A comprehensive review of small molecule drugs approved by the FDA in 2025: advance and prospect.
Small molecule drugs remain crucial in drug discovery, with advancements in design technologies driving their development. The review offers insights but lacks clinical outcome data.
Where it sits
this study against the rest of the nad+ (nicotinamide adenine dinucleotide) corpusSummary and findings
The review discusses the FDA approval of 46 drug marketing applications in 2025, focusing on 31 small molecule drugs. It highlights advancements in drug design technologies and the significance of me-too drugs in enhancing potency and development efficiency. The paper aims to provide insights into the development processes of these drugs for future research inspiration.
Abstract
In 2025, the FDA approved 46 drug marketing applications, 31 of which were small molecule drugs. Despite the advancements in biotechnologies such as antibody drugs, RNA-based treatments, and antibody-drug conjugates, small molecule drugs remain dominant in new drug discovery. With progress in computer-aided drug design and scaffold-based drug design <i>etc</i>, modern drug discovery has stepped into a phase of rapid development. The marketed drugs in the same field often share similar structures and biological activities, while development of me-too drugs can notably enhance potency and streamline the development process. Comprehending the development process of newly launched drugs helps to identify mainstream technologies and provides structural scaffolds and inspirations for future research. This review comprehensively summarises the development progress of new drugs approved in 2025, including molecular design, structural modification, structure-activity relationship, and enhancement of drug-like properties to offer valuable insights to pharmaceutical chemists and bring inspiration for future research.
Background
The paper addresses the ongoing relevance of small molecule drugs in the context of modern drug discovery, despite the rise of biotechnologies like antibody and RNA-based treatments. Understanding the development of these drugs is crucial for identifying current trends and technologies in pharmaceutical chemistry. This study is significant as it provides a comprehensive overview of the drug development landscape in 2025, which can guide future research and innovation.
Methods
This is a review article that summarizes the development of drugs approved by the FDA in 2025. It focuses on the molecular design, structural modification, and structure-activity relationships of these drugs. The review does not involve original experimental research but compiles data from various sources to provide an overview of the current state of drug development.
Results
The review highlights that 31 out of 46 FDA-approved drugs in 2025 were small molecule drugs. It discusses the role of computer-aided and scaffold-based drug design in the development of these drugs. The paper also notes the prevalence of me-too drugs, which share similar structures and activities with existing drugs, as a means to enhance drug potency and streamline development.
Interpretation
The findings suggest that small molecule drugs continue to play a dominant role in drug discovery, supported by modern design technologies. While the review provides valuable insights into drug development processes, it lacks specific clinical data to assess the real-world impact of these drugs. The emphasis on me-too drugs indicates a trend towards optimizing existing drug frameworks rather than developing entirely novel compounds.
Key findings
- 46 drug marketing applications approved by FDA in 2025.
- 31 of the approved drugs were small molecule drugs.
- Advancements noted in computer-aided drug design and scaffold-based drug design.
- Me-too drugs can enhance potency and streamline development.
Limitations
- No specific clinical outcomes reported.
- Review article, no original experimental data.
- Focuses on drug design rather than clinical efficacy.