LDL-C: 32.6 percentage-point reduction vs placebo · Day 84 (12 weeks)
BROADWAY · Phase 3 · Primary trial poster · 10 mg once daily · Placebo-adjusted least-squares mean changes at day 84; LDL within-arm decrease was 29.9% versus a 2.7% placebo increase.
LDL-C: 32.6 percentage-point reduction vs placebo · Day 84 (12 weeks)
10 mg once daily
Established ASCVD and/or heterozygous familial hypercholesterolemia
Placebo-adjusted least-squares mean changes at day 84; LDL within-arm decrease was 29.9% versus a 2.7% placebo increase. EU Ubeslo/Evlarco authorizations announced September 21, 2026; U.S. approval and definitive PREVAIL outcome remain unverified.
Safety context
Treatment-emergent events: 59.7% vs 60.8%; serious events: 12.5% vs 13.9%; discontinuations: 4.0% vs 5.1% (obicetrapib/placebo).
Limitations: HDL increases are biomarker changes, not proof of protection. Cardiovascular-event analysis in BROADWAY was exploratory.
Status in this atlas: EU Ubeslo/Evlarco authorizations announced September 21, 2026; U.S. approval and definitive PREVAIL outcome remain unverified. Status source
Inhibits cholesteryl ester transfer protein (CETP).
EU obicetrapib 10 mg + ezetimibe 10 mg combination; distinct product. Authorization announced; local launch not verified.
Uses, doses and availability depend on the formulation, indication and country. Study doses below describe research; they are not prescribing instructions.
A next milestone is not summarized for this therapy. This does not mean development has ended.
Development history5 selected milestones
Obicetrapib · compound history across indications
Selected sourced milestones, not a complete development history. Dates distinguish study starts, publications, announcements and approvals; the first listed date is not necessarily when development began. September 22 selectively adds sponsor-announced European authorization; earlier history retained.
Publication
TULIP phase 2 results
The early randomized study of TA-8995, later named obicetrapib, reported LDL-C lowering in 364 participants with mild dyslipidemia. The publication explicitly identified cardiovascular outcomes as requiring a separate trial.
NewAmsterdam announced the first participant dosed in PREVAIL, the phase 3 trial designed to test cardiovascular events in people with ASCVD despite lipid-lowering therapy. This is a trial-launch milestone, not an outcomes result.
The randomized ROSE trial reported the effects of adding obicetrapib to high-intensity statins, extending its clinical development into patients requiring additional lipid lowering.
BROADWAY reported a 32.6-percentage-point placebo-adjusted LDL-C reduction at day 84 in patients at high cardiovascular risk. This is the source trial for the obicetrapib lipid endpoints plotted here; biomarker efficacy alone does not establish cardiovascular-event benefit.
European Ubeslo and Evlarco authorizations announced
Menarini and NewAmsterdam announced European Commission authorization of Ubeslo (obicetrapib 10 mg) and Evlarco (obicetrapib 10 mg/ezetimibe 10 mg) for primary hypercholesterolaemia or mixed dyslipidaemia. U.S. approval and PREVAIL cardiovascular-event results remain unverified. National launch is a separate question; final Commission document was not retrieved.
