Indole therapeutics: Latest FDA updates, ongoing trials, and future directions

Butt N., BAYTAŞ S.

Drug Discovery Today, cilt.30, sa.10, 2025 (SCI-Expanded) identifier identifier

  • Yayın Türü: Makale / Derleme
  • Cilt numarası: 30 Sayı: 10
  • Basım Tarihi: 2025
  • Doi Numarası: 10.1016/j.drudis.2025.104471
  • Dergi Adı: Drug Discovery Today
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus, Academic Search Premier, Aerospace Database, Biotechnology Research Abstracts, Communication Abstracts, EMBASE, International Pharmaceutical Abstracts, MEDLINE, Metadex, Civil Engineering Abstracts
  • Anahtar Kelimeler: cancer, clinical trials, drug development, FDA approvals, indole, neurological disorders, viral infectious
  • Gazi Üniversitesi Adresli: Evet

Özet

Indole-based compounds serve as versatile pharmacophores across anticancer, antiviral, neurological, antimicrobial, and metabolic therapies. This review systematically analyses FDA-approved, withdrawn, and investigational indole-containing drugs over the past decade, focusing on evolving clinical outcomes, regulatory decisions, and therapeutic repositioning. It explores the shift from cytotoxic to targeted anticancer agents, the rise of indole-based antivirals in response to the COVID-19 pandemic, and the expanding interest in neuroactive indoles, particularly psychedelic compounds. Additionally, it highlights the underrepresentation of indole-based antibiotics and outlines progress in epigenetic and metabolic modulators. Through a detailed evaluation of pharmacological classes, clinical trial data, and structural characteristics, this review presents a comprehensive framework to guide future optimization and multi-target development of indole scaffolds.