Zelsuvmi (berdazimer)
Research Synopsis
- Zelsuvmi (berdazimer) is a topical gel that was recently approved in January 2024 for the treatment of molluscum contagiosum (MC) in both adults and children aged 1 and older.
- The unique formulation utilizes nitric oxide-releasing technology (NITRICIL™), which offers a novel approach to managing this contagious skin condition.
- Multiple clinical trials have demonstrated the efficacy of berdazimer gel, showing a complete clearance rate of 30% compared to 19.8% for a placebo, highlighting its effectiveness across various demographic groups.
- Safety assessments revealed that while the gel is generally well-tolerated, mild to moderate local skin reactions such as pain and redness can occur, warranting monitoring during treatment.
- Recent studies indicate that berdazimer not only reduces viral replication in laboratory settings but also interferes with early gene expression in cells infected with poxviruses, explaining its effectiveness against MC.
- A systematic review of studies involving over 1,800 patients suggests that berdazimer consistently reduces lesions associated with MC but should be used with caution due to possible adverse effects, especially in children.
- The promising results from Phase 3 trials position berdazimer as a leading candidate for FDA approval in treating MC, which currently has no officially sanctioned medications on the market.
- Ongoing research is exploring berdazimer’s antiviral properties and its potential application in treating other dermatological conditions linked to viral infections.
- The public sentiment surrounding the introduction of berdazimer is largely positive, with expectations for improved quality of life for those suffering from molluscum contagiosum due to increased efficacy and minimized side effects compared to traditional therapies.
- Overall, berdazimer represents a significant advancement in the treatment landscape for analyzing and addressing molluscum contagiosum and possibly other skin-related viral conditions.
Zelsuvmi (berdazimer)
A Phase 2, Controlled, Dose-Ranging Study of SB208, an Investigational Topical Nitric Oxide-Releasing Drug, for the Treatment of Tinea Pedis.
London, UK
2 hours ago
1 Received
- Tinea pedis, or athlete's foot, is a common fungal skin infection treated topically, with SB208 being a new treatment that releases nitric oxide to combat the infection.
- A phase 2 trial showed that patients treated with SB208 had a higher rate of negative fungal cultures after 14 days compared to those using a placebo, particularly with the 4% dose.
- At 42 days, SB208 also demonstrated greater mycological and clinical cures, and it was generally safe with no serious side effects reported.
$100 - $150
Hourly Rate
A Phase 2 Controlled Study of SB206, a Topical Nitric Oxide-Releasing Drug for Extragenital Wart Treatment.
London, UK
2 hours ago
1 Received
- Nitric oxide (NO) is a gas produced in the body that can fight off viruses, and the experimental drug SB206 uses NO to treat genital warts caused by HPV types 6 and 11, which current treatments struggle with.
- A study involving 108 patients evaluated the safety and effectiveness of varying concentrations of SB206 for up to 12 weeks, comparing it to a placebo treatment.
- Results showed that patients using the SB206 treatment had a significantly higher rate of complete clearance of genital warts compared to those using the placebo, indicating SB206 is both effective and well tolerated.
$100 - $150
Hourly Rate
NVN1000, a novel nitric oxide-releasing compound, inhibits HPV-18 virus production by interfering with E6 and E7 oncoprotein functions.
London, UK
2 hours ago
1 Received
$100 - $150
Hourly Rate
Efficacy and tolerability of an investigational nitric oxide-releasing topical gel in patients with molluscum contagiosum: A randomized clinical trial.
London, UK
2 hours ago
1 Received
- A clinical trial was conducted to compare the effectiveness and comfort of topical SB206 (berdazimer sodium gel) against a placebo in treating molluscum contagiosum, a skin condition.
- The trial involved 256 patients, mainly around 7 years old, and found that SB206 12% applied once daily led to the highest clearance rate of skin lesions (41.9%) compared to only 20% in the placebo group.
- While some side effects like application-site irritation were noted, SB206 12% showed a favorable balance of effectiveness and tolerability, suggesting it deserves further study in larger trials.
$100 - $150
Hourly Rate
A Nitric Oxide-Releasing Topical Medication as a Potential Treatment Option for Atopic Dermatitis through Antimicrobial and Anti-Inflammatory Activity.
London, UK
2 hours ago
1 Received
$100 - $150
Hourly Rate
Efficacy and Safety of Topical Nitric Oxide-Releasing Berdazimer Gel in Patients With Molluscum Contagiosum: A Phase 3 Randomized Clinical Trial.
London, UK
2 hours ago
1 Received
- Molluscum contagiosum (MC) is a contagious skin condition with no approved medications in the US; a study looked at berdazimer gel as a treatment option.
- The trial involved 891 participants across 55 clinics, where they either received berdazimer gel or a placebo vehicle gel applied daily for 12 weeks.
- Results showed that 32.4% of those using berdazimer gel achieved complete clearance of MC lesions compared to 19.7% in the placebo group, indicating that the gel is effective.
$100 - $150
Hourly Rate
Pharmacokinetic Profile, Safety, and Tolerability of Topical Berdazimer Gel, 10.3% in Patients With Molluscum Contagiosum.
London, UK
2 hours ago
1 Received
- Berdazimer gel (10.3%) is a new topical treatment designed for molluscum contagiosum (MC), a common skin infection, and was tested for safety and effectiveness in a 12-week study.
- The trial involved 34 patients aged 2 to 12 years, most having around 50 MC lesions, and found that the gel had minimal systemic absorption with only mild adverse effects reported.
- Overall, the gel was considered well-tolerated, showing promising results without significant complications or high absorption rates.
$100 - $150
Hourly Rate
New Developing Treatments for Molluscum Contagiosum.
London, UK
2 hours ago
1 Received
- * Common physical treatments are often painful, require multiple doctor visits, and can lead to skin issues like scarring or discoloration.
