Pelthos Therapeutics Launches ZELSUVMI™ (berdazimer) Topical Gel 10.3%, the First and Only FDA-Approved At-Home Treatment for Molluscum Contagiosum
Pelthos Therapeutics (NYSE American: PTHS) has launched ZELSUVMI™ (berdazimer) topical gel 10.3%, marking a significant milestone as the first and only FDA-approved at-home treatment for molluscum contagiosum. The novel nitric oxide-releasing gel, which received FDA Novel Drug designation in January 2024, is now commercially available through prescription.
In Phase 3 clinical trials involving 891 patients, ZELSUVMI demonstrated complete clearance in 33% of patients compared to 19.7% in the control group at week 12, with some patients showing results within two weeks. The treatment targets an estimated 16.7 million affected people in the United States, with up to 6 million new cases annually.
To support the launch, Pelthos has deployed 50 sales territory managers nationwide and implemented the ZelsuvmiGo patient support program to facilitate patient access and education.
Pelthos Therapeutics (NYSE American: PTHS) ha lanciato ZELSUVMI™ (gel topico berdazimer) al 10,3%, segnando un traguardo importante come il primo e unico trattamento approvato dalla FDA per l'uso domiciliare contro il mollusco contagioso. Il nuovo gel a rilascio di ossido nitrico, che ha ricevuto la designazione di Nuovo Farmaco dalla FDA a gennaio 2024, è ora disponibile su prescrizione.
Nei trial clinici di Fase 3 con 891 pazienti, ZELSUVMI ha mostrato una risoluzione completa nel 33% dei pazienti rispetto al 19,7% del gruppo di controllo alla settimana 12, con alcuni pazienti che hanno ottenuto risultati già entro due settimane. Il trattamento si rivolge a circa 16,7 milioni di persone colpite negli Stati Uniti, con fino a 6 milioni di nuovi casi ogni anno.
Per supportare il lancio, Pelthos ha impiegato 50 manager di territorio commerciale a livello nazionale e ha implementato il programma di supporto ai pazienti ZelsuvmiGo per facilitare l'accesso e l'educazione dei pazienti.
Pelthos Therapeutics (NYSE American: PTHS) ha lanzado ZELSUVMI™ (gel tópico berdazimer) al 10,3%, marcando un hito importante como el primer y único tratamiento aprobado por la FDA para uso domiciliario contra el molusco contagioso. El novedoso gel liberador de óxido nítrico, que recibió la designación de Nuevo Medicamento de la FDA en enero de 2024, ya está disponible con receta médica.
En ensayos clínicos de Fase 3 con 891 pacientes, ZELSUVMI demostró una eliminación completa en el 33% de los pacientes frente al 19,7% del grupo control en la semana 12, con algunos pacientes mostrando resultados en tan solo dos semanas. El tratamiento está dirigido a un estimado de 16,7 millones de personas afectadas en Estados Unidos, con hasta 6 millones de nuevos casos anuales.
Para apoyar el lanzamiento, Pelthos ha desplegado 50 gerentes de territorio de ventas a nivel nacional e implementado el programa de apoyo al paciente ZelsuvmiGo para facilitar el acceso y la educación del paciente.
Pelthos Therapeutics (NYSE American: PTHS)가 ZELSUVMI™ (베르다지머) 국소 젤 10.3%를 출시하며 FDA 승인 최초이자 유일한 가정용 물사마귀 치료제라는 중요한 이정표를 세웠습니다. 2024년 1월 FDA 신약 지정(Novel Drug designation)을 받은 이 새로운 질산화질소 방출 젤은 현재 처방전을 통해 상업적으로 이용 가능합니다.
891명의 환자33%의 환자에서 완전 제거를 보였으며, 대조군은 19.7%에 그쳤습니다. 일부 환자는 2주 이내에 효과를 보였습니다. 이 치료제는 미국 내 약 1,670만 명의 환자를 대상으로 하며, 연간 최대 600만 건의 신규 환자가 발생합니다.
