Journey Medical Launches Emrosi, a Dual-Release Minocycline for Rosacea

Journey Medical Corporation announced today it has officially launched Emrosi (40 mg minocycline hydrochloride modified-release capsules) for the treatment of rosacea.¹

The launch follows the US FDA approval of Emrosi, formerly DFD-29, in November 2024.²

Emrosi's approval was supported by promising results of 2 phase 3 clinical trials—MVOR-1 (NCT05296629) and MVOR-2 (NCT05343455)—that demonstrated the drug’s superior efficacy and safety in treating moderate to severe papulopustular rosacea. With over 650 participants across multiple centers in the US and Germany, these trials confirmed that Emrosi was far more effective than both placebo and the commonly prescribed doxycycline (Oracea), offering substantial improvement in the reduction of inflammatory lesions and erythema.³

Full results of the MVOR-1 and MVOR-2 trials were recently published in the Journal of the American Medical Association - Dermatology.⁴ In the MVOR-1 trial, 65% of patients on Emrosi achieved Investigator's Global Assessment success compared to 46.1% of those on doxycycline and just 31.2% of those on a placebo. Additionally, participants on Emrosi experienced an average reduction of 21.3 lesions, compared to 15.8 lesions with doxycycline and 12.1 lesions with placebo. The improvements were also seen in the Clinician’s Erythema Assessment scale, with Emrosi showing a statistically significant reduction in redness and erythema.

The approval of Emrosi by the FDA in November 2024 was based on these impressive results, making Emrosi the first and only oral treatment approved to address both erythema and inflammatory lesions associated with rosacea. The drug’s unique formulation offers both immediate-release and extended-release minocycline, making it the lowest-dose oral minocycline on the market.¹

“We are thrilled that the initial distribution to pharmacies is ongoing and the first Emrosi prescriptions have been filled,” said Claude Maraoui, co-founder, president, and CEO of Journey Medical, in a news release.¹ “The launch of Emrosi marks a major milestone for Journey Medical and underscores our commitment to improving the quality of life for those living with dermatology conditions such as rosacea.”

References

1. Journey Medical Corporation launches Emrosi (40 mg minocycline hydrochloride modified-release capsules, 10 mg immediate release and 30 mg extended release) for the treatment of rosacea. News release. March 24, 2025. Accessed March 24, 2025. https://ir.journeymedicalcorp.com/new-events/press-releases/detail/82/journey-medical-corporation-launches-emrosi-40-mg
2. Journey Medical Corporation announces US FDA approval of Emrosi (minocycline hydrochloride extended release capsules, 40 mg) for the treatment of rosacea. GlobeNewswire. November 4, 2024. Accessed March 24, 2025. https://www.globenewswire.com/news-release/2024/11/04/2973917/0/en/Journey-Medical-Corporation-Announces-U-S-FDA-Approval-of-Emrosi-Minocycline-Hydrochloride-Extended-Release-Capsules-40-mg-for-the-Treatment-of-Rosacea.html
3. Journey Medical Corp announces positive topline results from its two phase 3 clinical trials (MVOR-1 and MVOR-2) evaluating DFD-29 for the treatment of papulopustular rosacea in adults. News release. Journey Medical Corp. July 11, 2023. Accessed March 24, 2025. https://ir.journeymedicalcorp.com/new-events/press-releases/detail/47/journey-medical-corporation-announces-positive-topline
4. Journey Medical Corporation announces publication in the Journal of the American Medical Association - Dermatology of the phase 3 clinical trial results of Emrosi (DFD-29) to treat rosacea. News release. March 5, 2025. Accessed March 24, 2025. https://ir.journeymedicalcorp.com/new-events/press-releases/detail/79/journey-medical-corporation-announces-publication-in-the