Elanco Receives USDA Approval for TruCan™ Ultra CIV H3N2/H3N8 (Canine Influenza Vaccine) Bringing to Market a High Standard of Respiratory Protection

Rhea-AI Summary

Elanco Animal Health (NYSE:ELAN) has received USDA approval for TruCan™ Ultra CIV H3N2/H3N8, a groundbreaking canine influenza vaccine. The vaccine is the only ½ mL bivalent CIV vaccine offering protection against both H3N2 and H3N8 strains, achieving 100% virus neutralization against 33 current field isolates.

Key clinical achievements include zero lung lesions in vaccinated dogs post H3N2 challenge and proven reduction in viral shedding. The vaccine is particularly significant for high-risk breeds, including brachycephalic dogs, and completes Elanco's Tru Portfolio of vaccines featuring PureFil™ Technology. The product is now available for pre-order with shipping expected within 30 business days.

Positive

• 100% virus neutralization demonstrated against 33 current field isolates
• Zero lung lesions in vaccinated dogs post H3N2 challenge
• Proven reduction in viral shedding
• Completes Elanco's extensive Tru Portfolio vaccine line
• First vaccine line recommended by Fear Free® organization

Negative

• Relatively low rate of CIV vaccination in the U.S. may impact market penetration
• Product requires 30 business days before shipping begins

Insights

Veterinary Medicine Specialist

Elanco's new TruCan Ultra CIV vaccine offers superior canine influenza protection with strong efficacy data, completing their premium vaccine portfolio.

Elanco's newly USDA-approved TruCan Ultra CIV H3N2/H3N8 vaccine represents a significant advancement in canine respiratory disease protection. The product differentiates itself through three key clinical advantages: it's the only ½ mL bivalent vaccine targeting both major CIV strains, it demonstrated 100% virus neutralization against 33 current field isolates, and uniquely shows zero lung lesions in vaccinated dogs post-challenge – a critical efficacy marker not matched by competitors.

The clinical data is particularly compelling for brachycephalic breeds (French Bulldogs, Pugs, etc.), which comprise 6 of the top 25 US dog breeds and face disproportionate respiratory disease risks. With respiratory disorders causing 17% of deaths in these breeds, this vaccine addresses a significant unmet need in veterinary medicine.

Strategically, this approval completes Elanco's premium "Tru Portfolio" of vaccines featuring their proprietary PureFil Technology, designed to minimize adverse reactions. The Fear Free® recommendation further enhances market positioning in the growing segment of pet owners concerned with minimizing veterinary stress.

This launch addresses the concerning low CIV vaccination rates in the US despite the risk of facility-shuttering outbreaks. For veterinary practices, having a comprehensive solution from a single manufacturer streamlines inventory and protocol management, likely driving adoption of Elanco's full vaccine line rather than just this individual product.

Financial Analyst

This USDA approval strengthens Elanco's competitive position in the companion animal vaccine market by completing their premium vaccine portfolio with a differentiated respiratory product. The approval timing (July 2025) allows Elanco to capitalize on the growing brachycephalic breed market, where 6 of the top 25 US dog breeds have heightened respiratory vulnerability.

The product's clinical advantages provide strong commercial differentiation: ½ mL dose (convenience factor), 100% neutralization against current field isolates, and the unique claim of zero lung lesions post-challenge. These features offer clear marketing advantages over existing products.

This launch aligns with Elanco's strategy to expand its pet health business, which typically generates higher margins than livestock segments. By completing their "Tru Portfolio" vaccine line, Elanco creates cross-selling opportunities and higher customer retention by offering veterinarians a comprehensive solution from a single manufacturer.

The Fear Free® endorsement provides additional market differentiation in the premium segment where pet owners are willing to pay more for products perceived as providing better experiences. The immediate availability for pre-order indicates confidence in manufacturing readiness and suggests potential revenue contribution beginning in Q3 2025.

While financial projections aren't provided, this approval represents a positive catalyst for Elanco's pet health segment by addressing a demonstrated clinical need with a differentiated product in a market with currently low vaccination rates but high disease impact.

• TruCan Ultra CIV is the only ½ mL bivalent Canine Influenza Virus (CIV) vaccine offering broad protection against H3N2 and H3N8.
• 100% virus neutralization against 33 current field isolates.¹
• Unlike currently available products, only TruCan Ultra CIV demonstrates zero lung lesions in vaccinated dogs post H3N2 challenge.^2,3,4
• TruCan Ultra CIV completes Elanco's extensive line of Tru Portfolio vaccines.

GREENFIELD, Ind., July 9, 2025 /PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN) today announced the U.S. Department of Agriculture (USDA) has approved TruCan Ultra CIV H3N2/H3N8, a canine influenza vaccine designed to provide broad respiratory disease protection. The approval of TruCan Ultra CIV completes Elanco's Tru Portfolio of comfortable and convenient combination vaccines made with PureFil™ Technology, an exclusive process for creating highly purified vaccines designed to reduce adverse reactions and deliver better experiences.

