal of Medicine · 2025-07-03 · accessed 2026-09-29
  40. 40Tirzepatide for the Treatment of Obstructive Sleep Apnea and Obesity (SURMOUNT-OSA)New England Journal of Medicine · 2024-10-03 · accessed 2026-09-29
  41. 41Tirzepatide for Heart Failure with Preserved Ejection Fraction and Obesity (SUMMIT)New England Journal of Medicine · 2025-01-30 · accessed 2026-09-29
  42. 42Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes (SURPASS-CVOT)New England Journal of Medicine · 2025-12-18 · accessed 2026-09-29
  43. 43MOUNJARO (tirzepatide) injection, prescribing informationU.S. National Library of Medicine (DailyMed), FDA-approved label · 2026-09 · accessed 2026-09-29
  44. 44ZEPBOUND (tirzepatide) injection, prescribing informationU.S. National Library of Medicine (DailyMed), FDA-approved label · 2026-09 · accessed 2026-09-29
  45. 45Drug Trials Snapshots: MOUNJAROU.S. Food and Drug Administration · 2023-06-13 · accessed 2026-09-29
  46. 46FDA Approves New Medication for Chronic Weight ManagementU.S. Food and Drug Administration · 2023-11-08 · accessed 2026-09-29
  47. 47FDA Approves First Medication for Obstructive Sleep ApneaU.S. Food and Drug Administration · 2024-12-20 · accessed 2026-09-29
  48. 48Mounjaro (tirzepatide): European public assessment reportEuropean Medicines Agency · 2022-09-15 · accessed 2026-09-29
  49. 49MOUNJARO (tirzepatide) injection prescribing informationU.S. Food and Drug Administration · 2026-09 · accessed 2026-09-29
  50. 50ZEPBOUND (tirzepatide) injection prescribing informationU.S. Food and Drug Administration · 2026-09 · accessed 2026-09-29
  51. 51FDA clarifies policies for compounders as national GLP-1 supply begins to stabilizeU.S. Food and Drug Administration · 2026-04-01 · accessed 2026-09-29
  52. 52List of Bulk Drug Substances for Which There Is a Clinical Need Under Section 503B (proposal not to include semaglutide, tirzepatide, liraglutide)Federal Register (FDA) · 2026-05-01 · accessed 2026-09-29
  53. 53MHRA authorises diabetes drug Mounjaro (tirzepatide) for weight management and weight lossMedicines and Healthcare products Regulatory Agency (MHRA) · 2023-11-08 · accessed 2026-09-29
  54. 54Tirzepatide for managing overweight and obesity (TA1026)National Institute for Health and Care Excellence (NICE) · 2024-12-23 · accessed 2026-09-29
  55. 55Mounjaro (tirzepatide) price increase: Drug Tariff redeterminationNHS Business Services Authority (NHSBSA) · 2025-09 · accessed 2026-09-29
  56. 56Fake Mounjaro (tirzepatide) KwikPen 15mg pre-filled pensMedicines and Healthcare products Regulatory Agency (MHRA) · 2026-02-24 · accessed 2026-09-29
  57. 57New diabetes and obesity medicines: an AIFA guideItalian Medicines Agency (AIFA) · 2026-05-18 · accessed 2026-09-29
  58. 58Obesite: prise en charge de Wegovy et Mounjaro a partir du 15 juin 2026, sous conditionsVidal · 2026-05-28 · accessed 2026-09-29
  59. 59Arzneimittel-Richtlinie Anlage II: Lifestyle-Arzneimittel (Stand 20. August 2025)Gemeinsamer Bundesausschuss (G-BA) · 2025-08-20 · accessed 2026-09-29
  60. 60MOUNJARO tirzepatide solution for injection pre-filled pen (ARTG 379330)Therapeutic Goods Administration (TGA) · 2022-12 · accessed 2026-09-29
  61. 61AusPAR: Mounjaro (tirzepatide), new chemical entityTherapeutic Goods Administration (TGA) · 2023-11-16 · accessed 2026-09-29
  62. 62AusPAR: Mounjaro (tirzepatide), extension of indications (chronic weight management)Therapeutic Goods Administration (TGA) · 2024-09-26 · accessed 2026-09-29
  63. 63PBS Medicines Status: tirzepatide (Mounjaro), type 2 diabetes mellitusAustralian Government Department of Health, Disability and Ageing (PBS) · 2026-06-30 · accessed 2026-09-29
  64. 64Prescription medicines under evaluation: Mounjaro (tirzepatide), proposed use from age 10 (accepted September 2025)Therapeutic Goods Administration (TGA) · 2025-09 · accessed 2026-09-29
  65. 65Prescription medicines under evaluation: Mounjaro (tirzepatide), cardiovascular risk reduction (accepted December 2025)Therapeutic Goods Administration (TGA) · 2025-12 · accessed 2026-09-29
  66. 66Manufacturing, supplying and advertising compounded medicines lawfullyTherapeutic Goods Administration (TGA) · 2026-05-14 · accessed 2026-09-29
  67. 67Drug Product Database: ZEPBOUND product recordHealth Canada (Drug Product Database) · 2026-09 · accessed 2026-09-29
  68. 68Product Monograph: ZEPBOUND (tirzepatide injection)Eli Lilly Canada Inc. · 2026-06-11 · accessed 2026-09-29
  69. 69Product Monograph: MOUNJARO (tirzepatide injection)Eli Lilly Canada Inc. · 2026-06-23 · accessed 2026-09-29
  70. 70Generic submissions under review (list current as of 2026-08-31)Health Canada · 2026-08-31 · accessed 2026-09-29
  71. 71Unauthorized injectable peptide drugs seized and sold by Canada Peptide may pose serious health risksHealth Canada · 2025-08-01 · accessed 2026-09-29
  72. 72Thinking about buying GLP-1 drugs like Ozempic or Mounjaro? Beware of fake or unauthorized productsHealth Canada · 2026-01-21 · accessed 2026-09-29