- * Two experimental treatments, VP-102 (topical cantharidin) and SB206 (topical nitric oxide), show promise in large studies for safety and effectiveness and could become the first FDA-approved options for MC.
$100 - $150
Hourly Rate
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.
London, UK
2 hours ago
1 Received
- Molluscum contagiosum is a skin condition that leads to persistent lesions, and this study aimed to understand what patients and caregivers view as meaningful success in treatment.* -
- The B-SIMPLE4 study involved 891 patients who were assigned to use either a special gel (berdazimer) or a placebo gel over 12 weeks, with many reporting significant improvement in their lesions.* -
- Results showed that a high percentage of patients in the berdazimer group reported improvement in their condition compared to those using the placebo, with exit interviews revealing an average duration of the skin condition of nearly 2 years.*
$100 - $150
Hourly Rate
Molluscum Contagiosum Virus Evasion of Immune Surveillance: A Review.
London, UK
2 hours ago
1 Received
- Molluscum contagiosum (MC) is a common viral infection, primarily affecting children, characterized by few initial symptoms but can provoke significant inflammation during recovery, often lasting for months or even years.
- The study highlights the mechanisms by which the molluscum contagiosum virus (MCV) evades the immune system, identifying 11 viral proteins that may suppress immune responses.
- Although no MC treatments have FDA approval yet, two potential therapies in development (berdazimer gel 10.3% and VP-102 cantharidin, 0.7%) show promise in targeting these immune evasion mechanisms, although the specifics of their interaction with MCV remain unclear.
$100 - $150
Hourly Rate
The Antiviral Effect of Berdazimer Sodium on Molluscum Contagiosum Virus Using a Novel In Vitro Methodology.
London, UK
2 hours ago
1 Received
- Molluscum contagiosum (MC) is a common skin infection in children caused by the highly contagious molluscum contagiosum poxvirus (MCV), with limited treatment options available.
- Researchers are investigating berdazimer sodium, a new topical treatment, to assess its antiviral properties against poxviruses using vaccinia virus as a model since MCV can't be studied directly in the lab.
- The study shows that berdazimer sodium not only reduces virus replication but also interferes with early gene expression in MCV-infected cells, offering a possible explanation for its effectiveness in treating MC.
$100 - $150
Hourly Rate
Berdazimer gel for molluscum contagiosum: An integrated analysis of 3 randomized controlled trials.
London, UK
2 hours ago
1 Received
- An out-of-office treatment for molluscum contagiosum is needed, and this study evaluates the effectiveness and safety of berdazimer gel, 10.3%, compared to a placebo vehicle over 12 weeks.
- A total of 1,598 patients participated, with berdazimer showing a significantly higher complete clearance rate (30.0%) compared to the vehicle (19.8%), and it was effective across various subgroups.
- While berdazimer demonstrated positive outcomes, it also caused mild to moderate local skin reactions, like pain and redness, and the study's limitations included a focus only on US patients and no follow-up beyond 12 weeks.
$100 - $150
Hourly Rate
Searching for a pox on the house of molluscum.
London, UK
2 hours ago
1 Received
$100 - $150
Hourly Rate
Cantharidin topical solution (Ycanth) for molluscum contagiosum.
London, UK
2 hours ago
1 Received
$100 - $150
Hourly Rate
Berdazimer Topical Gel, 10.3%: First Approval.
London, UK
2 hours ago
1 Received
- Berdazimer topical gel, 10.3% (ZELSUVMI™) is a new treatment for molluscum contagiosum developed by Novan Inc., utilizing a unique nitric oxide (NO) technology (NITRICIL™).
- It was officially approved in January 2024 for use in both adults and children aged 1 year and older in the USA.
- The article details the significant milestones and progress made during the development of this topical gel leading to its approval.
$100 - $150
Hourly Rate
Berdazimer gel for molluscum contagiosum in patients with atopic dermatitis.
London, UK
2 hours ago
1 Received
- The study examined the effectiveness and safety of berdazimer gel, a topical antiviral treatment, in controlling molluscum contagiosum (MC) infections in patients with and without atopic dermatitis (AD).
- It involved a combined analysis of three Phase 3 clinical trials, where patients applied berdazimer or a placebo daily for 12 weeks, measuring the complete clearance of lesions as the primary outcome.
- Results indicated higher clearance rates for berdazimer compared to the placebo in both subgroups, though some application-site adverse effects were noted, particularly in patients with concurrent AD.
$100 - $150
Hourly Rate
NOS2-derived low levels of NO drive psoriasis pathogenesis.
London, UK
2 hours ago
1 Received
- * Researchers found that while NOS2 mRNA is strongly expressed in psoriatic skin, its protein translation is hindered by IL-17-induced miR-31, leading to lower nitric oxide (NO) levels.
- * In experiments with a psoriasis mouse model, altering NO levels through gene knockout or a NO-releasing treatment showed significant effects on psoriatic inflammation, suggesting that NO donor therapy could be a promising new treatment for psoriasis.
$100 - $150
Hourly Rate
Safety and efficacy of topical nitric oxide-releasing berdazimer gel for molluscum contagiosum clearance: A systematic review and meta-analysis of randomized controlled trials.
London, UK
2 hours ago
1 Received
- Molluscum contagiosum (MC) is a contagious but generally harmless skin infection that can cause aesthetic issues and other complications, leading people to feel socially isolated.
- Several treatments exist for MC, including a new gel called berdazimer, which releases nitric oxide and is being examined for its effectiveness.
- A meta-analysis of 1854 patients from multiple randomized controlled trials indicates that berdazimer can effectively reduce MC lesions, but its use, especially in children, should consider possible side effects.
$100 - $150
Hourly Rate