Florquinitau F-18

Tauklarify (florquinitau F 18 injection), sponsored by Cerveau (Lantheus), was approved by the FDA on 13 August 2026 under NDA 220496 (original approval, FDA classification Type 1 new molecular entity, standard review). It is indicated for PET of the brain in adults with cognitive impairment who are being evaluated for Alzheimer's disease, to identify patients with tau neurofibrillary tangle (NFT) pathology. The label limits use to Alzheimer's disease: safety and effectiveness are not established for non-Alzheimer tauopathies, and it warns that a negative scan does not exclude, and a positive scan does not confirm, tau NFT pathology.

The recommended activity is 185 MBq (5 mCi) as an intravenous bolus in up to 10 mL, with imaging started about 90 minutes after injection; the whole-body effective dose from 185 MBq in an adult is estimated at 5.4 mSv, before any CT. CYP1A2 inducers, including tobacco smoking, should be avoided for at least 7 days beforehand. Effectiveness rests on two blinded read studies (279 and 338 subjects) in which five independent readers per study classified scans as tau-positive or negative against a reference standard built from cognitive status and amyloid PET; in Study 1, positive percent agreement ranged from 80% to 88% across readers and negative percent agreement from 98% to 99%. Across 1,734 subjects in the clinical trials, the most common adverse reaction was headache (0.7%).