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    Obicetrapib

    Also known as Ubeslo, Evlarco, CETP inhibitor obicetrapib

    Obicetrapib is a once-daily oral CETP inhibitor developed by NewAmsterdam Pharma that lowered LDL cholesterol by about a third versus placebo in the BROADWAY trial.[1] The European Commission approved it in September 2026 as Ubeslo, and with ezetimibe as Evlarco, its first approval anywhere. Whether it prevents heart attacks will be tested in the PREVAIL trial, with an interim analysis planned for late 2026.[2][3]

    Editor reviewedStrict sourcingUpdated WikiHealth and medicine, GLP-1 and metabolic medicine, Life sciences
    Key facts

    Obicetrapib is a CETP inhibitor, a drug class with a troubled history, and in September 2026 it won its first approval, in the EU. It is a pill taken once a day, alone or combined with ezetimibe.[1][4][2]

    This page is general information, not medical advice. Talk to a clinician about cholesterol treatment.

    Trial results

    In BROADWAY, published in July 2025, 2,530 patients with atherosclerotic disease or heterozygous familial hypercholesterolemia took obicetrapib 10 mg or placebo daily. All were already on maximum tolerated lipid-lowering therapy. LDL fell by 32.6 percentage points more with obicetrapib at day 84, and adverse-event rates were similar.[1] In TANDEM, a single pill of obicetrapib 10 mg plus ezetimibe 10 mg lowered LDL by 48.6% versus placebo over 84 days.[4]

    Regulatory status

    On 24 July 2026 the EMA’s scientific committee, the CHMP, recommended approval of Ubeslo (obicetrapib) and Evlarco (obicetrapib plus ezetimibe) for primary hypercholesterolaemia and mixed dyslipidaemia.[5] The European Commission granted authorisation on 21 September 2026. The company called this the first regulatory approval of obicetrapib worldwide. The authorisation requires NewAmsterdam to submit final results from the PREVAIL outcomes trial.[2]

    The CETP history

    Earlier CETP inhibitors sharply raised HDL (“good”) cholesterol. Torcetrapib raised HDL by 72%, but its 15,067-patient trial was stopped because deaths and cardiovascular events rose.[6] Anacetrapib later more than doubled HDL and produced a modest reduction in major coronary events (rate ratio 0.91) over about four years.[7] Obicetrapib is being developed mainly as an LDL-lowering drug. Its outcome data are still pending.[1][3]

    What comes next

    NewAmsterdam said in May 2026 that it would run an interim analysis of PREVAIL, which has over 9,500 patients, in the fourth quarter of 2026. It expects to report the result in the first quarter of 2027, and to complete the trial by the end of 2027 if it does not stop early for efficacy.[3] In late September 2026 the company dosed the first patient in SPINOZA, a Phase 2b trial in preclinical Alzheimer’s disease.[8] Compare other add-on drugs in pcsk9-inhibitors and the cholesterol drugs guide.

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    Questions readers ask

    What is obicetrapib?

    An oral, once-daily CETP inhibitor that lowers LDL cholesterol. In BROADWAY, 10 mg daily lowered LDL by 32.6 percentage points more than placebo in high-risk patients already on maximum tolerated therapy.[1]

    Is obicetrapib approved?

    In the European Union, yes. The European Commission granted marketing authorisation for Ubeslo (obicetrapib) and Evlarco (obicetrapib with ezetimibe) in September 2026, described by the company as the first approval of obicetrapib worldwide.[2]

    Does obicetrapib reduce heart attacks?

    Not yet known. The PREVAIL outcomes trial of over 9,500 patients is testing that; NewAmsterdam planned an interim analysis in the fourth quarter of 2026 with results expected in the first quarter of 2027.[3]

    Why were earlier CETP inhibitors a problem?

    Torcetrapib raised HDL by 72% but increased deaths and cardiovascular events, and its trial was stopped early. Anacetrapib later produced a modest reduction in major coronary events.[6][7]

    Sources

    · 9 claims from 4 publishers

    Each numbered claim is a statement we checked against the sources listed with it. Tap a number in the text to see its sources in place.

    1. [1]

      In BROADWAY (2,530 patients with ASCVD or heterozygous familial hypercholesterolemia on maximum tolerated lipid-lowering therapy), obicetrapib 10 mg daily, a selective CETP inhibitor, lowered LDL cholesterol by 32.6 percentage points more than placebo at day 84, with similar adverse-event rates. confirmedas of 2026-10-11

    2. [2]

      On 21 September 2026 NewAmsterdam and Menarini announced that the European Commission had granted marketing authorisation for Ubeslo and Evlarco, the first regulatory approval of obicetrapib worldwide, with a requirement to submit final results of the PREVAIL outcomes trial. confirmedas of 2026-10-11

    3. [3]

      NewAmsterdam said in May 2026 that it would run an interim analysis of the PREVAIL cardiovascular outcomes trial (over 9,500 patients) in the fourth quarter of 2026, expects to report the result in the first quarter of 2027, and anticipates completion by the end of 2027 if the trial does not stop early for efficacy. confirmedas of 2026-10-11

    4. [4]

      In the TANDEM trial (407 participants, 84 days), a fixed-dose pill of obicetrapib 10 mg plus ezetimibe 10 mg lowered LDL cholesterol by 48.6% versus placebo. confirmedas of 2026-10-11

    5. [5]

      On 24 July 2026 NewAmsterdam Pharma and its European partner Menarini announced that the EMA's CHMP had adopted a positive opinion recommending marketing authorisation for obicetrapib as Ubeslo (monotherapy) and Evlarco (with ezetimibe) for primary hypercholesterolaemia and mixed dyslipidaemia. confirmedas of 2026-10-11

    6. [6]

      The earlier CETP inhibitor torcetrapib raised HDL cholesterol by 72.1% but its outcome trial (15,067 patients) was stopped early because it increased cardiovascular events (hazard ratio 1.25) and death from any cause (hazard ratio 1.58). confirmedas of 2026-10-11

    7. [7]

      In REVEAL (30,449 adults on intensive statin therapy, median 4.1 years), the CETP inhibitor anacetrapib raised HDL cholesterol by 104% and modestly reduced major coronary events (10.8% vs 11.8%; rate ratio 0.91). confirmedas of 2026-10-11

    8. [8]

      On 29 September 2026 NewAmsterdam announced dosing of the first patient in SPINOZA, a Phase 2b trial of obicetrapib in people with preclinical Alzheimer's disease. confirmedas of 2026-10-11

    9. [9]

      If lifestyle and statins do not lower LDL cholesterol enough, the 2026 guideline recommends adding nonstatin therapy such as ezetimibe, bempedoic acid or a PCSK9 monoclonal antibody, and notes that inclisiran is still being studied to show whether its LDL lowering reduces cardiac events. confirmedas of 2026-10-11

    Revision history (1)
    1. Page created.

    Created Oct 11, 2026. Last reviewed by an editor on Oct 11, 2026. Next scheduled review: Dec 31, 2026.

    Cite this page

    "Obicetrapib." ContentLora, updated Oct 11, 2026. https://contentlora.com/wiki/obicetrapib

    Spotted an error? Suggest a correction or emailcorrections@contentlora.com.

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