A New Regenerative Injectable for Hair Loss Is Heading Into FDA Trials
NewBeauty Facebook Pinterest Instagram Youtube find a doctor Face Adult Acne Antioxidants Anti-Aging Celebrity Chronic Skin Conditions Eye Hydration Hyperpigmentation Makeup View All Eyebrows Eye Color Foundation Fragrance Lip Color Makeovers Male Skin Care Peels Pre-Event Prep Retinoids Sensitive Skin Skin Care Skin Health Smile Sun Care Treatments Fillers Microneedling Post-Procedure Skin Care Neurotoxins Regenerative Aesthetics Skin Lifting Body Body Sculpting Breasts Butts Cellulite Hair Removal Hands + Nails Legs Pregnancy Find a Doctor Hair Bond Repair Celebrity Dry Hair Frizzy Hair Gray Hair Hair Color Hair Growth Hair Repair Scalp Health Styling + Tips Awards NB100 Awards 15th Annual Beauty Awards 2025 NewBeauty Readers’ Choice Awards Shopping Gift Guides Product Reviews NewBeauty Storefront Wellness Fitness GLP-1s Health Menopause About Us TESTTUBE Search for: Search HomeCosmetic TreatmentsRegenerative Aesthetics A New Regenerative Injectable for Hair Loss Is Heading Into FDA Trials What to know. Originally Published on Dermatology Times Published: Mar 24, 2026 Getty Images Today, the US FDA accepted an Investigational New Drug (IND) application for Xvie, an injectable regenerative therapy under development for androgenetic alopecia, according to an announcement from Xtressé. As reported by Dermatology Times, the decision clears the way for a controlled Phase 1/2 clinical trial to evaluate the safety and efficacy of the therapy under FDA oversight, representing a notable step for a category that has seen limited pharmacologic innovation in recent decades. The investigational product, Xvie, is described as an amniotic fluid–derived, multi-signal concentrate designed to support follicular biology. While a topical version—Xvie XO Concentrate—is already being used in-office by qualified providers, the injectable formulation will now enter formal clinical evaluation. Clinicians are well aware that androgenetic alopecia is driven by a complex interplay of hormonal, genetic, and microenvironmental factors. Current FDA-approved pharmacologic options remain limited and largely focus on single pathways, without directly addressing regenerative…