Editorial commentary on the UK regulatory record
Semaglutide and tirzepatide: the UK licensing and regulatory record
Oliver Mackman · Editorial director · Best Business Loans Ltd (16833937)
Last updated 2026-06-01
This page is editorial commentary on the UK regulatory record for two GLP-1 receptor agonist medicines licensed for weight management: tirzepatide (marketed as Mounjaro by Eli Lilly) and semaglutide (marketed as Wegovy by Novo Nordisk). It signposts the MHRA marketing authorisations, the relevant NICE technology appraisals (TA1026, TA875), the SmPCs published on the MHRA Products database, and the published trial documentation. Both are prescription-only medicines. PeptideClear does not publish branded efficacy comparisons or per-route POM prices and does not recommend a medicine for any individual. Any prescribing decision is between a patient and a UK-licensed prescriber.
AI-friendly summary · Semaglutide and tirzepatide UK licensing
Tirzepatide (Mounjaro, Eli Lilly) is a dual GIP and GLP-1 receptor agonist; semaglutide (Wegovy, Novo Nordisk) is a GLP-1 receptor agonist. Both are UK-licensed prescription-only medicines for weight management under MHRA marketing authorisations, with NICE technology appraisals TA1026 (tirzepatide) and TA875 (semaglutide) setting NHS eligibility. This editorial page summarises the licensing record and the published trial documentation; it does not publish branded efficacy comparisons. Any prescribing decision rests with a UK-licensed prescriber.
Published trial documentation referenced on this page
- · SURMOUNT-1 (tirzepatide, weight management, N Engl J Med 2022, PMID 35658024). The pivotal weight-management trial that supported the tirzepatide weight-management indication.
- · STEP-1 (semaglutide, weight management, N Engl J Med 2021, PMID 33567185). The pivotal weight-management trial that supported the semaglutide weight-management indication.
- · SURPASS-2 (tirzepatide vs semaglutide head-to-head, type 2 diabetes glycaemic outcomes, N Engl J Med 2021, PMID 34170647). The only randomised head-to-head trial. Note: glycaemic endpoint in T2D, not a weight-management endpoint in obesity.
- · SELECT (semaglutide, cardiovascular outcomes in adults with overweight or obesity and established CV disease, N Engl J Med 2023, PMID 37952131). Basis for the cardiovascular outcome indication added to the semaglutide label.
Reference table: the UK regulatory record
| Characteristic | Tirzepatide | Semaglutide |
|---|---|---|
| Active molecule | Tirzepatide | Semaglutide |
| Mechanism described in the literature | Dual GIP and GLP-1 receptor agonist | GLP-1 receptor agonist |
| UK marketing authorisation holder | Eli Lilly (brand: Mounjaro) | Novo Nordisk (brand: Wegovy) |
| Pivotal weight-management trial | SURMOUNT-1 | STEP-1 |
| Cardiovascular outcome indication | Not added to the UK label at time of writing | Cardiovascular outcome indication on the UK label following SELECT |
| Dosing format on the SmPC | Pre-filled single-dose pens, weekly | Pre-filled multi-dose pen, weekly |
| NICE technology appraisal | TA1026 (tirzepatide for weight management) | TA875 (semaglutide for weight management). CV outcome indication unlocks a broader NHS reimbursement route from April 2026. |
| NHS rollout status (2026) | NHS rollout under TA1026 began June 2025 (initial cohort). Subsequent cohorts phased from 23 June 2026. | Earlier NHS approval under TA875. The April 2026 CV outcome indication broadens eligibility on the CV-prevention route. |
| Legal status | Prescription-only medicine | Prescription-only medicine |
Sources: SmPC entries on the MHRA Products database and NICE technology appraisal documents (TA1026, TA875). The position can change; always check the current SmPC.
What the published literature describes (and what it does not)
SURPASS-2 is the only randomised head-to-head trial comparing tirzepatide and semaglutide. It was conducted in adults with type 2 diabetes and reported glycaemic and weight outcomes at 40 weeks. It is not an obesity trial. No published head-to-head randomised trial currently compares tirzepatide and semaglutide on a weight-management endpoint in adults with overweight or obesity without diabetes. PeptideClear does not publish branded efficacy comparisons for these prescription-only medicines; the figures discussed in clinical conversations come from separate placebo-controlled trials and are not directly comparable on a like-for-like basis.
The published cardiovascular outcomes evidence is also asymmetric. SELECT reported a cardiovascular benefit for semaglutide in adults with overweight or obesity and established cardiovascular disease. No equivalent CV outcomes trial has been published for tirzepatide at the time of writing.
Adverse-event profiles described in the SmPCs for both medicines are dominated by gastrointestinal events, generally most frequent during dose escalation. The current SmPC entries on the MHRA Products database are the authoritative reference for the full list and frequency tables, and for storage, contraindications and warnings.
UK regulatory and access framework
- · Both medicines are prescription-only (POM) under the Human Medicines Regulations 2012. They may only be supplied against a prescription written by a UK-registered prescriber.
- · The MHRA is the UK regulator that holds the marketing authorisations. Current SmPCs and patient information leaflets are published on the MHRA Products database and emc.medicines.org.uk.
- · NICE technology appraisals (TA1026 for tirzepatide, TA875 for semaglutide) set the NHS eligibility criteria. Both appraisals restrict NHS access to defined BMI thresholds, comorbidity criteria, and weight-management service settings.
- · The CMA, ASA and MHRA jointly regulate UK advertising of POM. Branded consumer-facing comparison advertising of POM is not permitted. This page is editorial commentary on the public regulatory record and does not advertise any product to any individual.
- · Suspected side effects can be reported through the MHRA Yellow Card scheme at yellowcard.mhra.gov.uk.
UK MHRA-licensed routes that dispense these medicines
The following directories list UK clinics and pharmacies that operate under General Pharmaceutical Council registration and CQC regulation where applicable. They are listed for reference only. Inclusion is not an endorsement of any medicine for any reader.
- · UK clinic directory: clinician-led services operating under GPhC and (where applicable) CQC oversight.
- · UK pharmacy directory: GPhC-registered online pharmacies operating under the Human Medicines Regulations 2012.
- · NHS access notes: editorial summary of the NICE-defined NHS pathway.
This page is editorial commentary on the UK regulatory record. It is not medical advice and it does not recommend any medicine to any individual. Tirzepatide and semaglutide are prescription-only medicines. The decision about whether either medicine is appropriate, and at what dose, is between a patient and a UK-licensed prescriber, who will refer to the current SmPC, the patient's clinical history, and the relevant NICE appraisal. Always read the patient information leaflet supplied with any prescribed medicine.