SB204 - Acne Vulgaris

Novan is developing SB204 as a once-daily, topical monotherapy for the treatment of acne vulgaris, a multifactorial disease with several mechanistic contributors to the disease pathology.  Localized nitric oxide delivery may provide anti-inflammatory and antibacterial activity from a single active ingredient.

Clinical Trial Results

  • Statistical significance at week 12 on all three co-primary endpoints in one of two pivotal trials:
    • The proportion of patients with IGA success
    • The absolute change in inflammatory lesions
    • The absolute change in non-inflammatory lesions
  • Two Phase 2 trials with statistically significant efficacy with SB204 4% when compared to vehicle in both inflammatory and non-inflammatory lesion endpoints
  • Sustained treatment benefit shown in long-term safety trial
  • No measureable systemic exposure under maximal use conditions in adults or adolescents with moderate-to-severe acne

Click the links below to learn more about SB204

Nitric Oxide and Acne

About Acne Vulgaris

Acne vulgaris is the most common skin condition in the U.S., affecting approximately 40 million to 50 million Americans annually.  The disease ranges in severity from mild to severe cystic acne and causes both physical and psychological effects, including permanent scarring, anxiety, depression and poor self-esteem.  The complexity of the disease requires treatments that address more than one of the major causes of acne pathogenesis.