Published On: December 20, 2023Categories: Scientific news

Is it possible for a drug to go through a clinical trial more than once?

Potent drugs with high therapeutic efficacy, such as the anticancer drug doxorubicin, generate adverse effects that reduce their application in clinical practice, limiting healthcare professionals’ and patients’ choices.

Nanotechnology holds the promise to grant already approved drugs a second life.


Nanomedicine is a reality in daily clinical practice


Doxil®, the doxorubicin liposome formulation, was the first and clearest example of the enormous nanotechnology potential, not only in developing new drugs but also in enhancing the performance of already approved ones. Since 1995, others have followed, such as Abraxane®.

Nanomedicines exhibit distinctive biological effects due to their nano-scale dimensions, specific structure, and unique surface properties. By leveraging nanotechnology, it becomes possible to address the limitations of conventional drug formulations.

Nano-formulations offer the potential to mitigate side effects by targeted delivery, minimizing off-target impact on healthy tissues. Additionally, nanomedicine can contribute to optimizing drug dosages and release profiles, leading to a more controlled and tailored therapeutic approach, ultimately improving the overall safety profile.

Around 100 nanomedicine-based formulations have been approved by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), and 563 are in clinical process or other stages (663 in total). Most of these nanomedicines are in clinical phase I (33%) and phase II (21 %) (2021 data) [1]. Nanomedicines are a clinical reality in oncology and infectious diseases.

Efforts are being made to improve the efficacy of already-on-the-market medicines in new clinical trials, comparing their conventional dosage form with their encapsulated counterpart. As research in nanomedicine progresses, the potential for improving the landscape of treatments continues to grow.


A closer look at the nanomedicine that set the precedent


Doxorubicin has long been a cornerstone in cancer treatment due to its effectiveness against various malignancies. However, its therapeutic potential was hampered by dose-dependent toxicities, mainly due to its cumulative cardiotoxicity.

Far from becoming obsolete, nanotechnology gave a second life to this cancer drug by encapsulating it in lipid nanoemulsions. In 1995, Doxil® became the first nanomedicine ever approved by the Food and Drug Administration (FDA) and set a precedent for developing further nanotech-based medicines.

Doxil® is the pegylated (polyethylene glycol coated) liposome-encapsulated form of doxorubicin. The encapsulation using lipid nanoparticles increases enhanced permeability and retention (EPR), increasing the levels of doxorubicin in tumor cells and interstitial fluids compared to free doxorubicin. The encapsulation of doxorubicin in liposomes reduces cardiotoxicity compared to standard care [2]. It has proven effective in lowering myocardial drug concentrations, allowing for higher accumulated doses without compromising cardiac function. Patients undergoing Doxil® treatment experience fewer adverse effects, making it a more tolerable and patient-friendly option.


Tap into DIVERSA’s expertise for maximum impact!


At DIVERSA, we want to be part of the change engine and help improve patients’ quality of life by developing new nanomedicines. Our mission is to translate molecules into medicines to bridge the gap between bench and bedside.

We focus our R&D efforts on developing lipid nanoparticles to associate new molecules. From poorly soluble drugs to potent biomolecules such as peptides, proteins, and RNAs to efficiently deliver them in their therapeutic active form, enhancing their performance. Our R&D focuses on developing new nanomedicines in three therapeutic areas with unmet clinical needs: oncology, inflammatory, and rare diseases.


We are always open to initiating new collaborations and partnerships. If you want to explore a new way to boost the efficacy of your therapeutic molecule, contact us!