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Drug

Dalcetrapib

Late-stage clinical development
ClassCholesteryl ester transfer protein inhibitor
RxNorm872467ChEMBLCHEMBL313006UNII3D050LIQ3H
1
Active clinical trials
Cholesteryl ester transfer protein
Primary target
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS)

Clinical trial2026-06-22Results expected Q3 2027 · ClinicalTrials.gov

A Double-blind, Placebo-controlled, Phase 2a Proof-of-concept Trial of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19

Clinical trial2022-12-07Results posted · ClinicalTrials.gov

A Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial

Clinical trial2022-10-12Results posted · ClinicalTrials.gov

A Phase II, Double-Blind, Randomized, Placebo-controlled, Parallel Group Study, Evaluating the Efficacy and Safety of RO4607381 Over a 24-week Period in Patients With CHD or a CHD Risk Equivalent

Clinical trial2020-01-27Results posted · ClinicalTrials.gov

A Phase II, Placebo-Controlled, Double-Blind Extension Study of Study NC19453 Assessing Long-term Safety and Efficacy of RO4607381

Clinical trial2020-01-03Results posted · ClinicalTrials.gov

A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome

Clinical trial2020-01-03Results posted · ClinicalTrials.gov

A Randomized, Placebo-controlled Study of the Effect of RO4607381 on Progression or Regression of Atherosclerotic Plaque in Patients With Coronary Heart Disease (CHD) Including Patients With Other CHD Risk Factors

Clinical trial2020-01-03Results posted · ClinicalTrials.gov

A Randomized, Double-blind Study of the Effect of RO4607381 in Combination With Pravastatin on HDL-cholesterol (HDL-C) Levels in Patients With Low or Average HDL-C Levels

Clinical trial2020-01-02Results posted · ClinicalTrials.gov

A Randomized, Placebo-controlled Study of the Safety, Tolerability and Effect on Endothelial Function, as Measured by Flow Mediated Dilatation, of RO4607381 in Patients With Coronary Heart Disease (CHD) or CHD Risk Equivalents.

Clinical trial2020-01-02Results posted · ClinicalTrials.gov

A Single-center, Randomized, Open-label, Four Treatments, Four Periods, Four Sequence, Four-way Crossover Study to Explore the Pharmacokinetic Performance of Dalcetrapib and Atorvastatin Fixed Dose Combination Prototype Formulations in Healthy Volunteers

Clinical trial2019-12-17Results posted · ClinicalTrials.gov

An Open Label, Single Centre Study to Investigate the Metabolic Profile of Dalcetrapib After a Single Oral Dose in Healthy Male Subjects

Clinical trial2019-12-17Results posted · ClinicalTrials.gov

A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Dalcetrapib on Lipids, Lipoproteins, Apolipoproteins and Markers of Cardiovascular (CV) Risk in Patients Hospitalized for an Acute Coronary Syndrome (ACS) When Treatment is Initiated Within 1 Week After an ACS (Dal-ACUTE)

Clinical trial2019-07-30Results posted · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Dalcetrapib
RxNorm CUI
872467
ChEMBL ID
CHEMBL313006
UNII
3D050LIQ3H
Primary mechanism
Cholesteryl ester transfer protein inhibitor

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Cholesteryl ester transfer protein
CETP · P11597
INHIBITORCholesteryl ester transfer protein inhibitor

Clinical trials

14 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
14
registered trials across all phases
LATEST COMPLETION 2021
1
Active studies
1
Recruiting
6
Late-stage (III+)
12
Completed
1
Discontinued
PHASE DISTRIBUTIONn = 14
Phase 12Phase 26Phase 36

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS)

RecruitingPH IIIKey trialDalCor Pharmaceuticalsn=2,0002027

A Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial

CompletedPH IIIKey trialDalCor Pharmaceuticalsn=6,1472021

A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome

CompletedPH IIIKey trialHoffmann-La Rochen=15,8712012

A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients With Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD).

CompletedPH IIIKey trialHoffmann-La Rochen=2,2202012

A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Dalcetrapib on Lipids, Lipoproteins, Apolipoproteins and Markers of Cardiovascular (CV) Risk in Patients Hospitalized for an Acute Coronary Syndrome (ACS) When Treatment is Initiated Within 1 Week After an ACS (Dal-ACUTE)

CompletedPH IIIHoffmann-La Rochen=3002012

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase III, Double-blind, Randomized Placebo-controlled Study to Evaluate the Effects of Dalcetrapib on Cardiovascular (CV) Risk in a Genetically Defined Population With a Recent Acute Coronary Syndrome (ACS): The Dal-GenE Trial

CompletedPH IIIKey trialDalCor Pharmaceuticalsn=6,1472021

A Double-blind, Placebo-controlled, Phase 2a Proof-of-concept Trial of Dalcetrapib in Patients With Confirmed Mild to Moderate COVID-19

CompletedPH IIDalCor Pharmaceuticalsn=2272021

A Randomized, Double-blind, Placebo-controlled Study Assessing the Effect of RO4607381 on Cardiovascular Mortality and Morbidity in Clinically Stable Patients With a Recent Acute Coronary Syndrome

CompletedPH IIIKey trialHoffmann-La Rochen=15,8712012

A Phase 3b, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Study to Evaluate the Effect of Dalcetrapib 600 mg on Cardiovascular (CV) Events in Adult Patients With Stable Coronary Heart Disease (CHD), CHD Risk Equivalents or at Elevated Risk for Cardiovascular Disease (CVD).

CompletedPH IIIKey trialHoffmann-La Rochen=2,2202012

A Phase III, Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Efficacy and Safety of Dalcetrapib on Lipids, Lipoproteins, Apolipoproteins and Markers of Cardiovascular (CV) Risk in Patients Hospitalized for an Acute Coronary Syndrome (ACS) When Treatment is Initiated Within 1 Week After an ACS (Dal-ACUTE)

CompletedPH IIIHoffmann-La Rochen=3002012

An Open Label, Single Centre Study to Investigate the Metabolic Profile of Dalcetrapib After a Single Oral Dose in Healthy Male Subjects

CompletedPH IHoffmann-La Rochen=62011
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials