Regulatory reference · Liraglutide

Liraglutide (Saxenda): UK regulatory profile

Liraglutide is the active substance in the medicinal product marketed as Saxenda by Novo Nordisk for chronic weight management. The same molecule is authorised at a lower dose for type 2 diabetes under a separate brand. Saxenda is a Prescription Only Medicine in the United Kingdom. This page is editorial regulatory commentary covering the UK MHRA marketing authorisation, the published trial evidence (including paediatric data), and the regulated dispensing pathways through UK providers.

Mechanism (per MHRA-approved SmPC)

Liraglutide is a 31-amino-acid analogue of human GLP-1, modified by a fatty acid side chain that supports albumin binding. Its plasma half-life of approximately 13 hours underpins daily subcutaneous administration as set out in the approved product information.

According to the Novo Nordisk Summary of Product Characteristics, liraglutide is a selective GLP-1 receptor agonist. The recorded pharmacodynamic effects include slowed gastric emptying, glucose-dependent insulin secretion, and modulation of appetite signalling. Cardiovascular outcomes data at lower doses (under a separate brand authorisation) are documented in the LEADER trial.

UK MHRA marketing authorisation

· Marketing authorisation holder: Novo Nordisk A/S.
· UK MHRA marketing authorisation for chronic weight management: 2017.
· No longer under Black Triangle additional-monitoring status (sufficient post-marketing safety data accumulated).
· Licensed UK weight-management indication: BMI 30 or above, or BMI 27 or above with at least one weight-related comorbidity, as set out in the SmPC.
· Authoritative product information: the MHRA-approved Summary of Product Characteristics and Patient Information Leaflet are published on emc.medicines.org.uk.

Dosing, titration, contraindications, warnings, and adverse-event guidance are governed by the SmPC and PIL. PeptideClear does not republish dosing schedules. Please consult the PIL provided with the dispensed medicine.

Published clinical trial data

SCALE Obesity and Prediabetes (2015): 56-week randomised controlled trial in 3,731 adults. Published in the New England Journal of Medicine. The pivotal trial cited in the MHRA weight-management authorisation.
SCALE Diabetes (2015): published trial in adults with overweight or obesity and type 2 diabetes.
SCALE Maintenance (2013): trial supporting continued treatment for weight maintenance following initial response on a low-calorie diet.
SCALE Adolescent (2020): trial in adolescents aged 12 to 17 years. Liraglutide carries the longest published UK paediatric evidence base of the GLP-1 weight-management medicines.
LEADER (2016): cardiovascular outcomes trial at type 2 diabetes doses, supporting class-level cardiovascular safety findings.

Trial summaries are provided for editorial reference. Clinical interpretation for any individual remains the responsibility of a UK-registered prescriber.

UK regulatory and NHS framework

· Prescription Only Medicine under the Human Medicines Regulations 2012. Cannot be advertised to the public.
· NHS access historically governed by NICE Technology Appraisal TA664.
· Practical NHS commissioning in 2026 has largely shifted to weekly-injection alternatives under NICE TA875 (semaglutide) and TA1026 (tirzepatide). Liraglutide remains a UK-licensed option for selected clinical scenarios.
· Paediatric weight management: the published UK regulatory and trial evidence base for liraglutide in adolescents is the most established within the GLP-1 receptor agonist class.

Regulated UK dispensing routes

If a UK-registered prescriber determines that liraglutide is clinically appropriate, the medicine is supplied through UK MHRA-licensed pharmacies and CQC-registered clinics under the standard POM framework. The choice between liraglutide and a weekly-injection alternative is a clinical decision for the prescriber.

· NHS pathway: see NHS GLP-1 access.
· CQC-registered private clinics: directory at UK clinics.
· UK MHRA-licensed pharmacies: directory at UK pharmacies.

PeptideClear lists regulated dispensing routes for reference. We do not endorse any specific provider for any specific person. Your prescriber decides.

UK pricing context (2026)

Editorial commentary on the UK pricing environment for liraglutide is provided at UK GLP-1 cost and supply. Dispensed prices are set by the pharmacy or clinic at the point of supply.

Related editorial reference

PeptideClear is editorial. We do not prescribe, dispense, or sell prescription medication. The MHRA-approved Saxenda Summary of Product Characteristics and Patient Information Leaflet on emc.medicines.org.uk are authoritative. Your UK-registered prescriber decides whether a medicine is appropriate and how it should be used.