출시를 지원하기 위해 Pelthos는 전국적으로 50명의 영업 관리자를 배치했으며, 환자 접근성과 교육을 돕는 ZelsuvmiGo 환자 지원 프로그램을 시행했습니다.
Pelthos Therapeutics (NYSE American : PTHS) a lancé ZELSUVMI™ (gel topique berdazimer) à 10,3 %, marquant une étape importante en tant que premier et unique traitement approuvé par la FDA pour une utilisation à domicile contre le molluscum contagiosum. Ce gel novateur libérant de l'oxyde nitrique, qui a reçu la désignation de médicament innovant par la FDA en janvier 2024, est désormais disponible sur ordonnance.
Lors d'essais cliniques de phase 3 impliquant 891 patients, ZELSUVMI a démontré une clairance complète chez 33 % des patients contre 19,7 % dans le groupe témoin à la semaine 12, certains patients montrant des résultats dès deux semaines. Le traitement cible environ 16,7 millions de personnes affectées aux États-Unis, avec jusqu'à 6 millions de nouveaux cas chaque année.
Pour soutenir ce lancement, Pelthos a déployé 50 responsables commerciaux territoriaux à l'échelle nationale et mis en place le programme de soutien aux patients ZelsuvmiGo afin de faciliter l'accès et l'éducation des patients.
Pelthos Therapeutics (NYSE American: PTHS) hat ZELSUVMI™ (Berdazimer) topisches Gel 10,3 % auf den Markt gebracht und damit einen bedeutenden Meilenstein erreicht: die erste und einzige von der FDA zugelassene Behandlung für Molluscum contagiosum zur Anwendung zu Hause. Das neuartige Stickstoffmonoxid-freisetzende Gel, das im Januar 2024 die FDA-Auszeichnung als neuartiges Medikament erhielt, ist nun auf Rezept erhältlich.
In Phase-3-Studien mit 891 Patienten zeigte ZELSUVMI eine vollständige Abheilung bei 33 % der Patienten im Vergleich zu 19,7 % in der Kontrollgruppe nach 12 Wochen, wobei einige Patienten bereits nach zwei Wochen Ergebnisse zeigten. Die Behandlung richtet sich an geschätzte 16,7 Millionen Betroffene in den USA, mit bis zu 6 Millionen Neuerkrankungen jährlich.
Zur Unterstützung der Markteinführung hat Pelthos 50 Vertriebsgebietsleiter landesweit eingesetzt und das Patientenunterstützungsprogramm ZelsuvmiGo eingeführt, um den Zugang und die Aufklärung der Patienten zu erleichtern.
- First and only FDA-approved at-home treatment for molluscum contagiosum, addressing a significant unmet medical need
- Demonstrated 33% complete clearance rate in Phase 3 trials, significantly higher than control group
- Large addressable market with 16.7 million affected people and 6 million new cases annually in the US
- Robust commercial infrastructure with 50 sales territory managers deployed nationwide
- Multiple distribution channels established including retail pharmacies and mail-order options
- Complete clearance rate of 33% indicates majority of patients may not achieve full resolution
- Requires prescription access which may limit immediate market penetration
- Competition from existing procedural treatments may affect adoption rates
Insights
Pelthos launches first at-home treatment for molluscum contagiosum, addressing a 16.7M patient market with significant commercial potential.
Pelthos Therapeutics has successfully launched ZELSUVMI™ (berdazimer) topical gel 10.3%, representing a significant commercial milestone as the first and only FDA-approved at-home treatment for molluscum contagiosum. This launch targets an estimated 16.7 million affected patients with up to 6 million new cases annually in the U.S., predominantly children.
The product's Novel Drug designation from the FDA in January 2024 highlights its innovative approach. Clinical efficacy data shows complete clearance in nearly 33% of patients versus 19.7% in the control group at week 12, with some patients seeing results within two weeks. The convenience factor is substantial – this once-daily topical medication can be applied at home by patients or caregivers, eliminating the need for frequent office visits and uncomfortable in-office procedures.
