Is Zoledronic acid legal in the United Kingdom?

An approved once-yearly bone drug carrying the most interesting unexplained mortality signal in geroscience: 9.6 percent died on zoledronic acid against 13.3 percent on placebo in a trial after hip fracture, a secondary finding never satisfactorily explained. A meta-analysis of 38 osteoporosis drug trials then found no mortality benefit.

This is the most useful page in this batch and the easiest one to overstate, so the numbers come first and the interpretation comes second. 5 years to a yearly 5 mg intravenous infusion of zoledronic acid or placebo, starting within 90 days of surgical repair of a hip fracture.

Mechanism: Zoledronic acid binds avidly to bone mineral and is taken up by osteoclasts, where it inhibits farnesyl pyrophosphate synthase in the mevalonate pathway. That blocks prenylation of small GTPases the osteoclast needs, and the osteoclast stops resorbing bone and dies.

Regulatory history: FDA-approved. Marketed as Reclast for osteoporosis in postmenopausal women and men, glucocorticoid-induced osteoporosis and Paget disease of bone, and as Zometa for hypercalcaemia of malignancy and bone metastases. It is not approved for ageing, longevity or mortality reduction, and no such indication has been sought.

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 Zoledronic acid 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.