Combination parasiticide receives label extension to include flea tapeworms

Officials with the FDA have approved a label expansion for sarolaner, moxidectin and pyrantel chewable tablets (Simparica Trio; Zoetis) to include prevention for flea tapeworm (Dipylidium caninum) infections in dogs. According to Zoetis, this new approval makes this preventive combination drug the only canine combination parasiticide indicated for flea tapeworm infections by killing vector fleas (Ctenocephalides felis) before transmission.¹

Flea tapeworms are found in canine intestines and transmitted to dogs when fleas carrying tapeworm eggs are accidentally swallowed. They are flat, long, ribbony parasites that can grow up to 11 inches long.^1,2 Flea tapeworm infection can be reduced by controlling fleas to avoid parasite transmission.¹

Photo: ViniSouza128/Adobe Stock

A flea tapeworm proglottid

Tapeworm infection may be recognizable in dogs by worm eggs or rice-like proglottids found in feces or under the patient’s tail, scooting behavior, and a pet having had a recent infestation of fleas. However, in some cases, there are no clinical symptoms, according to Banfield Pet Hospital. A regiment of regular flea control is one way to help prevent tapeworm infection.²

Sarolaner, moxidectin and pyrantel chewable tablets are available with a veterinarian’s prescription. It has been administered to more than 15 million dogs over its 5 years of market availability, according to Zoetis. The combination drug is the first product to provide protection for dogs against a range of parasites that include heartworm, ticks, fleas, roundworms, and hookworms. Additionally, it is the only combination product that is approved by the FDA for 6 tick species, including deer ticks, which provides prevention of infections that may cause Lyme disease.¹

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“The best and easiest way to safeguard our pets from parasites is by taking preventative measures to help reduce or eliminate illness,” Tara Bidgood, DVM, PhD, DACVCP, vice president, head of veterinary professional services and medical affairs, US Independent Petcare at Zoetis, said in a news release.¹ “Preventing diseases like flea tapeworm infections with this latest FDA approval for Simparica Trio, helps protect our dogs’ health but also helps strengthen the unique bond dogs share with their owners.”

The FDA approval for the new label expansion is the second for Simparica Trio in recent months, according to Jared Shriver, president, US Operations at Zoetis. In January 2025.¹ Zoetis previously announced the inclusion of treatment and control of Asian longhorned tick (Haemaphysalis longicornis) infestations in canines aged 8 weeks or older and weighing 2.8 lbs or more.³

“Since the FDA approval of Simparica Trio in 2020, we have continued to build on the expansive body of research demonstrating the utility of this important preventative. With Simparica Trio, we are committed to delivering the comprehensive protection that every dog deserves,” Shriver said in a news release.¹

Mason Reichard, PhD, field parasitologist at Zoetis, noted that the label expansion for Asian longhorned ticks provides veterinarians with a valuable resource for treating and controlling infestation of the invasive tick species. “Ticks pose a significant health risk to pets. Ensuring readily available and efficient tick control options is crucial to safeguarding pets' health, ultimately enabling them to enjoy more quality time with their owners,” Reichard, said in a news release.³

Zoetis has also received label expansions for 2 additional products in the past 6 months: sarolaner (Simparica Chewables), and selamectin and sarolaner topical solution (Revolution Plus).^1,2 Sarolaner chewables received a label expansion for the treatment of Asian longhorned tick infestations in dogs ages 6 months and older at a weight of 2.8 lbs or more. Selamectin and sarolaner topical solution had its label expanded to include the prevention of tapeworm infections as a direct result of killing vector fleas with indication is for 1 month use in cats and kittens aged 8 weeks and older, and weighing 2.8 lbs or more.³

“This latest approval of a new indication for Simparica Trio is yet another example of how Zoetis is an industry leader in developing innovative, next generation parasiticide products and solutions for veterinarians and pet owners,” Shriver said.¹

References

1. FDA approves new indication for Zoetis’ Simparica Trio (sarolaner, moxidectin and pyrantel chewable tablets), now the first and only canine parasiticide to prevent flea tapeworm infections by killing vector fleas. News release. Zoetis. April 14, 2025. Accessed April 14, 2025. https://www.zoetisus.com/news-and-media/fda-approves-new-indication-for-zoetis-simparica-trio/
2. Tapeworms in dogs and cats. Banfield Pet Hospital. Accessed April 14, 2025. https://www.banfield.com/Wellness-at-banfield/Worms/Tapeworm
3. Crossley KC. FDA expands labels for 3 parasite prevention and treatment therapies. dvm360. January 14, 2025. Accessed April 14, 2025. https://www.dvm360.com/view/fda-expands-labels-for-3-parasite-prevention-and-treatment-therapies