NEW ORLEANS, LA – The U.S. Food and Drug Administration (FDA) has approved ZILXI™ (minocycline) topical foam, 1.5% for the treatment of inflammatory lesions of rosacea in adults. Developed by Menlo Therapeutics, ZILXI is the first and only topical minocycline formulation approved for rosacea, offering patients a new approach to managing this chronic and often distressing condition. Tyler Hastings, Managing Partner at DelRicht Research, praised the leadership of Dr. Deirdre Hooper and Dr. Sarah Jackson at Audubon Dermatology, who served as principal investigators in the pivotal trial.

Dr. Deirdre Hooper and Dr. Sarah Jackson, dermatologists and principal investigators at Audubon Dermatology in New Orleans, LA, contributed to the pivotal clinical research behind this approval in partnership with DelRicht Research. With numerous clinical trials conducted since 2016, Dr. Hooper and her team have led the charge in advancing dermatological innovation.

Tyler Hastings Highlights a New Class of Rosacea Treatment

Rosacea affects more than 16 million Americans and can cause persistent facial redness, papules, and pustules that resemble acne. ZILXI addresses the inflammatory component of the condition by delivering minocycline, a broad-spectrum tetracycline antibiotic with anti-inflammatory properties, directly to the skin through a novel foam-based topical delivery system.

The approval is based on data from two Phase 3 trials involving over 1,500 patients. In both studies, ZILXI significantly reduced the number of inflammatory lesions and improved Investigator Global Assessment (IGA) scores by week 12, without any treatment-related serious adverse events. The most commonly reported side effect was mild diarrhea, occurring in only 1% of patients.

“This is a meaningful step forward for patients seeking alternatives to oral antibiotics,” said Tyler Hastings, Managing Partner at DelRicht Research. “The work of Dr. Hooper, Dr. Jackson, and the entire Audubon Derm team reflects our commitment to advancing safe, effective, and accessible dermatologic care.”

“This is a meaningful step forward for patients seeking alternatives to oral antibiotics. The work of Dr. Hooper, Dr. Jackson, and the entire Audubon Derm team reflects our commitment to advancing safe, effective, and accessible dermatologic care.”

— Tyler Hastings, Managing Partner at DelRicht Research

Topical Innovation for a Difficult-to-Treat Condition

ZILXI is the second product to emerge from Menlo’s proprietary Molecule Stabilizing Technology (MST™), which allows unstable active ingredients like minocycline to be formulated for topical use. This is especially important for rosacea patients, many of whom are sensitive to systemic treatments or prefer to avoid oral medications.

“Patients deserve new options, especially those that reduce side effects without sacrificing results,” said Dr. Deirdre Hooper, Principal Investigator and board-certified dermatologist. “ZILXI offers a new, clinically validated way to manage rosacea topically, and it’s an exciting addition to our treatment toolkit.”

“Patients deserve new options, especially those that reduce side effects without sacrificing results. ZILXI offers a new, clinically validated way to manage rosacea topically, and it’s an exciting addition to our treatment toolkit.”

— Dr. Deirdre Hooper, Principal Investigator at DelRicht Research

ZILXI is expected to be available for prescribing in the fourth quarter of 2020.

Advancing Research-Driven Dermatology

The FDA approval of ZILXI highlights how dedicated physician-researchers and site networks can accelerate dermatologic breakthroughs. Audubon Dermatology and DelRicht Research continue to play an active role in advancing treatments that address both the physical symptoms and emotional burden of skin conditions like rosacea.

Read the full press release on GlobeNewswire.