From a commercial execution standpoint, Pelthos has deployed 50 sales territory managers nationwide focusing on high-volume prescribers and implemented the ZelsuvmiGo patient support program to facilitate patient onboarding. The company has secured distribution through retail pharmacies, ASPN pharmacy services, and mail-order options, creating multiple access points for patients.
The addressable market is substantial given the condition's prevalence, contagious nature, and previous lack of at-home treatment options. With the product now commercially available, investors should monitor prescription uptake rates, payor coverage developments, and initial revenue generation in coming quarters to gauge commercial traction in this previously underserved market.
- ZELSUVMI is now commercially available via prescription through retail pharmacies, ASPN pharmacy services and for at-home delivery through mail-order pharmacies
- Once-daily topical prescription medication can be applied by patients, parents and caregivers outside of a physician's office, at home or on the go
- Molluscum contagiosum is a highly contagious viral skin condition that afflicts an estimated 16.7 million people with up to 6 million new incidents per year in the United States, most of them children
DURHAM, N.C., July 10, 2025 (GLOBE NEWSWIRE) -- Pelthos Therapeutics Inc. (NYSE American: PTHS), a biopharmaceutical company committed to commercializing innovative therapeutic products for high unmet patient needs, today announced the launch of ZELSUVMI™ (berdazimer) topical gel,
“We believe that the commercial launch of ZELSUVMI marks a significant advancement for patients with molluscum and their caregivers, who previously lacked an at-home treatment option for this burdensome skin infection,” said Scott Plesha, CEO of Pelthos. “We are excited to make ZELSUVMI widely available for the millions of patients afflicted by this condition. Our commercial efforts will aim to provide stellar education and support for patients seeking effective treatment for their molluscum infections.”
ZELSUVMI is a novel, topical nitric oxide-releasing gel for the treatment of molluscum at the time of diagnosis. The once-daily prescription medication is effective, well tolerated, and convenient for at-home or on-the-go application and can be used to treat infections on the body, including sensitive areas such as the face, groin, or underarms. ZELSUVMI was studied in the largest randomized clinical trial for the treatment of molluscum. The trial was a multicenter, randomized, double-blind, vehicle controlled, parallel-group, Phase 3 study of the efficacy and safety of ZELSUVMI in 891 patients. Complete clearance of molluscum lesions was seen in nearly
"Many parents delay seeking treatment for their children's uncomfortable lesions because current procedural treatments and frequent office visits can be inconvenient, while therapeutic options are limited. Untreated molluscum can spread throughout the child’s body but also to other family members," said Nanette Silverberg, MD, Chief of Pediatric Dermatology at the Mount Sinai Health System. “A safe and effective topical gel for molluscum, like ZELSUVMI, which can be applied at home or on the go, would make a significant difference for this young patient population and address a serious, unmet medical need."
"We are launching our ZelsuvmiGo patient support program, which we expect to help onboard patients seamlessly and provide resources for caregivers," said Sai Rangarao, Chief Commercial Officer at Pelthos. "To ensure that ZELSUVMI reaches the people who need it quickly, we have hired 50 sales territory managers across the country to work with physicians who treat a high volume of patients with molluscum. We have also implemented extensive digital outreach and awareness efforts to ensure ZELSUVMI can be prescribed by any healthcare provider at any time. These patients have waited a long time for an at-home treatment option."
ZELSUVMI is now commercially available through retail pharmacies, ASPN pharmacy services and for at-home delivery through mail-order pharmacies via prescription. For more information about ZELSUVMI visit zelsuvmi.com.
