Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
DFD-29 · 1 trial · 1 indication
Proportion of subjects with Investigator Global Assessment (IGA) 'treatment success' - Grade 0 or 1 at the end of study with at least 2 grade reduction from Baseline to Week 16.
The total inflammatory lesion count is carried out by visual inspection by the Investigator at every study visit from Screening up to Week 16 (or at early termination). Inflammatory lesions will be recorded on a diagram of a human face, divided in 4 quadrants.
| Arm | Type | Description |
|---|---|---|
| DFD-29 Extended Release Capsules (40 mg) | EXPERIMENTAL | DFD-29 (minocycline HCl) Extended Release Capsules (40 mg) once per day for 16 weeks. |
| DFD-29 Extended Release Capsules (20 mg) | EXPERIMENTAL | DFD-29 (minocycline HCl) Extended Release Capsules (20 mg) once per day for 16 weeks. |
| Oraycea® (doxycycline) Capsules | EXPERIMENTAL | Oraycea® (doxycycline) Modified Release Hard Capsules (40 mg) once per day for 16 weeks. |
| Placebo Capsules | PLACEBO_COMPARATOR | Placebo Capsules once per day for 16 weeks. |
| Name | Type | Description |
|---|---|---|
| DFD-29 Extended Release Capsules (40 mg) | DRUG | Oral Treatment |
| DFD-29 Extended Release Capsules (20 mg) | DRUG | Oral Treatment |
| Oraycea® (doxycycline) Capsules | DRUG | Oral Treatment |
| Placebo Capsules | DRUG | Oral Treatment |
Inclusion Criteria: 1. Subjects must be able to understand the requirements of the study and be willing to give written informed consent. 2. Male and female subjects aged 18 years and above. 3. Subjects, any gender or ethnicity (and of Fitzpatrick skin type I - III), must be in good general health ...
DFD-29 is an investigational small molecule being developed for the treatment of rosacea, a chronic inflammatory skin condition. It is formulated as an extended release oral capsule. The drug is currently in clinical development and has not been approved by regulatory authorities.
DFD-29 is a small molecule, but its specific molecular target has not been disclosed. The drug is being studied for its efficacy, safety, and tolerability in patients with rosacea, a condition that involves inflammation and vascular changes in the skin.
DFD-29 is being developed by Dr. Reddy's Laboratories Ltd, a pharmaceutical company listed on the stock exchange under the ticker RDY. The company is conducting clinical trials to evaluate the drug's potential as a treatment for rosacea.
DFD-29 is in Phase 2 clinical development. A Phase 2 trial has been completed, and the drug remains investigational. It has not received FDA approval, and further clinical studies would be needed to establish its safety and efficacy.
DFD-29 has one completed clinical trial, registered as NCT03340961. This Phase 2 study assessed the efficacy, safety, and tolerability of oral DFD-29 extended release capsules in 205 participants with rosacea. The trial was randomized, double-blind, and placebo-controlled, and was conducted in Germany.
DFD-29 is a distinct investigational drug developed by Dr. Reddy's Laboratories. It is not known to be the same as any other marketed rosacea treatment. Its unique formulation as an extended release oral capsule differentiates it from topical therapies commonly used for rosacea.