Elanco Receives FDA Approval for Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets), the Broadest(i) Canine Oral Parasiticide Protection in a Single Monthly Dose
Elanco Animal Health (NYSE: ELAN) has received FDA approval for Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets), the broadest canine oral parasiticide, offering protection against six parasites: fleas, ticks, heartworms, roundworms, hookworms, and tapeworms. This product is the first to combine four active ingredients in a single, monthly chewable tablet for dogs aged eight weeks and older. Credelio Quattro starts killing ticks and fleas within 4 hours, achieving over 99% flea kill within 8 hours and 100% within the first day, remaining effective for a month. It provides 100% protection against heartworm disease from the first dose and is effective against zoonotic parasites, which can infect both pets and humans. Elanco plans to launch Credelio Quattro in Q1 2025, joining its existing portfolio of parasiticides, including Seresto® and Advantage®.
Elanco Animal Health (NYSE: ELAN) ha ricevuto l'
Elanco Animal Health (NYSE: ELAN) ha recibido la aprobación de la FDA para Credelio Quattro™ (tabletas masticables de lotilaner, moxidectina, praziquantel y pirantel), el parásito oral canino más completo, que ofrece protección contra seis parásitos: pulgas, garrapatas, gusanos del corazón, lombrices, anquilostomas y tenias. Este producto es el primero en combinar cuatro ingredientes activos en una única tableta masticable mensual para perros de ocho semanas de edad o mayores. Credelio Quattro comienza a matar garrapatas y pulgas en 4 horas, logrando más del 99% de eliminación de pulgas en 8 horas y el 100% en el primer día, manteniéndose efectivo durante un mes. Proporciona un 100% de protección contra la enfermedad del gusano del corazón desde la primera dosis y es efectivo contra parásitos zoonóticos, que pueden infectar tanto a mascotas como a humanos. Elanco planea lanzar Credelio Quattro en el primer trimestre de 2025, uniéndose a su cartera existente de parásitos, que incluye Seresto® y Advantage®.
엘란코 동물 건강 (NYSE: ELAN)는 Credelio Quattro™ (로틸라너, 목시덱틴, 프라지쿠안텔, 피란텔 씹는 정제)의 FDA 승인을 받았습니다. 이는 여섯 가지 기생충인 벼룩, 진드기, 심장사상충, 둥글이, 갈고리충 및 촌충에 대한 보호를 제공하는 가장 광범위한 개용 구강 기생충 치료제입니다. 이 제품은 8주 이상의 개를 위한 한 개의 월간 씹는 정제에서 네 가지 활성 성분을 결합한 최초의 제품입니다. Credelio Quattro는 4시간 이내에 진드기와 벼룩을 죽이기 시작하며, 8시간 내 99% 이상의 벼룩 제거에 도달하고, 첫날에 100% 제거를 달성하며, 한 달 동안 효과를 유지합니다. 첫 번째 용량부터 심장사상충 질병에 대해 100%의 보호를 제공하며, 반려동물과 인간 모두 감염될 수 있는 인수공통 기생충에 대해서도 효과적입니다. 엘란코는 2025년 1분기에 Credelio Quattro를 출시할 계획이며, 이는 Seresto® 및 Advantage®을 포함한 기존 기생충 치료제 포트폴리오에 추가됩니다.
Elanco Animal Health (NYSE: ELAN) a reçu l'approbation de la FDA pour Credelio Quattro™ (comprimés à mâcher de lotilaner, moxidectine, praziquantel et pyrantel), le plus large antiparasitaire oral pour chiens, offrant une protection contre six parasites : les puces, les tiques, les vers du cœur, les vers ronds, les ankylostomes et les ténias. Ce produit est le premier à combiner quatre ingrédients actifs dans un seul comprimé à mâcher mensuel pour les chiens âgés de huit semaines et plus. Credelio Quattro commence à éliminer les tiques et les puces en 4 heures, atteignant plus de 99 % d'élimination des puces en 8 heures et 100 % dès le premier jour, tout en restant efficace pendant un mois. Il offre 100 % de protection contre la maladie du ver du cœur dès la première dose et est efficace contre les parasites zoonotiques pouvant infecter à la fois les animaux de compagnie et les humains. Elanco prévoit de lancer Credelio Quattro au premier trimestre 2025, rejoignant son portefeuille existant d'antiparasitaires, y compris Seresto® et Advantage®.
