Emcitate (tiratricol)

The FDA approved tiratricol on 28 September 2026 on the basis of two studies. In Study 1 (NCT05579327, ReTRIACt), 15 participants on a stable dose were randomized to placebo (8) or continued tiratricol (7) for 30 days; the ratio of the serum total T3 rate of change (placebo/tiratricol) was 1.5 (95% CI 1.0 to 2.2; p=0.034), and the rescue criterion was met by 4 of 8 placebo participants (50.0%) and 1 of 7 tiratricol participants (14.3%, one premature discontinuation counted as rescue), a difference in proportions of 0.36 (95% CI -0.16 to 0.77). In Study 2 (NCT02060474, Triac Trial I), 46 participants were enrolled; among 45 analyzed, mean serum total T3 decreased by 205.2 ng/dL (95% CI 174.6 to 235.7) from a baseline of 323.4 ng/dL at month 12, with mean changes of -8.9 beats per minute in heart rate (34 participants) and -4.1 mmHg in systolic blood pressure (35 participants). Triac Trial II enrolled 22 participants younger than 30 months and did not meet its co-primary neurodevelopmental endpoints, although serum T3 concentrations decreased. The most common adverse reactions in the prescribing information are diarrhea, vomiting, rash, and hyperhidrosis, each reported in 0% to 13% of participants per study, and the label carries a boxed warning against use for the treatment of obesity or for weight loss.