Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as DFD-29 (Minocycline) Fed, DFD-29 Fed, Minocycline hydrochloride capsules
DFD-29 · 2 trials · 1 indication
Proportion of subjects with IGA (modified scale without erythema) 'treatment success' - Grade 0 or 1 at Week 16 with at least 2 grade reduction from Baseline to Week 16, in the DFD-29 group compared to Placebo. The modified IGA scale is a 5-point scale from Grade 0 to Grade 4, wherein Grade 0 is Clear, Grade 1 is Near Clear, Grade 2 is Mild, Grade 3 is Moderate and Grade 4 is Severe Rosacea. A lowering of the score with treatment indicates an improvement in the disease condition and a beneficial outcome.
Total inflammatory lesion count (sum of papules, pustules, and nodules) change from Baseline to Week 16, in the DFD-29 group compared to Placebo.
| Arm | Type | Description |
|---|---|---|
| DFD-29 | EXPERIMENTAL | DFD-29 (40 mg) extended release capsules |
| Doxycycline 40 mg | ACTIVE_COMPARATOR | Doxycycline 40 mg modified release capsules |
| Placebo | PLACEBO_COMPARATOR | Placebo capsules matching DFD-29 |
| Name | Type | Description |
|---|---|---|
| DFD-29 | DRUG | DFD-29 (40 mg) extended release capsules |
| Doxycycline | DRUG | Doxycycline 40 mg capsules |
| Placebo | DRUG | Placebo capsules |
Key Inclusion Criteria: * Male and female subjects aged 18 years and above. * Subjects must be in good general health as determined by the investigator and supported by the medical history. * Subjects must have a clinical diagnosis of papulopustular rosacea with IGA grade 3 (moderate) or IGA grade ...
DFD-29 is an investigational oral small molecule being developed for the treatment of papulopustular rosacea, a form of rosacea marked by inflammatory bumps and pimples. It is a Phase 3 candidate and is not yet approved for commercial use.
DFD-29 is being developed by Journey Medical Corporation, which trades on the Nasdaq under the ticker DERM. The company is the sponsor of the clinical program evaluating the drug in papulopustular rosacea.
DFD-29 is in Phase 3 development. Two Phase 3 trials have been completed, and no trials are currently listed as active. The drug remains investigational and has not been approved by the FDA.
DFD-29 has been studied in two completed Phase 3 trials: NCT05343455, also called MVOR-2, which enrolled 330 participants in the United States and Germany, and NCT05296629, which enrolled 323 participants in the United States. Both were randomized, double-blind, placebo-controlled studies in papulopustular rosacea.
DFD-29 is also referred to as DFD-29 (Minocycline) Fed and DFD-29 Fed, indicating it is an oral minocycline-based formulation. Searches using those alternative names refer to the same Phase 3 candidate developed by Journey Medical Corporation for papulopustular rosacea.
The two completed Phase 3 trials of DFD-29 enrolled a combined 653 participants. NCT05343455 enrolled 330 patients, and NCT05296629 enrolled 323 patients. Both studies required participants to be at least 18 years old and enrolled all sexes.