Zelsuvmi Access Briefing for Providers

Since its FDA approval in January 2024, Zelsuvmi (berdazimer) topical gel, 10.3%, has represented a paradigm shift in the management of molluscum contagiosum — the first FDA-approved at-home topical treatment for MC. However, the path from approval to patient access has been far from straightforward.

This briefing covers the current availability landscape, prescribing considerations, insurance and cost dynamics, and practical strategies for helping your patients access Zelsuvmi in 2026.

Timeline: From Approval to Availability

Understanding the timeline is essential context for the current access challenges:

• January 2024: FDA approves Zelsuvmi (berdazimer topical gel, 10.3%) for the topical treatment of molluscum contagiosum in adults and pediatric patients 1 year of age and older.
• 2024: Ligand Pharmaceuticals, the original developer, licenses commercialization. No commercial product available during this period.
• Early 2025: Pelthos Therapeutics, formed through a merger of Channel Therapeutics with Ligand's dermatology assets, assumes commercialization responsibility. Backed by a $50 million investment.
• July 2025: Zelsuvmi officially launches commercially, available through retail pharmacies, ASPN Pharmacy Services, and Amazon Pharmacy.
• December 2025: Pelthos signs a major PBM agreement expanding formulary access to approximately 20 million covered lives, effective December 1, 2025.
• 2026: Distribution continues expanding, though pharmacy stocking remains inconsistent.

The 18-month gap between FDA approval and commercial launch is atypical and has contributed significantly to access challenges, prescriber uncertainty, and limited pharmacy stocking.

Prescribing Implications

Clinical Profile

Zelsuvmi is a nitric oxide-releasing agent indicated for the topical treatment of MC in patients ≥1 year. Key clinical data from the B-SIMPLE trials:

• Efficacy: 32.4% complete clearance with Zelsuvmi vs. 19.7% with vehicle at 12 weeks (B-SIMPLE4, n=891)
• Dosing: Mix equal amounts (0.5 mL) from Tube A and Tube B; apply once daily to each lesion for up to 12 weeks
• Safety: Most common adverse reactions are application site reactions — pain/burning/stinging (19%), erythema (12%), pruritus (6%), exfoliation (5%), dermatitis (5%)
• No boxed warnings
• No known significant drug interactions (topical application with minimal systemic absorption)

For detailed mechanism of action information to share with patients, see: How does Zelsuvmi work?

Patient Selection Considerations

Zelsuvmi is particularly well-suited for:

• Pediatric patients (≥1 year) — the primary MC population
• Patients with numerous lesions where in-office procedures are impractical
• Patients who prefer at-home treatment over repeated office visits
• Cases where cryotherapy or curettage have been refused or are contraindicated

Patients who may need alternative approaches include those with insurance plans that don't cover Zelsuvmi, those unable to adhere to daily application for 12 weeks, or patients requiring immediate lesion removal.

Current Availability Picture

As of early 2026, Zelsuvmi is not on the FDA drug shortage list. The access challenge is distribution-based, not supply-based:

• Pharmacy stocking: Primarily available through Walgreens (select locations), Amazon Pharmacy (home delivery), and ASPN Pharmacy Services. Most independent pharmacies and many chain locations don't stock it routinely.
• Storage requirements: Must be refrigerated (2-8°C) until dispensed. Product must be discarded 60 days after removal from refrigeration. Contains alcohol — keep away from open flame.
• Patient tip: Direct patients to Medfinder for Providers to help identify pharmacies with current availability in your area.

Cost and Access Landscape

Pricing

• Average retail price: ~$2,350 per kit (Tube A 14g + Tube B 17g)
• GoodRx coupon price: ~$1,910
• No generic available

Insurance Coverage

Coverage continues to expand but remains inconsistent:

• Many commercial plans require prior authorization
• Common PA criteria include: confirmed MC diagnosis, dermatologist consultation, documentation that lesions haven't resolved within 12 months, or presence of complications
• December 2025 PBM agreement expanded formulary access to ~20 million additional covered lives
• Medicare Part D and Medicaid coverage varies by plan/state

Patient Support Programs

Pelthos Therapeutics offers ZelsuvmiGO, a comprehensive patient support program:

• Copay assistance: Commercially insured patients may pay as little as $0. Enrollment at zelsuvmi.com/copay or call (888) 215-8372
• Patient assistance program (PAP): For uninsured or underinsured patients. Call (888) 309-0186
• Insurance navigation support: Help with prior authorization and coverage issues
• Prescription reminders and refill scheduling

Note: Patients on Medicare, Medicaid, TRICARE, or VA healthcare are not eligible for the copay assistance program.

Tools and Resources for Your Practice

• Medfinder for Providers: Search for pharmacies with Zelsuvmi in stock in your area
• ZelsuvmiGO provider line: (888) 309-0186 — assistance with pharmacy location, PA support, and patient enrollment
• Prescribing to specific pharmacies: If you know which pharmacies in your area stock Zelsuvmi, route prescriptions there directly. Amazon Pharmacy and ASPN Pharmacy Services are reliable options for e-prescribing.
• Prior authorization tips: Include diagnosis code (B08.1 for molluscum contagiosum), duration of lesions, number of lesions, prior treatments attempted, and any complications.

You may also find it helpful to share our patient-facing guides: How to find Zelsuvmi in stock and How to save money on Zelsuvmi.

Alternative Treatments

When Zelsuvmi isn't accessible or appropriate, consider:

• Ycanth (cantharidin 0.7%): FDA-approved in-office treatment for MC in patients ≥2 years. Applied by provider. Causes blistering to remove lesions.
• Cryotherapy: Widely available, well-established. Requires multiple visits.
• Curettage: Effective for limited lesions. May require local anesthesia.
• Imiquimod: Off-label for MC. Available as generic. Evidence is mixed, particularly in pediatric populations.
• Watchful waiting: MC is self-limiting (6-18 months). Appropriate for select patients with few, non-bothersome lesions.

For a patient-friendly comparison: Alternatives to Zelsuvmi.

Looking Ahead

The access picture for Zelsuvmi is improving, driven by expanding PBM coverage, growing prescriber adoption, and Pelthos's ongoing investment in distribution infrastructure. As more prescriptions are written and filled, pharmacy stocking should increase organically.

Pelthos's acquisition of Xepi (ozenoxacin) and Xeglyze (abametapir) in late 2025, with targeted availability in H2 2026, signals a long-term commitment to the dermatology space and suggests continued investment in the distribution and access pathways that also serve Zelsuvmi.

Final Thoughts

Zelsuvmi represents the most significant therapeutic advance for molluscum contagiosum in decades — the first FDA-approved at-home treatment for a condition that affects millions of patients. While access challenges persist, they are steadily improving. Proactive use of the available tools — particularly Medfinder for Providers, the ZelsuvmiGO support program, and targeted pharmacy routing — can meaningfully reduce the barriers your patients face.