Pelthos Therapeutics Announces Expanded Formulary Coverage for ZELSUVMI® (berdazimer) Topical Gel, 10.3%

What the company announced

Pelthos announced a new formulary agreement with a major Pharmacy Benefit Manager that the company says opens access to ZELSUVMI (berdazimer) topical gel, 10.3% for 24 million covered lives, and a separate regional health plan update covering approximately 3 million lives. The company reports these updates increase formulary coverage for ZELSUVMI to 127 million commercially covered lives and states the product also has Medicaid coverage of more than 70 million lives. These statements are reported by the issuer and derive from the company press release.

Sources: S1

Regulatory and commercial status noted by Pelthos

Pelthos described ZELSUVMI as having launched in July 2025 for the treatment of molluscum contagiosum in adults and pediatric patients one year of age and older. The company also noted that ZELSUVMI received a Novel Drug designation from the U.S. Food and Drug Administration in January 2024 and that it is the first and only approved topical prescription medication for at-home application to treat molluscum contagiosum, per the press release.

Sources: S1

Product description and safety information

In the release Pelthos described ZELSUVMI as a nitric oxide-releasing topical gel indicated for molluscum contagiosum and summarized important safety information, including application site reactions and a list of commonly reported adverse reactions with their reported frequencies. The company directed readers to the full prescribing information and safety information for additional details.

Sources: S1

Why this may matter (editorial inference)

If the reported formulary additions translate into increased patient access, a larger insured population may have fewer payer barriers to obtaining the prescription product. Expanded formulary placement without prior authorization, as reported for the national PBM, could reduce administrative steps for prescribers and patients. These are inferences based on the issuer's statements about coverage and formulary placement in the press release and are not independently verified here.

Sources: S1

What remains uncertain

• Coverage and access statements are issuer-reported and not independently verified in this draft.
• The press release describes formulary coverage counts and percentages but does not provide underlying contract terms, utilization limits, or prior authorization criteria beyond the specific claim about one PBM adding ZELSUVMI without prior authorization effective October 1, 2026.
• Reported safety event frequencies and clinical effectiveness references are summarized by the company; independent assessment of those data would require review of the cited clinical publications and prescribing information.