Hepatorenal Syndrome - Pipeline Insight, 2025

This “Hepatorenal syndrome - Pipeline Insight, 2025” report provides comprehensive insights about 2+ companies and 3+ pipeline drugs in Hepatorenal syndrome 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.

Hepatorenal syndrome: Understanding

Hepatorenal syndrome: Overview

Hepatorenal syndrome (HRS) is a serious and often fatal condition characterized by the rapid deterioration of kidney function in individuals with severe liver disease, particularly cirrhosis. This syndrome results from functional renal failure, where the kidneys are histologically normal but fail to perform their filtering functions effectively due to reduced renal blood flow and altered hemodynamics associated with liver dysfunction. HRS is classified into two types: Type 1, which is rapidly progressive and can lead to acute kidney failure within days, and Type 2, which has a more gradual onset and typically progresses over weeks to months. The pathophysiology of HRS involves significant portal hypertension and systemic vasodilation, leading to renal vasoconstriction, reduced glomerular filtration rate, and subsequent kidney impairment. In addition, the activation of neurohormonal systems, such as the renin-angiotensin-aldosterone system (RAAS), exacerbates renal dysfunction by promoting sodium retention and further vasoconstriction.

The etiology of hepatorenal syndrome (HRS) is primarily linked to advanced liver disease, particularly cirrhosis, which leads to significant alterations in hemodynamics and renal function. The most common underlying cause of HRS is portal hypertension, a condition that arises from increased pressure in the portal vein due to liver scarring and dysfunction. This elevated pressure results in systemic vasodilation, which decreases effective arterial blood volume and triggers renal vasoconstriction, thereby impairing kidney perfusion. The renal vasoconstriction, in turn, further exacerbates kidney dysfunction by reducing glomerular filtration rate and impairing the kidneys’ ability to excrete waste products. In addition to cirrhosis, other contributing factors include spontaneous bacterial peritonitis (SBP), a common infection among patients with ascites that can precipitate renal failure, and gastrointestinal bleeding, which may lead to hypovolemia and worsen renal perfusion.

The clinical presentation of hepatorenal syndrome (HRS) is characterized by a combination of symptoms associated with both advanced liver disease and renal dysfunction. Patients typically exhibit signs of liver failure, including jaundice (a yellow tint to the skin and eyes due to elevated bilirubin levels), ascites (fluid accumulation in the abdomen), and hepatic encephalopathy, which can manifest as confusion, altered mental status, or drowsiness. In terms of renal function, patients may experience a significant reduction in urine output, often described as oliguria or anuria, along with symptoms of fluid retention such as edema in the extremities and pulmonary edema in more severe cases. Blood tests often reveal elevated levels of creatinine and blood urea nitrogen (BUN), indicating impaired kidney function. Patients may also have a low urine sodium concentration and a high fractional excretion of sodium, which reflect renal vasoconstriction and reduced kidney perfusion. The progression of HRS can vary; Type 1 HRS is characterized by rapid deterioration over days to weeks, while Type 2 HRS progresses more slowly over weeks to months, with less pronounced renal dysfunction.

The treatment and management of hepatorenal syndrome (HRS) focus on addressing the underlying liver disease while attempting to restore renal function. The only definitive treatment for HRS is liver transplantation, which corrects both liver dysfunction and associated impaired renal function. However, due to limited donor availability and contraindications for transplantation, not all patients are candidates. In cases where transplantation is not immediately feasible, pharmacological therapies are employed to manage the renal dysfunction and improve hemodynamics. Terlipressin, a vasoconstrictor, has emerged as a first-line treatment option, particularly when combined with albumin, as it helps improve renal perfusion by increasing systemic vascular resistance. Other vasoconstrictors, such as norepinephrine and midodrine, may also be utilized in conjunction with albumin to enhance outcomes.

'Hepatorenal syndrome- Pipeline Insight, 2025' report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Hepatorenal syndrome pipeline landscape is provided which includes the disease overview and Hepatorenal syndrome treatment guidelines. The assessment part of the report embraces, in depth Hepatorenal syndrome 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, Hepatorenal syndrome 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 Hepatorenal syndrome R&D. The therapies under development are focused on novel approaches to treat/improve Hepatorenal syndrome.

Hepatorenal syndrome Emerging Drugs Chapters

This segment of the Hepatorenal syndrome report encloses its detailed analysis of various drugs in different stages of clinical development, including phase III, 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.

Hepatorenal syndrome Emerging Drugs

Ambrisentan: Noorik Biopharmaceuticals AG

Ambrisentan is an endothelin receptor antagonist currently under investigation for its potential use in treating hepatorenal syndrome (HRS). It works by blocking the effects of endothelin-1, a potent vasoconstrictor that contributes to increased vascular resistance and reduced renal blood flow, which are critical factors in the pathophysiology of HRS. By improving renal perfusion and function, ambrisentan may offer a therapeutic benefit for patients suffering from this syndrome. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Hepatorenal syndrome.

R2R01: Ocelot Bio, Inc

R2R01 is a novel therapeutic agent currently being investigated for its potential role in the treatment of Hepatorenal Syndrome (HRS), particularly in conjunction with terlipressin. R2R01 is a long-acting single-chain peptide agonist of the relaxin receptor RXFP1, which has shown promise in enhancing renal blood flow and improving renal function in preclinical studies. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Hepatorenal syndrome.

Hepatorenal syndrome: Therapeutic Assessment

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

Major Players in Hepatorenal syndrome

• There are approx. 2+ key companies which are developing the therapies for Hepatorenal syndrome. The companies which have their Hepatorenal syndrome drug candidates in the most advanced stage, i.e. Phase II include, Noorik Biopharmaceuticals AG

Phases

The report covers around 3+ 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

Hepatorenal syndrome 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.

Hepatorenal syndrome: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Hepatorenal syndrome 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 Hepatorenal syndrome drugs.

Hepatorenal syndrome Report Insights

• Hepatorenal syndrome Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Hepatorenal syndrome 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 Hepatorenal syndrome drugs?
• How many Hepatorenal syndrome drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Hepatorenal syndrome?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Hepatorenal syndrome 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 Hepatorenal syndrome and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• River 2 Renal Corp.

Noorik Biopharmaceuticals AG

Key Products

• R2R01
• Ambrisentan

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