Proveca Ltd submits a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Aqumeldi® (enalapril maleate), a prescription drug.
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Proveca Ltd submits a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Aqumeldi® (enalapril maleate), a prescription drug.
- The submission is made for the following indications:
- Treatment of hypertension in adults and children older than one month, to lower blood pressure.
- Treatment of symptomatic heart failure.
- Treatment of asymptomatic left ventricular dysfunction, to decrease the rate of development of overt heart failure and reduce hospitalization for heart failure.
On 6th March 2026, Proveca submitted its first NDA in the U.S., for Aqumeldi®. Aqumeldi® is already licensed for paediatric heart failure in Europe and in the UK. This application for the conditions listed above further expands Proveca’s reach into the U.S. and will provide a new medication for both adults and paediatric patients.
The FDA review process will now be initiated and potential approval expected in H1 2027.
“Submitting the NDA for Aqumeldi® is an important milestone in Proveca’s commitment to improving the availability of evidence-based medicines specifically designed for children.” said Dr. Simon Bryson, CEO of Proveca Ltd. “If approved, Aqumeldi® has the potential to provide clinicians, families and patients in the U.S. with an innovative treatment option for managing hypertension and heart failure.”
About Hypertension in the U.S.
High blood pressure affects nearly half of U.S. adults (48.1%) and significantly increases the risk of heart disease and stroke, two leading causes of death nationwide. In 2023, hypertension contributed to 664,470 deaths in the U.S., with only about one in four adults achieving controlled blood pressure despite its widespread prevalence. The condition also places a substantial economic burden on the nation, costing approximately $131 billion each year.
About Hypertension in Children in the U.S.
Hypertension is a clinically significant condition in the paediatric population, with limited age-appropriate treatment formulations currently available. Paediatric hypertension affects an estimated 2–4% of children in the U.S. —equivalent to approximately 3 million young patients—while an additional 14–16% have elevated blood pressure and are at risk of developing hypertension.
About Heart Failure in the U.S.
Heart failure affects an estimated 6.7 million adults in the U.S. with prevalence projected to rise to 8.7 million by 2030. It remains a major contributor to mortality, being involved in 425,147 deaths in 2022, representing 45% of all cardiovascular deaths. The lifetime risk of developing heart failure is now approximately 1 in 4, highlighting the urgent need for improved prevention, earlier diagnosis, and effective treatment strategies.
About Aqumeldi®
Aqumeldi® is an innovative orodispersible tablet (2mm in size) that contains enalapril maleate and was designed and evaluated for use in children. Enalapril maleate is an angiotensin converting enzyme (ACE) inhibitor that is widely used in the management of hypertension and heart failure.
Enalapril maleate is a widely-used ACE inhibitor and has been evaluated for safety in more than 10,000 adult patients and in controlled clinical studies involving 2,314 hypertensive patients and 363 patients with congestive heart failure. Very common adverse reactions (≥ 1/10) experienced with enalapril include dizziness, blurred vision, cough, nausea and aesthenia.
About Proveca
Proveca Ltd is a UK-founded pharmaceutical company, with technical and commercial operations globally. The company specialises in the development, licensing and commercialisation of evidence-based medicines to address the unmet medical needs of children, with a current paediatric product portfolio in neurology and cardiology.
For more information about Proveca and/or this press release, please contact:
Dr Simon Bryson, CEO
Phone: +44 161 468 2627
Email: medical@proveca.com
www.proveca.com
INT-ENA-26-0001 – March 2026