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HTK Custodiol
HTK Custodiol is an organ preservation solution that maintains cellular viability during cold storage by providing essential electrolytes, buffers, and substrates while minimizing ischemic injury.
HTK Custodiol is an organ preservation solution that maintains cellular viability during cold storage by providing essential electrolytes, buffers, and substrates while minimizing ischemic injury. Used for Cold preservation of donor organs for transplantation (heart, kidney, liver, pancreas), Organ preservation during transport and storage prior to transplantation.
At a glance
| Generic name | HTK Custodiol |
|---|---|
| Sponsor | Rigshospitalet, Denmark |
| Drug class | Organ preservation solution |
| Modality | Small molecule |
| Therapeutic area | Transplantation |
| Phase | FDA-approved |
Mechanism of action
Custodiol is a histidine-tryptophan-ketoglutarate (HTK) based solution designed to preserve organs during transplantation. It maintains intracellular electrolyte composition, provides metabolic substrates, and includes antioxidants and buffers to reduce ischemic reperfusion injury during the cold ischemia period before organ implantation.
Approved indications
- Cold preservation of donor organs for transplantation (heart, kidney, liver, pancreas)
- Organ preservation during transport and storage prior to transplantation
Common side effects
- Graft dysfunction
- Delayed graft function
- Ischemic reperfusion injury
Key clinical trials
- Adding Lidocaine to Custodiol Mixture (PHASE4)
- Custodiol-N Solution Compared With Custodiol Solution in Organ Transplantation (Kidney, Liver and Pancreas) (PHASE3)
- Evaluation of Clinical Impact of the Type of Cardioplegia Used in the Patient Undergoing Major Cardiac Surgery. (PHASE4)
- Custodiol Versus Blood Cardioplegaia in Paediatric Cardiac Surgery (PHASE2)
- Normothermic Machine Perfusion (NMP) Versus Static Cold Storage (SCS) in Human Kidney Transplantation (NA)
- Custodiol-HTK (Histidine-tryptophan-ketoglutarate) Solution as a Cardioplegic Agent (PHASE2)
- TOP-Study (Tacrolimus Organ Perfusion): Treatment of Ischemia Reperfusion Injury in Marginal Organs With an ex Vivo Tacrolimus Perfusion (PHASE2, PHASE3)
- Evaluation of Preimplantation Portal Vein and Hepatic Artery Flushing With Tacrolimus (NA)
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:
- HTK Custodiol CI brief — competitive landscape report
- HTK Custodiol updates RSS · CI watch RSS
- Rigshospitalet, Denmark portfolio CI