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Europe approves obicetrapib, first CETP inhibitor to reach market after two decades of failures

Europe approves obicetrapib, first CETP inhibitor to reach market after two decades of failures

New Capabilities

NewAmsterdam Pharma's cholesterol drug wins European Commission approval, the first worldwide authorization of obicetrapib

Today: European Commission approves Ubeslo and Evlarco

Overview

Updated 1 hour ago

The European Commission approved two obicetrapib-based cholesterol drugs on September 21, 2026. It's the first time any CETP inhibitor has reached the market, after Pfizer, Roche, Eli Lilly and Merck spent billions on the drug class and failed.

The drugs, sold as Ubeslo (obicetrapib alone) and Evlarco (obicetrapib plus ezetimibe), target patients who can't reach LDL-C goals on statins or can't tolerate them. In Phase 3 trials, obicetrapib cut LDL-C by up to 40% as monotherapy and about 50% combined with ezetimibe, with side effects comparable to placebo.

Why it matters

For patients who can't tolerate statins, an oral drug that cuts LDL-C by up to 50% is now available in Europe.

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Key Indicators

50%
LDL-C reduction with obicetrapib + ezetimibe
Approximately 50% reduction in LDL-C versus placebo in the Phase 3 TANDEM trial.
40%
LDL-C reduction with obicetrapib monotherapy
Up to 40% reduction in LDL-C versus placebo in the Phase 3 BROADWAY and BROOKLYN trials.
4
Failed CETP inhibitor programs
Torcetrapib, dalcetrapib, evacetrapib, and anacetrapib all failed before obicetrapib.
€833M
Potential milestone payments to NewAmsterdam
NewAmsterdam is eligible for up to €833 million in clinical, regulatory, and commercial milestones from Menarini, plus tiered royalties.

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People Involved

Organizations Involved

Timeline

December 2006 September 2026

6 events Latest: Today
Tap a bar to jump to that date
  1. European Commission approves Ubeslo and Evlarco

    Today Regulatory approval

    The European Commission granted marketing authorization for obicetrapib monotherapy and the obicetrapib-ezetimibe combination, the first worldwide approval.

  2. EMA panel recommends obicetrapib approval

    Regulatory

    The European Medicines Agency's CHMP adopted a positive opinion recommending approval of Ubeslo and Evlarco.

  3. Merck's anacetrapib shows modest benefit, not pursued

    Clinical trial result

    Merck's REVEAL trial showed anacetrapib reduced cardiovascular events modestly, but Merck declined to seek approval.

  4. Eli Lilly stops evacetrapib for futility

    Clinical trial failure

    Eli Lilly halted evacetrapib after an interim analysis showed it was unlikely to help patients.

  5. Roche drops dalcetrapib after no benefit

    Clinical trial failure

    Roche discontinued dalcetrapib after a Phase 3 trial showed no reduction in cardiovascular events.

  6. Pfizer halts torcetrapib after increased deaths

    Clinical trial failure

    Pfizer halted torcetrapib after a trial showed higher mortality among patients taking the drug.

Scenarios

1

FDA approves obicetrapib for the US market

Possible Resolves by End of 2027

Discussed by: Analysts covering NewAmsterdam Pharma

NewAmsterdam has said it plans to submit obicetrapib to the US Food and Drug Administration. US approval would open the largest cholesterol drug market and put obicetrapib in direct competition with PCSK9 inhibitors and bempedoic acid. The company's ongoing PREVAIL outcomes trial could support the submission.

2

PREVAIL trial shows cardiovascular benefit

Uncertain Resolves by End of 2028

Discussed by: Cardiologists and trial observers

The ongoing PREVAIL outcomes trial tests whether obicetrapib reduces heart attacks, strokes, and cardiovascular death. Positive results would strengthen the case for obicetrapib as a first-line non-statin option. Neutral results would limit it to a niche for statin-intolerant patients.

3

Obicetrapib struggles commercially against established rivals

Possible Resolves by End of 2027

Discussed by: Market analysts

European launch begins with Ubeslo and Evlarco competing against PCSK9 inhibitors (Repatha, Praluent) and bempedoic acid (Nexletol). Uptake depends on pricing, reimbursement, and physician familiarity with a drug class that failed for two decades. First-year sales below €100 million would signal a slow start.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

December 2006

Torcetrapib (2006)

Pfizer halted its CETP inhibitor torcetrapib after the ILLUMINATE trial showed a 58% increase in deaths among patients taking the drug. Pfizer had invested more than $800 million in the program.

Then

Pfizer wrote off the program and its stock fell sharply.

Now

The failure cast a shadow over the entire CETP class for a decade.

Why this matters now

Torcetrapib's failure made regulators and investors wary of CETP inhibitors, which is why obicetrapib's approval took two decades.

2015-2017

PCSK9 inhibitor launch (2015-2017)

Amgen's Repatha and Sanofi's Praluent launched as injectable cholesterol drugs that cut LDL-C dramatically. Both struggled with reimbursement and payer pushback despite strong efficacy.

Then

Sales grew slowly as insurers restricted access.

Now

The experience showed that even powerful new cholesterol drugs face commercial hurdles in a crowded market.

Why this matters now

Obicetrapib faces the same reimbursement and adoption challenges as an oral alternative to injectable PCSK9 inhibitors.

August 2017

Anacetrapib (2017)

Merck's REVEAL trial showed anacetrapib reduced major coronary events by 9% over four years. The benefit was real but modest, and Merck decided not to seek regulatory approval.

Then

Merck shelved anacetrapib despite positive results.

Now

The trial proved CETP inhibition could reduce cardiovascular events, validating the mechanism obicetrapib now uses.

Why this matters now

Anacetrapib showed the class could work. Obicetrapib is the first to turn that into an approved drug.

Sources

(6)