US biopharmaceutical company Vanda Pharmaceuticals Inc (Nasdaq: VNDA) on Monday reported positive topline results from its randomised controlled clinical study evaluating tradipitant, an oral neurokinin-1 (NK-1) receptor antagonist, for the prevention of nausea and vomiting induced by GLP-1 receptor agonist Wegovy in overweight and obese adults.
Patients were pre-treated with either tradipitant or placebo prior to a 1 mg injection of Wegovy, a dose that normally takes 9 weeks of titration to reach. The study met its primary endpoint, with only 29.3% of tradipitant-treated participants (17/58) experiencing vomiting compared to 58.6% on placebo (34/58), representing a 50% relative reduction. The key secondary endpoint was also met, with the proportion of participants experiencing vomiting and significant nausea at 22.4% in the tradipitant group (13/58) versus 48.3% on placebo (28/58). Tradipitant demonstrated a favourable safety profile consistent with previous studies, with no new safety signals observed.
Vanda said that it will evaluate an efficient development path towards obtaining regulatory approval for this unmet need.
A Phase III programme is anticipated to commence in the first half of 2026, positioning tradipitant as a key adjunct to improve outcomes in GLP-1 agonist treatments.
Pulmonary Fibrosis Foundation Launches New Five-Year Strategy: The PFF is ME
Acumen Pharmaceuticals begins open-label extension of Phase 2 Alzheimer's study
Incyte receives positive CHMP opinion for Minjuvi in relapsed or refractory follicular lymphoma
BioInvent secures EMA positive opinion for Orphan Drug Designation of BI-1808 in CTCL
IXICO wins GBP3.5m global Phase 3 Huntington's Disease trial contract
Japan's Ministry of Health, Labor and Welfare accepts Lundbeck's NDA for Vyepti (eptinezumab)
BodyLogicMD supports recommendation to remove black box warnings on certain forms of oestrogen
Fondazione Telethon reports positive opinion for Waskyra marketing authorisation in Europe