drugset

Drugs / Apolipoprotein A-I [human]

Follow last change Sep 2024 re-read 3 minutes ago

Apolipoprotein A-I [human]

also known as apoA-I

Protein / enzyme biologic

Developed for: acute coronary syndrome
Investigated by: CSL Behring

Trials 1

today NCT03473223 · Ph 3

2018201920202021202220232024202520262027

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 3	NCT03473223	Mar 2018 → Feb 2023	acute coronary syndrome	CSL Behring	Completed	Missed primary

News releases announcing trial results or a regulatory action · 4

Date	Issuer	Release
2024-02-11	CSL Behring	Results CSL Announces Top-line Results from the Phase 3 AEGIS-II Trial Evaluating the Efficacy and Safety of CSL112 (apolipoprotein A-I [human]) csl.com ↗
2016-11-15	CSL Behring	Results CSL Behring Presents Positive Results from the CSL112 AEGIS-I Phase 2b Trial csl.com ↗ CSL Behring today announced positive results from AEGIS-I, a Phase 2b safety and proof of mechanism clinical study of CSL112, a novel apolipoprotein A-I (apoA-I) infusion therapy.
2014-11-18	CSL Behring	Results CSL112 Found to Elevate Cholesterol Efflux in Patients with Coronary Artery Disease and Mechanism for Rapid Cholesterol Efflux Capacity Demonstrated csl.com ↗
2013-11-20	CSL Behring	Results Phase 2a Findings Demonstrate that CSL112, A Novel Apolipoprotein A-I Infusion Therapy, Has a Favorable Safety Profile, is Well Tolerated and Increases Cholesterol Efflux Capacity in Stable Atherothrombotic Patients csl.com ↗ Results of a Phase 2a trial of CSL112, sponsored by CSL Limited, demonstrated favorable safety and tolerability when administered to patients with stable atherothrombotic disease.

All press releases naming this drug 5 releases

Date	Issuer	Release
2024-02-11	CSL Behring	CSL Announces Top-line Results from the Phase 3 AEGIS-II Trial Evaluating the Efficacy and Safety of CSL112 (apolipoprotein A-I [human]) csl.com ↗
2020-11-05	CSL Behring	CSL Behring Publishes Design for First-Ever Outcomes Study of ApoA-I to Reduce Risk of Cardiovascular Events in Heart Attack Patients csl.com ↗
2016-11-15	CSL Behring	CSL Behring Presents Positive Results from the CSL112 AEGIS-I Phase 2b Trial csl.com ↗
2014-11-18	CSL Behring	CSL112 Found to Elevate Cholesterol Efflux in Patients with Coronary Artery Disease and Mechanism for Rapid Cholesterol Efflux Capacity Demonstrated csl.com ↗
2013-11-20	CSL Behring	Phase 2a Findings Demonstrate that CSL112, A Novel Apolipoprotein A-I Infusion Therapy, Has a Favorable Safety Profile, is Well Tolerated and Increases Cholesterol Efflux Capacity in Stable Atherothrombotic Patients csl.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

Field	Value	Cited text
Known as	Apolipoprotein A-I [human]	ClinicalTrials.gov intervention name — accepted as the source's own label NCT03473223 ↗
Known as	apoA-I	“Apolipoprotein A-I [human] (apoA-I) purified from human plasma for intravenous administration” NCT03473223 ↗
Modality	Protein / enzyme biologic	“a human apolipoprotein A-I derived from plasma” PMID 39230545 ↗ Sep 2024
Route	Intravenous	“purified from human plasma for intravenous administration” NCT03473223 ↗