Overview
- In the randomized TAMENDOX phase 1/2 study of 235 early-stage hormone receptor–positive patients across 38 German clinics, supplementation was guided by genotype or measured drug levels over six weeks.
- Patients receiving the add-on achieved blood concentrations comparable to those of normal metabolizers on standard therapy.
- Side effects were mild and occurred at similar rates to monotherapy, indicating good short-term tolerability.
- Premenopausal patients could benefit in particular because alternatives such as aromatase inhibitors are limited for them.
- A U.S. mid-stage trial in premenopausal women is ongoing, and study sponsor Atossa Therapeutics says it plans an FDA filing in 2026 as IKP advances European approval planning.