Elanco Launches Befrena™ (tirnovetmab), New Anti IL-31 Monoclonal Antibody, a Breakthrough in CAD

Elanco Animal Health Incorporated (NYSE: ELAN) today announced the phased launch of Befrena™ (tirnovetmab), a new anti-IL-31 monoclonal antibody (mAb) injection for treatment of canine allergic and atopic dermatitis. The launch comes at a key time, with a longer and more intense allergy season anticipated across the country this year as per Elanco data.

With nearly 2 in 3 itchy dogs experiencing worse itch during allergy season, Befrena expands Elanco’s dermatology portfolio by offering a new treatment option that starts controlling allergic itch within 24 hours. By neutralizing IL-31, a key cytokine involved in sending itch signals to the brain, Befrena offers a differentiated 6 to 8 weeks dosing interval, providing veterinarians and pet owners with a new level of convenience and efficacy.

Benefits of Befrena:

• Offers at least 6 to 8 weeks of itch relief, in contrast to the 4 to 8 weeks of the current market incumbent, lokivetmab, marketed as CYTOPOINT

• Starts controlling itch within 24 hours

• Given as an in-clinic injection administered by, or under the supervision of, a licensed veterinarian

Elanco received approval of Befrena from the U.S. Department of Agriculture (USDA) in December 2025, making it the company’s second dermatology product, alongside Zenrelia™ (ilunocitinib tablets), to be approved and launched in the past two years.

Elanco is also now the only pet health company with two USDA approved mAb products – Befrena and Trutect. Trutect is the first and only approved therapeutic solution to treat canine parvovirus.

“The commercial launch of Befrena into the $1.3 billion U.S. canine dermatology marketⁱⁱⁱ is another exciting milestone in our innovation journey,” said Bobby Modi, Executive Vice President, U.S. Pet Health and Global Digital Transformation. “We are seeing positive results from our Early Experience Program veterinarians who have started using Befrena in their clinics and will continue to increase supply of this new monoclonal antibody, as we scale our bioreactors with the anticipated manufacturing ramp-up.”

Make Best Friends Better – Meet the First Dogs Treated with Befrena

Nearly 9 in 10 dogs in the U.S. are “itchy dogs” according to their pet owners, having experienced symptoms of itch at any point throughout the yearⁱⁱ. Data in Elanco’s America’s Itchy Dogs Report also found that veterinarians say that itchy dog owners wait too long before bringing in their dog, resulting in raw and infected skin and an irritated dog owner who wants their dog to experience relief quickly.ⁱⁱ

As a part of the Befrena Early Experience Program, select veterinarians and veterinary dermatologists have already started using Befrena in their clinics and seen initial improvements in itchy dogs.

Beaux from Austin, TX was the first dog treated with Befrena after experiencing significant hair loss due to his constant itch.

According to Dr. Matt Lane at Liberty Animal Hospital at Beaux’s 3-week checkup appointment, “Beaux is doing amazing, and his owner is excited to see his hair growing back. He stopped itching within 24 hours of receiving the injection and his owner and I are extremely pleased with the results.”

Penelope and Zephyr were also treated with Befrena at Gigi’s Animal Shelter in Columbus, OH. Both dogs experience seasonal allergies that impact their behavior and quality of life and after discussing with their veterinarian both owners chose Befrena to control their dogs’ itch.

“We want to get these dogs relief and make sure they have the most comfortable experience as possible, and I think Befrena shows some real promise for that,” said Dr. Meghan Herron, Senior Director of Behavior, Research, and Education at Gigi’s.

Zephyr’s owner is also a licensed veterinary technician at Gigi’s and helped administer Zephyr’s injection. You can follow along their journey below.

https://elanco.wistia.com/medias/5nbmg3s2hk

“I have been involved with two clinical trials and the Early Experience Program which has shown Befrena to be a highly safe and effective product,” said Dr. Tom Lewis, veterinary dermatologist and founder of Dermatology for Animals, a group of veterinary dermatology clinics committed to caring for pets with allergies. “This will become a very important treatment option for many allergic dogs and I am excited to use Befrena in my clinic.”*

“I’ve used Befrena in a few patients so far and while it’s still relatively early, I’m very optimistic and excited about what’s going to happen with these cases,” said Dr. Jason Pieper, veterinary dermatologist and tenured associate professor of dermatology at Iowa State University College of Veterinary Medicine. “I’ve had several patients respond very well including one unique case that has failed multiple other treatments for atopic dermatitis. And so far, two weeks after receiving Befrena, this dog’s doing quite well, it’s wonderful.”*

Learn more about Befrena and sign up for future news and webinars at www.befrenaforvets.com.

*Drs. Pieper and Lewis are consultants for Elanco.

AHI Opinion – Launch of Befrena could not have come at more inopportune time for incumbent, Zoetis with its 1st MAb, Cytopoint in the canine allergy and atopic dermatitis segment. Zoetis reported a very muted sales performace for Q1′ 2026 which witnessed intense competition in Oral Therapies for Canine Atopic Dermatitis segment from Zenrelai of Elanco and Numelvi of MSD. Befrena launch in US is going to make it further tough for Zoetis and its brand -CYTOPOINT – which had a long, solo run for almost a decade.