Gout - Pipeline Insight, 2025

DelveInsight's, "Gout - Pipeline Insight, 2025" report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Gout 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

Gout: Understanding

Gout: Overview

Gouty Arthritis (Gout) is a common form of inflammatory arthritis that is very painful. It usually affects one joint at a time (often the big toe joint). There are times when symptoms get worse, known as flares, and times when there are no symptoms, known as remission. Repeated bouts of Gouty Arthritis (Gout) can lead to Gouty Arthritis (Gout) y arthritis, a worsening form of arthritis. There is no cure for Gouty Arthritis (Gout), but it can be effectively treated and managed with medication and self-management strategies.

Gout, also known as gouty arthritis, typically presents with sudden and intense flares that can last for days or weeks, followed by long periods of remission that may span weeks, months, or even years. It usually affects only one joint at a time, most commonly the big toe, but can also involve the lesser toe joints, ankle, or knee. The signs and symptoms in the affected joint(s) include intense pain, swelling, redness, and a sensation of heat.

The pathophysiology of gout involves a series of complex and interacting processes. Various genetic and metabolic factors contribute to hyperuricemia in the bloodstream, leading to the formation of monosodium urate (MSU) crystals. These crystals, along with metabolic, physiologic, and other characteristics, play a crucial role in triggering an acute inflammatory response. This response is mediated by soluble inflammatory factors, cellular elements, and innate immune processes, all influenced by the characteristics of the MSU crystals. The body then activates immune mechanisms to resolve the acute inflammation induced by these crystals. However, chronic inflammatory processes, along with the effects of immune cells and MSU crystals on osteoblasts, chondrocytes, and osteoclasts, can lead to cartilage attrition, bone erosion, joint injury, and the formation of tophi.

A medical doctor diagnoses Gouty Arthritis (Gout) by assessing the symptoms and the results of the physical examination, X-rays, and lab tests. Gouty Arthritis (Gout) can only be diagnosed during a flare when a joint is hot, swollen, and painful and when a lab test finds uric acid crystals in the affected joint. Gouty arthritis (gout) can be effectively treated and managed through a combination of medical treatment and self-management strategies. Healthcare providers may recommend a comprehensive treatment plan that includes managing the pain of a flare using nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, corticosteroids, or the anti-inflammatory medication colchicine. To prevent future flares, lifestyle and dietary changes-such as weight loss, limiting alcohol intake, and reducing consumption of purine-rich foods like red meat and organ meats-are often advised.

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

Gout Emerging Drugs Chapters

This segment of the Gout 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.

Gout Emerging Drugs

• LC350189: LG Chem

Tigulixostat (LC350189) is a novel xanthine oxidase inhibitor targeting the reduction of uric acid in purine metabolism, by inhibiting the activity of xanthine oxidase. It has a different structure from other xanthine oxidase inhibitors such as the purine analog xanthine oxidase inhibitor, allopurinol. Tigulixostat is under development as a first line treatment in the US and has demonstrated sufficient efficacy for sUA lowering and a good safety profile in a Phase II study. Currently, the drug is in the Phase III stage of its development for the treatment of Gout.

• SAP-001: Shanton Pharma

SAP-001 is a novel, clinical stage IIb small molecule drug developed to address significant unmet needs in the treatment of refractory and tophaceous gout. Positioned as a potential first-in-class and best-in-class therapy, SAP-001 aims to provide a comprehensive solution for patients with gout and hyperuricemia who are inadequately controlled by existing xanthine oxidase inhibitors such as allopurinol and febuxostat. Its mechanism of action (MOA) involves a dual-target approach that not only reduces uric acid production but also enhances uric acid excretion, thereby addressing both overproduction and underexcretion-two key pathological mechanisms of gout. This unique MOA enables SAP-001 to effectively lower serum urate levels and dissolve urate crystal deposits, offering promise for patients with severe or treatment-resistant disease.

• PRX-115: Protalix BioTherapeutics

PRX-115 is a recombinant PEGylated uricase enzyme developed by Protalix BioTherapeutics for the treatment of uncontrolled gout. Humans naturally lack uricase, an enzyme that converts uric acid into allantoin-a more soluble compound easily excreted by the kidneys. PRX-115 is produced using Protalix's proprietary ProCellEx(R) plant cell expression system and is chemically modified through PEGylation to enhance its stability, prolong its half-life, and reduce immunogenicity. In a Phase I clinical trial, PRX-115 demonstrated a dose-dependent reduction in plasma uric acid levels, maintaining levels below 6.0 mg/dL for up to 12 weeks following a single intravenous administration.

Gout: Therapeutic Assessment

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

• Major Players in Gout

There are approx. 20+ key companies which are developing the therapies for Gout. The companies which have their Gout drug candidates in the most advanced stage, i.e. Phase III include LG Chem.

Phases

DelveInsight's report covers around 25+ 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

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

• Intra-articular
• Intraocular
• Intrathecal
• Intravenous
• Oral
• Parenteral
• Subcutaneous
• Topical
• Transdermal
• Molecule Type

Products have been categorized under various Molecule types such as

• Oligonucleotide
• Peptide
• Small molecule
• Product Type

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

Gout: Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Gout 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 Gout drugs.

Gout Report Insights

• Gout Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Arthrosi Therapeutics
• Jiangsu Hengrui Medicine
• LG Chem
• InventisBio
• Shanton Pharma
• Dyve Biosciences
• Protalix BioTherapeutics
• Jiangsu Atom Bioscience and Pharmaceutical

Key Products

• AR-882
• SHR-4640
• LC350189
• D-0120
• SAP-001
• DYV700
• PRX-115
• ABP-745