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Custodiol-N
Custodiol-N is an organ preservation solution that maintains cellular viability and reduces ischemic injury during organ transplantation by providing essential electrolytes, substrates, and buffering capacity.
Custodiol-N is an organ preservation solution that maintains cellular viability and reduces ischemic injury during organ transplantation by providing essential electrolytes, substrates, and buffering capacity. Used for Cold preservation of donor organs for transplantation (kidney, liver, heart, pancreas).
At a glance
| Generic name | Custodiol-N |
|---|---|
| Also known as | Solution for organ preservation in transplantation |
| Sponsor | Dr. F. Köhler Chemie GmbH |
| Drug class | Organ preservation solution |
| Modality | Small molecule |
| Therapeutic area | Transplantation |
| Phase | Phase 3 |
Mechanism of action
Custodiol-N is a histidine-tryptophan-ketoglutarate (HTK) based preservation solution designed to protect donor organs during cold storage before transplantation. It maintains intracellular electrolyte composition, provides metabolic substrates, and buffers against acidosis to minimize reperfusion injury and extend organ preservation time.
Approved indications
- Cold preservation of donor organs for transplantation (kidney, liver, heart, pancreas)
Common side effects
Key clinical trials
- Study of Cardioplegia in Cardiac Surgery Due to Congenital Heart Malformation in Children (PHASE2)
- Study of Organ Perfusion in Heart Transplantation in Children (PHASE2)
- Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas) (PHASE3)
- Study of Organ Perfusion With Custodiol-N Solution Compared With Custodiol Solution in Heart Transplantation (PHASE3)
- Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol (PHASE3)
- Phase III Study Comparing Two Methods of Cardioplegia in Coronary Artery Bypass Surgery (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Custodiol-N CI brief — competitive landscape report
- Custodiol-N updates RSS · CI watch RSS
- Dr. F. Köhler Chemie GmbH portfolio CI