Gout - Pipeline Insight, 2024

This “Gout - Pipeline Insight, 2024,” 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 is a form of inflammatory arthritis characterized by sudden, severe attacks of pain, redness, and tenderness in the joints, often affecting the big toe. It results from the accumulation of urate crystals, which form when there are high levels of uric acid in the blood. Uric acid is a waste product produced during the breakdown of purines, substances naturally found in certain foods and cells. Normally, uric acid dissolves in the blood and is excreted by the kidneys, but when the body produces too much or the kidneys fail to eliminate enough, uric acid levels rise, leading to the formation of sharp, needle-like crystals in joints and surrounding tissues.

Gout typically occurs in four stages: asymptomatic hyperuricemia, acute gout, intercritical gout (the symptom-free periods between attacks), and chronic gout. Acute gout is marked by intense joint pain, swelling, and redness, usually in one joint at a time. The most commonly affected joint is the big toe, although other joints such as the ankles, knees, elbows, wrists, and fingers can also be involved. The attacks often occur suddenly, often at night, and can last from a few days to a couple of weeks.

Risk factors for gout include genetic predisposition, diet, obesity, certain medications, and medical conditions like high blood pressure, diabetes, and kidney disease. Alcohol consumption, especially beer and sugary drinks, as well as foods rich in purines, such as red meat and seafood, can increase uric acid levels and trigger gout attacks. Men are more likely to develop gout than women, but the risk for women increases after menopause due to hormonal changes.

Management of gout involves both short-term treatment to alleviate symptoms and long-term strategies to prevent future attacks and complications. Acute attacks are usually treated with nonsteroidal anti-inflammatory drugs (NSAIDs), colchicine, or corticosteroids to reduce pain and inflammation. Long-term management focuses on lowering uric acid levels through lifestyle changes and medications like allopurinol or febuxostat. These medications help prevent the formation of urate crystals and decrease the frequency of gout attacks. Dietary modifications, weight management, and reduced alcohol consumption are essential components of long-term gout management.

If left untreated, gout can progress to chronic gout, leading to joint damage, persistent pain, and the development of tophi - large, painful deposits of urate crystals under the skin. Chronic gout may also increase the risk of kidney stones and other complications. However, with early diagnosis, appropriate treatment, and lifestyle changes, gout can be effectively managed, minimizing its impact on quality of life..

"Gout - Pipeline Insight, 2024" report 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 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 an investigational drug developed by Shanton Pharma, specifically designed to treat refractory and tophaceous gout, a severe form of the condition that often does not respond to standard treatments. This drug functions as a urate transporter inhibitor, targeting the uric acid transporter 1 (URAT1) to lower urate levels in patients who have not adequately responded to traditional therapies like allopurinol or febuxostat. Currently, the drug is in the Phase II stage of its development for the treatment of Gout.

D-0120: InventisBio

D-0120 is a novel oral selective uric acid transporter (URAT1) inhibitor being developed for the treatment of gout by blocking the reabsorption of uric acid (UA) within the renal proximal tubule, thereby reducing serum uric acid concentrations. As a novel URAT1 inhibitor, D-0120 is anticipated to have more potent serum UA reducing effect than the approved URAT1 inhibitor lesinurad, but with less toxicity and wider therapeutic window. The pharmacological potential of D-0120 for the treatment of hyperuricemia and gout was demonstrated in preclinical studies.

The results of the in vitro hURAT1 expressed CHO cell model showed that the inhibitory activity of D-0120 is 150-fold more potent than lesinurad and slightly more potent than verinurad. A Phase I clinical trial for D-0120 has been completed in the US, and good efficacy and excellent safety profile have been observed. Currently, the drug is in the Phase II stage of its development for the treatment of Gout.

ABP-745: Jiangsu Atom Bioscience and Pharmaceutical

ABP-745 is an emerging small molecule drug developed by Atom Bioscience, primarily targeting the treatment of acute gout. While specific mechanisms are not fully detailed, ABP-745 is noted for its anti-inflammatory properties and is designed to be orally administered. Currently, it is in the Phase I clinical trial stage, with the first trial initiated on January 3, 2024, in the United States.

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. Phase III include, LG Chem.

Phases

The 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

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

Products have been categorized under various Molecule types such as

• Protein
• Small interfering RNA
• 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 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

• Jiangsu Atom Bioscience and Pharmaceutical
• LG Chem
• Shanton Pharma
• TWi Biotechnology
• Olatec Therapeutics
• JW Pharmaceutical
• Revive Therapeutics
• Hinova pharmaceuticals
• Arthrosi Therapeutics
• Dyve Biosciences
• Jiangsu Atom Bioscience and Pharmaceutical
• Swedish Orphan Biovitrum
• Allen Pharmaceuticals
• Teijin Pharma
• AstraZeneca
• R-Pharm
• InventisBio
• Sinovent
• Shenyang Sunshine Pharmaceutical

Key Products

• ABP-745
• SHR4640
• SEL-212
• LC350189
• SAP-001
• AC-201
• Dapansutrile
• URC-102
• Bucillamine
• HP501
• AR882
• DYV700
• ABP-671
• Anakinra
• ALLN-346
• TMX-049
• Verinurad
• RPH-104
• D-0120

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