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Timeline 3 due · 9 done

Dates for future items are the registry's or the sponsor's guidance; where only a window is known the entry says so and carries a placeholder date inside it. Corrected the day a result is public.

Due

  1. 2026

  2. European Commission decision expected

    Due, second half of 2026

    The Commission has on average about 67 days to act on a positive CHMP opinion, so a decision is expected in the second half of 2026. The date shown is a placeholder inside that window, not an announced date.

    obicetrapibregulatory

  3. PREVAIL primary completion

    Due, November 2026

    The registry primary completion date for the 9,541-patient cardiovascular outcomes trial of obicetrapib. This is the readout that decides whether CETP inhibition is a therapy or a twenty-year detour. The date is the registered one; a publication follows later.

    obicetrapiboutcomes trials
  4. 2027

  5. DalCor genotype-defined trial primary completion

    Due, August 2027

    Primary completion of the second genotype-selected dalcetrapib outcomes trial (NCT05918861, n=2,000), the continuing test of the ADCY9 hypothesis.

    dalcetrapibgeneticsoutcomes trials

Done

  1. 2026

  2. CHMP recommends Ubeslo and Evlarco

    The EMA's human medicines committee issues a positive opinion recommending marketing authorisation for obicetrapib monotherapy (Ubeslo) and the obicetrapib plus ezetimibe fixed-dose combination (Evlarco), on the strength of BROADWAY, BROOKLYN and TANDEM. The first favourable regulatory step any CETP inhibitor has ever received.

    obicetrapibregulatory
  3. 2024

  4. Obicetrapib phase 3 programme reads out

    BROADWAY (n=2,530), BROOKLYN (n=354) and TANDEM (n=407) complete, showing LDL-C reductions up to about 40% for obicetrapib monotherapy and roughly 50% in combination with ezetimibe, on top of maximally tolerated therapy, with tolerability comparable to placebo.

    LDL and apoBobicetrapibphase 3
  5. 2021

  6. dal-GenE completes: the genotype-first test

    The first prospective trial to select patients by the ADCY9 genotype that a retrospective analysis of dal-OUTCOMES had flagged as marking responders completes after enrolling 6,147 patients.

    dalcetrapibgeneticsoutcomes trials
  7. 2017

  8. REVEAL is positive, and anacetrapib is shelved

    Anacetrapib reduces major coronary events in 30,449 patients on intensive atorvastatin, the only positive outcomes trial the class has ever produced. Merck declines to file, citing a modest absolute benefit and the drug's accumulation in adipose tissue.

    anacetrapiboutcomes trials
  9. 2015

  10. ACCELERATE stopped for futility

    Evacetrapib more than doubles HDL-C and lowers LDL-C in 12,092 high-risk patients, and the event curves do not separate. The trial is stopped early for futility.

    evacetrapibHDL biologyoutcomes trials

  11. Mendelian randomisation reframes the class as apoB, not HDL

    Genetic studies of CETP variants converge on a conclusion the trials were slow to reach: the cardiovascular effect of lifelong lower CETP tracks apoB-containing lipoproteins, not HDL-C. Every subsequent development decision in the class, obicetrapib's LDL-C claim included, follows from this. The date is a marker for a body of work rather than a single publication.

    geneticsHDL biologyLDL and apoB
  12. 2012

  13. dal-OUTCOMES reports: raising HDL-C is not enough

    Dalcetrapib raises HDL-C by about a third in 15,871 patients after an acute coronary syndrome and produces no cardiovascular benefit. The first large, clean test of the HDL hypothesis with a CETP agent, and a negative one.

    dalcetrapibHDL biologyoutcomes trials
  14. 2006

  15. ILLUMINATE halted: torcetrapib increases mortality

    Pfizer stops the torcetrapib programme after the data monitoring board finds excess deaths and cardiovascular events among 15,067 randomised patients. The cause is later attributed to off-target effects on aldosterone and blood pressure, not to CETP inhibition itself, but the class carries the shadow for a decade.

    blood pressureoutcomes trialssafetytorcetrapib
  16. 1989

  17. CETP deficiency described in Japan

    Families with inherited CETP deficiency and very high HDL-C are described in Japan. The observation that people can live without functioning CETP, and do so with a striking lipid profile, is the origin of the whole therapeutic idea.

    geneticsHDL biologyhistory