This section highlights FDA-related milestones and regulatory updates for drugs developed by Journey Medical (DERM).
Over the past two years, Journey Medical has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
DFD-29 and Emrosi™. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
DFD-29 (Minocycline Modified Release Capsules 40 mg) FDA Regulatory Timeline and Events
DFD-29 (Minocycline Modified Release Capsules 40 mg) is a drug developed by Journey Medical for the following indication: Papulopustular rosacea.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- DFD-29 (Minocycline Modified Release Capsules 40 mg)
- Announced Date:
- December 10, 2025
- Indication:
- Papulopustular rosacea
Announcement
Journey Medical Corporation announced that results from the Phase 1 clinical trial (DFD-29-CD-006) assessing the impact of low-dose oral minocycline ("DFD-29" or commercially known as "Emrosi™) on skin, gastrointestinal ("GI") and vaginal microflora in healthy adults were published in the Journal of Drugs in Dermatology, a leading peer-reviewed publication in clinical dermatology.
AI Summary
Journey Medical reported that results from the Phase 1 trial DFD-29-CD-006, testing low-dose oral minocycline (DFD-29, commercially known as Emrosi™) on skin, gastrointestinal (GI) and vaginal microflora in healthy adults were published in the Journal of Drugs in Dermatology, a leading peer-reviewed clinical dermatology journal. The multicenter, randomized, double-blind, placebo-controlled study enrolled 60 healthy adults (30 men, 30 women) in a 2:1 randomization to DFD-29 or placebo, given once daily for 16 weeks. Microbiological samples were taken from the forehead, stool and vagina at multiple timepoints (ClinicalTrials.gov identifier NCT05597462).
The study met all three primary microbiological endpoints: no significant change in the normal microbiome of the skin, GI tract, or vagina; no detectable development of antibiotic resistance to minocycline; and no meaningful emergence of opportunistic organisms versus placebo. DFD-29 was well tolerated with no significant safety issues, supporting its safe use for up to 16 weeks without detectable impact on these microbiotas.
Read Announcement- Drug:
- DFD-29 (Minocycline Modified Release Capsules 40 mg)
- Announced Date:
- October 24, 2025
- Indication:
- Papulopustular rosacea
Announcement
Journey Medical Corporation today presented efficacy data from a pooled analysis of the two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea® in Rosacea-1 ("MVOR-1") and Minocycline Versus Oracea in Rosacea-2 ("MVOR-2"), evaluating DFD-29 (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) (or "Emrosi™") for the treatment of inflammatory lesions of rosacea in adults, at the 2025 Fall Clinical Dermatology Conference taking place October 23-26, 2025, in Las Vegas, NV.
AI Summary
Journey Medical presented efficacy data from two Phase 3 trials, MVOR-1 and MVOR-2, evaluating DFD-29 (Emrosi™) in adults with inflammatory rosacea at the 2025 Fall Clinical Dermatology Conference in Las Vegas. Emrosi™ is a 40 mg modified-release capsule combining 10 mg immediate release and 30 mg extended release.
The pooled analysis showed 62.7% of Emrosi-treated patients achieved Investigator’s Global Assessment (IGA) success at week 16, compared with 39.0% for Oracea® and 28.2% for placebo (p < 0.001). Emrosi™ also reduced inflammatory lesions by a mean of 19.2, versus 14.8 lesions for Oracea® and 11.3 for placebo (p < 0.001).
A total of 653 adults were randomized to once-daily Emrosi™, Oracea® or placebo for 16 weeks. Emrosi™ was well tolerated, with no serious drug-related safety issues reported. FDA-approved Emrosi™ is available by prescription in the US for adults with inflammatory rosacea lesions.
Read Announcement- Drug:
- DFD-29 (Minocycline Modified Release Capsules 40 mg)
- Announced Date:
- March 5, 2025
- Indication:
- Papulopustular rosacea
Announcement
Journey Medical Corporation announced that full results from two Phase 3 multicenter, randomized, double-blind, parallel-group, active-comparator and placebo-controlled clinical trials, Minocycline Versus Oracea® in Rosacea-1 ("MVOR-1") and Minocycline Versus Oracea in Rosacea-2 ("MVOR-2"), evaluating Minocycline Hydrochloride Extended Release Capsules, 40 mg ("DFD-29" or "Emrosi") for the treatment of moderate-to-severe papulopustular rosacea in adults were published in the Journal of the American Medical Association - Dermatology ("JAMA Dermatology").
AI Summary
Journey Medical Corporation announced that full results from two Phase 3 clinical trials—MVOR-1 and MVOR-2—evaluating 40 mg Minocycline Hydrochloride Extended Release Capsules (DFD-29 or Emrosi) were published in JAMA Dermatology. These trials involved adults with moderate-to-severe papulopustular rosacea and compared DFD-29 to both Oracea and a placebo over a 16‑week period. The studies showed that DFD-29 not only met the co-primary endpoints but also reached all secondary endpoints, including significant reductions in total lesion count and redness. Additionally, a higher percentage of subjects achieved treatment success with DFD-29 compared to the other groups. The data highlight the efficacy, safety, and tolerability of DFD-29, supporting its role as a potential new treatment option for rosacea patients. Journey Medical plans to launch Emrosi in early spring 2025.
Read Announcement
Emrosi™ FDA Regulatory Events
Emrosi™ is a drug developed by Journey Medical for the following indication: For the treatment of moderate-to-severe papulopustular rosacea.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Emrosi™
- Announced Date:
- June 20, 2025
- Indication:
- For the treatment of moderate-to-severe papulopustular rosacea
Announcement
Journey Medical Corporation announced that a data analysis from two Phase 3 multicenter clinical trials, evaluating Emrosi™ for the treatment of moderate-to-severe papulopustular rosacea in adults will be presented at the Society of Dermatology Physician Associates (SDPA) 2025 Summer Dermatology Conference taking place June 25-29 in Washington, DC.
AI Summary
Journey Medical Corporation announced that a data analysis from two Phase 3 multicenter clinical trials evaluating Emrosi™ for treating moderate-to-severe papulopustular rosacea in adults will be presented at the Society of Dermatology Physician Associates (SDPA) 2025 Summer Dermatology Conference in Washington, DC, from June 25-29, 2025. The trials compared Emrosi with both doxycycline and a placebo, and key results showed that body weight did not affect the drug’s efficacy. This body weight–independent property means doctors can prescribe Emrosi without needing weight-based dose adjustments, reducing potential dosing errors. The analysis highlights that Emrosi successfully reduced inflammatory lesions and improved clinical outcomes for patients in a wide range of body weights, supporting its role as a promising treatment option for rosacea. This presentation at the SDPA conference will offer further insights into the effectiveness and ease of use of Emrosi in clinical practice.
Read Announcement
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