Xvie advances into simultaneous Phase I/II trials, paving the way for a new category in hair restoration.
IRVINE, Calif., March 24, 2026 /PRNewswire/ -- Xtressé™, the advanced hair health company founded by dermatologists and scientists, today announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for Xvie, a regenerative therapy for androgenetic alopecia. The FDA acceptance marks an important milestone, allowing Xtressé™ to initiate a controlled Phase I/II clinical trial evaluating the safety and efficacy of an injectable formulation of Xvie under FDA oversight. A topical formulation of Xvie XO Concentrate is currently available for in-office administration through licensed and qualified medical providers.
"Hair loss is a biologically complex condition affecting over 80 million people1 nationwide, and meaningful treatment requires addressing more than a single pathway," said Dr. Matt Leavitt, DO, Co-Founder of Xtressé™. "We founded Xtressé™ to advance regenerative approaches that target the underlying biology of hair loss and support follicle function. Xvie was designed to create a signaling environment that promotes healthy follicle activity. Early topical results have been encouraging, and we are excited to advance this next phase."
Xvie is an amniotic fluid, multi-signal concentrate designed to support hair follicles, and the first of its kind on the market. Xvie contains a rich bioactive complement of growth factors, peptide molecules, extracellular vesicles, natural hyaluronic acid, lipids, and electrolytes, offering a unique bioactive profile that supports scalp and follicle health. Xvie is 100% natural, not cultured and expanded, and contains no added antibiotics, preservatives, or fragrance.
"Amniotic fluid is one of the most biologically complex substances in the human body, containing over 700 unique growth factors and proteins and it has been clinically underutilized as a therapeutic source,2,3" said Trillitye Paullin, PhD, Chief Scientific Officer and cellular and molecular biologist with more than 15 years in the field. "By isolating and concentrating the extracellular vesicles from decellularized human amniotic fluid, we've created something that, to our knowledge, has never entered the FDA clinical trial pathway for hair restoration before."
There are only two FDA-approved pharmacologic treatments for androgenetic alopecia and both are decades old with no regenerative mechanism. "Preclinical research on extracellular vesicle-based therapies has shown real promise on the follicular pathways that matter,4-9" said Trillitye Paullin, PhD.
Xvie XO Concentrate is currently available exclusively for in-office topical administration through qualified medical providers. The investigational formulation described in the IND application will be evaluated through the FDA clinical trial process and is not approved for use.
References
1American Academy of Dermatology 2024, accessed here
² De Coppi P, Bartsch G Jr, Siddiqui MM, et al. Isolation of amniotic stem cell lines with potential for therapy. Nat Biotechnol. 2007;25(1):100-106.
³ Davis JW. Skin transplantation with a review of 550 cases at the Johns Hopkins Hospital. Johns Hopkins Med J. 1910;15:307-396.
⁴ Cho CK, Shan SJ, Winsor EJ, Diamandis EP. Proteomics analysis of human amniotic fluid. Mol Cell Proteomics. 2007;6(8):1406-1415.
⁵ Kwack MH, Seo CH, Gangadaran P, et al. Exosomes derived from human dermal papilla cells promote hair growth in cultured human hair follicles and augment the hair-inductive capacity of cultured dermal papilla spheres. Exp Dermatol. 2019;28(7):854-857.
⁶ Rajendran RL, Gangadaran P, Bak SS, et al. Extracellular vesicles derived from MSCs activates dermal papilla cell in vitro and promotes hair follicle conversion from telogen to anagen in mice. Sci Rep. 2017;7(1):15560.
⁷ Liang Y, Tang X, Zhang X, et al. Adipose mesenchymal stromal cell-derived exosomes carrying MiR-122-5p antagonize the inhibitory effect of dihydrotestosterone on hair follicles by targeting the TGF-β1/SMAD3 signaling pathway. Int J Mol Sci. 2023;24(6):5703.
⁸ Zhou L, Wang H, Jing J, et al. Regulation of hair follicle development by exosomes derived from dermal papilla cells. Biochem Biophys Res Commun. 2018;500(2):325-332.
⁹ Chen Y, Huang J, Chen R, et al. Sustained release of dermal papilla-derived extracellular vesicles from injectable microgel promotes hair growth. Theranostics. 2020;10(3):1454-1478.
Clinical trial information available at: https://clinicaltrials.gov/study/NCT07482423
About Xtressé™
Xtressé™, the advanced hair health company founded by dermatologists and scientists, recently launched its first comprehensive stress-adaptive hair therapy system, marking a major milestone following the debut of its Hair Growth Gummies last year. Designed to address hair stress at every stage, including hormonal and age-related changes, the Xtressé™ Hair Therapy System uniquely combines at-home daily ritual with professional-grade, in-office care, delivering a truly end-to-end solution for hair thinning and loss. The system includes Xtressé™ Hair Growth Gummies, a superfood nutraceutical that feeds the follicle from within; FR Concentrate Serum, powered by the first oligopeptide blend formulated for follicle repair; and Xvie XO Concentrate. For more information, visit www.xtresse.com.
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