berdazimer sodium (NVN1000 SB206) / Novan, Sato Pharma - LARVOL DELTA

Treatments for Molluscum Contagiosum: A Systematic Review (CDA 2025) - "Recent Food and Drug Administration approvals of topical cantharidin and 10.3% berdazimer gel provide new therapeutic options, prompting a comprehensive evaluation of MC treatment safety and efficacy...Cantharidin, potassium hydroxide (KOH), and imiquimod demonstrated high complete clearance rates (84.9%, 75.1%, and 70.1%) with mild local side effects... Managing MC involves a range of treatments, including topical, physical, and immunological options, requiring consideration of patient factors (e.g., age, lesion severity, immune status). Cantharidin, KOH, cryotherapy, and podophyllotoxin remain first-line treatments, with autoinoculation showing promise, and immunotherapies and lasers used in recalcitrant cases. Standardized trials are needed to refine treatment strategies."

Review • CNS Disorders • Dermatology • Infectious Disease • Pain • Pediatrics

Berdazimer (Zelsuvmi) for the Treatment of Molluscum Contagiosum. (PubMed, Am Fam Physician) - No abstract available

Journal • Dermatology

This Month in JAAD International: April 2025: Options of molluscum contagiosum management. (PubMed, J Am Acad Dermatol) - No abstract available

Journal • Dermatology

The safety and tolerability of berdazimer gel 10.3% in Japanese patients with molluscum contagiosum. (PubMed, JAAD Int) - "Single-group study; small sample size. Safety and efficacy of berdazimer gel, 10.3% in Japanese patients were favorable and consistent with previous studies."

Journal • Dermatitis • Dermatology • Immunology • Infectious Disease • Pain • Pruritus

SB206 (berdazimer gel 10.3%) for the treatment of molluscum contagiosum: results from a Japanese Phase 2 Study (SKN15B01) (SID 2024) - No abstract available

Late-breaking abstract • P2 data • Dermatology

Cantharidin topical solution (Ycanth) for molluscum contagiosum. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dermatology

Berdazimer gel for molluscum contagiosum in patients with atopic dermatitis. (PubMed, Pediatr Dermatol) - "Berdazimer gel showed favorable efficacy regardless of AD status. Berdazimer-induced erythema may be indistinguishable from AD symptoms or with inflammatory response upon resolution of molluscum."

Clinical • Journal • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Infectious Disease • Inflammation • Pain • Pediatrics

Berdazimer Topical Gel, 10.3%: First Approval. (PubMed, Drugs) - "In January 2024, berdazimer topical gel, 10.3% was approved for the topical treatment of MC in adult and paediatric patients 1 year of age and older in the USA. This article summarizes the milestones in the development of berdazimer topical gel, 10.3% leading to this first approval for the treatment of MC."

Journal • Review • Dermatology • Pediatrics

The Antiviral Effect of Berdazimer Sodium on Molluscum Contagiosum Virus Using a Novel In Vitro Methodology. (PubMed, Viruses) - "Specifically, this is accomplished by studying the nuclear factor kappa-light-chain-enhancer of activated B cell (NF-kB)-blocking protein MC160 as an example of an early gene. The results provide a plausible unique antiviral mechanism of action supporting increased MCV resolution observed in patients treated with berdazimer gel, 10.3% and describe a novel methodology that overcomes limitations in investigating MCV response in vitro to a potential new MC topical medication."

Journal • Preclinical • Dermatology

Searching for a Pox on the House of Molluscum. (PubMed, J Am Acad Dermatol) - No abstract available

Journal • Dermatology

Berdazimer Gel for Molluscum Contagiosum: An Integrated Analysis of 3 Randomized Controlled Trials. (PubMed, J Am Acad Dermatol) - "Berdazimer gel, 10.3% showed favorable efficacy and safety across subgroups."

Journal • Dermatology • Pain • Pediatrics

Safety and efficacy of topical nitric oxide-releasing berdazimer gel for molluscum contagiosum clearance: A systematic review and meta-analysis of randomized controlled trials. (PubMed, Pediatr Dermatol) - "The meta-analysis included three reports and four RCT involving 1854 patients, with 1106 (59.6%) randomized to receive berdazimer. Our findings suggest that berdazimer is effective in the management of MC lesions, but the increased clearance of lesions and reduction of scarring must be weighed against the potential for topical adverse effects, particularly when considering the use of this therapy in pediatric patients."

Journal • Retrospective data • Review • Dermatitis • Dermatology • Immunology • Infectious Disease • Pediatrics

Safety and Efficacy of Topical Nitric Oxide-Releasing Berdazimer Gel for Molluscum Contagiosum Clearance: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (EADV-Sp 2023) - "Nevertheless, the increased clearance of lesions and reduction of scarring must be weighed against the potential for topical adverse effects, especially when considering this therapy for pediatric patients. Fig 1 Berdazimer Gel was superior to vehicle for the outcome of complete lesion clearance at weeks 8 a and 12 b. Additionally, it showed a significantly lower incidence of application-site scarring c"

Retrospective data • Review • Dermatitis • Dermatology • Immunology • Infectious Disease • Pain • Pediatrics • Pruritus

Meaningful change in children’s dermatology life quality index (DLQI) and lesion counts in patients with molluscum contagiosum (ISID 2023) - " B-SIMPLE1,2 & 4 Phase 3 trials evaluated the safety & efficacy of once-daily application of berdazimer gel 10.3% or vehicle gel for 12 weeks in patients with MC... cDLQI scores improved in patients with complete & 90% MC lesion count reduction regardless of treatment arm; there were no substantial differences between 90% & CC. GSA/GIC results suggests less than CC is associated with meaningful MC change & affirmed previously published observations that lesion reduction of at least 75% are perceived as meaningful. Limitations: MC lesion size & locations or adverse events were not factored in the assessment."

