CagriSema’s current regulatory status
CagriSema isn’t approved anywhere in the world as of May 2026.
In the United States, Novo Nordisk submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) on 18 December 2025.2 A first review decision is expected in late 2026.
In Europe, no submission to the European Medicines Agency (EMA) has been publicly confirmed by Novo Nordisk. The same is true in the UK, where the MHRA hasn’t yet announced a CagriSema filing.
Health Canada and other national regulators haven’t issued public confirmations either. The drug is currently investigational worldwide.
| Regulator |
Status (May 2026) |
Earliest realistic decision |
| FDA (US)2 |
NDA filed 18 December 2025 |
Late 2026 |
| EMA (EU) |
No public filing confirmed |
Not yet known |
| MHRA (UK) |
No public filing confirmed |
Not yet known |
| Health Canada |
No public filing confirmed |
Not yet known |
CagriSema’s results in trials so far
Novo Nordisk designed CagriSema to increase weight loss when used with semaglutide alone by combining it with cagrilintide, a synthetic form of the hormone amylin that has hunger-lowering effects.
The Phase 3 REDEFINE programme tested this across several populations.
In REDEFINE 1, CagriSema produced a mean weight loss of 22.7% at 68 weeks among participants who completed treatment.
Within this group, 60% lost at least 20% of body weight and 23% lost 30% or more.1
In people with type 2 diabetes (REDEFINE 2, 68 weeks), CagriSema produced an average weight loss of 15.7%.
Weight loss is typically lower in people with type 2 diabetes in other GLP-1 medications, like Mounjaro.
The headline figure missed Novo Nordisk’s internal 25% weight loss target, and the company’s share price fell on the news.
The weight loss achieved is still significant, but it’s still below the average weight loss often seen in Mounjaro, which can reach up to ~26% after two years.
In the REDEFINE 4 trial, CagriSema was directly compared with tirzepatide 15 mg (Mounjaro).
Over 84 weeks, CagriSema produced an average weight loss of 23.0%, compared with 25.5% for tirzepatide. Novo Nordisk announced in February 2026 that the trial’s primary endpoint was not achieved.5
A higher-dose CagriSema study (REDEFINE 11) is expected to be published in the first half of 2027.
The aim of this trial will be to cement CagriSema as the leading weight-loss medication on the market.
The UK approval pathway: MHRA, NICE, and the NHS
A new weight-loss medication reaches UK patients through three separate steps, each at a different time.
First, the MHRA reviews the clinical evidence and decides whether to grant a marketing authorisation. This is the licensing step. It allows the drug to be sold in the UK, including privately.
Second, the National Institute for Health and Care Excellence (NICE) carries out a technology appraisal.
NICE looks at clinical and cost-effectiveness and recommends (or doesn’t) whether the NHS should fund the drug.
Third, NHS England and the integrated care boards (ICBs) commission delivery, usually through specialist weight management services. This determines whether you can actually get a prescription.
Since Brexit, the MHRA reviews medicines independently of the EMA.
UK approval no longer automatically follows an EU decision, which could mean longer UK timelines if Novo Nordisk prioritises the EMA over the MHRA.
Wegovy and Mounjaro both went through this exact sequence, and their timelines serve as useful comparators for CagriSema.
Wegovy timeline (semaglutide)
The MHRA approved Wegovy for weight management in September 2021.
NICE published technology appraisal TA875 in March 2023, recommending Wegovy for NHS use in eligible adults.3 NHS commissioning followed in late 2023.
That’s roughly 18 months from MHRA approval to NICE recommendation, and over two years to NHS commissioning.
Mounjaro timeline (tirzepatide)
The MHRA approved Mounjaro for obesity management in November 2023.
NICE published technology appraisal TA1026 in December 2024, recommending tirzepatide for NHS use under specific eligibility rules.4 NHS commissioning began on 23 June 2025.
That’s around 13 months from MHRA approval to NICE recommendation, and 19 months to NHS rollout.
Both timelines suggest the UK process from MHRA filing to NHS access is rarely under 18 months and often longer.
When CagriSema could become available privately in the UK
Private access in the UK depends entirely on the MHRA. Until the agency grants a marketing authorisation, no UK pharmacy can legally supply CagriSema, even on a private prescription.
MHRA reviews of new medicines typically take 6 to 12 months from submission.
So if Novo Nordisk files with the MHRA in the first half of 2026, a private UK launch becomes plausible in late 2026 or during 2027.
Two routes could speed this up. The Innovative Licensing and Access Pathway (ILAP) offers earlier MHRA engagement for drugs that address unmet need.
The EC Decision Reliance Procedure allows the MHRA to lean on the EMA assessment. Novo Nordisk hasn’t confirmed using either.
This is an estimate based on regulatory norms, not a Novo Nordisk announcement. The company hasn’t published a UK-specific timeline, and the MHRA hasn’t yet confirmed a filing. If Novo Nordisk delays the submission, every downstream date slips with it.
When CagriSema could reach the NHS
Even after MHRA approval, NICE has to recommend the drug, and the NHS has to commission its delivery.
