Last reviewed 2026-04-23 · How we verify

Hydrogen-Rich Celsior Solution

RenJi Hospital · Phase 3 active Small molecule

Hydrogen-Rich Celsior Solution is a Organ preservation solution Small molecule drug developed by RenJi Hospital. It is currently in Phase 3 development for Organ preservation for transplantation (kidney, liver, heart, or other solid organs), Reduction of ischemia-reperfusion injury in organ transplantation. Also known as: HR solution.

Hydrogen-rich Celsior solution reduces ischemic reperfusion injury by providing antioxidant protection through molecular hydrogen during organ preservation and transplantation.

Hydrogen-rich Celsior solution reduces ischemic reperfusion injury by providing antioxidant protection through molecular hydrogen during organ preservation and transplantation. Used for Organ preservation for transplantation (kidney, liver, heart, or other solid organs), Reduction of ischemia-reperfusion injury in organ transplantation.

Likelihood of approval

58.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

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).

Predicted approval windows by jurisdiction (conditional on FDA approval)

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	Hydrogen-Rich Celsior Solution
Also known as	HR solution
Sponsor	RenJi Hospital
Drug class	Organ preservation solution
Target	Reactive oxygen species (ROS), particularly hydroxyl radicals
Modality	Small molecule
Therapeutic area	Transplantation/Organ Preservation
Phase	Phase 3

Mechanism of action

Molecular hydrogen acts as a selective antioxidant that neutralizes hydroxyl radicals and other reactive oxygen species generated during ischemia-reperfusion injury. By supplementing the standard Celsior organ preservation solution with hydrogen, the formulation aims to improve organ viability, reduce cellular damage, and enhance transplant outcomes. This approach targets the oxidative stress mechanism that occurs when blood flow is restored to previously ischemic organs.

Approved indications

Organ preservation for transplantation (kidney, liver, heart, or other solid organs)
Reduction of ischemia-reperfusion injury in organ transplantation

Common side effects

No common side effects on file.

Key clinical trials

Clinical Trial of Hydrogen-Rich Celsior Solution Applied in Aging DBD Liver/Kidney Transplantation (PHASE3)

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:

Hydrogen-Rich Celsior Solution CI brief — competitive landscape report
Hydrogen-Rich Celsior Solution updates RSS · CI watch RSS
RenJi Hospital portfolio CI

Frequently asked questions about Hydrogen-Rich Celsior Solution

What is Hydrogen-Rich Celsior Solution?

Hydrogen-Rich Celsior Solution is a Organ preservation solution drug developed by RenJi Hospital, indicated for Organ preservation for transplantation (kidney, liver, heart, or other solid organs), Reduction of ischemia-reperfusion injury in organ transplantation.

How does Hydrogen-Rich Celsior Solution work?

Hydrogen-rich Celsior solution reduces ischemic reperfusion injury by providing antioxidant protection through molecular hydrogen during organ preservation and transplantation.

What is Hydrogen-Rich Celsior Solution used for?

Hydrogen-Rich Celsior Solution is indicated for Organ preservation for transplantation (kidney, liver, heart, or other solid organs), Reduction of ischemia-reperfusion injury in organ transplantation.

Who makes Hydrogen-Rich Celsior Solution?

Hydrogen-Rich Celsior Solution is developed by RenJi Hospital (see full RenJi Hospital pipeline at /company/renji-hospital).

Is Hydrogen-Rich Celsior Solution also known as anything else?

Hydrogen-Rich Celsior Solution is also known as HR solution.

What drug class is Hydrogen-Rich Celsior Solution in?

Hydrogen-Rich Celsior Solution belongs to the Organ preservation solution class. See all Organ preservation solution drugs at /class/organ-preservation-solution.

What development phase is Hydrogen-Rich Celsior Solution in?

Hydrogen-Rich Celsior Solution is in Phase 3.

What does Hydrogen-Rich Celsior Solution target?

Hydrogen-Rich Celsior Solution targets Reactive oxygen species (ROS), particularly hydroxyl radicals and is a Organ preservation solution.

Drug class: All Organ preservation solution drugs
Target: All drugs targeting Reactive oxygen species (ROS), particularly hydroxyl radicals
Manufacturer: RenJi Hospital — full pipeline
Therapeutic area: All drugs in Transplantation/Organ Preservation
Indication: Drugs for Organ preservation for transplantation (kidney, liver, heart, or other solid organs)
Indication: Drugs for Reduction of ischemia-reperfusion injury in organ transplantation
Also known as: HR solution

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing