- The approved drugs in the gout space focus on a wide variety of targets. They are commonly administered via the oral route, with the remainder being available in intravenous and subcutaneous formulations.
- The majority of the industry-sponsored drugs in active clinical development for gout are in Phase II. Therapies in early and mid-stage development focus on targets such as uric acid, PPAR gamma, the IL-1 receptor, and the immune system/reactive oxygen species/free radicals. The majority of pipeline drugs are administered via the oral route, with the remainder being intramuscular, intravenous, and subcutaneous formulations.
- There were seven licensing and asset acquisition activities involving gout drugs during 2013-17, three of which occurred in 2013. The exclusive licensing agreement in 2016 between Ironwood and AstraZeneca, worth $265m, for the US rights to Zurampic (lesinurad) and the fixed-dose combination of lesinurad and allopurinol, was the largest deal during the period.
- Sales of Colcrys ranked highest among drugs in the gout space during 2012-16. However, during 2017-22, Ilaris is forecast to have the largest sales.
- The clinical trials distribution across Phase I-IV indicates that the majority of trials for gout have been in early and mid-phases of development, with 68% of trials in Phase I-II, and 32% in Phase III-IV.
- The US has a substantial lead in the number of gout clinical trials globally. Germany leads the major EU 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 64 completed trials.
- AstraZeneca has been the most active clinical trial sponsor for gout
2 DISEASE BACKGROUND
- Non-steroidal anti-inflammatory drugs (NSAIDs)
- Combination therapy
- Prevention of chronic gout
5 MARKETED DRUGS
- Approvals by country
7 KEY REGULATORY EVENTS
- Duzallo Approval Opens Gout Opportunity For Ironwood
- AZ's Gout Drug PASS-ed In Europe
- Recent deals
10 REVENUE OPPORTUNITY
11 CLINICAL TRIAL LANDSCAPE
- Sponsors by status
- Sponsors by phase
- Prescription Information
List of Figures
Figure 1: Trends in prevalent cases of gout, 2016-25
Figure 2: Pipeline drugs for gout in the US
Figure 3: Pipeline drugs for gout, by company
Figure 4: Pipeline drugs for gout, by drug type
Figure 5: Pipeline drugs for gout, by classifications
Figure 6: Licensing and asset acquisition deals in gout, 2012-17
Figure 7: Parent patents in gout
Figure 8: Clinical trials in gout
Figure 9: Top 10 drugs for clinical trials in gout
Figure 10: Top 10 companies for clinical trials in gout
Figure 11: Trial locations in gout
Figure 12: Gout trials status
Figure 13: Gout trials sponsors, by phase
List of Tables
Table 1: Prevalent cases of gout, 2016-25
Table 2: Marketed drugs for gout
Table 3: Approvals by country for gout
Table 4: Pipeline drugs for gout in the US
Table 5: Historical global sales, by drug ($m), 2012-16
Table 6: Forecasted global sales, by drug ($m), 2017-22