First treatment for delaying canine congestive heart failure receives FDA approval

The FDA has approved pimobendan (Vetmedin Chewable Tablets; Boehringer Ingelheim) and pimobendan oral solution (Vetmedin Solution; Boehringer Ingelheim), for delaying the onset of congestive heart failure in dogs with stage B2 preclinical myxomatous mitral valve disease (MMVD), Boehringer Ingelheim recently announced. The approval makes pimobendan the first and currently only FDA-approved treatment indicated for treating preclinical heart disease in dogs and extending symptom-free survival before the development of congestive heart failure.¹

The approval builds on the drug’s conditional approval in 2022 and also marks the first time the FDA has granted full approval for an animal drug indication that was initially conditionally approved. The decision was supported by 2 multi-site studies. In one 2016 study, the EPIC trial, dogs with stage B2 preclinical MMVD treated with Vetmedin experienced a delay of 15.6 months in the onset of congestive heart failure or cardiac-related death compared with untreated dogs.^1,2 A second study, according to Boehringer Ingelheim, found that 79% of dogs with stage B2 preclinical MMVD remained free of congestive heart failure after one year of Vetmedin therapy.¹ Additionally, studies have also shown that Vetmedin can extend survival and improve quality of life in dogs with heart failure due to MMVD or dilated cardiomyopathy.^1,3-5

Heart disease is one of the most prevalent conditions affecting dogs and cats.⁶ Researchers estimate that the disease affects approximately 10% of dogs, with MMVD accounting for approximately 75% of heart disease cases in dogs.⁷ Smaller breed dogs, especially, are more at risk of MMVD.⁶ Meanwhile, larger dogs, according to the Purina Institute, are more likely to develop dilated cardiomyopathy.⁶

In dogs and cats, MMVD and dilated cardiomyopathy can progress to congestive heart failure, a condition characterized by the heart’s inability to effectively pump blood to the body, causing fluid to accumulate in the abdomen (peripheral edema) or lungs (pulmonary edema).

Dogs in the early stages of MMVD often show no clinical signs and generally appear healthy. For dogs in stage B1, a heart murmur may be detected, but there will be no evidence of cardiac remodeling. By stage B2, there will be evidence of cardiac remodeling, although the disease will remain subclinical.⁶

MMVD progression is often unpredictable, though left atrial enlargement is a reliable sign of advancing disease. Research shows that dogs that reach congestive heart failure tend to have shorter survival compared with those in the early stage of MMVD.⁶

“Heart disease is most often present in dogs long before symptoms are visible, so the ability to treat dogs with Vetmedin early, before the disease progresses to [congestive heart failure], is incredibly significant and will help increase the survival time and quality of life in dogs," Daniel Watkins, head of US Pet at Boehringer Ingelheim, said in a news release by Boehringer Ingelheim announcing Vetmedin’s approval.¹ "Vetmedin has been helping dogs with heart disease for more than 25 years, and we are thrilled that this full additional approval will allow us to improve the lives of more dogs."

The approval broadens Vetmedin’s label, which already covers management of mild to severe congestive heart failure in dogs with clinical MMVD or DCM, including use alongside other congestive heart failure therapies such as furosemide when indicated.¹

References

1. FDA approves first drug to delay the onset of congestive heart failure in dogs. News release. Boehringer Ingelheim Animal Health USA Inc. January 19, 2026. Accessed January 20, 2026. https://prnmedia.prnewswire.com/news-releases/fda-approves-first-drug-to-delay-the-onset-of-congestive-heart-failure-in-dogs-302664755.html
2. Boswood A, Häggström J, Gordon SG, et al. Effect of pimobendan in dogs with preclinical myxomatous mitral valve disease and cardiomegaly: The EPIC Study — a randomized clinical trial. J Vet Intern Med. 2016;30(6):1765-1779. doi:10.1111/jvim.14586
3. Häggström J, Boswood A, O’Grady MR, et al. Effect of pimobendan or benazepril hydrochloride on survival times in dogs with congestive heart failure caused by naturally occurring myxomatous mitral valve disease: the QUEST Study. J Vet Intern Med. 2008;22(5):1124-1135.
4. Lombard CW, Jöns O, Bussadori C. Clinical efficacy of pimobendan versus benazepril for the treatment of acquired atrioventricular valvular disease in dogs. J Am Anim Hosp Assoc. 2006;42(4):249-261. doi:10.5326/0420249
5. Fuentes VL, Corcoran B, French A, Schober KE, Kleemann R, Justus C. A double-blind, randomized, placebo-controlled study of pimobendan in dogs with dilated cardiomyopathy. J Vet Intern Med. 2002;16(3):255-261.
6. Cardiac conditions. Purina Institute. Accessed January 20, 2026. https://www.purinainstitute.com/science-of-nutrition/transforming-heart-health/cardiac-conditions
7. Keene BW, Atkins CE, Bonagura JD, et al. ACVIM consensus guidelines for the diagnosis and treatment of myxomatous mitral valve disease in dogs. J Vet Intern Med. 2019;33(3):1127-1140. doi:10.1111/jvim.15488