Elanco Tiergesundheit (NYSE: ELAN) hat die FDA-Zulassung für Credelio Quattro™ (Kaubleistungen von Lotilaner, Moxidectin, Praziquantel und Pyrantel) erhalten, das umfangreichste orale Antiparasitikum für Hunde, das Schutz vor sechs Parasiten bietet: Flöhe, Zecken, Herzwürmer, Spulwürmer, Hakenwürmer und Bandwürmer. Dieses Produkt ist das erste, das vier Wirkstoffe in einer einzigen, monatlichen Kaubtablette für Hunde ab einem Alter von acht Wochen kombiniert. Credelio Quattro beginnt innerhalb von 4 Stunden mit dem Abtöten von Zecken und Flöhen und erzielt eine Überlebensquote von über 99% innerhalb von 8 Stunden und 100% innerhalb des ersten Tages, wobei die Wirksamkeit für einen Monat erhalten bleibt. Es bietet 100% Schutz vor Herzwurmerkrankungen ab der ersten Dosis und ist wirksam gegen zoonotische Parasiten, die sowohl Haustiere als auch Menschen infizieren können. Elanco plant, Credelio Quattro im ersten Quartal 2025 auf den Markt zu bringen und damit sein bestehendes Portfolio von Antiparasitika, darunter Seresto® und Advantage®, zu erweitern.
- FDA approval for Credelio Quattro™.
- Protection against six types of parasites.
- First product to combine four active ingredients.
- Effective flea and tick kill within hours.
- 100% protection from heartworm disease.
- Effective against zoonotic parasites.
- Launch planned for Q1 2025.
- None.
Insights
The FDA approval of Credelio Quattro™ is a significant development in canine parasiticide treatments. This product's unique combination of four active ingredients addresses a broader spectrum of parasites than existing solutions, including three species of tapeworms often overlooked by competitors. The single monthly dose format enhances convenience for pet owners, potentially improving compliance.
From a market perspective, Credelio Quattro™ positions Elanco strongly in the competitive pet health sector. The product's rapid onset of action against fleas and ticks, combined with its comprehensive parasite coverage, could drive veterinarian recommendations and consumer preference. The emphasis on zoonotic disease prevention aligns with growing awareness of pet-to-human disease transmission, potentially expanding the market for premium parasiticides.
However, the 2025 launch timeline means Elanco won't see immediate revenue impact. Investors should monitor market reception and adoption rates upon launch, as well as any potential competitive responses from other animal health companies in the interim.
Elanco's Credelio Quattro™ approval represents a strategic move in the $5 billion global parasiticide market. The product's unique selling proposition as the broadest canine oral parasiticide could potentially capture significant market share, especially given the increasing pet ownership trends and heightened focus on pet health.
Key market drivers supporting this product include:
- Growing awareness of zoonotic diseases
- Increasing pet humanization trends
- Rising demand for convenient, all-in-one pet health solutions
The delayed launch until Q1 2025 allows Elanco time for market preparation but also gives competitors a window to respond. Investors should watch for:
- Pre-launch marketing strategies
- Pricing strategy relative to existing products
- Potential impact on Elanco's other parasiticide product lines
Overall, Credelio Quattro™ could be a significant growth driver for Elanco, potentially boosting its position in the animal health market.
- Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and pyrantel chewable tablets) is the first and only canine oral parasiticide to protect against six parasites, including fleas, ticks, heartworms, roundworms, hookwormsii and three different species of tapeworm that other brands skip creating a gap in coverageiii
- Warming temperatures and changing consumer habits have increased parasite pressure and spread across geographies, bringing with them increased public health risk.
- Experts recommend monthly treatment for zoonotic parasitesiv, like Echinococcus granulosus, a type of tapeworm.
- Credelio Quattro launch expected in first quarter of 2025
"Today is another milestone in Elanco's historic era of innovation, with the third of three approvals for blockbuster potential products in the
Credelio Quattro is the newest addition to the Credelio® (lotilaner) franchise and the first FDA-approved parasiticide product with four active ingredients. Credelio Quattro:
- Starts to kill ticksv and fleas in just 4 hours.
- Kills >
99% of fleas within 8 hours of administration and100% in the first day and remains effective for an entire month. - Provided
100% protection from heartworm disease from the first monthly dose in laboratory studies. - Contains lotilaner that kills ticksvi twice as fastvii as sarolaner in Simparica Trio® and afoxolaner in NexGard®viii.
- Is gentle enough for puppies as small as 3.3 pounds and as young as 8 weeks.
- Comes in a tasty beef-flavored, easy-to-administer chewable.
- Provides coverage against internal parasites with zoonotic potential, meaning parasites that have the potential to infect people as well as pets, including echinococcus tapeworm.
