Gout Pipeline Insight

DelveInsight’s, “Gout - Pipeline Insight, 2025” report provides comprehensive insights about 25+ companies and 30+ 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

Gout, historically referred to as the ""disease of kings and king of diseases,"" is one of the most common causes of chronic inflammatory arthritis, particularly in the United States. It is defined by the deposition of monosodium urate crystals in joints and surrounding tissues, driven by hyperuricemia—serum urate levels exceeding 6.8 mg/dL, the solubility threshold of urate in blood. Clinically, gout can present as acute inflammatory arthritis flares, chronic joint damage (gouty arthropathy), tophaceous deposits, uric acid kidney stones, and chronic kidney disease. Despite its long-recognized history, gout remains a well-studied and manageable condition.

Gout typically presents with sudden, severe joint pain, most often affecting a single joint such as the big toe. The pain is usually intense, making even light contact unbearable, and is accompanied by swelling, redness, warmth, and extreme tenderness in the affected area. Attacks often occur at night and may limit joint mobility due to stiffness. If left untreated, gout can progress to chronic stages, leading to the formation of tophi—hard uric acid deposits under the skin—and permanent joint damage. Some individuals may also experience fatigue or a general sense of illness during acute flares. In more advanced cases, gout can affect multiple joints and mimic other types of inflammatory arthritis. The condition may also be associated with systemic inflammation, kidney stones, or underlying metabolic disorders. Early diagnosis and proper management are essential to prevent long-term complications and improve quality of life.

Gout is a chronic inflammatory arthritis driven by the deposition of monosodium urate (MSU) crystals, the end product of purine metabolism, in joints, bones, and soft tissues. Hyperuricemia plays a central role in crystal formation and inflammation, often influenced by genetic, metabolic, and dietary factors. The disease manifests in various forms including acute flares, chronic arthritis, tophaceous deposits, and renal complications. MSU crystals trigger intense inflammatory responses through immune mechanisms, notably via activation of the NLRP3 inflammasome and IL-1β production. Over time, unresolved inflammation leads to joint damage, cartilage degradation, and bone erosion. Advanced gout is marked by tophi—organized MSU deposits surrounded by chronic inflammatory cells—and ongoing joint destruction, even in the absence of acute symptoms. Proper understanding of the disease’s multifactorial pathophysiology is essential for effective management and prevention of long-term complications.

The treatment of gout involves a multifaceted approach aimed at both acute symptom relief and long-term management to prevent flares and joint damage. During acute flares, rapid initiation of anti-inflammatory therapies such as NSAIDs, colchicine, or glucocorticoids is essential to reduce pain and inflammation. Long-term management centers on urate-lowering therapy (ULT) to maintain serum uric acid levels below 6 mg/dL, using agents like allopurinol or febuxostat (xanthine oxidase inhibitors), and in select cases, uricosuric agents or pegloticase. Colchicine is commonly used for flare prophylaxis during ULT initiation. Lifestyle modifications including weight loss, dietary changes, and management of comorbidities also play a critical role. Treatment strategies must be individualized, considering renal function, comorbidities, and the severity of disease. Emerging therapies targeting interleukin-1 and SGLT2 inhibitors offer additional tools, particularly in refractory cases or patients with complex metabolic profiles.

 

"Gout- Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. 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

• NASP: Swedish Orphan Biovitrum AB

NASP is a novel investigational medicine designed to reduce serum urate (SU) levels in people with uncontrolled gout, potentially reducing harmful tissue urate deposits which when left untreated can lead to debilitating gout flares and joint deformity. NASP is administered every 4-weeks as a sequential, two-component, infusion therapy consisting of tolerogenic nanoencapsulated sirolimus (NAS) which mitigates the formation of anti-drug antibodies (ADAs) and a uricase, pegadricase (P), which reduces serum uric acid. ADAs develop due to unwanted immune responses to biologic medicines, reducing their efficacy and tolerability, which remains an issue across multiple therapeutic modalities and disease states including uncontrolled gout. Sobi announced the initiation of a rolling Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for SEL-212. The submission is based on the results of the DISSOLVE I and II pivotal studies. SEL-212 is an innovative biologic therapy in development for the treatment of chronic refractory gout. This significant milestone follows the FDA's Fast Track designation of SEL-212, underscoring the urgent need for new treatment options for patients with chronic refractory gout. Currently, the drug is in Phase Preregistration stage of its development for the treatment of Gout.

 

• AR882: Arthrosi Therapeutics

AR882 is a potent and selective inhibitor of uric acid transporter 1 (URAT1), which is responsible for a majority of reabsorption of filtered uric acid from the renal tubular lumen. By inhibiting URAT1, AR882 increases uric acid urinary excretion and thereby lowers serum uric acid (sUA). Preclinically, AR882 has demonstrated inhibitory effect on uric acid uptake and good tolerability in pharmacology, pharmacokinetic and toxicology studies. Currently, the drug is in Phase III stage of its development for the treatment of Gout.

 

• ABP-671: Jiangsu Atom Bioscience and Pharmaceutical Co., Ltd.

ABP-671 is an inhibitor of urate transporter 1 (URAT1) proteins, which are involved in reabsorption of uric acid by the kidneys. As a first line monotherapy, administered once a day in an oral tablet, ABP-671 reduces uric acid reabsorption, increasing its excretion in urine to reduce serum uric acid (sUA) levels. In long-term treatment this will reduce the number and size of tophi which will prevent gout attacks. By maintaining normal levels of sUA, the drug can also reduce the potential for complications associated with hyperuricemia, such as diabetes and heart and kidney disease. For the treatment of gout, there is a general agreement that targeting sUA levels of less than 6 and 5 mg/dL will inhibit the formation of new crystals and promote dissolution of existing crystals. Reduction of sUA levels to less than 5 mg/dL can further increase the velocity of tophi resolution, in both number and size. ABP-671 has demonstrated the ability to reach both sUA targets in a recent Phase IIa clinical trial. Approximately 93% and 77% of participants receiving ABP-671 treatment experienced reduction in sUA level to less than 6 and 5 mg/dL, respectively.. Currently, the drug is in Phase II/III stage of its development for the treatment of Gout.

 

• PRX-115: Protalix Biotherapeutics Inc.

PRX-115 is a recombinant PEGylated uricase enzyme, chemically modified enzyme in development for the potential treatment of uncontrolled gout.PRX-115 is our recombinant PEGylated uricase (urate oxidase), a chemically modified enzyme under development for the potential treatment of patients with uncontrolled gout. The uricase enzyme that does not exist naturally in humans converts uric acid to allantoin, which is easily eliminated through urine. This recombinant enzyme, expressed via our ProCellEx system, is designed to lower uric acid levels and improve clinical manifestation of the disease while having low immunogenicity and increased half-life of the drug in the blood. Pre-clinical data demonstrates long half-life, reduced immunogenic risk and high specific activity which supports the potential of PRX-115 to be a safe and effective treatment for patients with uncontrolled gout. One-month multiple dosing toxicity studies in two species and 6-month multiple dosing toxicity study in one specie were conducted to support single and multiple dose studies in humans. Currently, the drug is in Phase I stage of its development for the treatment of Gout.

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

 

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. 25+ key companies which are developing the therapies for Gout. The companies which have their Gout drug candidates in the most advanced stage, i.e. Preregistration include, Swedish Orphan Biovitrum AB.

 

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

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

• 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.

 

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?