{"entity":{"id":"idea-tr1-food-effect-dose-reduction","kind":"idea","name":"Use food effects to cut the dose and cost of oral drugs that absorb better with meals","aka":[],"tldr":"Some cancer pills are absorbed several times better with food, but the label says take them fasting at a high dose. Taking a quarter of the dose with breakfast can give the same drug levels at a quarter of the price.","summary":"Randomised PK and non-inferiority trials of low-dose-with-food versus standard fasting dosing for oral agents with large positive food effects (abiraterone is the established example; others include several kinase inhibitors), followed by label changes and guideline adoption. Regulators accept PK-bridged non-inferiority; payers fund the trials because savings are immediate.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Wrong doses): FDA Oncology Center of Excellence, Project Optimus","url":"https://www.fda.gov/about-fda/oncology-center-excellence/project-optimus"}],"tags":[],"related":[],"cancers":["prostate"],"sections":[],"technologies":["kinase-inhibitors","androgen-deprivation"],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":["b-dose-optimisation","b-drug-pricing"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"Low-dose-with-food regimens will show equivalent exposure and non-inferior efficacy for most agents with a fourfold or greater food effect, cutting drug cost by 50-75 percent.","rationale":"Fasting dosing was chosen to reduce variability, not to maximise benefit; for drugs whose absorption is limited fasting, feeding is a cheap way to increase exposure, and the variability concern can be tested directly.","test":"Identify candidates from label PK data; run PK-bridged randomised non-inferiority trials for the two with the largest spend, with a pre-agreed pathway to label change.","maturity":"early-clinical","actor":"research","cost":"small","horizonYears":2},"route":"/ideas/idea-tr1-food-effect-dose-reduction/","neighbours":{"cancer":[{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"technology":[{"id":"androgen-deprivation","kind":"technology","name":"Androgen deprivation & AR pathway inhibitors","route":"/technologies/androgen-deprivation/"},{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"bottleneck":[{"id":"b-drug-pricing","kind":"bottleneck","name":"Prices and value","route":"/bottlenecks/b-drug-pricing/"},{"id":"b-dose-optimisation","kind":"bottleneck","name":"Wrong doses","route":"/bottlenecks/b-dose-optimisation/"}]}}