Acute Kidney Injury (AKI) Clinical Trial Pipeline Analysis: 20+ Key Companies Shaping the Future of AKI Therapeutics | DelveInsight

DelveInsight's Acute Kidney Injury (AKI) Pipeline Insight 2026 report provides comprehensive global coverage of available, marketed, and pipeline Acute Kidney Injury therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the Acute Kidney Injury pipeline domain.

Key takeaways from the Acute Kidney Injury Clinical Trial Landscape Report
• DelveInsight's Acute Kidney Injury pipeline report depicts a robust space with 20+ active players working to develop 25+ pipeline therapies for Acute Kidney Injury treatment.
• Key Acute Kidney Injury companies such as AstraZeneca, Guard Therapeutics AB, Keli Therapeutics, Curacle, Arch Biopartners, and others
• Promising Acute Kidney Injury pipeline therapies in various stages of development include Ravulizumab, LSALT Peptide, RMC-035, KELI-101, MT-101, and others.

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What is Acute Kidney Injury (AKI)?
Acute Kidney Injury, also known as acute renal failure (ARF), is a sudden episode of kidney failure or kidney damage that occurs within a few hours or days. AKI leads to the accumulation of waste products in the blood and affects the kidneys' ability to maintain proper fluid balance in the body. The disease can also impact other organs such as the brain, heart, and lungs. AKI commonly occurs in hospitalized patients, especially those in intensive care units and older adults. Symptoms may include decreased urine output, swelling in the legs or ankles, fatigue, confusion, nausea, chest pain, and shortness of breath. Diagnosis involves serum creatinine measurements, urine output monitoring, laboratory tests, and imaging studies. Treatment focuses on correcting the underlying cause, maintaining fluid and electrolyte balance, and supporting kidney function, including dialysis in severe cases.

Emerging Acute Kidney Injury Drug Profiles

Ravulizumab: AstraZeneca
Ravulizumab (Ultomiris) is a long-acting monoclonal antibody developed by AstraZeneca that inhibits complement protein C5, preventing downstream inflammatory damage. It is currently being evaluated in the Phase III ARTEMIS trial for the prevention of acute kidney injury in patients with chronic kidney disease undergoing cardiac surgery. By blocking terminal complement activation, ravulizumab aims to reduce ischemia-reperfusion injury and lower the incidence of major adverse kidney events post-surgery.

RMC-035: Guard Therapeutics AB
RMC-035 is an investigational recombinant protein therapy being developed for the treatment of Acute Kidney Injury. The therapy is currently in Phase II clinical development and is administered intravenously. It is designed to protect kidney tissues from oxidative stress and inflammation associated with AKI progression.

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Recent Developments in the Acute Kidney Injury Clinical Trial Landscape
• In June 2025, Evotec SE announced that it had joined the NURTuRE-AKI consortium for establishing a patient cohort for Acute Kidney Injury, aiming to identify key mechanisms driving AKI and support the discovery of innovative therapies.
• In May 2025, SeaStar Medical Holding Corporation announced that it had reached the halfway point in the NEUTRALIZE-AKI pivotal clinical trial, enabling a prespecified interim analysis by the trial's independent Data Safety Monitoring Review Board (DSMB).
• In May 2025, CalciMedica reported that enrollment is ongoing in the KOURAGE Phase II trial evaluating AuxoraTM in patients with Stage 2 or Stage 3 Acute Kidney Injury associated with acute hypoxemic respiratory failure (AHRF).
• In March 2026, Arch Biopartners announced that Fraser Health Authority entered into a Clinical Trial Agreement to support patient recruitment in the ongoing Phase II study evaluating LSALT peptide for cardiac surgery-associated Acute Kidney Injury.

Scope of the Acute Kidney Injury Pipeline Report
• Coverage: Global
• Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination
• Therapeutic Assessment By Clinical Stages: Preclinical, Phase I, Phase I/II, Phase II, Phase III
• Therapeutics Assessment By Route of Administration: Oral, Intravenous, Subcutaneous, Others
• Therapeutics Assessment By Molecule Type: Monoclonal antibody, Recombinant proteins, Peptide, Mesenchymal stem cell therapies, Antibodies
• Key Acute Kidney Injury Companies: AstraZeneca, Guard Therapeutics AB, Keli Therapeutics, Curacle, Arch Biopartners, and others
• Key Acute Kidney Injury Pipeline Therapies: Ravulizumab, LSALT Peptide, RMC-035, KELI-101, MT-101, and others

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Table of Contents
1. Acute Kidney Injury Pipeline Report Introduction
2. Acute Kidney Injury Pipeline Report Executive Summary
3. Acute Kidney Injury Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Acute Kidney Injury Pipeline Therapeutics
6. Acute Kidney Injury Pipeline: Late Stage Products (Phase III)
7. Acute Kidney Injury Pipeline: Mid Stage Products (Phase II)
8. Acute Kidney Injury Pipeline: Early Stage Products (Phase I/II)
9. Acute Kidney Injury Pipeline Therapeutics Assessment
10. Inactive Products in the Acute Kidney Injury Pipeline
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products in the Acute Kidney Injury Pipeline
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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