Pelthos Therapeutics Launches 窜贰尝厂鲍痴惭滨鈩� (berdazimer) Topical Gel 10.3%, the First and Only FDA-Approved At-Home Treatment for Molluscum Contagiosum
Pelthos Therapeutics (NYSE American: PTHS) has launched 窜贰尝厂鲍痴惭滨鈩� (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 窜贰尝厂鲍痴惭滨鈩� (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, 猫 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 gi脿 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 窜贰尝厂鲍痴惭滨鈩� (gel t贸pico berdazimer) al 10,3%, marcando un hito importante como el primer y 煤nico tratamiento aprobado por la FDA para uso domiciliario contra el molusco contagioso. El novedoso gel liberador de 贸xido n铆trico, que recibi贸 la designaci贸n de Nuevo Medicamento de la FDA en enero de 2024, ya est谩 disponible con receta m茅dica.
En ensayos cl铆nicos de Fase 3 con 891 pacientes, ZELSUVMI demostr贸 una eliminaci贸n 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 est谩 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 educaci贸n del paciente.
Pelthos Therapeutics (NYSE American: PTHS)臧赌 窜贰尝厂鲍痴惭滨鈩� (氩犽ゴ雼れ毹�) 甑唽 鞝� 10.3%毳� 於滌嫓頃橂┌ FDA 鞀轨澑 斓滌磮鞚挫瀽 鞙犾澕頃� 臧赌鞝曥毄 氍检偓毵堦穩 旃橂鞝�霛茧姅 欷戩殧頃� 鞚挫爼響滊ゼ 靹胳洜鞀惦媹雼�. 2024雲� 1鞗� FDA 鞁犾暯 歆�鞝�(Novel Drug designation)鞚� 氚涭潃 鞚� 靸堧鞖� 歆堨偘頇旍靻� 氚╈稖 鞝れ潃 順勳灛 觳橂癌鞝勳潉 韱淀暣 靸侅梾鞝侅溂搿� 鞚挫毄 臧赌電ロ暕雼堧嫟.
891氇呾潣 頇橃瀽33%鞚� 頇橃瀽鞐愳劀 鞕勳爠 鞝滉卑毳� 氤挫榾鞙茧┌, 雽�臁瓣蛋鞚� 19.7%鞐� 攴胳长鞀惦媹雼�. 鞚茧秬 頇橃瀽電� 2欤� 鞚措偞鞐� 須臣毳� 氤挫榾鞀惦媹雼�. 鞚� 旃橂鞝滊姅 氙戈淡 雮� 鞎� 1,670毵� 氇呾潣 頇橃瀽毳� 雽�靸侅溂搿� 頃橂┌, 鞐瓣皠 斓滊寑 600毵� 瓯挫潣 鞁犼窚 頇橃瀽臧赌 氚滌儩頃╇媹雼�.
於滌嫓毳� 歆�鞗愴晿旮� 鞙勴暣 Pelthos電� 鞝勱淡鞝侅溂搿� 50氇呾潣 鞓侅梾 甏�毽瀽毳� 氚办箻頄堨溂氅�, 頇橃瀽 鞝戧芳靹标臣 甑愳湣鞚� 霃曤姅 ZelsuvmiGo 頇橃瀽 歆�鞗� 頂勲攴鸽灗鞚� 鞁滍枆頄堨姷雼堧嫟.
Pelthos Therapeutics (NYSE American : PTHS) a lanc茅 窜贰尝厂鲍痴惭滨鈩� (gel topique berdazimer) 脿 10,3 %, marquant une 茅tape importante en tant que premier et unique traitement approuv茅 par la FDA pour une utilisation 脿 domicile contre le molluscum contagiosum. Ce gel novateur lib茅rant de l'oxyde nitrique, qui a re莽u la d茅signation de m茅dicament innovant par la FDA en janvier 2024, est d茅sormais disponible sur ordonnance.
Lors d'essais cliniques de phase 3 impliquant 891 patients, ZELSUVMI a d茅montr茅 une clairance compl猫te chez 33 % des patients contre 19,7 % dans le groupe t茅moin 脿 la semaine 12, certains patients montrant des r茅sultats d猫s deux semaines. Le traitement cible environ 16,7 millions de personnes affect茅es aux 脡tats-Unis, avec jusqu'脿 6 millions de nouveaux cas chaque ann茅e.
Pour soutenir ce lancement, Pelthos a d茅ploy茅 50 responsables commerciaux territoriaux 脿 l'茅chelle nationale et mis en place le programme de soutien aux patients ZelsuvmiGo afin de faciliter l'acc猫s et l'茅ducation des patients.
Pelthos Therapeutics (NYSE American: PTHS) hat 窜贰尝厂鲍痴惭滨鈩� (Berdazimer) topisches Gel 10,3 % auf den Markt gebracht und damit einen bedeutenden Meilenstein erreicht: die erste und einzige von der FDA zugelassene Behandlung f眉r 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 erh盲ltlich.
In Phase-3-Studien mit 891 Patienten zeigte ZELSUVMI eine vollst盲ndige 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 gesch盲tzte 16,7 Millionen Betroffene in den USA, mit bis zu 6 Millionen Neuerkrankungen j盲hrlich.
Zur Unterst眉tzung der Markteinf眉hrung hat Pelthos 50 Vertriebsgebietsleiter landesweit eingesetzt und das Patientenunterst眉tzungsprogramm ZelsuvmiGo eingef眉hrt, um den Zugang und die Aufkl盲rung 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 窜贰尝厂鲍痴惭滨鈩� (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 鈥� 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 窜贰尝厂鲍痴惭滨鈩� (berdazimer) topical gel,
鈥淲e 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,鈥� said Scott Plesha, CEO of Pelthos. 鈥淲e 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.鈥�
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鈥檚 body but also to other family members," said Nanette Silverberg, MD, Chief of Pediatric Dermatology at the Mount Sinai Health System. 鈥淎 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 .
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 窜贰尝厂鲍痴惭滨鈩� (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 (鈮�
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鈥檚 lead product 窜贰尝厂鲍痴惭滨鈩� (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鈥� current expectations. All statements, other than statements of historical fact, could be deemed to be forward-looking statements. In some instances, words such as 鈥減lans,鈥� 鈥渂elieves,鈥� 鈥渆xpects,鈥� 鈥渁nticipates,鈥� and 鈥渨ill,鈥� 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
(914) 315-6072
Investors:
LifeSci Advisors, LLC
Mike Moyer, Managing Director
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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鈥揝17.
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?
How effective is ZELSUVMI in treating molluscum contagiosum based on clinical trials?
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When did ZELSUVMI receive FDA approval and what type of drug designation?
