review · Molecules
In 2024, the United States Food and Drug Administration authorised 50 new drugs, consistent with annual averages observed between 2018 and 2023. Biologics and complex molecular types represented a substantial share of these approvals, led by a record 13 monoclonal antibodies that accounted for over a quarter of the total. Combined with three proteins and four TIDES molecules (comprising two oligonucleotides and two peptides), small molecules made up only one in three approved therapeutics. No antibody-drug conjugates secured approval in 2024. Market authorisations also included two deuterated drugs and two PEGylated peptides, demonstrating renewed commercial confidence in PEGylation strategies to prolong drug half-life. Among the authorised small molecules, two-thirds incorporated fluorine atoms and nitrogen-aromatic heterocycles. These 50 therapies are classified and evaluated strictly according to their structural chemistries.
Tracking annual drug authorisations provides a clear picture of shifting clinical and industrial trends across medicinal chemistry. The 2024 outcomes highlight the sustained rise of biologics over conventional small molecules. Identifying recurring chemical features, such as fluorination and deuteration, allows research teams to recognise structural designs that have successfully navigated the stringent regulatory hurdles required to reach patients.
Because this work analyses compounds that have already received FDA regulatory clearance, the molecules represent completed commercialisation pathways at full market readiness. The structural patterns provide biopharmaceutical companies, research institutes, and technology transfer officers with empirical benchmarks for late-stage pipeline planning, highlighting strong commercial momentum behind monoclonal antibodies, PEGylated peptides, and fluorinated or heterocyclic small molecules.
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The U.S. Food and Drug Administration (FDA) has authorized 50 new drugs in 2024, which matches the average figure for recent years (2018-2023). The approval of 13 monoclonal antibodies (mAbs) sets a new record, with these molecules accounting for more than 25% of all drugs authorized this year. Three proteins have been added to the list of biologics, and with the inclusion of four TIDES (two oligonucleotides and two peptides), only one in three approved drugs this year is a small molecule. As of 2023, no antibody-drug conjugates (ADCs) have reached the market this year. Two deuterated drugs have been approved, bringing the total approvals for this class of compounds to four. This year saw the authorization of two more PEGylated drugs-both peptides-highlighting a renewed interest in this strategy for extending drug half-life, despite the setback caused by the withdrawal of peginesatide from the market in 2014 due to adverse side effects. <i>N</i>-aromatic heterocycles and fluorine atoms are present in two-thirds of all the small molecules approved this year. Herein, the 50 new drugs authorized by the FDA in 2024 are analyzed exclusively on the basis of their chemical structure. They are classified as the following: biologics (antibodies, proteins), TIDES (oligonucleotides and peptides), combined drugs, natural products, F-containing molecules, nitrogen aromatic heterocycles, aromatic compounds, and other small molecules.
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DOI: 10.3390/molecules30030482
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