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Custodiol HTK
Custodiol HTK is a Organ preservation solution Small molecule drug developed by Marc Sakwa, MD. It is currently in Phase 3 development for Preservation of donor organs (heart, kidney, liver, pancreas) during cold storage prior to transplantation. Also known as: Histidine-tryptophan-ketoglutarate cardioplegia solution.
Custodiol HTK is an organ preservation solution that maintains cellular viability and reduces ischemic injury during organ transplantation by providing a balanced electrolyte composition and metabolic substrates.
Custodiol HTK is an organ preservation solution that maintains cellular viability and reduces ischemic injury during organ transplantation by providing a balanced electrolyte composition and metabolic substrates. Used for Preservation of donor organs (heart, kidney, liver, pancreas) during cold storage prior to transplantation.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Custodiol HTK |
|---|---|
| Also known as | Histidine-tryptophan-ketoglutarate cardioplegia solution |
| Sponsor | Marc Sakwa, MD |
| Drug class | Organ preservation solution |
| Modality | Small molecule |
| Therapeutic area | Transplantation |
| Phase | Phase 3 |
Mechanism of action
Custodiol HTK (histidine-tryptophan-ketoglutarate solution) is a specialized preservation medium designed to protect donor organs during the cold storage period before transplantation. It maintains intracellular electrolyte balance, reduces cellular edema, and provides metabolic support to minimize reperfusion injury and extend organ viability time compared to standard preservation solutions.
Approved indications
- Preservation of donor organs (heart, kidney, liver, pancreas) during cold storage prior to transplantation
Common side effects
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:
- Custodiol HTK CI brief — competitive landscape report
- Custodiol HTK updates RSS · CI watch RSS
- Marc Sakwa, MD portfolio CI
Frequently asked questions about Custodiol HTK
What is Custodiol HTK?
How does Custodiol HTK work?
What is Custodiol HTK used for?
Who makes Custodiol HTK?
Is Custodiol HTK also known as anything else?
What drug class is Custodiol HTK in?
What development phase is Custodiol HTK in?
Related
- Drug class: All Organ preservation solution drugs
- Manufacturer: Marc Sakwa, MD — full pipeline
- Therapeutic area: All drugs in Transplantation
- Indication: Drugs for Preservation of donor organs (heart, kidney, liver, pancreas) during cold storage prior to transplantation
- Also known as: Histidine-tryptophan-ketoglutarate cardioplegia solution
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing