Sold as Tauklarify. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Florquinitau F-18 (sold as Tauklarify), first approved Aug 13, 2026, with 0 new uses approved and 0 published complete response letters.
| Neuronavigation-guided FUS-induced BBB Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and TauAlzheimer Disease, Early Onset · Columbia University | Phase 1 | Not yet recruiting | Sep 19, 2024 |
| Alzheimer's Disease Neuroimaging Initiative 4Mild Cognitive Impairment, Alzheimer Disease · University of Southern California | — | Enrolling by invitation | Nov 15, 2022 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Aug 13, 2026 | TauklarifyNDA 220496 · New molecular entity | Cerveau Lantheus | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
