LISCure BioSciences announced that its proprietary hair health probiotic Mobiome® has received New Dietary Ingredient (NDI) Notification from the U.S. Food and Drug Administration (FDA), marking the first such recognition worldwide for a probiotic targeting hair health. The South Korean biotechnology company achieved this regulatory milestone on September 9, 2025, following extensive scientific validation in both preclinical and clinical studies.
Clinical Evidence and Mechanisms of Action
Mobiome® demonstrated multiple mechanisms of action in clinical studies, including enhanced antioxidant activity, reduced inflammation, stimulation of hair follicle cell proliferation, and regulation of the hair follicle cell cycle. In clinical trials, the probiotic achieved statistically significant improvements (p<0.05, 95% CI) in hair gloss and elasticity, alongside higher consumer satisfaction scores in parameters such as hair texture, split ends, dryness, and damage.
The ingredient had previously received approval from the Korean Ministry of Food and Drug Safety (MFDS) as a new functional ingredient, providing additional regulatory validation for its safety and efficacy profile.
Regulatory Significance and Market Impact
The FDA's NDI Notification process represents one of the most rigorous regulatory pathways globally, requiring comprehensive evidence of safety and scientific efficacy. The evaluation process covers the ingredient's characteristics, toxicological safety, gastrointestinal survivability, and functional validation data. Achieving NDI status provides a critical credential for companies seeking to expand in the global dietary supplement market.
"With FDA acceptance of the NDI notification for Mobiome®, we have strengthened our competitive position not only in Korea but across the global nutraceutical market," said Hwa-sup Chin, CEO of LISCure BioSciences. "We are now accelerating expansion plans with partners in North America, Europe, and key Asian markets."
Expanding Pipeline and Pharmaceutical Development
Beyond hair health applications, LISCure is developing a pipeline of individually recognized functional ingredients targeting body fat reduction, joint health, kidney health, and cognitive improvement, with additional FDA NDI submissions currently underway.
In its core pharmaceutical business, LISCure is advancing multiple programs including its Brain Shuttle Platform 'ExoPN-101' for global partnership and potential licensing opportunities. The company's LB-P8, a therapeutic candidate for primary sclerosing cholangitis (PSC), has received FDA Orphan Drug Designation (ODD) and Fast Track Designation and is currently in U.S. Phase 2 trials.
Additionally, LB-P2D, an immuno-oncology therapeutic candidate supported by robust preclinical efficacy data, is advancing toward clinical trials in the United States. This dual approach combining pharmaceutical innovation with functional health products positions LISCure to drive sustainable growth and deliver impactful health solutions worldwide.
