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They fall instead under the general remit of the Human Medicines Regulations 2012, which is why unlicensed injectable preparations cannot lawfully be supplied for human administration regardless of "research use only" labelling [3][4]
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In one trial (NCT00859898), 638 patients randomized to 1 of 3 treatment arms following a 1-week lead-in period received: FARXIGA 10 mg plus metformin XR (up to 2,000 mg per day), FARXIGA 10 mg plus placebo, or metformin XR (up to 2,000 mg per day) plus placebo