Custodiol

Phase 3Small molecule

DDr. F. Köhler Chemie GmbH

Custodiol is one of 2 small molecule programs targeting CAD. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

CADRecruiting

CADPhase 3

Recruiting

Competition

Competitive Landscape

1 competitor in CAD

#DrugCompanyPhaseTrials

Xylocaine

CCitius Pharmaceuticals, Inc.

Phase 3

1 2

Custodiol

DDr. F. Köhler Chemie GmbH

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

ApprovedRecruiting

CAD

NCT07205757

Q3 2027

Phase 2Recruiting

Heart Transplantation

NCT06032195

Clinical

Trials by Indication[1]

Heart Transplantation2 trials

Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation

Completed·DDr. F. Köhler Chemie GmbH·Phase 3·NCT02869022·105 enrolled

Study of Organ Perfusion in Heart Transplantation in Children

Recruiting·DDr. F. Köhler Chemie GmbH·Phase 2·NCT06032195·15 enrolled

Coronary Artery Bypass1 trial

Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery

Completed·DDr. F. Köhler Chemie GmbH·Phase 2·NCT01444235·102 enrolled

Cardiac Surgery1 trial

Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery

Completed·KKing Faisal Specialist Hospital & Research Center·Phase 2·NCT03082716·49 enrolled

Metabolism1 trial

Comparing the Protective Effects of Two Cardioplegic Solutions, on Cardiac Metabolism, as Assessed Using Microdialysis

Completed·—·Phase 3·NCT01401140·29 enrolled

Age1 trial

CUstodiol Versus RInger: whaT Is the Best Agent?

Completed·SScientific Institute San Raffaele·Phase 4·NCT02327611·90 enrolled

2 more indications

Aortic Valve Surgery1 trial

Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol

Completed·DDr. F. Köhler Chemie GmbH·Phase 3·NCT02098772·530 enrolled

CAD1 trial

Adding Lidocaine to Custodiol® Cardioplegia to Decrease Post-bypass Ventricular Arrhythmias in Adult Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery; A Prospective Randomized Double-Blinded Clinical Trial.

Recruiting·FFayoum University Hospital·Approved·NCT07205757·70 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for Custodiol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Custodiol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Custodiol. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Dr. F. Köhler Chemie GmbH company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: DDr. F. Köhler Chemie GmbH

Custodiol

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q3 2027

Trials by Indication[1]

Heart Transplantation2 trials

Coronary Artery Bypass1 trial

Cardiac Surgery1 trial

Metabolism1 trial

Age1 trial

Aortic Valve Surgery1 trial

CAD1 trial

References

Drug Info

Quick Facts

Related News