Clinical • Dermatology

Antiviral effect of berdazimer sodium on molluscum contagiosum virus: Potential implications for clinical observations of lesion resolution (ISID 2023) - "Berdazimer sodium reduced the infectivity of the two poxviruses studied, VacV and MCV. For MCV, expression of MC160, an MCV protein critical to modulation and evasion of host immunity, was inhibited. The results provide a plausible mechanism of action(s) supporting the increased MC resolution observed in patients treated with berdazimer gel, 10.3% during Phase 3 clinical trials."

Clinical • Dermatology • Infectious Disease

Safety of Berdazimer Gel 10.3% in the Treatment of Molluscum Contagiosum: Integrated Results from the B-SIMPLE Phase 3 Program (AAD 2023) - "The B-SIMPLE Phase 3 program demonstrates favorable safety and tolerability of berdazimer gel 10.3%."

Clinical • P3 data • Dermatology • Pain • Pruritus

Efficacy of Berdazimer Gel 10.3% in the Treatment of Molluscum Contagiosum: Integrated Results from the B-SIMPLE Phase 3 Program (AAD 2023) - No abstract available

Clinical • Late-breaking abstract • P3 data • Dermatology

FDA Accepts Novan’s NDA for Berdazimer Gel, 10.3% for the Treatment of Molluscum Contagiosum with a PDUFA Goal Date of January 5, 2024 (GlobeNewswire) - "Novan’s commercial team and sales force ready to prepare for launch of berdazimer gel, 10.3%, if approved...Novan, Inc...announced that the U.S. Food and Drug Administration ('FDA') accepted for filing Novan’s New Drug Application (“NDA”) seeking approval for berdazimer gel, 10.3% (SB206) for the treatment of molluscum contagiosum ('molluscum'). The Company also received its Prescription Drug User Fee ('PDUFA') goal date of January 5, 2024."

NDA • PDUFA date • Dermatology • Infectious Disease

Molluscum Contagiosum Virus Evasion of Immune Surveillance: A Review. (PubMed, J Drugs Dermatol) - "MCV is distinctive in evading immune surveillance by inhibiting or dampening several immune pathways via the production of viral proteins. The result is decreasing local inflammatory response which contributes to the prolonged survival of MCV in the epidermis. Persistent MC can be a nuisance for some patients and treatment may be desired. Currently, no treatment has been approved by the US Food and Drug Administration (FDA). Two approaches in the pipeline may affect the immune avoidance mechanisms; nevertheless, their exact mechanisms between the potential therapeutics and viral proteins remain enigmatic. J Drugs Dermatol. 2023;22(2):182-189. doi:10.36849/JDD.7230."

Journal • Review • Dermatology • Immunology • Infectious Disease • Inflammation • Pediatrics

A Patient-Centered Perspective of Molluscum Contagiosum as Reported by B-SIMPLE4 Clinical Trial Patients and Caregivers: Global Impression of Change and Exit Interview Substudy Results. (PubMed, Am J Clin Dermatol) - P3 | "Molluscum contagiosum lesion reductions, with or without complete clearance, may be considered a therapeutic "success" by the patient/caregiver."

Interview • Journal • Dermatology • Pain

New Developing Treatments for Molluscum Contagiosum. (PubMed, Dermatol Ther (Heidelb)) - "Two experimental topical drugs, a new standardized preparation of topical cantharidin, called VP-102, and a topical nitric oxide (NO)-releasing product containing berdazimer, called SB206, represent promising products that have been designed to overcome the limitations of current treatments. They have recently shown good results in terms of safety and efficacy in large cohorts of patients in phase III studies and have the potential to be the first FDA-approved therapies for the treatment of MC."

Journal • Review • Dermatology • Pain

Pharmacokinetic Profile, Safety, and Tolerability of Topical Berdazimer Gel, 10.3% in Patients With Molluscum Contagiosum. (PubMed, J Drugs Dermatol) - "Once-daily berdazimer gel, 10.3% was well-tolerated with minimal systemic absorption. J Drugs Dermatol. 2022;21(10):1104-1110. doi:10.36849/JDD.6938."

Journal • PK/PD data • Dermatology • Pain

Efficacy and Safety of Topical Nitric Oxide-Releasing Berdazimer Gel in Patients With Molluscum Contagiosum: A Phase 3 Randomized Clinical Trial. (PubMed, JAMA Dermatol) - P3 | "Use of berdazimer gel, 10.3%, for MC appears to demonstrate favorable efficacy and safety with low adverse event rates. ClinicalTrials.gov Identifier: NCT04535531."

Clinical • Journal • P3 data • Dermatology • Pain • Pediatrics

Berdazimer 10.3% Gel (SB206): A Novel, Topical Nitric Oxide Releasing Medication: Results from a Pivotal Phase 3 Study in Patients (Children and Adults) with Molluscum Contagiosum (AAD 2022) - No abstract available

Clinical • Late-breaking abstract • P3 data • Dermatology

Efficacy of topical treatments for molluscum contagiosum in randomized controlled trials. (PubMed, Clin Dermatol) - "Treatment modalities included podophyllotoxin, imiquimod, sodium nitrite, myrtle leaf extract, phenol, Salatac Gel (salicylic acid with lactic acid), potassium hydroxide, cantharidin, SB206, and VP-102. Overall, studies were of sufficient quality and had low risk of bias, but they had small sample sizes and lacked adequate explanation of statistical analysis. Current first-line treatment entails mechanical methods such as cryotherapy and curettage, which may be frightening to children with MC, so the development and assessment of topical treatments allows for alternative efficacious techniques."

Clinical • Journal • Review • Dermatology • Infectious Disease