Sanofi’s small interfering RNA hemophilia drug QFITLIA (fitusiran) recently became the latest of our 2025 Drugs to Watch to secure FDA approval.
The drug, approved March 28, is a first-in-class antithrombin-lowering therapy for use as a prophylactic treatment to prevent or reduce bleeding episodes in people with hemophilia A or B, with or without inhibitors. Developed using Alnylam Pharmaceutical Inc’s ESC-GalNAc conjugate technology, the treatment’s once-monthly or every-other-monthly subcutaneous infusions promise to lower treatment burdens for patients and enhance compliance while also offering an alternative for the 20-30% of patients treated with replacement therapies who develop inhibitors at some point.
Mike Ward, Global Head of Thought Leadership at Clarivate, recently spoke to four analysts who worked on the report about some of their other 2025 picks. Among them:
- Cobenfy – Bristol Myers Squibb’s innovative schizophrenia drug, the first novel treatment for the disease in decades, launched late last year, recording $10 million in Q4 sales but forecast to be a blockbuster by 2030.
“Cobenfy could help address the need for more effective treatments for both the positive and as well as negative symptoms,” said Prakhar Saxena, an analyst on the CNS team at Clarivate. “It has an improved side effect profile — for example, a lack of extrapyramidal symptoms — and its novel mechanism of action could benefit schizophrenia patients.”
- Zanzalintinib – a third generation multitargeted tyrosine kinase inhibitor (TKI) developed by Exelixis, zanzalintinib is in testing both as a standalone and in combination with other treatments for solid tumors, notably non-clear cell renal cell carcinoma, where there is tremendous unmet need.
“Zanzalintinib could become the first therapy specifically approved for patients with the non-clear cell histology of RCC” said Catherine Willoughby, Ph.D., an oncology analyst at Clarivate. Furthermore, the treatment “has an improved pharmacokinetic profile,” and “has shown a favorable safety profile, with fewer adverse events compared with other TKIs, potentially making it more tolerable for long term use.” - CagriSema – Novo Nordisk’s next generation GLP-1 combination therapy for weight loss and type 2 diabetes, pairs semaglutide with cagrilintide, a long-acting amylin analogue. In March, the company reported findings from the REDEFINE 2 trial showing an average weight loss of 15.7% after 68 weeks, disappointing investors, who were looking for the drug to meet company projections of a 25% loss. The earlier phase 3 REDEFINE 1 trial found a 22.7% average weight loss for the same period in patients with obesity, with 40.5% achieving upwards of 25% — still short of investor expectations.
“The results fell short of the 25% weight loss target expected by both Novo and investors but are superior to those achieved by the individual components of CagriSema,” said Carles Recasens-Alvarez, Ph.D., a healthcare and data research analyst at Clarivate who studies the cardiovascular, renal, metabolic and hematology space.
- mRESVIA – Moderna’s mRNA vaccine for respiratory syncytial virus (RSV), which won FDA approval for use in adults 60 and up last May, is the third RSV vaccine to market but the first based on mRNA technology.
“The mRNA technology allows for rapid design and production of the vaccine as well as providing potential for quick adaptation to new RSV strains as needed,” said Sukhvinder Singh, Lead Healthcare Research and Data Analyst at Clarivate.
Watch the full webinar for in-depth analysis of these four Drugs to Watch.
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