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 (NYSE: ELAN) received USDA approval for TruCan Ultra Lyme-L4, the first and only 1/2 mL combination vaccine for dogs protecting against both Lyme disease and leptospirosis.

Rhea-AI Summary

Elanco (NYSE: ELAN) received USDA approval for TruCan Ultra Lyme-L4, the first and only 1/2 mL combination vaccine for dogs protecting against both Lyme disease and leptospirosis.

The low-volume vaccine uses proprietary PureFil Technology and is expected to begin shipping within 30 days as part of Elanco's TruCan Ultra portfolio.

Positive

• USDA approval of TruCan Ultra Lyme-L4 1/2 mL combination vaccine
• First and only 1/2 mL vaccine covering both Lyme and leptospirosis in dogs
• Uses proprietary PureFil Technology designed to reduce vaccination reactions
• TruCan Ultra Lyme vaccines showed 92.2% efficacy in natural infection areas
• TruCan Ultra Lyme vaccines demonstrated 100% efficacy in laboratory studies
• Product expected to begin shipping within 30 days, enabling near-term sales

Negative

• None.

Argus Jun 15 session

+0.50% close to close Open Argus

Details

News Market Reaction – ELAN

On Jun 15, the day this news came out, ELAN closed 0.50% above the previous close.

Data tracked by StockTitan Argus for the Jun 15 session.

Key Figures

Dose volume: 1/2 mL Prior dose volume: 1 mL Natural infection efficacy: 92.2% +3 more

Dose volume

1/2 mL

Combination vaccine volume for Lyme and leptospirosis

Prior dose volume

1 mL

Category‑exclusive earlier TruCan Ultra formulation

Natural infection efficacy

92.2%

TruCan Ultra Lyme vaccines in highly endemic areas

Laboratory efficacy

100%

TruCan Ultra Lyme vaccines in lab studies

Protection gap

over 40%

At‑risk dogs in endemic states lacking current Lyme vaccine

Shipping timeline

next 30 days

Expected start of TruCan Ultra Lyme‑L4 shipments

Historical Context

5 past events · Latest: Jun 04

5 events

1. Jun 04

   Parasite threat response

   24h Move

   +0.6%

   Outlined product support after first U.S. livestock New World screwworm case.

2. Jun 03

   Pet spending research

   24h Move

   +4.0%

   Released survey showing resilient pet health spending and growth outlook.

3. May 18

   Product launch

   24h Move

   +0.3%

   Launched Befrena, a new mAb therapy in U.S. canine dermatology market.

4. May 14

   Investor conferences

   24h Move

   -0.7%

   Announced participation in Stifel and William Blair investor conferences.

5. May 06

   Q1 2026 earnings

   24h Move

   +13.9%

   Reported strong Q1 results and raised 2026 guidance across revenue and EPS.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

lyme disease, leptospirosis, core vaccine, bivalent

4 terms

lyme disease medical

"designed to protect dogs against both Lyme disease and leptospirosis"

An infection spread by tick bites caused by bacteria that can lead to fever, fatigue, joint pain, and neurological or heart problems if untreated. Investors track it because diagnosis, treatment, prevention tools, and long-term care drive demand for diagnostics, drugs, and medical services, and changes in case numbers, regulatory approvals, or reimbursement can affect companies in those markets. Think of it as a seasonal public-health risk that influences related health-care businesses.

leptospirosis medical

"designed to protect dogs against both Lyme disease and leptospirosis"

A bacterial infection spread mainly through contact with contaminated water, soil or animal urine that can cause fever, organ damage and, in severe cases, hospitalization. For investors, leptospirosis matters because outbreaks can disrupt agriculture and livestock production, increase demand for medical treatments and vaccines, trigger regulatory action or recalls, and raise costs for insurers and travel-related businesses — similar to how a plumbing leak can damage a house and lead to repair bills.

core vaccine medical

"Leptospirosis is now recognized as a core vaccine per American Animal Hospital Association"

A core vaccine is one that health authorities and medical guidelines designate as essential for widespread use because it prevents a common, serious, or highly contagious disease and has a well‑established safety record. For investors, a core vaccine represents steady baseline demand and lower commercial and regulatory risk—like a utility product in a company’s portfolio—because it is typically included in routine vaccination programs or standard care.

bivalent medical

"the only 1/2 mL bivalent canine influenza vaccine"

A bivalent product, when used in medical and regulatory contexts, is designed to target two distinct strains or types of a pathogen at once—like a locksmith carrying two keys instead of one. For investors, bivalent approvals or sales matter because they can broaden market demand, affect regulatory reviews, and change competitive positioning, similar to a company offering a product that meets two different customer needs simultaneously.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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• 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

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Elanco (NYSE: ELAN) announce about TruCan Ultra Lyme-L4 on June 15, 2026?

Elanco announced USDA approval of TruCan Ultra Lyme-L4, a 1/2 mL combination vaccine for dogs against Lyme disease and leptospirosis. According to Elanco, this expands its TruCan Ultra portfolio of low-volume, highly purified canine vaccines.

Why is TruCan Ultra Lyme-L4 important for dogs at risk of Lyme and leptospirosis?

TruCan Ultra Lyme-L4 protects dogs against both Lyme disease and leptospirosis in a single low-volume dose. According to Elanco, this helps address protection gaps as leptospirosis is now a core vaccine and Lyme risk is spreading to new geographies.

How effective are Elanco’s TruCan Ultra Lyme vaccines mentioned in the ELAN announcement?

Elanco reports TruCan Ultra Lyme vaccines achieved 92.2% efficacy against natural infection in highly endemic areas and 100% efficacy in laboratory studies. According to Elanco, this efficacy supports strong protection for dogs in high-risk Lyme regions.

When will TruCan Ultra Lyme-L4 from Elanco (ELAN) be available to veterinarians?

Elanco expects TruCan Ultra Lyme-L4 to begin shipping within 30 days of the June 15, 2026 announcement. According to Elanco, this timing allows veterinary teams to soon offer the new 1/2 mL combination vaccine in clinical practice.

How does TruCan Ultra Lyme-L4 improve the vaccination experience for dogs and owners?

TruCan Ultra Lyme-L4 combines protection against Lyme disease and leptospirosis into one 1/2 mL injection. According to Elanco, reducing shots from two to one and using PureFil Technology is designed to support comfort and low-stress wellness visits.

What role does PureFil Technology play in Elanco’s TruCan Ultra Lyme-L4 vaccine?

PureFil Technology is Elanco’s proprietary platform designed to reduce vaccination reactions linked to unwanted protein. According to Elanco, incorporating PureFil in TruCan Ultra Lyme-L4 aims to maintain protection while supporting patient comfort during canine immunization.