Menopause company Bonafide Health has announced the launch of Thermella, a new hormone-free, prescription-free neurokinin 3 receptor (NK3R) antagonist designed to relieve hot flashes and night sweats. The botanical supplement targets the thermoregulatory zone and is clinically tested to reduce vasomotor symptoms (VMS).
Thermella operates by rebalancing the body’s thermoregulatory center through blocking the neurokinin B (NKB) pathway, which is the same mechanism of action as current prescription options like VeozahTM. Bonafide’s launch of Thermella is supported by the presentation of two research studies at The Menopause Society’s annual meeting earlier this month.
The first study was a three-month, double-blind, placebo-controlled trial involving 74 peri- and postmenopausal women aged 40-65, with 68 completing the trial and 65 included in the analysis. Participants consumed two capsules daily of the blend for 12 weeks. The results indicated significant reductions in the frequency of hot flashes and night sweats, confirming the efficacy of the first hormone-free NK3R antagonist botanical blend in reducing VMS.
Initial findings for Thermella include:
- Over 90% of participants experienced improvement in moderate to severe hot flashes by 12 weeks, with significant improvement noted as early as 2 weeks.
- Women reported average reductions of 60% for total VMS and 71% for moderate to severe hot flashes by 12 weeks.
- Significant improvements in quality of life and sleep were observed, alongside the use of the supplement, as measured by daily interferences of hot flashes.
- No serious adverse events were reported during the study, nor were there significant changes in full metabolic panel health markers, including liver enzymes.
In the second study presented at the annual meeting, the proprietary blend used in Thermella demonstrated no effect on MCF-7 cells, a common estrogen-sensitive breast cancer cell line. This finding suggests a favorable safety profile for women seeking a hormone-free option for treating VMS.
“These findings are incredibly exciting and welcome news for women suffering with VMS symptoms,” says Dr. Alyssa Dweck, MS MD FACOG, Bonafide’s Chief Medical Officer and co-author of one of the studies. “The hormone-free nature of this botanical blend offers a novel option, made with naturally derived ingredients, for women who are interested in a non-hormonal and non-drug solution.”
Thermella is formulated from a concentrated blend of optimized curcumin extract, decaffeinated, purified green tea extract, and spirulina extract, all of which are known for their NK3R antagonist effects and ability to reduce NKB levels.
“Many women prefer a non-medication approach to their menopausal symptoms, particularly hot flashes. Thermella now offers them this option, with demonstrated effectiveness and safety,” adds Dr. Mary Jane Minkin, MD FACOG, clinical professor at Yale University School of Medicine and co-author of one of the studies.
Bonafide plans to invest over $3 million this year in scientific research and development to address the lack of innovation in menopause treatments derived from natural ingredients. Menopause is an often-overlooked segment of the healthcare industry, leaving a significant unmet need for hormone-free, drug-free products that are both clinically tested and effective. Since its inception, Bonafide has conducted or sponsored over 35 clinical trials of products and specific ingredients.
