- The author estimates that in 2016, there were 579.6 million prevalent cases of overactive bladder worldwide among adults aged 20 years and older, and forecasts that number to increase to 649.4 million by 2025.
- The approved drugs in the overactive bladder space target the calcium channel, muscarinic acetylcholine receptor, SNARE proteins, and beta-3 adrenergic receptor. The majority of these drugs are administered via the oral route, with the remainder being available in intramuscular, intravesical, intradermal, intraarticular, topical, and transdermal formulations.
- The majority of industry-sponsored drugs in active clinical development for overactive bladder are in Phase II, with only one drug in the NDA/BLA phase.
- Therapies in early- and mid-stage development for overactive bladder focus on targets such as beta-3 adrenergic receptor, muscarinic acetylcholine receptor, SNARE proteins, and transient receptor potential vanilloid receptor 1. The majority of pipeline drugs are administered via the oral route, with the remainder being available in subcutaneous and intravesical formulations.
- High impact upcoming events comprise PDUFA dates for Myrbetriq and Solifenacin/Mirabegron. There have been 18 licensing and asset acquisition deals involving overactive bladder drugs during 2013-18. The largest deal was the October 2016 $25.0m exclusive licensing agreement between UroGen Pharma and Allergan to license worldwide rights to UroGen’s RTGel delivery system technology for use with neurotoxins.
- The US product patent of Vesicare is set to expire in 2019, and the US patents of Detrol (formulation) and Oxytrol (method of use) are set to expire in 2020, which will open the door to generic entry.
- Therapeutic Botox’s sales ranked highest among drugs approved in the overactive bladder space during 2012-16. The distribution of clinical trials across Phase I-IV indicates that there is an even distribution of trials for overactive bladder, with 54% of trials in Phase I-II, and 46% in Phase III-IV.
- The US has a substantial lead in the number of overactive bladder clinical trials globally. Germany leads the major EU markets, while Japan has the top spot in Asia.
- Clinical trial activity in the overactive bladder space is dominated by completed trials. Astellas Pharma has the highest number of completed clinical trials for overactive bladder, with 162 trials. Astellas Pharma also leads industry sponsors with the highest number of Phase III clinical trials for overactive bladder, followed by Pfizer
Lifestyle modifications and control techniques
Medical and surgical treatment
Products and devices
KEY UPCOMING EVENTS
KEY REGULATORY EVENTS
After Hiccups, Astellas’s Mirabegron On Course For Indian Debut?
Bluewind Medical Secures CE Mark For Tibial Neurostimulator For Overactive Bladder
Will Axonics Square Up To Medtronic In Sacral Neuromodulation Market?
LICENSING AND ASSET ACQUISITION DEALS
Roivant Launches Urovant, Gets Rights To Merck's Phase III Vibegron
CLINICAL TRIAL LANDSCAPE
Trials by status
Trials by phase
List of Figures
Figure 1: Trends in prevalent cases of overactive bladder, 2016-25
Figure 2: Overview of pipeline drugs for overactive bladder in the US
Figure 3: Pipeline drugs for overactive bladder, by company
Figure 4: Pipeline drugs for overactive bladder, by drug type
Figure 5: Pipeline drugs for overactive bladder, by classifications
Figure 6: Key upcoming events in overactive bladder
Figure 7: Licensing and asset acquisition deals in overactive bladder, 2013-18
Figure 8: Parent patents in overactive bladder
Figure 9: Clinical trials in overactive bladder
Figure 10: Top 10 drugs for clinical trials in overactive bladder
Figure 11: Top 10 companies for clinical trials in overactive bladder
Figure 12: Trial locations in overactive bladder
Figure 13: Overactive bladder trials status
Figure 14: Overactive bladder trials sponsors, by phase
List of Tables
Table 1: Prevalent cases of overactive bladder, 2016-25
Table 2: Marketed drugs for overactive bladder
Table 3: Approvals by country for overactive bladder
Table 4: Pipeline drugs for overactive bladder in the US
Table 5: Historical global sales, by drug ($m), 2012-16
Table 6: Forecasted global sales, by drug ($m), 2017-22