MHRA grants semaglutide a landmark liver disease indication
On 3 July 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) approved semaglutide (Wegovy) for the treatment of metabolic-associated steatohepatitis (MASH) — formerly known as non-alcoholic steatohepatitis (NASH) — in adults with moderate-to-advanced liver fibrosis (stage F2 to F3). This marks the first time a GLP-1 receptor agonist has been licensed for a liver disease indication in the United Kingdom.
The approval expands semaglutide's UK licensed indications beyond type 2 diabetes (Ozempic), weight management (Wegovy), and cardiovascular risk reduction. Researchers tracking the therapeutic pipeline of GLP-1 peptides should note this as a significant regulatory milestone: it demonstrates that the MHRA recognises histological improvement in MASH as a clinically meaningful endpoint warranting a licensed indication.
The trial evidence behind the approval
The MHRA's decision was supported by data from the pivotal Phase 3 trial programme investigating semaglutide in MASH. In the key trial, semaglutide demonstrated a statistically significant improvement in liver histology compared to placebo, with a meaningful proportion of treated patients achieving MASH resolution without worsening of fibrosis. The trial enrolled adults with biopsy-confirmed MASH and fibrosis stage F2 or F3.
It is important to note that semaglutide did not demonstrate a statistically significant improvement in fibrosis stage as a standalone endpoint in the original Phase 3a readout. The MHRA's approval is specifically for MASH resolution in the context of existing fibrosis, not for reversal of fibrosis itself. This nuance matters for researchers evaluating the mechanistic limits of GLP-1 agonism in liver disease.
Novo Nordisk is continuing to investigate a dedicated fixed-ratio combination of semaglutide and an amylin analogue (cagrilintide, marketed as CagriSema) for MASH in ongoing Phase 3 trials, which may offer enhanced efficacy given the complementary mechanisms of GLP-1 and amylin receptor agonism on appetite and metabolism.
UK regulatory context
The MHRA's decision aligns with a broader regulatory trend. The US FDA approved resmetirom (Rezdiffra), a thyroid hormone receptor beta agonist, for MASH in March 2024 — the first-ever approved MASH drug. The European Medicines Agency (EMA) is also reviewing GLP-1 agonists and other agents for MASH indications. The MHRA's semaglutide approval positions the UK alongside these regulators in recognising MASH as a treatable condition.
Semaglutide remains a prescription-only medicine (POM) in the UK. The MASH indication does not change its legal status: it is not available over the counter, and the MHRA has repeatedly warned against unauthorised supply channels for GLP-1 agonists. For research peptide suppliers, this new indication reinforces that semaglutide is a licensed medicine with an expanding therapeutic scope — not a research chemical.
What this means for peptide researchers
For those studying GLP-1 receptor agonists, the MASH approval has several implications:
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Expanding indication landscape: GLP-1 agonists are moving beyond glycaemic control and weight loss into liver disease, cardiovascular protection, and potentially neurodegenerative conditions. Researchers should track which indications are receiving regulatory attention.
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Histological endpoints matter: The MHRA accepted MASH resolution (without worsening fibrosis) as an approvable endpoint. This may influence trial design for other investigational peptides targeting liver disease.
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Combination therapy pipeline: The ongoing CagriSema MASH programme suggests that dual GLP-1/amylin agonism may be the next frontier for liver disease treatment, potentially offering greater fibrosis improvement than GLP-1 agonism alone.
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UK legal clarity: The approval further solidifies semaglutide's status as a licensed POM in the UK. Research-grade semaglutide sold for non-research purposes falls outside the legal framework and is subject to MHRA enforcement.
Looking ahead
The MASH indication for semaglutide is likely to be followed by additional GLP-1 agonist approvals for liver disease. Eli Lilly's tirzepatide is being investigated in MASH trials, and several next-generation multi-agonist peptides (including survodutide, retatrutide, and pemvidutide) have shown promising liver fat reduction in early- and mid-stage trials. Researchers should monitor ClinicalTrials.gov and MHRA announcements for further regulatory developments.
For our detailed compound profile on semaglutide, including mechanism, dosing, and UK legal status, see the semaglutide compound profile. For the latest on CagriSema Phase 3 results, see our CagriSema REDEFINE-1 coverage.
This article is AI-researched and editorially reviewed. It is provided for research and educational purposes only and is not medical advice. Research peptides are not licensed for human consumption in the UK.