"Zoonotic disease is more common than many might think. One of our own Elanco veterinarians recently found echinococcus tapeworm lurking in her back yard," said Dr. David Gosche, veterinarian and
Hear more from Dr. Elise Kelly, Elanco veterinarian, who found tapeworm in her backyard. https://elanco.wistia.com/medias/zdwym2swei
Credelio Quattro joins Elanco's broad portfolio of parasiticides, including Seresto® and the Advantage® family, to provide veterinarians and pet owners with an innovative new solution while also offering a wide range of products at a variety of price points where consumers choose to shop. Elanco expects Credelio Quattro to launch in the first quarter of 2025. Learn more about Credelio Quattro at CredelioQuattroVet.com.
ABOUT ELANCO
Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco,we are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose™ sustainability pillars – all to advance the health of animals, people, the planet and our enterprise. Learn more at www.elanco.com.
Indications
Credelio Quattro is indicated for the prevention of heartworm disease caused by Dirofilaria immitis and for the treatment and control of roundworm (immature adult and adult Toxocara canis and adult Toxascaris leonina), hookworm (adult Uncinaria stenocephala), and tapeworm (Dipylidium caninum, Taenia pisiformis, and Echinococcus granulosus) infections. Credelio Quattro kills adult fleas and is indicated for the treatment and prevention of flea infestations (Ctenocephalides felis) and the treatment and control of tick infestations [Amblyomma americanum (lone star tick), Dermacentor variabilis (American dog tick), Ixodes scapularis (black-legged tick), and Rhipicephalus sanguineus (brown dog tick)] for one month in dogs and puppies 8 weeks of age and older and weighing 3.3 pounds or greater.
Important Safety Information
Lotilaner, an ingredient in Credelio Quattro, belongs to the isoxazoline class and has been associated with neurologic adverse reactions like tremors, ataxia, and seizures even in dogs without a history of seizures. Use with caution in dogs with a history of seizures or neurologic disorders. Dogs should be tested for existing heartworm infections before Credelio Quattro administration as it is not effective against adult D. immitis. The safe use in breeding, pregnant, or lactating dogs has not been evaluated. The most frequently reported adverse reactions in clinical trials were vomiting and diarrhea. For full prescribing information see Credelio package insert.
NexGard is a registered trademark of Boehringer Ingelheim Animal Health USA Inc. Simparica TRIO is a registered trademark of Zoetis Services LLC.
Credelio Quattro, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. Other company and product names are trademarks of their respective owners. © 2024 Elanco or its affiliates.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws, including, without limitation, statements concerning Credelio Quattro as product for canine parasite protection, the timeline for launch, commercial uptake, as well as future studies, publications and other milestones related to Credelio Quattro, and reflects Elanco's current beliefs and expectations. However, as with any animal health pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that planned or ongoing studies will be completed as planned, that future study results will be consistent with study results to date, that future studies will receive regulatory approval, or that Elanco will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Elanco's expectations, see Elanco's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Elanco undertakes no duty to update forward-looking statements to reflect events after the date of this release.
i Based on label comparison of number of parasite types covered.
ii Uncinaria stenocephala
iii NexGard® Plus package insert.
iv CAPC CAPC Echinococcus spp 2022 (v2.0). Available at: https://capcvet. org/guidelines/echinococcus-spp/. Accessed Jul 19, 2023.
v Ixodes ricinus
vi Amblyomma americanum (lone star tick)
vii Based on the time to statistical significance vs control in a single study on Day 21 and Day 28 for reinfestations. The study compared Credelio™ (lotilaner)—not Credelio Quattro™, which contains lotilaner as well as moxidectin, praziquantel, and pyrantel—to the active ingredients in Simparica Trio™ (sarolaner, moxidectin, and pyrantel) and NexGard™ (afoxolaner).
viii Reif KE, Kollasch TM, Neilson JC, Herrin BH, Ryan WG, Bell MC, Beltz MS, Dryden MW, Jesudoss Chelladurai JRJ, Miller KR, Sutherland CJ. Comparative speed of kill provided by lotilaner (Credelio™), sarolaner (Simparica Trio™), and afoxolaner (NexGard™) to control Amblyomma americanum infestations on dogs. Parasite Vectors. 2024 Jul 20;17(1):313.
Investor Contact: Katy Grissom (317) 273-9284 kathryn.grissom@elancoah.com
Media Contact: Season Solorio (765) 316-0233 season.solorio@elancoah.com
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SOURCE Elanco Animal Health
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