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  • ||||||||||  berdazimer sodium (NVN1000 SB206) / Novan, Sato Pharma
    Review, Journal:  Berdazimer Topical Gel, 10.3%: First Approval. (Pubmed Central) -  Feb 27, 2024   
    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.
  • ||||||||||  berdazimer sodium (NVN1000 SB206) / Novan, Sato Pharma
    Journal:  Searching for a Pox on the House of Molluscum. (Pubmed Central) -  Jan 15, 2024   
    This article summarizes the milestones in the development of berdazimer topical gel, 10.3% leading to this first approval for the treatment of MC. No abstract available
  • ||||||||||  berdazimer sodium (NVN1000 SB206) / Novan, Sato Pharma
    Preclinical, Journal:  The Antiviral Effect of Berdazimer Sodium on Molluscum Contagiosum Virus Using a Novel In Vitro Methodology. (Pubmed Central) -  Dec 27, 2023   
    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.
  • ||||||||||  berdazimer sodium (NVN1000 SB206) / Novan, Sato Pharma
    Meaningful change in children () -  Mar 4, 2023 - Abstract #ISID2023ISID_991;    
    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.
  • ||||||||||  berdazimer sodium (SB206) / Novan, Sato Pharma
    Review, Journal:  New Developing Treatments for Molluscum Contagiosum. (Pubmed Central) -  Oct 15, 2022   
    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.
  • ||||||||||  berdazimer sodium (SB206) / Novan, Sato Pharma
    Clinical, Review, Journal:  Efficacy of topical treatments for molluscum contagiosum in randomized controlled trials. (Pubmed Central) -  Dec 21, 2021   
    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.
  • ||||||||||  berdazimer sodium (NVN1000 SB206) / Novan, Sato Pharma
    Trial completion:  B-SIMPLE4: A Phase 3 Molluscum Contagiosum Efficacy and Safety Study (clinicaltrials.gov) -  Aug 12, 2021   
    P3,  N=891, Completed, 
    The two studies whose data are analyzed in this study are registered at ClinicalTrials.gov with the identifiers NCT03927703 and NCT03927716. Active, not recruiting --> Completed
  • ||||||||||  berdazimer sodium (NVN1000 SB206) / Novan, Sato Pharma
    Enrollment closed:  B-SIMPLE4: A Phase 3 Molluscum Contagiosum Efficacy and Safety Study (clinicaltrials.gov) -  Feb 2, 2021   
    P3,  N=891, Active, not recruiting, 
    SB206 may trigger BOTE inflammation and shorten the duration of MC infection. Recruiting --> Active, not recruiting
  • ||||||||||  berdazimer sodium (NVN1000 SB206) / Novan, Sato Pharma
    Enrollment open:  B-SIMPLE4: A Phase 3 Molluscum Contagiosum Efficacy and Safety Study (clinicaltrials.gov) -  Sep 2, 2020   
    P3,  N=750, Recruiting, 
    Of the doses studied, SB206 12% applied once daily provided the best balance between MC lesion clearance and tolerability for evaluation in a larger study. Not yet recruiting --> Recruiting
  • ||||||||||  berdazimer sodium (NVN1000 SB206) / Novan, Sato Pharma
    Trial primary completion date:  B-SIMPLE2: A Phase 3 Efficacy & Safety of SB206 & Vehicle Gel for the Treatment of MC (clinicaltrials.gov) -  Jan 5, 2020   
    P3,  N=340, Active, not recruiting, 
    Active, not recruiting --> Completed | Trial completion date: May 2020 --> Jan 2020 Trial primary completion date: May 2020 --> Nov 2019
  • ||||||||||  berdazimer sodium (NVN1000 SB206) / Novan, Sato Pharma
    Enrollment open:  B-SIMPLE2: A Phase 3 Efficacy & Safety of SB206 & Vehicle Gel for the Treatment of MC (clinicaltrials.gov) -  Jul 5, 2019   
    P3,  N=340, Recruiting, 
    Together these in vitro results demonstrate that NO-releasing treatments rapidly penetrate the nail plate and eradicate the fungal infection, representing promising novel topical therapies for the treatment of onychomycosis and other cutaneous fungal infections. Not yet recruiting --> Recruiting
  • ||||||||||  SB208 / Novan
    Trial completion:  SB208 for the Treatment of Tinea Pedis (clinicaltrials.gov) -  Dec 18, 2017   
    P2,  N=222, Completed, 
    Active, not recruiting --> Completed Active, not recruiting --> Completed
  • ||||||||||  berdazimer sodium (SB204) / Sato Pharma, Novan
    Trial completion, Trial primary completion date:  Pharmacokinetics of Topical SB204 in Adolescents With Acne Vulgaris (clinicaltrials.gov) -  Dec 18, 2017   
    P1,  N=18, Completed, 
    Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial primary completion date: Jun 2017 --> Aug 2016 | Active, not recruiting --> Completed | Trial primary completion date: Jun 2017 --> Aug 2016 | Active, not recruiting --> Completed | Trial primary completion date: Jun 2017 --> Aug 2016
  • ||||||||||  berdazimer sodium (SB204) / Sato Pharma, Novan
    Trial completion:  P3 Long Term Safety Study of Once Daily SB204 in Acne (clinicaltrials.gov) -  Dec 18, 2017   
    P3,  N=605, Completed, 
    Active, not recruiting --> Completed | Trial primary completion date: Jun 2017 --> Aug 2016 | Active, not recruiting --> Completed | Trial primary completion date: Jun 2017 --> Aug 2016 | Active, not recruiting --> Completed | Trial primary completion date: Jun 2017 --> Aug 2016 Active, not recruiting --> Completed