Emrosi (minocycline modified release) / Dr. Reddy’s, Fortress - LARVOL DELTA

Impact of Low-Dose Oral Minocycline (DFD-29) on Skin, Gastrointestinal, and Vaginal Microflora in Healthy Adults. (PubMed, J Drugs Dermatol) - "Administration of DFD-29 for 16 weeks had no detectable effects on skin, GI tract, or vaginal microflora and was well tolerated in healthy adults, reinforcing its potential as a therapeutic option in moderate-to-severe rosacea. &nbsp."

Clinical • Journal • Dermatology • Gastrointestinal Disorder • Rosacea

Efficacy and safety of oral DFD-29, a low-dose formulation of minocycline versus doxycycline in rosacea: A systematic review and meta-analysis of randomized placebo-controlled trials (EADV 2025) - "In cases where rosacea is not adequately controlled with sub- antimicrobial dosing with doxycycline, evaluating the efficacy and safety of an alternative tetracycline class of sub- antimicrobial treatment, minocycline, will expand therapeutic options to treat rosacea. In conclusion, our meta-analysis showed that DFD-29, a sub-antimicrobial extended-release formulation of minocycline, at 40 mg daily, is a superior and well-tolerated alternative to sub-antimicrobial dosing of doxycycline for moderate-to-severe papulopustular rosacea."

Retrospective data • Review • Atrial Fibrillation • Cardiovascular • Dermatology • Rosacea

Doxycycline 40 mg vs. DFD-29 40 mg for Rosacea Treatment: A Meta-Analysis of Three Randomized Controlled Trials (EADV 2025) - "Recent randomized controlled trials (RCTs) have demonstrated the efficacy of DFD-29, a minocycline extended-release oral capsule, as a novel treatment option. DFD-29 (40 mg) may offer superior efficacy and safety compared to doxycycline (40 mg) for the treatment of rosacea. However, our findings should be interpreted with caution due to potential heterogeneity, which may stem from variations in rosacea subtypes and severity, as well as the limited sample size. Future randomized controlled trials (RCTs) are warranted to further clarify the potential superiority of DFD-29, particularly in specific rosacea subtypes."

Retrospective data • Dermatology • Inflammation • Rosacea

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 (GlobeNewswire) - "Journey Medical Corporation...today announced the launch of and the first prescriptions filled for Emrosi (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) for the treatment of inflammatory lesions of rosacea in adults....The FDA approved Emrosi for the treatment of inflammatory lesions of rosacea in adults in November 2024."

Launch US • Rosacea

Efficacy, Safety, and Tolerability of Oral DFD-29, a Low-Dose Formulation of Minocycline, in Rosacea: Two Phase 3 Randomized Clinical Trials. (PubMed, JAMA Dermatol) - P3 | "A low-dose modified formulation of minocycline hydrochloride, DFD-29, is under evaluation for treating papulopustular rosacea (PPR). In this study, DFD-29 was superior in efficacy to both doxycycline and placebo and demonstrated a favorable risk-benefit profile in the treatment of PPR. ClinicalTrials.gov Identifiers: NCT05296629 and NCT05343455."

Clinical • Journal • P3 data • Dermatology • Infectious Disease • Novel Coronavirus Disease • Rosacea

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 (GlobeNewswire) - P3 | N=323 | MVOR-1 (NCT05296629) | "In the DFD-29 group, 65.0% of subjects demonstrated IGA success, while 46.1% showed IGA success in the Oracea group and 31.2% of subjects showed IGA success in the placebo group. The difference between the DFD-29 and Oracea groups was statistically significant with a p-value of 0.01, and the difference between the DFD-29 and the placebo groups was statistically significant with a p-value of <0.001. The DFD-29 group showed a mean reduction of 21.3 lesions, while the Oracea group showed a mean reduction of 15.8 lesions, and the placebo group showed a mean reduction of 12.1 lesions from baseline to week 16....Additionally, at Week 16, a significantly greater percentage of participants on DFD-29 experienced at least a 2-grade reduction from baseline in CEA score versus placebo (31.7% vs 13.8%; p-value of 0.006)."

P3 data • Rosacea

MVOR-2 Results (GlobeNewswire) - P3 | N=330 | MVOR-2 (NCT05343455) | "In the DFD-29 group, 60.1% of subjects demonstrated IGA success, while 31.4% showed IGA success in the Oracea group and 26.8% of subjects showed IGA success in the placebo group. The difference between the DFD-29 and Oracea groups was statistically significant with a p-value of <0.001, and the difference between the DFD-29 and the placebo groups was statistically significant with a p-value of <0.001. The DFD-29 group showed a mean reduction of 18.0 lesions, while the Oracea group showed a mean reduction of 14.9 lesions, and the placebo group showed a mean reduction of 11.1 lesions from baseline to week 16....Additionally, at Week 16, a significantly greater percentage of participants on DFD-29 experienced at least a 2-grade reduction from baseline in CEA score versus placebo (24.5% vs 12.0%; p-value of 0.02)."

P3 data • Rosacea

Journey Medical Corporation to Exhibit at the 2025 American Academy of Dermatology Annual Meeting in Orlando, Florida (GlobeNewswire) - "Journey Medical Corporation...announced that it will be exhibiting at the 2025 American Academy of Dermatology ('AAD') Annual Meeting, taking place March 7-11, 2025 in Orlando, Florida. Journey Medical plans to highlight the launch of Emrosi and showcase its line of prescription dermatology products."

