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A map of molecular drug targets and therapeutics for the US FDA-approved drugs: The impact of expedited regulatory pathways and first-in-class drug approvals on drug innovation
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DOI：10.1016/j.pharmthera.2025.108945.png)
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Abstract
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Despite advances in pharmaceutical innovation, there is a lack of insights into recent FDA drug approval trends, particularly concerning molecular targets, therapeutic areas, and diseases. Here, we map the molecular targets of 465 drugs approved by the US FDA from 2015 to 2024: 29% were biologics, 71% were NMEs, 50% targeted orphan diseases, and 41% were first-in-class drugs with novel mechanisms. Five major protein classes predominate as drug targets: enzymes (17%), kinases (16%), GPCRs (12%), transporter proteins (4%), and nuclear receptors (3.7%), highlighting a focus on chronic and life-threatening diseases, especially orphan disease indications. We compare regular and expedited review pathways across different therapeutic areas and observe that FDA expedited review programs have significantly increased access (67%) to new therapeutics, notably in oncology, where 80% to 100% of drugs utilize at least one expedited pathway. More than 70% of expedited approvals involved multiple pathways. Priority review emerged as the most common approval type, while accelerated approval was the least frequent. These findings illustrate ongoing trends in first-in-class drugs, the factors that drive drug innovation, and expedited approval processes. They also emphasize the importance of regulatory mechanisms in expediting the delivery of new treatments to patients. In our study, we examine the trends in drug approvals for non-communicable diseases, including cardiovascular diseases (8.6%), cancer (29%), respiratory illnesses (4.3%), and diabetes (3%), along with their pharmacological properties.
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