Oncotelic Therapeutics and Sapu Bioscience Define Sub-15 nm Nanoparticles as New Frontier in Drug Delivery

Oncotelic Therapeutics, Inc. (OTCQB: OTLC) and joint venture partner Sapu Bioscience have announced the publication of their comprehensive review article examining nanoparticles exclusively within the 5–15 nm range, marking the first systematic analysis of this emerging scale in nanomedicine. The paper, titled "Sub-15 nm Nanoparticles for Drug Delivery: Emerging Frontiers and Therapeutic Potential," appears in the International Journal of Molecular Sciences (IJMS 2025, 26, 10842; https://doi.org/10.3390/ijms262210842) and establishes this size regime as a new pharmacological paradigm with significant implications for drug development and therapeutic delivery.

Authored by Dr. Tapas De, Vuong Trieu, Scott Myers, Sanjive Qazi, Saran Saund, and Cynthia Lee, the review highlights how sub-15 nm nanoparticles achieve superior performance characteristics compared to both small molecules and larger nanocarriers. These systems demonstrate enhanced tissue penetration capabilities, reaching deeper into target tissues while reducing accumulation in non-target organs. The smaller size enables faster renal clearance, potentially mitigating toxicity concerns that have plagued larger nanoparticle formulations, while simultaneously improving diffusion across critical biological barriers including the blood-brain barrier.

The breakthrough potential of this size range lies in its ability to overcome fundamental limitations in current drug delivery approaches. Traditional small molecules often suffer from rapid clearance and limited targeting specificity, while larger nanoparticles face challenges with tissue penetration and potential toxicity from prolonged organ retention. The sub-15 nm nanoparticles represent a middle ground that combines the favorable pharmacokinetic properties of small molecules with the targeting capabilities of nanotechnology. This could enable more effective delivery of therapeutics to previously inaccessible sites, potentially revolutionizing treatment for conditions ranging from solid tumors to neurological disorders.

For the pharmaceutical industry, this research establishes a new framework for nanoparticle design and optimization. The comprehensive examination of sub-15 nm systems provides critical insights for drug developers seeking to improve therapeutic efficacy while reducing side effects. The findings suggest that this specific size range may represent an optimal balance between circulation time, tissue penetration, and clearance kinetics, potentially leading to more predictable and controllable drug delivery profiles.

The publication in the International Journal of Molecular Sciences (https://doi.org/10.3390/ijms262210842) represents a significant contribution to the scientific literature, as it systematically defines the unique properties and advantages of nanoparticles in this specific size range. By establishing sub-15 nm particles as a distinct category with specialized characteristics, the review provides researchers and developers with clear guidelines for future nanomedicine development. This could accelerate the translation of nanoparticle-based therapies from laboratory research to clinical applications, potentially benefiting patients through more effective and safer treatment options.

As nanomedicine continues to evolve, the identification of this optimal size range represents a critical advancement in the field. The ability to precisely control nanoparticle size and understand its implications for drug delivery could lead to more targeted therapies with improved safety profiles. This research establishes a foundation for future developments in personalized medicine and targeted drug delivery systems that could transform treatment approaches across multiple therapeutic areas.