Elanco Announces USDA Approval of TruCan™ Ultra Lyme-L4, the First and Only 1/2 mL Combination Vaccine for Lyme and Leptospirosis for Dogs

Elanco Announces USDA Approval of TruCan™ Ultra Lyme-L4, the First and Only 1/2 mL Combination Vaccine for Lyme and Leptospirosis for Dogs

• TruCan Ultra Lyme-L4 is the first and only 1/2 mL combination vaccine protecting against both Lyme disease and leptospirosis, all in a low-volume dose
• By combining two injections into one, the vaccine minimizes "pokes" supporting comfortable wellness visits for pets
• Features proprietary PureFil™ Technology, designed to reduce vaccination reactions associated with unwanted protein^i,ii,iii
• Product expected to begin shipping in the next 30 days

INDIANAPOLIS, June 15, 2026 /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) today announced the U.S. Department of Agriculture (USDA) approval of TruCan Ultra Lyme-L4, expanding its extensive TruCan Ultra Portfolio of comfortable and convenient combination vaccines. This milestone marks the introduction of the first and only 1/2 mL combination vaccine designed to protect dogs against both Lyme disease and leptospirosis, two increasingly prevalent threats to canine health.

As an expansion of the TruCan Ultra line, this new 1/2 mL formulation provides the same broad protection as the category-exclusive 1 mL version but in half the volume. This combination formulation allows veterinarians to provide essential protection without the need for multiple injections.

TruCan Ultra Lyme-L4 is engineered with Elanco's proprietary PureFil^TM Technology, designed to reduce vaccination reactions associated with unwanted protein, allowing clinicians to support patient comfort without compromising on protection.^i,ii,iii

"USDA approval of TruCan Ultra Lyme-L4 is a testament to our commitment to vaccine innovation," said Bobby Modi, Executive Vice President, U.S. Pet Health and Global Digital Transformation. "By offering a low-volume, highly-purified combination vaccine, we are providing veterinarians with a powerful tool to help close critical protection gaps while encouraging a comfortable, low-stress experience."

This approval comes at a critical time for canine wellness as all dogs are at risk for leptospirosis regardless of breed, size, lifestyle, or geographic location.^iv Leptospirosis is now recognized as a core vaccine per American Animal Hospital Association (AAHA) guidelines,^v meaning all dogs should be vaccinated. Additionally, the risk of Lyme disease is spreading to new geographies; however, recent data show a significant "protection gap," with over 40% of at-risk dogs in endemic states lacking a current Lyme vaccine, despite having received their core vaccines.^vi

"Leptospirosis and Lyme disease remain important infectious threats for dogs in the U.S.," says Dr. Jessica Pritchard, Clinical Assistant Professor in Small Animal Internal Medicine at the University of Wisconsin-Madison School of Veterinary Medicine, "Leptospirosis vaccination is now considered core for dogs because the exposure risk exists nationwide, including in suburban and urban environments. Vaccination, along with risk-based lifestyle discussions between veterinarians and pet owners, plays an important role in protecting dogs from these preventable diseases."

TruCan Ultra Lyme vaccines have demonstrated 92.2% efficacy against natural infection in highly endemic areas^vii and 100% efficacy in laboratory studies.^viii By reducing the number of injections required—one "poke" versus two—the combination vaccine is designed to improve the overall wellness visit for pets, owners and veterinary staff.

This approval follows recent USDA approvals of TruCan Ultra B (Oral), the first 1/2 mL oral Bordetella vaccine, and TruCan Ultra CIV H3N2/H3N8, the only 1/2 mL bivalent canine influenza vaccine. Together, these advancements add to a comprehensive suite of low-volume, highly purified vaccines that allow veterinary teams to tailor immunization protocols to the specific needs of every dog.

TruCan Ultra Lyme-L4 is expected to begin shipping in the next 30 days. To learn more about TruCan Ultra Lyme-L4 visit https://my.elanco.com/us/trucan.

PM-US-26-1076

TruCan, PureFil, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates
© 2026 Elanco or its affiliates.

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 70 years of animal health heritage, we are committed to breaking boundaries and going beyond to help 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 purpose – all to Go Beyond for Animals, Customers, Society and Our People. Learn more at www.elanco.com.

ⁱ Elanco Animal Health. Data on File. REF-29478
ⁱⁱ Franco J, Aryal UK, HogenEsch H, Moore GE. Proteomic analysis of canine vaccines. Am J Vet Res. 2023;84(3):ajvr.22.11.0192. Published 2023 Jan 24. doi:10.2460/ajvr.22.11.0192
ⁱⁱⁱ Ohmori K, Masuda K, Maeda S, et al. IgE reactivity to vaccine components in dogs that developed immediate type allergic reactions after vaccination. Vet Immunol Immunopathol. 2005;104(3–4):249–256. doi:10.1016/j.vetimm.2004.12.003
^iv Sykes JE, Francey T, Schuller S, Stoddard RA, Cowgill LD, Moore GE. Updated ACVIM consensus statement on leptospirosis in dogs. J Vet Intern Med. 2023 Nov-Dec;37(6):1966-1982. doi: 10.1111/jvim.16903
^v AAHA Guidelines
^vi Malter KB, et al. Vaccine 2022
^vii Levy SA. Vet Ther 2002
^viii Elanco Data on File. REF-04031 

Investor Contact: Tiffany Kanaga (765) 740-0314 tiffany.kanaga@elancoah.com
Media Contact: Season Solorio (765) 316-0233 season.solorio@elancoah.com

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SOURCE Elanco Animal Health