Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FMX101 · 1 trial · 1 indication
The efficacy assessments will inflammation lesion counts at week12
| Arm | Type | Description |
|---|---|---|
| FMX101 | EXPERIMENTAL | FMX101 4% minocycline foam |
| Vehicle Foam | PLACEBO_COMPARATOR | Vehicle Foam |
| Name | Type | Description |
|---|---|---|
| FMX101 | DRUG | topically once daily |
Inclusion Criteria: 1. Has completed and signed an appropriately administered Informed Consent Form (ICF) prior to any study-related procedures. Subjects less than 18 years of age (or as required by state law) must sign an Assent Form for the study and a parent or legal guardian must sign the ICF. ...
FMX101 is an investigational small molecule being developed for the treatment of acne vulgaris. It is formulated as a foam containing minocycline hydrochloride and is intended for topical application. The drug is currently in clinical development and has not been approved by regulatory authorities.
FMX101 contains minocycline hydrochloride, an antibiotic that works by inhibiting bacterial protein synthesis. It targets Propionibacterium acnes, the bacteria implicated in acne vulgaris, reducing inflammation and bacterial growth in the skin. This mechanism helps treat moderate-to-severe acne.
FMX101 is being developed by cbdMD, Inc., a company traded on the NYSE American under the ticker symbol YCBD. The company is conducting clinical trials to evaluate the drug's efficacy and safety for the treatment of acne vulgaris.
FMX101 is in Phase 3 clinical development. A Phase 3 trial has been completed, evaluating the efficacy and safety of minocycline hydrochloride foam in treating moderate-to-severe acne vulgaris. The drug remains investigational and is not yet approved for commercial use.
FMX101 has one completed Phase 3 clinical trial, identified as NCT04960930. This randomized, double-blind, placebo-controlled study enrolled 372 participants in China to evaluate the efficacy and safety of minocycline hydrochloride foam in treating moderate-to-severe acne vulgaris. The trial included participants aged 9 years and older.
FMX101 is the brand name for a minocycline hydrochloride foam formulation. The active ingredient is minocycline hydrochloride, an antibiotic. The drug is being developed specifically as a topical foam for acne vulgaris, and the clinical trial NCT04960930 evaluates this formulation.