LISCure BioSciences announced that Mobiome, its proprietary hair health probiotic, has received New Dietary Ingredient (NDI) Notification from the U.S. Food and Drug Administration (FDA) —the first such recognition worldwide for targeting hair health.

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Mobiome had previously been approved by the Korean Ministry of Food and Drug Safety (MFDS) as a new functional ingredient, based on extensive scientific validation in both preclinical and clinical studies. Results demonstrated multiple mechanisms of action, including enhanced antioxidant activity, reduced inflammation, stimulation of hair follicle cell proliferation, and regulation of the hair follicle cell cycle. In clinical trials, Mobiome archieved statistically significant improvements (p<0.05, 95% CI) in hair gloss and elasticity, as along with higher consumer satisfaction scores in parameters such as hair texture, split ends, dryness, and damage.

A New Standard for Probiotic Innovation

The FDA’s NDI Notification process is one of the most rigorous in the world, requiring comprehensive evidence of safety and scientific efficacy. Evaluations cover the ingredient’s characteristics, toxicological safety, gastrointestinal survivability, and functional validation data — Achieving NDI status therefore represents a critical credential for companies seeking to expand in the global dietary supplement market.

Accelerating Global Expansion

“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.”

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Beyond hair health, LISCure is developing a pipeline of individually recognized functional ingredients for body fat reduction, joint health, kidney health, and cognitive improvement, with additional FDA NDI submissions underway.

Parallel Advancement in Pharmaceuticals In its core pharmaceutical business, LISCure is advancing multiple programs:

  • Brain Shuttle Platform ‘ExoPN-101’ – global partnership and potential licensing
  • LB-P8, a therapeutic candidate for PSC, granted FDA Orphan Drug Designation (ODD) and Fast Track Designation, now in U.S. Phase 2

LB-P2D, immuno-oncology therapeutic candidate supported by robust preclinical efficacy data, is advancing toward clinical trials in the U.S. By combining innovation in both pharmaceuticals and functional health products, LISCure is positioned to drive sustainable growth and deliver impactful health solutions worldwide.

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Source- PR Newswire