Is PEG-loxenatide legal in the United Kingdom?

Approved in China in 2019 on two placebo-controlled phase 3 trials in 361 and about 360 patients, where it lowered glycated haemoglobin about 1.0 to 1.3 percentage points. Its weight effect in those registration trials was small; the large weight figures come from later single-centre trials at doses well above the licensed ones.

Polyethylene glycol loxenatide, usually written PEX168 in the trial literature, is a PEGylated analogue of exendin-4 from Hansoh Pharmaceutical. It was approved in China in 2019, which makes it one of the earliest domestically developed weekly GLP-1 agonists to reach a market anywhere.

Mechanism: An analogue of exendin-4 modified with polyethylene glycol at a defined site. PEGylation increases molecular size and slows renal clearance, converting a peptide that would need twice-daily injection into a once-weekly one.

Regulatory history: Not approved in the United States. Approved in China in 2019 for type 2 diabetes and widely used there. No Western regulatory filing located.

Licenses medicines for the UK market. A compound without a marketing authorisation is an unlicensed medicine, which can only lawfully be supplied for human use through a prescriber under the specials scheme, not sold as a research product.

The classification above is the The Longevity Archive reading of Medicines and Healthcare products Regulatory Agency listings for PEG-loxenatide at the reviewed date, not a legal opinion. Rules change, and importing, prescribing and possessing a compound can each be treated differently. Check the regulator directly before acting on anything here.