Citation: Qian Wang, Yeping Bian, Elias Abouchabaka, Daniel Baecker, Gagan Dhawan, Anas Semghouli, Loránd Kiss, Wei Zhang, Vadim A. Soloshonok, Jianlin Han. Fluorine-containing drugs approved by the FDA in 2025[J]. Chinese Chemical Letters, ;2026, 37(9): 112640. doi: 10.1016/j.cclet.2026.112640 shu

Fluorine-containing drugs approved by the FDA in 2025

Qian Wang ^a ,
Yeping Bian ^{b, *,} ,
Elias Abouchabaka ^c ,
Daniel Baecker ^{c, *,} ,
Gagan Dhawan ^{d, e, *,} ,
Anas Semghouli ^f ,
Loránd Kiss ^{f, *,} ,
Wei Zhang ^{g, *,} ,
Vadim A. Soloshonok ^{h, *,} ,
Jianlin Han ^{a, *,}

a.
Jiangsu Co-Innovation Center of Efficient Processing and Utilization of Forest Resources, College of Chemical Engineering, Nanjing Forestry University, Nanjing 210037, China
b.
Department of Intensive Care Unit, Geriatric Hospital of Nanjing Medical University, Nanjing 210024, China
c.
Department of Pharmaceutical and Medicinal Chemistry, Institute of Pharmacy, Freie Universität Berlin, Königin-Luise-Straße 2+4, Berlin 14195, Germany
d.
School of Allied Medical Sciences, Delhi Skill and Entrepreneurship University, Dwarka, New Delhi 110077, India
e.
Department of Biomedical Science, Acharya Narendra Dev College, University of Delhi, Kalkaji, New Delhi 110019, India
f.
Institute of Organic Chemistry, Stereochemistry Research Group, HUN-REN Research Centre for Natural Sciences, Magyar tudósok krt. 2, Budapest H-1117, Hungary
g.
Department of Chemistry, University of Massachusetts Boston, Boston, MA 02125, United States
h.
IKERBASQUE, Basque Foundation for Science, María Díaz de Haro 3, Bilbao, Plaza Bizkaia 48013, Spain

bianyeping@jspgh.com

d.baecker@fu-berlin.de

gagandhawan@andc.du.ac.in

kiss.lorand@ttk.hu

wei2.zhang@umb.edu

vadym.soloshonok@ehu.es

hanjl@njfu.edu.cn

Received Date: 25 December 2025
Revised Date: 9 March 2026
Accepted Date: 17 March 2026
Available Online: 20 March 2026

Figures(24)

Fluorine substitution has emerged as a cornerstone of modern drug design, profoundly influencing the pharmacological properties of therapeutic agents. Owing to its high electronegativity and small atomic radius, fluorine imparts unique electronic and steric effects that enhance lipophilicity, metabolic stability, binding affinity, and pK_a, thereby improving efficacy, bioavailability, and pharmacokinetics. Often referred to as an "enchanted atom", fluorine can decisively alter the trajectory of drug candidates, reducing attrition and increasing clinical success. Within synthetic organic chemistry, the pursuit of novel biologically active compounds is closely tied to monitoring advances in approved pharmaceuticals, with fluorine-containing drugs representing one of the most dynamic areas of innovation. In this review, we profile fourteen new pharmaceuticals approved by the U.S. Food and Drug Administration (FDA) in 2025, including datopotamab deruxtecan, suzetrigine, mirdametinib, avutometinib/defactinib, taletrectinib, sunvozertinib, sebetralstat, rilzabrutinib, imlunestrant, paltusotine, remibrutinib, elinzanetant, ziftomenib, and zoliflodacin. For each compound, we examine the medicinal chemistry discovery, therapeutic application, and FDA approval timeline, with particular emphasis on synthetic strategies and the role of fluorine incorporation. This review aims to provide a timely resource and inspiration for researchers in academia and the pharmaceutical industry, as well as for students engaged in drug design, fluorine chemistry, and medicinal chemistry.
- Fluorine-containing compounds,
- Blockbuster drugs,
- Pharmaceuticals,
- Anti-cancer,
- Drug design and development,
- FDA,
- Asymmetric synthesis
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沈阳化工大学材料科学与工程学院沈阳 110142