NICE technology appraisals usually start around the time of MHRA approval and conclude 9 to 12 months later.
NHS commissioning then takes a further 6 months or more. Using Wegovy and Mounjaro as examples, that’s a minimum of 13 to 18 months after MHRA approval.
If MHRA approval is granted in late 2026 or 2027, NHS access for CagriSema would realistically be available from 2028 onwards. This assumes NICE recommends it, which isn’t guaranteed given the head-to-head data against tirzepatide.
The Mounjaro NHS rollout is also a useful warning sign. As of August 2025, only 8 of England’s 42 integrated care boards were providing tirzepatide for obesity, despite NICE recommending it nationally.4
CagriSema would join that already-constrained pathway, so real-world NHS access is likely to be patchy at first.
Why no UK pharmacy is selling it yet
CagriSema doesn’t have a UK marketing authorisation. Without one, it can’t be lawfully sold or supplied through a UK pharmacy.
Selling or supplying an unlicensed medicine outside narrow clinical exemptions breaches the Human Medicines Regulations 2012. This applies to UK-registered pharmacies and to overseas websites that ship into the UK.
Any website claiming to sell CagriSema in the UK right now is operating outside the law. We’d recommend avoiding these sources entirely.
The product on offer may be counterfeit, unsafely stored, or not what it claims to be.
CagriSema can only be advertised by a UK pharmacy after the MHRA grants a marketing authorisation. At that point, the licensed prescribing information becomes public.
Likely NHS eligibility
We don’t yet know what NHS eligibility for CagriSema will look like.
NICE hasn’t started a technology appraisal, and the criteria for each drug are decided case by case.
Still, we can speculate based on how Wegovy and Mounjaro were introduced to the NHS.
If CagriSema followed Mounjaro’s NICE pathway, NHS access would likely require a body mass index (BMI, a measure of body weight relative to height) of 40 or higher, plus at least 4 of 5 weight-related comorbidities.4
The five comorbidities specified for tirzepatide are type 2 diabetes, high blood pressure, dyslipidaemia (raised cholesterol or triglycerides), obstructive sleep apnoea, and cardiovascular disease.
NICE also requires patients to be enrolled in a specialist weight management service. These exact criteria aren’t confirmed for CagriSema.
NICE could choose a different threshold based on the REDEFINE trial evidence and cost-effectiveness modelling. The Mounjaro pathway is the closest available comparison.
Wegovy’s NICE eligibility under TA875 is somewhat broader, with a BMI threshold of 35 plus at least one weight-related comorbidity in most circumstances.3 CagriSema could fall closer to either model.
Alternatives available in the UK now
For most people, there’s no clinical reason to wait for CagriSema.
The head-to-head REDEFINE 4 trial showed tirzepatide produced slightly more weight loss than CagriSema (25.5% vs 23.0% over 84 weeks), and tirzepatide is already licensed and available in the UK.5
That open-label trial design has limits. Patients knew which drug they were taking, which can influence outcomes.
Even so, tirzepatide currently has the strongest evidence for weight loss among prescription medicines licensed in the UK.
Mounjaro (tirzepatide)
The closest comparison to CagriSema in terms of average weight loss, and the only licensed UK drug in that range.
Available privately and through the NHS under NICE TA1026 for adults meeting strict eligibility criteria.4
Wegovy (semaglutide)
Available as a weekly injection. The standard 2.4 mg dose produced an average weight loss of 14.9% in STEP 1.
The MHRA approved a higher dose of 7.2 mg in January 2026, based on STEP UP trial data showing 20.7% weight loss at 72 weeks.
The 7.2 mg dose is rolling out privately in 2026.
Oral Wegovy (oral semaglutide 25 mg)
A daily tablet rather than a weekly injection. FDA approved in December 2025. An MHRA submission is expected in 2026.
The Phase 3 OASIS 4 trial showed a mean weight loss of 16.6% at 64 weeks among participants who completed the trial. This may suit people who can’t or don’t want to use injections.
Rather than waiting for CagriSema, we’d recommend speaking to your GP about whether you’d qualify for tirzepatide or semaglutide on the NHS, or speaking to a private weight management clinic about a prescription.
Frequently asked questions
When will CagriSema be approved in the UK?
There’s no confirmed UK approval date. Novo Nordisk hasn’t yet announced an MHRA filing as of May 2026.
If Novo Nordisk files with the MHRA in the coming months, approval could realistically arrive in 2027, based on typical 6 to 12-month review times.
Can I buy CagriSema online in the UK?
No. CagriSema doesn’t have a UK marketing authorisation, so no UK pharmacy can lawfully supply it.
Any website offering CagriSema for sale in the UK is operating outside the Human Medicines Regulations 2012.
We’d advise avoiding these sellers because the product may be counterfeit, unsafely stored, or not what it claims to be.
Is CagriSema available on the NHS?
No. NHS access requires a NICE technology appraisal recommending the drug, and NICE hasn’t started one for CagriSema.
