Zelsuvmi (berdazimer topical gel) / Pelthos Therapeutics - LARVOL DELTA

Nitric Oxide-releasing Topical Gel for the Management of Moderate-to-severe Acne Vulgaris: A Meta-analysis. (AAD 2026) - "In brief, the 4% nitric oxide-releasing topical gel effectively reduces acne lesions in adults with acne vulgaris, displaying promise despite limited IGA improvement. Safety analysis indicates a modestly increased pain incidence, with dryness and erythema similar to placebo, implying an overall favorable safety profile, necessitating further comprehensive research for confirmation. Key words: Acne Vulgaris, Acne, Nitric Oxide, Berdazimer, SB-204, NVN100."

Retrospective data • Acne Vulgaris • Dermatology • Inflammation

PRT08 Challenging the Watch‑and‑Wait Paradigm: Introducing Zelsuvmi™ (berdazimer) topical gel, 10.3% (AAD 2026) - "Sponsored by: Pelthos Therapeutics DESCRIPTION Join us for an engaging presentation on challenging the traditional watch-and-wait thinking by examining unmet needs, patient burden, and emerging topical science that may influence how clinicians approach management decisions."

Zelsuvmi for Molluscum Contagiosum: Clinical Evidence, Mechanisms, and Therapeutic Significance. (PubMed, Ann Med Surg (Lond)) - "The recent FDA approval of Zelsuvmi, a topical gel containing 10.3% berdazimer, marks a significant milestone in MC management...The introduction of Zelsuvmi provides healthcare professionals with a potent, well-tolerated option for managing MC. This advancement addresses a critical gap in MC care, offering improved outcomes and enhanced quality of life for patients."

Journal • Review • Atopic Dermatitis • Dermatitis • Dermatology • Immunology • Pain

ZELSUVMI: Pioneering At-Home Treatment for Molluscum Contagiosum. (PubMed, Infect Disord Drug Targets) - "The product is sup-plied in two separate tubes: one contains berdazimer gel and the other contains hydrogel. The most common negative effects of Zelsuvmi are usually experienced in the applied area, such as distress-ing burning, itching, redness, and irritation. Zelsuvmi is anticipated to be commercially accessible in the United States by late 2024, broadening the spectrum of treatment choices for molluscum contagiosum."

Journal • Dermatology • Inflammation

Improving Molluscum Treatment Options: Overcoming the Challenge of Poor Adherence. (PubMed, J Clin Aesthet Dermatol) - "Several studies suggest that commonly used topical medications for molluscum suffer from poor adherence, reducing treatment efficacy. Addressing adherence to these medications may promote the utility of topicals to deliver the need for safe, painless, and efficacious treatments for molluscum. Larger, well-designed trials accounting for adherence are needed before evidence-based treatment recommendations can be made for topical molluscum treatments. Our findings propose that in-office topicals like cantharidin may overcome nonadherence and enhance efficacy compared to daily home-administered topical medications."

Journal • Review • Dermatology • Pain • Pediatrics

Berdazimer gel (Zelsuvmi) for molluscum contagiosum. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Dermatology

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