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IV-EVE: EVE for Injection-ADME, Pharmacokinetic and Toxicological Evaluation for Novel Deciparticle EVE Formulation
Wen-Han Chang1, Nancy Chang1, Sheng-Hao Min1
1Sapu Bioscience LLC, 10840 Thornmint Road, Suite 118, San Diego, CA 92127, USA.
Biomedicines
|July 28, 2026
Summary
Intravenous everolimus (IV-EVE) offers improved bioavailability and predictable pharmacokinetics compared to oral everolimus (Oral-EVE). This formulation may overcome oral delivery limitations for patients with advanced cancers.
Area of Science:
- Pharmacology
- Drug Delivery Systems
- Oncology
Background:
- Oral everolimus (Oral-EVE) is effective for malignancies but limited by poor oral bioavailability and first-pass metabolism.
- Intravenous everolimus (IV-EVE) formulation aims to bypass GI absorption and enhance pharmacokinetic predictability.
Purpose of the Study:
- To evaluate the pharmacokinetic and ADME properties of IV-EVE compared to Oral-EVE.
- To assess the safety profile of IV-EVE in preclinical models.
Main Methods:
- In vitro ADME studies across species.
- Pharmacokinetic, tissue distribution, metabolism, and excretion studies in rats comparing IV-EVE and Oral-EVE.
- Repeat-dose toxicology studies in rats.
Main Results:
- IV-EVE demonstrated higher and more consistent systemic exposure than Oral-EVE.
- Comparable elimination half-lives and metabolic profiles were observed between IV-EVE and Oral-EVE.
- IV-EVE showed broad tissue distribution without GI accumulation and no treatment-related gastric pathology in rats.
Conclusions:
- Intravenous administration of everolimus overcomes limitations of oral delivery.
- IV-EVE exhibits favorable PK and safety profiles, supporting clinical evaluation for advanced malignancies.
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