Exploring the clinical trials, regulatory insights, and challenges of PROTACs in oncology

Sowndharya M1, Ramesh Joga1, Kajal Gandhi1

  • 1Department of Regulatory Affairs, National Institute of Pharmaceutical Education and Research, Hyderabad, Telangana, India.

Seminars in Oncology
|April 20, 2025
PubMed

Insights

Proteolysis-targeting chimeras (PROTACs) offer a novel cancer therapy by degrading disease-causing proteins. This technology shows immense potential for improved cancer treatment outcomes.

Area of Science:

  • Oncology
  • Molecular Biology
  • Drug Discovery

Background:

  • Cancer treatment faces challenges with drug resistance.
  • Proteolysis-targeting chimeras (PROTACs) are emerging as a novel therapeutic strategy.
  • PROTACs utilize the ubiquitin-proteasome system (UPS) to degrade target proteins.

Purpose of the Study:

  • To explore the classification and regulatory landscape of PROTAC technology in cancer.
  • To review ongoing clinical trials and the potential of PROTACs in cancer management.
  • To highlight challenges and opportunities for PROTAC implementation in oncology.

Main Methods:

  • Review of scientific literature and clinical trial data on PROTACs in cancer.
  • Analysis of PROTAC classification and regulatory pathways.
  • Discussion of the mechanism of action and therapeutic potential of PROTACs.

Main Results:

  • PROTACs demonstrate promising outcomes in degrading cancer-related proteins.
  • Several PROTACs are currently in various stages of clinical trials.
  • Regulatory compliance is crucial for expediting PROTAC approvals.

Conclusions:

  • PROTACs represent a significant advancement in cancer therapeutics.
  • Their ability to induce targeted protein degradation offers new hope for patients.
  • Further research and development are essential to fully realize the potential of PROTACs.

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