Berdazimer Sodium CAS No. 1846565-00-1

Uses and Applications

• Primary Indications:

  • Molluscum Contagiosum: Completed Phase 3 clinical trials as a topical gel (10.3%) for the treatment of this common, contagious viral skin infection in adults and children.

  • Common Warts: In development for the treatment of common warts caused by the human papillomavirus (HPV).

  • Acne Vulgaris: Explored for its potential use in inflammatory acne due to its anti-inflammatory properties.

Properties and Characteristics

• Form: Sodium salt of berdazimer (a nitric oxide–releasing compound)

• Drug Class: Nitric oxide–releasing agent; topical dermatological therapeutic

• Developer: Novan, Inc. (now marketed under ZELSUVMI™, FDA-approved 2024)

• Formulation Name: Berdazimer Gel, 10.3%

• Intended Use: Treatment of molluscum contagiosum, a viral skin infection

• Route of Administration: Topical (skin application)

• Status: FDA Approved (2024) — first nitric oxide–releasing topical for molluscum contagiosum in patients ≥1 year old.

• Chemical Structure: Berdazimer sodium is a polymer with an indeterminate molecular formula and molar mass. Its chemical name is poly[{[3-(methylamino)propyl]silasesquioxane}-co-{[3-(1-methyl-2-nitroso-2-oxidohydrazin-1-yl)propyl]silasesquioxane}-co-silicate (1:3:6 x)], partially hydrolyzed (Si:OH ~10:5).

• Mechanism of Action: As a nitric oxide donor, berdazimer sodium releases nitric oxide (NO) upon application to the skin, which has antiviral and anti-inflammatory properties. The exact mechanism for treating molluscum contagiosum is unknown, but studies suggest it inhibits poxvirus replication, including molluscum contagiosum virus (MCV). Pharmacokinetics show minimal systemic absorption; in pediatric studies, plasma levels of a structural marker (hMAP3) were mostly undetectable, with no significant changes in nitrate or methemoglobin levels.

Safety and Handling

• Dosage and Administration:

  • Zelsuvmi is supplied in two tubes: Tube A (containing berdazimer gel) and Tube B (hydrogel). Equal amounts (e.g., 0.5 mL each) are mixed immediately before use and applied as a thin layer to each lesion once daily for up to 12 weeks.

  • Hands should be washed after application (unless treating the hands), and the area should dry for 10 minutes.

  • Avoid swimming or bathing for 1 hour post-application.

  • It is for topical use only and not for oral, ophthalmic, or intravaginal administration.

• Efficacy:

  • In phase 3 clinical trials involving over 1,500 participants (mostly pediatric), berdazimer gel led to complete lesion clearance in 30-32% of patients by week 12, compared to 18-20% with vehicle (placebo).

  • It also reduced lesion counts and showed efficacy in Japanese patients.

  • Research is ongoing for other uses, such as acne vulgaris, where it has shown promise in reducing non-inflammatory lesions.

• Side Effects and Safety:

  • Common adverse reactions (≥1%) are primarily at the application site and include pain (18.7%), erythema (11.7%), pruritus (5.7%), exfoliation (5.0%), dermatitis (4.9%), swelling (3.5%), erosion (1.6%), discoloration (1.5%), vesicles (1.5%), irritation (1.2%), and infection (1.1%).

  • Other effects like fever, vomiting, and upper respiratory infections occur less frequently.

  • Most reactions are mild to moderate and resolve within 24 hours, but allergic contact dermatitis may require discontinuation.

  • There are no contraindications or known drug interactions.

• Use in Specific Populations:

  • Pregnancy: Limited data; animal studies showed malformations at high oral doses with maternal toxicity, but relevance to topical use is unclear.

  • Lactation: No data on presence in breast milk; weigh benefits vs. risks.

  • Pediatrics: Safe and effective for ages 1+; not established under 1 year.

  • Geriatrics: Limited data; no differences expected, but insufficient studies in those ≥65.

Product Documents

• Safety Data Sheet (SDS)
• Certificate of Analysis
• Product Brochure
• Technical Data Sheet