Acute Kidney Injury- Pipeline Insight, 2025

DelveInsight’s, “Acute Kidney Injury- Pipeline Insight, 2025” report provides comprehensive insights about 30+ companies and 30+ pipeline drugs in Acute Kidney Injury pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered

• Global coverage

Acute Kidney Injury: Understanding

Acute Kidney Injury: Overview

Acute kidney injury (AKI), also known as acute renal failure (ARF), is a sudden episode of kidney failure or kidney damage that happens within a few hours or a few days. AKI causes a build-up of waste products in blood and makes it hard for kidneys to keep the right balance of fluid in body. AKI can also affect other organs such as the brain, heart, and lungs. Acute kidney injury is common in patients who are in the hospital, in intensive care units, and especially in older adults. There are rarely any symptoms until the condition has progressed to a late stage. However, if there are symptoms, the most common one is a decrease in urine output. Doctors diagnose acute kidney injury by measuring the level of creatinine in the blood. (Creatinine is a chemical waste product removed by the body entirely by the kidneys. If the kidneys are not working properly, there will be an increase in levels in the blood).

Common risk factors include diseases that affects blood flow to the kidneys or causes kidney damage such as chronic kidney disease, impaired left ventricular systolic function, advanced age (over 75 years old), diabetes, and dehydration. Other risk factors include time spent in a heart-lung machine, use of an intra-aortic balloon pump, the need for blood transfusions and hemodilution.

Acute kidney failure can occur when the patient have a condition that slows blood flow to kidneys and the experience direct damage to kidneys. The kidneys' urine drainage tubes (ureters) become blocked and wastes can't leave body through urine.

If the signs and symptoms suggest that have acute kidney failure, doctor may recommend certain tests and procedures to verify diagnosis. These may include urine output measurements, urine tests, blood tests, imaging tests and removing a sample of kidney tissue for testing. Treating AKI depends on the underlying cause of the condition. If it is caused by medications, the doctor may ask to stop taking that specific medication. If it’s caused by an infection, the doctor may look for ways to treat the infection.

""Acute Kidney Injury- Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Acute Kidney Injury pipeline landscape is provided which includes the disease overview and Acute Kidney Injury treatment guidelines. The assessment part of the report embraces, in depth Acute Kidney Injury commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Acute Kidney Injury collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights

• The companies and academics are working to assess challenges and seek opportunities that could influence Acute Kidney Injury R&D. The therapies under development are focused on novel approaches to treat/improve Acute Kidney Injury.

Acute Kidney Injury Emerging Drugs Chapters

This segment of the Acute Kidney Injury report encloses its detailed analysis of various drugs in different stages of clinical development, including phase II, I, preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Acute Kidney Injury Emerging Drugs

• Ilofotase alfa: AM-Pharma Holding

Ilofotase alfa is a proprietary recombinant alkaline phosphatase, constructed from two human isoforms of alkaline phosphatase that has been shown to be stable and highly active in multiple clinical trials. The recombinant enzyme displays exquisite activity towards dephosphorylating and detoxifying damage-associated molecular patterns (DAMPs) and pathogen-associated molecular patterns (PAMPs) such as lipopolysaccharide (LPS), ATP, ADP and other extracellular substrates that drive acute inflammation, coagulation and microvascular ischemia found in kidney following sepsis or ischemia-induced damage. Currently, the drug is in Phase III stage of its development for the treatment of acute kidney injury.

• RMC-035: Guard Therapeutics AB

Guard Therapeutics is developing RMC-035 (ROSgard), a biological drug candidate that utilizes one of the body's most powerful and universal protections against oxidative stress. RMC-035 is naturally designed to ""target"" the kidneys, allowing RMC-035 to be present when the kidneys are attacked by oxidative stress. Treatment with RMC-035 has the potential to save lives and prevent the risk of both acute and chronic kidney damage with subsequent serious consequences due to impaired kidney function, such as life-sustaining dialysis treatment. Currently, it is in Phase II stage of clinical trial evaluation to treat Acute Kidney Injury.

• SBI 101: Sentien Biotechnologies

SBI-101 solves the problems by reprogramming the blood in an extracorporeal device that mimics the natural environment of MSCs and maintains MSC viability for the duration of treatment. This design facilitates the natural function of MSCs in dynamically sensing and responding to inflammatory stimuli to restore balance to a dysregulated immune system. Currently, the drug is in Phase I/II stage of its development for the treatment of acute kidney injury.

Further product details are provided in the report……..

Acute Kidney Injury: Therapeutic Assessment

This segment of the report provides insights about the different Acute Kidney Injury drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Acute Kidney Injury
• There are approx. 30+ key companies which are developing the therapies for Acute Kidney Injury. The companies which have their Acute Kidney Injury drug candidates in the most advanced stage, i.e. Phase III include, AM-Pharma Holding.
• Phases

DelveInsight’s report covers around 30+ products under different phases of clinical development like

• 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
• Route of Administration

Acute Kidney Injury pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

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

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Acute Kidney Injury: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Acute Kidney Injury therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Acute Kidney Injury drugs.

Acute Kidney Injury Report Insights

• Acute Kidney Injury Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Acute Kidney Injury Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Acute Kidney Injury drugs?
• How many Acute Kidney Injury drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Acute Kidney Injury?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Acute Kidney Injury therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Acute Kidney Injury and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• 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

Key Products

• Ilofotase alfa
• SBI 101
• RMC-035
• TIN816
• Interferon beta 1a
• KB 1801
• Glycopyranosyl lipid adjuvant
• LSALT Peptide
• Alprostadil liposome injection
• R2R01
• RMC-035
• SBI 101

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