Gout is a common form of inflammatory arthritis, characterized by acute but sporadic episodes of synovitis along with joint swelling and pain (acute gouty arthritis). It is a metabolic disorder caused by excess uric acid in the body. The excess uric acid or hyperuricemia forms tiny needle-shaped crystals that are deposited in the synovial fluid, bones, tendons, cartilage, bursas, or other sites, which can trigger an acute inflammatory attack. The inflammation usually subsides within one or two weeks, and the pain can be managed by taking anti-inflammatory medications.

Key Takeaways

• Datamonitor Healthcare estimates that in 2019, there were 35.4 million prevalent cases of gout in people aged 15 years and older worldwide, and forecasts that number to increase to 39.4 million prevalent cases by 2028.
• The approved drugs in the gout space focus on targets such as microtubules, URAT1, xanthine oxidase, interleukin-1, and uric acid. These drugs are commonly administered via the oral route, with the remainder being available in intravenous and subcutaneous formulations.
• The largest proportion of industry-sponsored drugs in active clinical development for gout are in Phase I, with just a single product in Phase III.
• Drugs in development for gout focus on targets such as uric acid, URAT1, xanthine oxidase, and NLR protein-3/inflammasome. The largest proportion of pipeline drugs are administered via the oral route, with the remainder being intravenous, intramuscular, and topical formulations.
• High-impact upcoming events for drugs in the gout space comprise topline Phase II trial results for ALLN-346, and topline Phase III trial results for SEL-212.
• The overall likelihood of approval of a Phase I arthritis asset is 8.8%, and the average probability a drug advances from Phase III is 80%. Drugs, on average, take 9.0 years from Phase I to approval, compared to 9.2 years in the overall autoimmune/immunology space.
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for gout have been in the early and midphases of development, with 71% of trials in Phase I–II, and 29% in Phase III–IV.
• The US has a substantial lead in the number of gout clinical trials globally. Germany leads the major European markets, while Japan has the top spot in Asia.
• Clinical trial activity in the gout space is dominated by completed trials. AstraZeneca has the highest number of completed clinical trials for gout, with 71 trials.
• AstraZeneca leads industry sponsors with the highest overall number of clinical trials for gout