In Canine Influenza Virus (CIV) studies, TruCan Ultra CIV was shown to be highly effective in protecting dogs' lungs and improving clinical signs:

• Zero vaccinated dogs developed lung lesions post H3N2 challenge²
• 100% neutralization of 33 currently circulating CIV field isolates¹
• Proven to reduce viral shedding^2,5
• Proven safe across multiple breed and ages in field safety study⁵

"With the recent USDA approval for TruCan Ultra CIV, Elanco continues to lead the charge in innovative animal health solutions," said Bobby Modi, Executive Vice President, U.S. Pet Health and Global Digital Transformation. "This vaccine not only offers broad protection against canine influenza but also integrates seamlessly into our Tru Portfolio. Our commitment to delivering safe, effective and advanced solutions reaffirms our position as a trusted partner in animal health, driving forward our mission to enrich lives through the health of animals."

Respiratory disease outbreaks can be devastating for patients, their families and veterinary clinics, sometimes leading to facility shutdowns and large financial impact. Canine Infectious Respiratory Disease Complex (CIRDC) is a collection of respiratory diseases of various causative agents, including CIV among others.

Certain breeds can be at a higher risk for severe symptoms associated with CIRDC, especially Brachycephalic dogs – dog breeds with short heads, flat faces and snub noses.⁶ These highly at-risk breeds, which includes French Bulldogs, Bulldogs, Pugs, Boston Terriers and more, continue to grow in popularity with six of the top 25 breeds in the U.S. being brachycephalic.⁷

Unfortunately, there is a relatively low rate of vaccination for CIV in the U.S. leaving these highly susceptible patients particularly at risk for developing infection when exposed to CIV.⁸ Patients with the highest risk factors include social dogs, dogs with pre-existing airway disease and those that are unvaccinated or incompletely vaccinated. Brachycephalics strongly benefit from added protection from respiratory disease as they can be life-threatening, with upper respiratory disorders being the cause of death in 17% of those breeds.⁶ It only takes one patient shedding CIV to spark an outbreak.

"With TruCan Ultra CIV, we are improving our ability to protect dogs from serious respiratory disease while remaining committed to helping provide a happier clinic experience for pets and their owners," said Dr. Jennifer Miller, technical veterinarian at Elanco. "This addition to our vaccine portfolio means our veterinarian customers can confidently offer a more complete set of immunizations tailored to the needs of all dogs, ensuring their long-term health and happiness."

Elanco's Tru Vaccine line is the first vaccine line recommended by Fear Free®, an organization whose mission is to prevent and alleviate fear, anxiety and stress in pets by inspiring and educating the people who care for them.

"Fear, anxiety and stress in pets can stem from many factors, including illness," said Dr. Marty Becker, Founder of Fear Free. "When veterinarians have effective tools to help protect pets from diseases like canine influenza, it can contribute to a smoother, less stressful experience for both pets and their people. Solutions like TruCan Ultra CIV support the goal of reducing fear, anxiety and stress by keeping pets healthier and more comfortable in the veterinary setting."

The approval of TruCan Ultra CIV is a key addition to completing Elanco's vaccine portfolio by addressing respiratory disease outbreaks. TruCan Ultra CIV is now available for pre-order and will ship within the next 30 business days.

Learn more about TruCan Ultra CIV at https://my.elanco.com/us/campaign/trucan-ultra.

*Drs. Becker and Reinero are consultants for Elanco Animal Health.

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. 

^1,2 Elanco Animal Health. Data on File.
³ USDA APHIS. https://www.aphis.usda.gov/sites/default/files/2024-09/165a-15p5r0.pdf
⁴ USDA APHIS. https://www.aphis.usda.gov/sites/default/files/2023-10/190-15q520.pdf
⁵ Elanco Animal Health. Data on File. 
⁶ The Humane Society of the United States. https://www.humanesociety.org/resources/flat-face-dog-breeds-and-health-issues
⁷ American Kennel Club. Most Popular Dog Breeds of 2023 - American Kennel Club
⁸ Malter et al. Vaccine 40 (2022) 1001-1009.  

Trucan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates. © 2025 Elanco or its affiliates. PM-US-25-0067(2)

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

What are the key benefits of Elanco's new TruCan Ultra CIV H3N2/H3N8 vaccine?

The vaccine offers 100% virus neutralization against 33 field isolates, demonstrates zero lung lesions in vaccinated dogs post H3N2 challenge, and is the only ½ mL bivalent CIV vaccine protecting against both H3N2 and H3N8 strains.

When will Elanco's (NYSE:ELAN) TruCan Ultra CIV vaccine be available?

The vaccine is currently available for pre-order and will ship within the next 30 business days following the July 9, 2025 announcement.

Which dog breeds benefit most from Elanco's new canine influenza vaccine?

The vaccine is particularly beneficial for brachycephalic breeds (dogs with short heads and flat faces) such as French Bulldogs, Bulldogs, Pugs, and Boston Terriers, as they are at higher risk for severe respiratory symptoms.

What makes Elanco's TruCan Ultra CIV vaccine different from other canine influenza vaccines?

It's the only ½ mL bivalent vaccine for both H3N2 and H3N8 strains, features PureFil™ Technology for reduced adverse reactions, and is the first vaccine line recommended by Fear Free®.

What is the clinical efficacy of Elanco's TruCan Ultra CIV vaccine?

Clinical studies show 100% neutralization of 33 current CIV field isolates, zero lung lesions in vaccinated dogs after H3N2 challenge, and proven reduction in viral shedding.