Based on how long Wegovy and Mounjaro took to reach the NHS, CagriSema would realistically arrive from 2028 onwards if MHRA approval comes through in 2026 or 2027.
How much will CagriSema cost in the UK?
Novo Nordisk hasn’t yet announced UK pricing.
As a benchmark, private monthly costs for Wegovy and Mounjaro in the UK currently range from £150 to £375+, depending on dose and provider.
CagriSema will likely launch at a similar level or slightly higher. Any specific figures circulating online are speculation until Novo Nordisk publishes a list price.
Where is CagriSema currently approved?
Nowhere yet, as of May 2026. The FDA review is ongoing in the United States, and no other regulator has publicly confirmed an approval or a filing.
Is CagriSema available privately in the UK now?
No. Without an MHRA marketing authorisation, neither a private prescriber nor a UK pharmacy can supply it. Private and NHS supplies both depend on the MHRA approving the drug first.
Will CagriSema work for type 2 diabetes?
The REDEFINE 2 trial tested CagriSema in adults with type 2 diabetes and obesity, showing a mean weight loss of 15.7% at 68 weeks.
If approved, this is the most likely population for which CagriSema would be licensed, alongside obesity-only use.
Mounjaro is currently licensed for both obesity and type 2 diabetes in the UK.
What’s a similar weight-loss medication I can get in the UK now?
Mounjaro (tirzepatide) is the licensed UK option with outcomes closest to those reported for CagriSema in trials.
It’s available privately and through the NHS for eligible adults under NICE TA1026.4
Wegovy (semaglutide) is the other licensed option, with broader NICE eligibility criteria under TA875.3 A higher 7.2 mg dose of Wegovy was MHRA-approved in January 2026.
When will Novo Nordisk file CagriSema with the MHRA?
Novo Nordisk hasn’t announced an MHRA filing date. The first regulatory submission was the FDA NDA filed on 18 December 2025.2
An MHRA filing would typically be expected within months of the FDA submission, but timing is at the company’s discretion.
Take home message
CagriSema isn’t approved anywhere in the world as of May 2026.
Novo Nordisk filed for FDA approval on 18 December 2025, with a first U.S. decision expected late 2026.
No MHRA filing has been publicly confirmed in the UK. If an application happens soon, a private UK launch becomes plausible in late 2026 or 2027.
NHS access would likely be later than these dates. Based on the Wegovy and Mounjaro pathways, NHS commissioning of CagriSema would realistically begin in 2028.
The head-to-head REDEFINE 4 trial showed tirzepatide produced slightly more weight loss than CagriSema.
There’s no clinical reason to wait. Mounjaro and Wegovy are licensed UK options that work now, both privately and on the NHS, for eligible adults.
Second Nature’s Mounjaro programme combines the medication with personalised nutrition guidance from registered dietitians and nutritionists, built around a balanced plate of half vegetables, a quarter protein, a quarter complex carbohydrates, plus a serving of fat.
A peer-reviewed evaluation of Second Nature’s semaglutide-supported programme, published in JMIR Formative Research, found that active subscribers lost an average of 19.1% of their body weight at 12 months, with 77.7% achieving at least 10% weight loss.6
Second Nature's Mounjaro and Wegovy programmes
Second Nature provides Mounjaro or Wegovy as part of our Mounjaro and Wegovy weight-loss programmes.
Why choose Second Nature over other medication providers, assuming you're eligible?
Because peace of mind matters.
We've had the privilege of working with the NHS for over eight years, helping people across the UK take meaningful steps toward a healthier, happier life.
Our programmes are designed to meet people where they are, whether that means support with weight loss through compassionate one-to-one health coaching, or access to the latest weight-loss medications (like Mounjaro and Wegovy) delivered alongside expert care from a multidisciplinary team of doctors, psychologists, dietitians, and personal trainers.
At the heart of everything we do is a simple belief: real, lasting change comes from building better habits, not relying on quick fixes. We're here to support that change every step of the way.
With over a decade of experience, thousands of lives changed, and a long-standing record of delivering programmes used by the NHS, we believe we're the UK's most trusted weight-loss programme.
We hope to offer you something invaluable: peace of mind, and the support you need to take that first step.
References
- Garvey, W.T. et al. (2025). Coadministered cagrilintide and semaglutide in adults with overweight or obesity. New England Journal of Medicine, 393(7), 635-647.
- Novo Nordisk. (2025). Novo Nordisk files for FDA approval of CagriSema, the first once-weekly combination of GLP-1 and amylin analogues for weight management. PR Newswire press release, 18 December 2025.
- NICE. (2023). Semaglutide for managing overweight and obesity. Technology Appraisal TA875.
- NICE. (2024). Tirzepatide for managing overweight and obesity. Technology Appraisal TA1026.
- Novo Nordisk. (2026). 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. GlobeNewswire press release, 23 February 2026.
- Richards, R. et al. (2025). A Remotely Delivered GLP-1RA-Supported Specialist Weight Management Program in Adults Living With Obesity: Retrospective Service Evaluation. JMIR Formative Research, 9(1), e72577.
