Legal status · United Kingdom
Is BGM0504 legal in the United Kingdom?
Written by Aaron CuhaReviewed Sep 2026
Direct answer
No. BGM0504 is not approved for any medical use in the United Kingdom; its classification is "Investigational, not licensed". Lawful access is limited to registered clinical trials. "Research use only" labeling on vials sold online does not make human use lawful. On the evidence, 2 human studies are cited on its profile.
BGM0504 in the United Kingdom at a glance
| Classification | Investigational, not licensed |
|---|---|
| Note | No MHRA filing located. |
| MHRA approval status | Not approved by MHRA; investigational |
| Human studies cited | 2 of 3 citations on the profile |
| Reviewed | Sep 2026 |
Classification and note come from the BGM0504 profile, checked against Medicines and Healthcare products Regulatory Agency (MHRA) listings at the reviewed date.
What this means
- 01
BGM0504 is being studied in registered clinical trials but has not received MHRA marketing approval in the United Kingdom.
- 02
Lawful human access is limited to trial participation or a formal early-access scheme where one exists; there is no pharmacy product to prescribe.
- 03
Vials sold online "for research use only" are not trial material, and that label does not make human use lawful.
What BGM0504 is
A tirzepatide-derived dual agonist that beat semaglutide 1 mg on glycated haemoglobin and weight in a 64 person phase 2. Its phase 3 obesity result, widely quoted at 19.3 percent weight loss, exists only as a company press release and has not been published.
BGM0504 comes from BrightGene Bio-Medical in Suzhou and is explicitly derived from tirzepatide. The published design paper says so: molecular dynamics simulations identified a salt bridge between the parent peptide and both receptors, the acylation side chain was repositioned on that basis, and the resulting molecule showed two to three times the agonist activity of tirzepatide in vitro while keeping a long plasma half-life.
Mechanism: A dual agonist at the GLP-1 receptor and the glucose-dependent insulinotropic polypeptide receptor, the same receptor pair tirzepatide acts on, engineered from the tirzepatide scaffold. The published optimisation work used molecular dynamics simulation to identify a salt bridge between the parent peptide and both receptors at residue K20 that was not visible in the cryo-electron microscopy structures, then repositioned the fatty acid acylation side chain to preserve it.
Regulatory history: Not approved anywhere. Multiple phase 3 trials are recruiting in China and Indonesia, and a tablet formulation is in phase 1. The phase 3 obesity result announced in May 2026 has not been published in a peer-reviewed journal as of this review.
How MHRA treats this kind of product
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 BGM0504 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.
BGM0504 in other countries
Frequently asked questions
Is BGM0504 legal in the United Kingdom?
No. BGM0504 is not approved for any medical use in the United Kingdom; its classification is "Investigational, not licensed". Lawful access is limited to registered clinical trials. "Research use only" labeling on vials sold online does not make human use lawful. On the evidence, 2 human studies are cited on its profile. Note: No MHRA filing located.
Can I buy BGM0504 in the United Kingdom?
No approved product exists to buy. In the United Kingdom BGM0504 is classified as "Investigational, not licensed", so there is no licensed pharmacy product. Vendors selling it "for research use only" are not selling it for human use, and that label does not change its legal status. This site does not list or recommend vendors. Note: No MHRA filing located.
Is BGM0504 MHRA approved?
No. In the United Kingdom BGM0504 is classified as "Investigational, not licensed", which is not a MHRA marketing approval. For comparison, the US FDA status is: Not approved anywhere. Multiple phase 3 trials are recruiting in China and Indonesia, and a tablet formulation is in phase 1. The phase 3 obesity result announced in May 2026 has not been published in a peer-reviewed journal as of this review.. On the evidence, 2 human studies are cited on its profile.
Related compounds in the United Kingdom
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for BGM0504 live on its compound profile.
BGM0504 profileThis page is general information about the regulatory status of BGM0504 in the United Kingdom, current as of Sep 2026. It is not legal advice, and classifications change; check Medicines and Healthcare products Regulatory Agency directly or consult a lawyer for a specific situation. Educational use only. This database summarizes published research. It is not medical advice and contains no dosing protocols or recommendations for personal use. The Longevity Archive has no vendor relationships and does not recommend where to buy anything.