Legal status · United Kingdom
Is Lanifibranor legal in the United Kingdom?
No. Lanifibranor 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. Human evidence to date: Moderate.
Lanifibranor in the United Kingdom at a glance
| Classification | Investigational, not licensed |
|---|---|
| MHRA approval status | Not approved by MHRA; investigational |
| Evidence level | Moderate (research strength: Strong) |
| Reviewed | Sep 2026 |
Classification and note come from the Lanifibranor profile, checked against Medicines and Healthcare products Regulatory Agency (MHRA) listings at the reviewed date.
What this means
- 01
Lanifibranor 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 Lanifibranor is
An oral pan-PPAR agonist for MASH whose 1,000-patient Phase 3 (NATiV3) completed its last patient visit in September 2026, with results due by year end.
Lanifibranor activates all three PPAR isoforms (alpha, delta, gamma), addressing liver inflammation, fibrosis and insulin resistance together. The NATiV2 Phase 2b met its endpoints, and Inventiva's NATiV3 Phase 3 in F2/F3 MASH reached its last patient visit on September 2, 2026, with topline data expected in the fourth quarter and a filing in 2027 if positive.
Mechanism: Pan-PPAR agonism improving hepatic lipid metabolism, reducing inflammation and stellate-cell activation.
Regulatory history: Investigational; Phase 3 completed dosing
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 Lanifibranor 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.
Lanifibranor in other countries
Frequently asked questions
Is Lanifibranor legal in the United Kingdom?
No. Lanifibranor 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. Human evidence to date: Moderate.
Can I buy Lanifibranor in the United Kingdom?
No approved product exists to buy. In the United Kingdom Lanifibranor 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.
Is Lanifibranor MHRA approved?
No. In the United Kingdom Lanifibranor is classified as "Investigational, not licensed", which is not a MHRA marketing approval. For comparison, the US FDA status is: Investigational; Phase 3 completed dosing. Evidence level: Moderate.
Related compounds in the United Kingdom
Full research profile
Mechanism, cited studies, FDA status and the full legal summary for Lanifibranor live on its compound profile.
Lanifibranor profileThis page is general information about the regulatory status of Lanifibranor 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.