{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T21:39:17Z","timestamp":1790631557986,"version":"4.1.0"},"reference-count":210,"publisher":"Wiley","issue":"9","license":[{"start":{"date-parts":[[2026,3,2]],"date-time":"2026-03-02T00:00:00Z","timestamp":1772409600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2026,3,2]],"date-time":"2026-03-02T00:00:00Z","timestamp":1772409600000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/doi.wiley.com\/10.1002\/tdm_license_1.1"}],"content-domain":{"domain":["bpspubs.onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["British J Pharmacology"],"published-print":{"date-parts":[[2026,5]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:p>\n                    In the 2025 novel drug mini\u2010review, one can take a full measure of the ingenuity that underlies current drug design and development, despite the year's smaller harvest (46 novel drugs) compared to 2024 (53) and 2023 (70). 54% of the novel drugs are first\u2010in\u2010class (FIC). The emphasis on proteins\/antibodies is maintained (~25% novel drugs in 2025), an industry trend that does not seem to abate. Fewer than half of the novel medicines address major or common disorders. Among the FIC drugs, it is worth mentioning the Na\n                    <jats:sub>v<\/jats:sub>\n                    1.8 channel inhibitor suzetrigine, the first non\u2010opioid approved to palliate acute pain; the first positive allosteric modulator of transient receptor potential melastatin 8 (TRPM8), acoltremon, that increases basal tear production in dry eye disease, a globally common disorder; lerodalcibep, a \u2018third generation\u2019 adnectin inhibitor of the protease Proprotein Convertase Subtilisin\/Kexin type 9 (PCSK9) to treat elevated LDL\u2010c; and zoliflodacin and gepotidacin, both innovatively targeting bacterial topoisomerases to treat uncomplicated urinary tract infections. Most of the approved medicines target unmet medical need areas and\/or orphan indications (the latter alone accounting for 41% of the 2025 novel drugs) by applying imaginative approaches. These approaches include: the combination of\n                    <jats:italic>two<\/jats:italic>\n                    FIC drugs, the RAF\/MEK clamp avutometinib paired with the FAK\/Pyk2 inhibitor defactinib, to block more efficiently the RAS\u2013RAF\u2013MEK\u2013ERK\/FAK oncogenic pathway in low\u2010grade serous ovarian cancer; fitusiran, the first RNAi therapy for haemophilia, targeting for the first time the production of the natural anticoagulant anti\u2010thrombin in the liver; and brensocatib, which attenuates the activation of downstream neutrophil proteases by inhibiting the protease DPP1, thereby preventing lung tissue destruction in bronchiectasis. The landscape of novel drugs approved in 2025 reveals that pharmaceutical innovation continues to advance through FIC mechanisms, sophisticated therapeutic approaches, and a strong focus on unmet medical need.\n                  <\/jats:p>","DOI":"10.1111\/bph.70376","type":"journal-article","created":{"date-parts":[[2026,3,8]],"date-time":"2026-03-08T16:34:41Z","timestamp":1772987681000},"page":"1779-1813","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":4,"title":["Novel drugs approved by the EMA, the FDA and the MHRA in 2025: A year in review"],"prefix":"10.1111","volume":"183","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4253-5930","authenticated-orcid":false,"given":"Andreas","family":"Papapetropoulos","sequence":"first","affiliation":[{"name":"Laboratory of Pharmacology, Department of Pharmacy National and Kapodistrian University of Athens  Athens Greece"},{"name":"Clinical, Experimental Surgery and Translational Research Center Biomedical Research Foundation of the Academy of Athens  Athens Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5443-5016","authenticated-orcid":false,"given":"Stavros","family":"Topouzis","sequence":"additional","affiliation":[{"name":"Department of Pharmacy University of Patras  Patras Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-4417-497X","authenticated-orcid":false,"given":"Steve P. 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