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Updated: May 6, 2026
High-Density Lipoprotein-Specific Phospholipid Efflux Assay
Published on: September 30, 2025
Reconstituted HDL for the acute treatment of acute coronary syndrome
Brian R Krause1, Alan T Remaley
1aAlphaCore Pharma, Ann Arbor, Michigan bLipoprotein Metabolism Section, Cardiopulmonary Branch, National Heart, Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland, USA.
Insights
Reconstituted HDL (rHDL) shows promise for stabilizing acute coronary syndrome (ACS) patients by reducing plaque volume. Further research is needed to optimize rHDL therapy for clinical use.
Area of Science:
- Cardiovascular Medicine
- Lipid Metabolism
- Pharmacology
Background:
- Acute coronary syndrome (ACS) requires new therapies targeting nonculprit lesions for rapid patient stabilization.
- Reconstituted high-density lipoprotein (rHDL), composed of apoA-I and phospholipids, is under investigation for this purpose.
Purpose of the Study:
- To review the current status of reconstituted HDL (rHDL) as a therapeutic strategy for acute coronary syndrome (ACS).
- To evaluate the efficacy and potential of rHDL in treating nonculprit lesions in ACS patients.
Main Methods:
- Review of clinical trials involving various rHDL formulations (SRC-rHDL, CSL-111, CSL-112, ETC-216).
- Assessment of rHDL's effects on cholesterol mobilization and atherosclerotic plaque regression in preclinical and clinical studies.
- Analysis of intravascular ultrasound data for plaque volume changes in ACS patients.
Main Results:
- Multiple rHDL formulations have demonstrated efficacy in preclinical models for cholesterol mobilization and plaque regression.
- Two rHDL agents, ETC-216 and CSL-111, showed significant plaque volume reduction in ACS patients after limited treatments.
- Clinical trials assessing hard clinical endpoints for rHDL therapy in ACS are not yet completed.
Conclusions:
- rHDL represents a promising therapeutic avenue for ACS, with demonstrated potential in reducing atherosclerotic plaque burden.
- Further research is essential to elucidate the mechanism of action, optimize formulation and delivery, and establish monitoring protocols for rHDL therapy.
- Significant questions remain regarding the translation of rHDL's plaque-modifying effects into improved clinical outcomes for ACS patients.
Purpose Of Review:
New therapeutic strategies are needed for the rapid stabilization of acute coronary syndrome (ACS) patients by treating nonculprit lesions. Reconstituted HDL (rHDL), which is apoA-I combined with phospholipids, is currently being tested in clinical trials for this purpose and is the subject of this review.
Recent Findings:
At least four different formulations (SRC-rHDL, CSL-111, CSL-112 and ETC-216) have been tested in clinical trials. The various rHDL preparations have been shown to be effective in the rapid mobilization of excess cholesterol from cells and in regressing atherosclerotic plaques in animal models. Two of the rHDL agents, namely ETC-216 and CSL-111, have been shown to be effective after only a few treatments in reducing plaque volume in ACS patients, as assessed by intravascular ultrasound, but no clinical trials assessing clinical endpoints have yet been completed.
Summary:
rHDL is a promising new potential therapy for ACS patients, but much work remains to be done, and there are many unresolved questions. Progress in developing rHDL into a therapy will depend on improving our understanding of their mechanism of action, determining the optimum formulation and delivery and how to monitor rHDL therapy.
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