About Molluscum Contagiosum
Molluscum is a poxvirus and one of the most common skin infections seen by dermatologists, pediatric dermatologists, and pediatricians. This highly contagious viral skin condition afflicts an estimated 16.7 million people, with up to 6 million new incidents every year in the United States, most of them children.i,ii,iii Individuals with compromised immune systems are at an elevated risk of contracting molluscum, with the condition impacting approximately
About ZELSUVMI™ (berdazimer) topical gel,
ZELSUVMI (berdazimer) topical gel,
IMPORTANT SAFETY INFORMATION
Contraindications: None.
Warnings: Application site reactions, including, allergic contact dermatitis occurred. Discontinue ZELSUVMI and initiate appropriate therapy.
Adverse Reactions: The most commonly reported adverse reactions (≥
About Pelthos Therapeutics
Pelthos Therapeutics (NYSE American: PTHS) is a biopharmaceutical company committed to commercializing innovative, safe, and efficacious therapeutic products to help patients with unmet treatment burdens. The company’s lead product ZELSUVMI™ (berdazimer) topical gel,
Forward-Looking Statements
This press release contains forward-looking statements, as defined in Section 21E of the Securities Exchange Act of 1934, regarding Pelthos’ current expectations. All statements, other than statements of historical fact, could be deemed to be forward-looking statements. In some instances, words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. Readers are cautioned not to place undue reliance on these forward-looking statements, which reflect our good faith beliefs (or those of the indicated third parties) and speak only as of the date hereof. These forward-looking statements include, without limitation, references to our expectations regarding (i) our belief that the commercial launch of ZELSUVMI marks a significant advancement for patients with molluscum and their caregivers, (ii) our commercial efforts will aim to provide stellar education and support for patients seeking effective treatment for their molluscum infections, (iii) our expectation that the launch of ZelsuvmiGo patient support program will help onboard patients seamlessly and provide resources for caregivers; and (iv) the timing of product launches, including ZELSUVMI. These statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Factors that could cause actual results to differ materially from those set forth in such forward-looking statements include, but are not limited to, risks and uncertainties related to changes in general economic conditions, including as a result of war, conflict, epidemic diseases, the implementation of tariffs, and ongoing or future litigation could expose us to significant liabilities and have a material adverse effect on us. These and other risks and uncertainties are described more fully in our filings with the U.S. Securities and Exchange Commission. The information in this press release is provided only as of the date of this press release, and we undertake no obligation to update any forward-looking statements contained in this press release based on new information, future events, or otherwise, except as required by law.
Contacts
Media:
KWM Communications
Kellie Walsh / Rachel Kessler
pelthos@kwmcommunications.com
(914) 315-6072
Investors:
LifeSci Advisors, LLC
Mike Moyer, Managing Director
mmoyer@lifesciadvisors.com
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i ZELSUVMI. Prescribing information. EPIH SPV, LLC. 2024.
ii Browning JC, Enloe C, Cartwright M, et al. Efficacy and safety of topical nitric oxide-releasing berdazimer gel in patients with molluscum contagiosum: a phase 3 randomized clinical trial. JAMA Dermatol. 2022;158(8):871-878.
iii Han H, Smythe C, Yousefian F, Berman B. Molluscum contagiosum virus evasion of immune surveillance: a review. J Drugs Dermatol. 2023;22(2):182-189.
iv Neal Bhatia, Adelaide A Hebert, James Q Del Rosso. Comprehensive Management of Molluscum Contagiosum: Assessment of Clinical Associations, Comorbidities, and Management Principles. Journal of Clinical and Aesthetic Dermatology. 2023 Aug;16(8 Suppl 1):S12–S17.
v Olsen JR, Gallacher J, Finlay A, Piguet V, Francis NA. Time to resolution and effect on quality of life of molluscum contagiosum in children in the UK: a prospective community cohort study. Lancet Infect Dis. 2015;15:190-195
vi Molluscum contagiosum: overview. American Academy of Dermatology. Accessed December 9, 2024. https://www.aad.org/public/diseases/a-z/molluscum-contagiosum-overview
FAQ
What is ZELSUVMI and what did Pelthos Therapeutics (PTHS) announce about it?
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