Azelaic acid - How It Works
Clinical pharmacology details from the US FDA-approved label: how Azelaic acid works in your body, how it's absorbed, how long it stays active, and how it's eliminated.
Mechanism of Action
12.1 Mechanism of Action The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action The mechanism(s) by which azelaic acid interferes with the pathogenic events in rosacea are unknown.
12.2 Pharmacodynamics The pharmacodynamics of azelaic acid in association with the treatment of rosacea are unknown.
12.3 Pharmacokinetics The percutaneous absorption of azelaic acid after topical application of azelaic acid gel could not be reliably determined.
Mean plasma azelaic acid concentrations in rosacea subjects treated with azelaic acid gel twice daily for at least 8 weeks are in the range of 42 to 63.1 ng/mL.
These values are within the maximum concentration range of 24 to 90.5 ng/mL observed in rosacea subjects treated with vehicle only.
This indicates that azelaic acid gel does not increase plasma azelaic acid concentration beyond the range derived from nutrition and endogenous metabolism.
In vitro and human data suggest negligible cutaneous metabolism of 3 H-azelaic acid after topical application of 20% azelaic acid cream.
Azelaic acid is mainly excreted unchanged in the urine, but undergoes some ß-oxidation to shorter chain dicarboxylic acids.
Pharmacokinetics
12.3 Pharmacokinetics The percutaneous absorption of azelaic acid after topical application of azelaic acid gel could not be reliably determined. Mean plasma azelaic acid concentrations in rosacea subjects treated with azelaic acid gel twice daily for at least 8 weeks are in the range of 42 to 63.1 ng/mL. These values are within the maximum concentration range of 24 to 90.5 ng/mL observed in rosacea subjects treated with vehicle only. This indicates that azelaic acid gel does not increase plasma azelaic acid concentration beyond the range derived from nutrition and endogenous metabolism. In vitro and human data suggest negligible cutaneous metabolism of 3 H-azelaic acid after topical application of 20% azelaic acid cream. Azelaic acid is mainly excreted unchanged in the urine, but undergoes some ß-oxidation to shorter chain dicarboxylic acids.