A Framework for Fitness-for-Purpose and Reuse in Computational Phenotyping
November 17, 2025
Brand Name :
N/A
Synonyms :
epofolate
Class :
Antineoplastic agents
Dosage Forms & StrengthsÂ
IntravenousÂ
5mgÂ
Indicated for Advanced Solid Tumours:
In phase I/II clinical trials
In the first study, patients received BMS-753493 once a day on Days 1, 4, 8, and 11 of every 21 days at an initial dose of 5 mg intravenously.
In Study 2, patients received BMS-753493 once a day on Days 1-4 of every 21 days at an initial dose of 2.5 mg everyday intravenously.
Outcomes In all, two investigations involved the treatment of sixty-five individuals.
In Study 1, the maximum tolerated dosage (MTD) was 15 mg, while in Study 2, it was 26 mg.
Dosage Forms & StrengthsÂ
Safety and efficacy not establishedÂ
Refer adult dosingÂ
Actions and Spectrum:Â
epofolate, explored in trials for the treatment of Advanced Solid Tumors, is a folate conjugate derived from the epothilone analog BMS-748285. This innovative compound was specifically designed to target cancer cells expressing folate receptors. During Phase I/IIa pharmacokinetic and safety studies, epofolate exhibited general tolerability.
Common toxicities associated with the broader epothilone class of anticancer agents were observed. However, peripheral neuropathy and neutropenia appeared to manifest less frequently and with reduced severity compared to traditional epothilones. Despite these observations, the trials did not demonstrate significant antitumor activity. Consequently, the further development of BMS-753493, also known as epofolate, has been discontinued.Â
N/AÂ Â Â Â Â Â Â
Black box warning:Â
NoneÂ
Contraindications/caution:Â
N/AÂ
Pregnancy consideration: Insufficient data availableÂ
Lactation: Excretion of the drug in human breast milk is unknownÂ
Pregnancy category:Â
Category A: well-controlled and Satisfactory studies show no risk to the fetus in the first or later trimester.Â
Category B: there was no evidence of risk to the fetus in animal studies, and there were not enough studies on pregnant women.Â
Category C: there was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.   Â
Category D: adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.   Â
Category X: Drugs listed in this category outweigh the risks over benefits. Hence, these categories of drugs need to be avoided by pregnant women.   Â
Category N: There is no data available for the drug under this categoryÂ
Pharmacology:Â
epofolate, explored in trials for the treatment of Advanced Solid Tumors, is a folate conjugate derived from the epothilone analog BMS-748285. This innovative compound was specifically designed to target cancer cells expressing folate receptors. During Phase I/IIa pharmacokinetic and safety studies, epofolate exhibited general tolerability. Common toxicities associated with the broader epothilone class of anticancer agents were observed.Â
Pharmacokinetics:Â
N/AÂ
Administration:Â
It is administered intravenouslyÂ
Patient information leafletÂ
Generic Name: epofolateÂ
Why do we use epofolate?Â
A synthetic combination of folic acid and epothilone is called epofolate. It has been used in clinical studies to treat Advanced Solid tumors.Â