Acute Kidney Injury Pipeline Insight 2025: 30+ Companies Targeting Renal Repair, Inflammation, and Ischemia-Reperfusion Injury | DelveInsight

DelveInsight's "Acute Kidney Injury (AKI) - Pipeline Insight, 2025" highlights a promising and evolving therapeutic landscape aimed at addressing the unmet clinical needs in AKI-a sudden loss of kidney function often triggered by ischemia, sepsis, or nephrotoxic injury. AKI remains a major cause of morbidity and mortality, especially among hospitalized and critically ill patients, with limited FDA-approved therapies currently available beyond supportive care and dialysis.

In 2025, the AKI pipeline features over 30 active companies exploring novel therapeutic approaches focused on renal protection, anti-inflammatory pathways, cellular repair, and microvascular preservation. Key mechanisms under investigation include the inhibition of pro-inflammatory cytokines, targeting mitochondrial dysfunction, modulating immune responses, and promoting tubular regeneration. Drug candidates such as ANG-3777 (ANGION), RMC-035 (Renalytix), and QPI-1002 (Quark Pharmaceuticals) have reached mid-to-late-stage trials, demonstrating the potential to reduce kidney injury severity and improve renal recovery.

Additionally, regenerative and cell-based therapies, such as mesenchymal stem cells (MSCs) and exosome-based interventions, are gaining momentum for their role in repairing damaged renal tissues and promoting long-term kidney function restoration. Regulatory support via fast-track and orphan drug designations is catalyzing innovation, while improved AKI biomarkers and patient stratification tools are optimizing clinical trial design. As the field advances, the AKI pipeline is poised to shift from symptomatic management to disease-modifying interventions that can significantly improve patient outcomes across ICU and surgical settings.

Interested in learning more about the current treatment landscape and the key drivers shaping the acute kidney injury pipeline? Click here: https://www.delveinsight.com/report-store/acute-kidney-injury-aki-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Acute Kidney Injury Pipeline Report
• DelveInsight's acute kidney injury pipeline analysis depicts a strong space with 30+ active players working to develop 30+ pipeline drugs for acute kidney injury treatment.
• The leading acute kidney injury companies include AM-Pharma Holding, Sentien Biotechnologies, Guard Therapeutics AB, Novartis Pharmaceuticals, Faron Pharmaceuticals, Kantum Pharma, Revelation Biosciences, Arch Biopartners Inc., CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Metro International Biotech, LLC, River 2 Renal Corp., Guard Therapeutics AB, Sentien Biotechnologies, and others are evaluating their lead assets to improve the acute kidney injury treatment landscape.
• Key acute kidney injury pipeline therapies in various stages of development include ANG-3777, Ilofotase alfa, SBI 101, RMC-035, TIN816, Interferon beta 1a, KB 1801, Glycopyranosyl lipid adjuvant, LSALT Peptide, Alprostadil liposome injection, R2R01, QPI-1002, SBI 101, and others.
• As of July 2025, the FDA is requiring stronger label warnings across all GLP-1 receptor agonists-including popular medications such as Ozempic and Wegovy-highlighting the risk of acute kidney injury due to dehydration from gastrointestinal side effects like nausea, vomiting, or diarrhea
• In January 2025, the FDA accepted a qualification plan for an eight-proof urine biomarker panel developed by the Foundation for NIH and Critical Path Institute. Designed for early detection of drug-induced kidney injury, this panel offers more sensitive monitoring compared to conventional tests like creatinine or BUN.
• In January 2025, the FDA expanded semaglutide's indication (brand name OZEMPIC) to include the reduction of kidney disease progression, kidney failure, and related cardiovascular death in adults with type 2 diabetes and chronic kidney disease. This represents the first GLP-1 therapy approved with kidney-protective labeling.

Request a sample and discover the recent breakthroughs happening in the acute kidney injury pipeline landscape at https://www.delveinsight.com/report-store/acute-kidney-injury-aki-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Acute Kidney Injury Overview
Acute Kidney Injury is a sudden and rapid decline in kidney function, typically occurring over hours to days. It leads to the accumulation of waste products, fluid imbalances, and electrolyte disturbances in the body. Common causes include reduced blood flow to the kidneys (due to dehydration, shock, or heart failure), direct kidney damage (from toxins, medications, or infections), and obstruction of urine flow. AKI can range from mild to severe and may occur in hospitalized patients, especially those in intensive care or undergoing major surgery.

Early detection and prompt management of AKI are critical to improving outcomes and preventing progression to chronic kidney disease or permanent kidney failure. Treatment focuses on addressing the underlying cause, maintaining fluid and electrolyte balance, and in some cases, initiating renal replacement therapy such as dialysis. Ongoing research is exploring novel therapies, biomarkers for early detection, and strategies to reduce long-term complications.

Find out more about acute kidney injury medication at https://www.delveinsight.com/report-store/acute-kidney-injury-aki-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Acute Kidney Injury Treatment Analysis: Drug Profile
Ilofotase alfa: AM-Pharma Holding
Ilofotase alfa is a proprietary recombinant form of alkaline phosphatase, engineered from two human isoforms to achieve high stability and enzymatic activity, as demonstrated in multiple clinical trials. This enzyme is specifically designed to dephosphorylate and detoxify damage-associated (DAMPs) and pathogen-associated molecular patterns (PAMPs), including lipopolysaccharide (LPS), ATP, and ADP. These molecules are key drivers of acute inflammation, coagulation, and microvascular ischemia-common consequences of sepsis or ischemia-induced kidney damage. Ilofotase alfa is currently in Phase III clinical development for the treatment of Acute Kidney Injury.

RMC-035: Guard Therapeutics AB
RMC-035 (ROSgard) is a biologic drug candidate developed by Guard Therapeutics that harnesses one of the body's natural defenses against oxidative stress. Specifically designed to target the kidneys, RMC-035 is present at the site of injury when oxidative stress damages renal tissues. This targeted approach holds the potential to reduce the risk of both acute and long-term kidney damage, potentially avoiding serious complications such as the need for dialysis. RMC-035 is currently in Phase II clinical trials for the treatment of Acute Kidney Injury.

Learn more about the novel and emerging acute kidney injury pipeline therapies at https://www.delveinsight.com/report-store/acute-kidney-injury-aki-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Acute Kidney Injury Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• Late-stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

By Molecule Type
• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy

Scope of the Acute Kidney Injury Pipeline Report
• Coverage: Global
• Key Acute Kidney Injury Companies: AM-Pharma Holding, Sentien Biotechnologies, Guard Therapeutics AB, Novartis Pharmaceuticals, Faron Pharmaceuticals, Kantum Pharma, Revelation Biosciences, Arch Biopartners Inc., CSPC ZhongQi Pharmaceutical Technology Co., Ltd., Metro International Biotech, LLC, River 2 Renal Corp., Guard Therapeutics AB, Sentien Biotechnologies, and others.
• Key Acute Kidney Injury Pipeline Therapies: ANG-3777, Ilofotase alfa, SBI 101, RMC-035, TIN816, Interferon beta 1a, KB 1801, Glycopyranosyl lipid adjuvant, LSALT Peptide, Alprostadil liposome injection, R2R01, QPI-1002, SBI 101, and others.

To dive deep into rich insights for drugs used for acute kidney injury treatment, visit: https://www.delveinsight.com/report-store/acute-kidney-injury-aki-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. 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)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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jvimal@delveinsight.com
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This release was published on openPR.