Clinical data • Dermatology • Rosacea

Journey Medical Corporation to Host Conference Call to Discuss U.S. Commercial Launch Plan for Emrosi (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the Treatment of Rosacea (Fortress Biotech Press Release) - "Journey Medical Corporation...today announced that its management team will host a conference call to provide an update on the commercial launch plan for Emrosi (Minocycline Hydrochloride Extended Release Capsules, 40 mg), formerly referred to as DFD-29."

Launch US • Rosacea

Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea (GlobeNewswire) - "Journey Medical Corporation...announced today that the FDA has accepted the Company’s New Drug Application ('NDA') for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) for the treatment of inflammatory lesions and erythema of rosacea in adults. The FDA has set a Prescription Drug User Fee Act ('PDUFA') goal date of November 4, 2024....'The NDA submission is supported by positive data from Journey Medical’s two DFD-29 Phase 3 clinical trials for the treatment of rosacea.'"

NDA • PDUFA date • Dermatology • Rosacea

Impact of DFD-29, a Low-Dose Oral Minocycline, on Skin, Gastrointestinal Tract, and Vaginal Microflora in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Trial (AAD 2024) - "Background: Minocycline hydrochloride modified release capsules, 40 mg (DFD-29), have shown significant therapeutic benefit versus placebo and doxycycline in treating papulopustular rosacea. Administration of DFD-29 for 16 weeks had no detectable effects on skin, GI tract, or vaginal microflora and was safe and well tolerated in healthy adults."

Clinical • Dermatology • Gastrointestinal Disorder • Rosacea

Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks (clinicaltrials.gov) - P1 | N=60 | Completed | Sponsor: Journey Medical Corporation | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Rosacea

MVOR-1: A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea. (clinicaltrials.gov) - P3 | N=323 | Completed | Sponsor: Journey Medical Corporation | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Rosacea

A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2) (clinicaltrials.gov) - P3 | N=330 | Completed | Sponsor: Journey Medical Corporation | Active, not recruiting ➔ Completed

Trial completion • Dermatology • Rosacea

Journey Medical Corporation 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 (GlobeNewswire) - P3 | N=323 | MVOR-1 (NCT05296629) | "In the DFD-29 group, 65.0% of subjects demonstrated IGA success, while 46.1% showed IGA success in the Oracea group and 31.2% of subjects showed IGA success in the placebo group. The difference between the DFD-29 and Oracea groups was statistically significant with a p-value of 0.007, and the difference between the DFD-29 and the placebo groups was statistically significant with a p-value of <0.001. The DFD-29 group showed a mean reduction of 21.3 lesions, while the Oracea group showed a mean reduction of 15.9 lesions, and the placebo group showed a mean reduction of 12.2 lesions from baseline to week 16."

P3 data: top line • Dermatology • Rosacea

Journey Medical Corporation 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 (GlobeNewswire) - P3 | N=330 | MVOR-2 (NCT05343455) | "In the DFD-29 group, 60.1% of subjects demonstrated IGA success, while 31.4% showed IGA success in the Oracea group and 26.8% of subjects showed IGA success in the placebo group. The difference between the DFD-29 and Oracea groups was statistically significant with a p-value of <0.001, and the difference between the DFD-29 and the placebo groups was statistically significant with a p-value of <0.001. The DFD-29 group showed a mean reduction of 18.4 lesions, while the Oracea group showed a mean reduction of 14.9 lesions, and the placebo group showed a mean reduction of 11.1 lesions from baseline to week 16. The difference between the DFD-29 and Oracea groups and the difference between the DFD-29 and placebo groups were statistically significant, each with a p-value of <0.001."

P3 data: top line • Dermatology • Rosacea

A Comparative Bioavailability Study of DFD-29 Capsules 40 mg Versus SOLODYN® Tablets 105 mg, Under Fasting & Fed Conditions in Healthy Adult Human Subjects (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Journey Medical Corporation | Active, not recruiting ➔ Completed | Trial completion date: Sep 2022 ➔ May 2022 | Trial primary completion date: Sep 2022 ➔ May 2022

Trial completion • Trial completion date • Trial primary completion date

A Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea (MVOR-2) (clinicaltrials.gov) - P3 | N=330 | Active, not recruiting | Sponsor: Journey Medical Corporation | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2022 ➔ Apr 2023 | Trial primary completion date: Dec 2022 ➔ Apr 2023

Enrollment closed • Trial completion date • Trial primary completion date • Dermatology • Rosacea

MVOR-1: A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea. (clinicaltrials.gov) - P3 | N=323 | Active, not recruiting | Sponsor: Journey Medical Corporation | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2022 ➔ Apr 2023 | Trial primary completion date: Dec 2022 ➔ Apr 2023

Enrollment closed • Trial completion date • Trial primary completion date • Dermatology • Rosacea

Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks (clinicaltrials.gov) - P1 | N=60 | Active, not recruiting | Sponsor: Journey Medical Corporation | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Rosacea

Impact of DFD-29 on Microbial Flora of Healthy, Adult Human Subjects When Administered Over 16 Weeks (clinicaltrials.gov) - P1 | N=60 | Recruiting | Sponsor: Journey Medical Corporation

New P1 trial • Dermatology • Rosacea

A Comparative Bioavailability Study of DFD-29 Capsules 40 mg Versus SOLODYN® Tablets 105 mg, Under Fasting & Fed Conditions in Healthy Adult Human Subjects (clinicaltrials.gov) - P1 | N=24 | Active, not recruiting | Sponsor: Journey Medical Corporation

New P1 trial

A Randomized, Double-Blind Study to Assess the Safety, Efficacy and Tolerability of Oral DFD-29 Capsules for the Treatment of Rosacea. (MVOR-2) (clinicaltrials.gov) - P3 | N=320 | Recruiting | Sponsor: Journey Medical Corporation

New P3 trial • Dermatology • Rosacea