The British Journal of Pharmacology (BJP) has published its mini-review of ‘Novel drugs approved by the EMA, the FDA and the MHRA in 2025’.
This is the third yearly mini-review that the journal has published, covering the exciting pharmacology of the novel drugs that were approved in the preceding calendar year by three major drug regulatory authorities: the European Medicines Agency (EMA), the US Food and Drug Administration (FDA), and the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
The mini-review of 2025 highlights 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). More than half (54%) of the novel drugs are first-in-class (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:
- Suzetrigine - the Nav1.8 channel inhibitor and the first non-opioid approved to palliate acute pain.
- Acoltremon - the first positive allosteric modulator of transient receptor potential melastatin 8 (TRPM8), that increases basal tear production in dry eye disease, a globally common disorder.
- Lerodalcibep - a ‘third generation’ adnectin inhibitor of the protease Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) to treat elevated LDL-c.
- 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 two FIC drugs, the RAF/MEK clamp avutometinib paired with the FAK/Pyk2 inhibitor defactinib, to block more efficiently the RAS–RAF–MEK–ERK/FAK oncogenic pathway in low-grade serous ovarian cancer.
- Fitusiran - the first RNAi therapy for haemophilia, targeting for the first time the production of the natural anticoagulant anti-thrombin in the liver
- 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.
Authors of the review: Andreas Papapetropoulos, Stavros Topouzis, Steve P. H. Alexander, Miriam M. Cortese-Krott, Zsuzsanna Helyes, Kirill Martemyanov, Claudio Mauro, Nithyanandan Nagercoil, Reynold A. Panettieri Jr, Hemal H. Patel, Rainer Schulz, Barbara Stefanska, Gary J. Stephens, Nathalie Vergnolle, Xin Wang, Stephen Ward, Péter Ferdinandy
