FOI2026/01056 – Unpublished Clinical Study Reports
Published 23 September 2026
© Crown copyright 2026
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This publication is available at https://www.gov.uk/government/publications/vmd-foieir-requests-june-2026/foi202601056-unpublished-clinical-study-reports
1. Your request
I request to be provided with electronic copies of any and all datasets containing data from the study described on page 10 of the August 2025 “Publicly Available Assessment Report for a Veterinary Medicinal Product, Zenrelia 4.8 mg Film-coated Tablets for Dogs, Zenrelia 6.4 mg Film-coated Tablets for Dogs, Zenrelia 8.5 mg Film-coated Tablets for Dogs, Zenrelia 15 mg Film-coated Tablets for Dogs” as “The EU trial compared the product with an authorised control product, containing the active ingredient oclacitinib. The products were given to a population of 338 dogs, at the recommended doses, over a time of up to 112 days. For the primary efficacy endpoint, both pruritus reduction and lesion scores reduction were assessed. Results for lesion and pruritus scores showed significant reduction from baseline to day 28, and when the groups were compared, a statistically significant difference was found that was in favour of the ilunocitinib product. The study concluded non-inferiority of the product compared to the control.”
2. Our reply
We are refusing this request under Section 41(1) of the Freedom of Information Act, as the information was obtained from a third party and its disclosure would constitute an actionable breach of confidence.
The information requested forms part of proprietary data submitted to the VMD by a Marketing Authorisation Holder as part of a regulatory application. It includes detailed scientific, technical and commercial information which is not in the public domain.
This information has the necessary quality of confidence, was provided in circumstances importing an obligation of confidence, and disclosure would be likely to cause detriment to the confider through the release of commercially sensitive regulatory data.
While we recognise the public interest in transparency around clinical trial data and regulatory decision-making, this does not override the duty of confidence owed in this case.
We note that the study you refer to is summarised in the Publicly Available Assessment Report (PAR) for this product, which is available on GOV.UK. This provides an overview of the study design, results, and the VMD’s assessment.