Chemistry:Obicetrapib
Obicetrapib is a CETP inhibitor that is intended to treat dyslipidemia. Obicetrapib is a lipid-modifying agent that blocks a blood protein called CETP, thereby lowering the level of LDL cholesterol.[1]
The most common side effects include hypertension, dizziness, headache, diarrhea, and abdominal pain.[1]
History
Obicetrapib was initially developed by Amgen as AMG-899 and was abandoned in 2017.[2] In 2020, Amgen licensed the drug to NewAmsterdam Pharma.[3] In 2022, NewAmsterdam Pharma licensed the drug to Menarini Group.[4]
In a clinical trial, as an add-on to statins, compared with placebo, it decreased concentrations of LDL-C (by up to 51%), apolipoprotein B (by up to 30%) and non-high-density lipoprotein cholesterol (non-HDL-C) (by up to 44%), and increased HDL-C concentration (by up to 165%).[5][6]
Obicetrapib's ability to lower LDL cholesterol (“bad” cholesterol) compared with placebo was observed in two 52-week, randomized, double-blind, placebo-controlled studies in adults with high cholesterol and/or mixed dyslipidemia who were already receiving the maximum tolerated cholesterol-lowering treatment.[1]
Society and culture
Legal status
On Sept 21,2026 the European Commission granted marketing authorisation to NewAmsterdam and Menarini for Ubeslo (obicetrapib 10mg monotherapy) and Evlarco (10mg obicetrapib plus 10mg ezetimibe fixed-dose combination).[7]
Names
Obicetrapib is the International nonproprietary name.[8]
References
- ↑ 1.0 1.1 1.2 "Ubeslo EPAR". 24 July 2026. https://www.ema.europa.eu/en/medicines/human/EPAR/ubeslo. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
- ↑ Amgen kills off CETP inhibitor after seeing Merck data
- ↑ NewAmsterdam bags $196M to resurrect Amgen's discarded CETP drug
- ↑ "Menarini Group's Obicetrapib and Obicetrapib/Ezetimibe Marketing Authorisation Applications Accepted for Review by the European Medicines Agency (EMA) for the Treatment of adults with primary hypercholesterolaemia (Heterozygous familial and non-familial)". https://www.menarini.com/en-us/news/news-detail/menarini-group-s-obicetrapib-and-obicetrapib-ezetimibe-marketing-authorisation-applications-accepted-for-review-by-the-european-medicines-agency.html.
- ↑ Ballantyne, Christie M.; Ditmarsch, Marc; Kastelein, John JP; Nelson, Adam J.; Kling, Douglas; Hsieh, Andrew; Curcio, Danielle L.; Maki, Kevin C. et al. (July 2023). "Obicetrapib plus ezetimibe as an adjunct to high-intensity statin therapy: A randomized phase 2 trial". Journal of Clinical Lipidology 17 (4): 491–503. doi:10.1016/j.jacl.2023.05.098. PMID 37277261.
- ↑ Nicholls, Stephen J.; Ditmarsch, Marc; Kastelein, John J.; Rigby, Scott P.; Kling, Douglas; Curcio, Danielle L.; Alp, Nicholas John; Davidson, Michael H. (August 2022). "Lipid lowering effects of the CETP inhibitor obicetrapib in combination with high-intensity statins: a randomized phase 2 trial" (in en). Nature Medicine 28 (8): 1672–1678. doi:10.1038/s41591-022-01936-7. ISSN 1546-170X. PMID 35953719.
- ↑ Debbarma, Salong (September 22, 2026). "EC approves Menarini and NewAmsterdam’s obicetrapib therapies". Pharmaceutical Technology. https://www.pharmaceutical-technology.com/news/ec-menarini-newamsterdams-obicetrapib-therapies/.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 77". WHO Drug Information 31 (1). 2017.
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