Drugs / DFD-29
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | rosacea | 2024-01-05 | “The Company submitted its NDA to the FDA seeking approval for DFD-29 for the treatment of inflammatory lesions and erythema of rosacea in adults” journeymedicalcorp.com ↗ “Journey Medical submitted its NDA to the FDA seeking approval for DFD-29 in January 2024.” journeymedicalcorp.com ↗ “has submitted a New Drug Application (“NDA”) to the FDA seeking approval for DFD-29” journeymedicalcorp.com ↗ |
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05343455 | Mar 2022 → Jun 2023 | rosacea | Journey Medical Corporation | Completed | Met primary |
News releases announcing trial results or a regulatory action · 13
| Date | Issuer | Release |
|---|---|---|
| 2025-12-10 | Journey Medical Corporation | Results Journey Medical Corporation Announces Publication of Clinical Trial Results Assessing the Impact of Emrosi™ (DFD-29) on Microbial Flora of Healthy Adults in the Journal of Drugs in Dermatology journeymedicalcorp.com ↗
The results indicate that DFD-29 administration for 16 weeks had no detectable effects on skin, GI tract or vaginal microflora and it was well tolerated in healthy adults, supporting its use as a therapeutic option for patients with moderate-to-severe rosacea. |
| 2025-10-24 | Journey Medical Corporation | Results Journey Medical Corporation Reports Combined Emrosi™ (DFD-29) Phase 3 Clinical Trial Efficacy Data Analysis Presented at the 2025 Fall Clinical Dermatology Conference journeymedicalcorp.com ↗
DFD-29 demonstrated superior efficacy in IGA success rates and inflammatory lesion counts versus both placebo and doxycycline (P<0.001 for all comparisons) |
| 2025-06-20 | Journey Medical Corporation | Results Journey Medical Corporation Announces Emrosi™ Data Analysis to be Presented at the Society of Dermatology Physician Associates (SDPA) 2025 Annual Summer Dermatology Conference journeymedicalcorp.com ↗
The analysis determined that differences in body weight did not affect the efficacy of Emrosi in the two Phase 3 trials, which supported its November 2024 FDA approval. |
| 2025-03-05 | Journey Medical Corporation | Results 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 journeymedicalcorp.com ↗
DFD-29 (40 mg Minocycline Hydrochloride Modified-Release Capsules, 10 mg immediate release and 30 mg extended release) achieved the co-primary and all secondary endpoints with no significant safety issues when administered once daily for 16 weeks |
| 2024-11-04 | Journey Medical Corporation | Regulatory Journey Medical Corporation Announces U.S. FDA Approval of Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg) for the Treatment of Rosacea journeymedicalcorp.com ↗
today announced that the FDA has approved Emrosi™ (Minocycline Hydrochloride Extended Release Capsules, 40 mg), formerly referred to as DFD-29, for the treatment of inflammatory lesions of rosacea in adults. |
| 2024-10-25 | Journey Medical Corporation | Results Journey Medical Corporation Announces DFD-29 Data Presented at 44th Fall Clinical Dermatology Conference journeymedicalcorp.com ↗
With its modified-release formulation, DFD-29 (40 mg) provides higher dermal concentration than doxycycline from Day 1 onward at a similar dose, expected to translate into a clinically meaningful impact for treating patients with rosacea |
| 2024-03-18 | Journey Medical Corporation | Regulatory Journey Medical Corporation Announces U.S. FDA Acceptance of New Drug Application for DFD-29 for the Treatment of Rosacea journeymedicalcorp.com ↗ |
| 2024-03-11 | Journey Medical Corporation | Results Journey Medical Corporation Announces Presentation of Data from Phase 1 Clinical Trial Assessing the Impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on Microbial Flora of Healthy Adults at 2024 AAD Annual Meeting journeymedicalcorp.com ↗
Results indicate that DFD-29 can be safely used for up to 16 weeks with no detectable effects on microbiota in the skin, GI tract, or vagina |
| 2024-01-05 | Journey Medical Corporation | Regulatory Journey Medical Corporation Submits New Drug Application to FDA for DFD-29 to Treat Rosacea journeymedicalcorp.com ↗
today announced that the Company has submitted a New Drug Application (“NDA”) to the FDA seeking approval for DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) for the treatment of inflammatory lesions and erythema of rosacea in adults. |
| 2023-10-20 | Journey Medical Corporation | Results Journey Medical Corporation Announces Data from Bioavailability Study of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) vs. Solodyn® (Minocycline Hydrochloride Extended-Release Tablets, 105 mg) journeymedicalcorp.com ↗
The results of this bioavailability study successfully demonstrate that the systemic exposure of minocycline with DFD-29 (40 mg) was significantly lower than that of Solodyn (105 mg),” said Srinivas Sidgiddi, M.D., Vice President, Research & Development of Journey Medical. |
| 2023-07-11 | Journey Medical Corporation | Results 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 journeymedicalcorp.com ↗
The Phase 3 clinical trials achieved the co-primary and all secondary endpoints and subjects completed the 16-week treatment with no significant safety issues |
| 2023-06-13 | Journey Medical Corporation | Results Journey Medical Corporation Announces Positive Topline Data from Phase 1 Clinical Trial Assessing the Impact of DFD-29 (Minocycline Hydrochloride Modified Release Capsules, 40 mg) on Microbial Flora of Healthy Adult Subjects journeymedicalcorp.com ↗
The study achieved all primary objectives and no significant safety issues were noted during the study. |
| 2022-12-20 | Journey Medical Corporation | Results Journey Medical Corporation Announces Positive Comparative Pharmacokinetic (PK) Data for DFD-29 journeymedicalcorp.com ↗
The study successfully demonstrated that the systemic exposure of DFD-29 (40 mg) was significantly lower than that of SOLODYN (105 mg). |
All press releases naming this drug 19 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | DFD-29 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05343455 ↗ |
| Route | Oral | “Participants were randomized 3:3:2 to oral DFD-29 (minocycline hydrochloride capsules), 40 mg; doxycycline, 40 mg; or placebo once daily for 16 weeks.” PMID 40042869 ↗ May 2025 |