Overactive Bladder Pipeline Shows Rapid Advancements in the Clinical Trials: A Review by DelveInsight

Los Angeles, USA, June 07, 2021 (GLOBE NEWSWIRE) -- Overactive Bladder Pipeline Shows Rapid Advancements in the Clinical Trials: A Review by DelveInsight

Overactive Bladder therapies with different mechanisms of action are currently being studied with excellent market potential. Ongoing scientific research has provided with greater sophistication and a clearer understanding of the mechanisms of therapeutic interventions, combined with improved outcome measures to assess the efficacy and patient satisfaction, as well as high-quality Overactive Bladder clinical trials with proper design, which would translate into more refined and directed therapies in future years. 

DelveInsight’s “Overactive Bladder Pipeline Insight” report provides comprehensive insights about 15+ companies and 15+ pipeline drugs in the Overactive Bladder pipeline landscapes. It comprises Overactive Bladder pipeline drug profiles, including clinical and non-clinical stage products. It also includes the Overactive Bladder therapeutics assessment by product type, stage, route of administration, and molecule type and further highlights the inactive Overactive Bladder pipeline products.     

Some of the key takeaways from the Overactive Bladder Pipeline Report  

• Notable companies such as AbbVie, Medytox, Velicept Therapeutics, Sumitovant Biopharma, Hugel, Imbrium Therapeutics, Lipella Pharmaceuticals, Bayer, Sumitovant Biopharma, Aetas Pharma, and others are developing potential drug candidates to boost the Overactive Bladder treatment scenario. 
• Velicept Therapeutics (formed by NeXeption Forms) merged Velicept with privately-held AltheRx Pharmaceuticals, Inc. to advance the development of solabegron, a highly differentiated beta 3-adrenoceptor agonist for the treatment of Overactive Bladder.
• Velicept Therapeutics announced that its next-generation beta-3 adrenoceptor agonist solabegron met the primary endpoint in VEL-2002, a phase IIb study in Overactive Bladder patients.
• In March 2011, AltheRx Inc announced that it had purchased all assets related to Solabegron from GlaxoSmithKline.
• Urovant Sciences’ URO-902, a novel gene therapy using a naked DNA plasmid vector, which is currently in Phase II development in the US. This innovative treatment has the capability to tackle an unmet need for patients who have failed oral pharmacologic therapies and are concerned with potential urinary retention or surgical interventions pertinent to current third-line Overactive Bladder treatments.
• TAC-302, an orally bioavailable drug, stimulates neurite outgrowth activity in cultured peripheral neurons and has beneficial effects on bladder denervation and storage/voiding dysfunctions. TAC-302 is being developed and investigated in the phase II stage of development by Taiho Pharmaceutical to treat overactive bladder. 
• BAY 1817080 is a purinergic P2X3 receptor antagonist being developed by Bayer to treat persistent overactive bladder. Phase II clinical trials were initiated by Bayer for BAY 1817080 in September 2020 to determine how well the drug BAY1817080 works in Overactive Bladder patients with urgency urinary incontinence (UUI).
• Botulax, an Acetylcholine inhibitor, is being developed by Hugel. Phase I clinical trials are being evaluated for Botulax for the treatment of patients with Overactive Bladder. 

Get an overview of pipeline landscape @ Overactive Bladder Clinical Trials Analysis 

Overactive Bladder (OAB) causes a frequent and sudden urge to urinate that may be difficult to control. One may need to pass urine many times during the day and night and may also experience unintentional loss of urine. 

There are six antimuscarinic agents available for the OAB treatment worldwide- oxybutynin, tolterodine, fesoterodine, trospium, darifenacin, and solifenacin.

Overactive Bladder Emerging Drugs

• Neuronox: AbbVie/Medytox

Neuronox, an acetylcholine inhibitor is being developed by Medy-Tox for the treatment of the Overactive Bladder. The active ingredients involve Clostridium botulinum toxin type A. It is currently in the phase III stage of development. In September 2020, US drugmaker Allergan entered into a license agreement with South Korea’s Medytox under the terms of which, on closing, Allergan would pay Medytox an upfront of USD 65 million and Medytox would grant Allergan exclusive rights, worldwide outside of Korea, to develop and, if approved, commercialise certain neurotoxin product candidates currently in development, including a potential liquid-injectable product. In May 2020, AbbVie announced that it had finished its acquisition of Allergan plc. following receipt of regulatory approval from all government authorities needed by the transaction agreement and approval by the Irish High Court.

Research and Development
Phase III 
NCT04113941: In August 2019, Medy-Tox initiated a phase III trial, a randomised, double-blind, placebo-controlled, multi-centre study to assess the efficacy and safety of Meditoxin in subject with Idiopathic Overactive Bladder. This study is for patients who have idiopathic overactive bladder symptoms. This study will assess the efficacy and safety of Neuronox against placebo. The trial is currently in the active not recruiting stage with an estimated enrollment of 216 participants and anticipated to be completed in August 2021.

• URO-902: Sumitovant Biopharma

Urovant Sciences is developing URO-902 for the treatment of the Overactive Bladder. URO-902 has the potential to be the first gene therapy for OAB patients. This innovative treatment has the capability to tackle an unmet need for patients who have failed oral pharmacologic therapies and are concerned with potential urinary retention or surgical interventions pertinent to existing third-line OAB treatments. It is currently in the phase II stage of development.

Research and Development
Phase II 
NCT04211831: In December 2019, Urovant Sciences GmbH initiated a phase II trial titled “An exploratory phase IIa study evaluating the efficacy and safety of URO-902 in subjects with Overactive Bladder and Urge Urinary Incontinence”. This study will investigate the efficacy, safety, and tolerability of a single dose of URO-902 24 milligrams (mg) and 48 mg (administered via intradetrusor injection), compared with placebo, in participants with overactive bladder (OAB) and urge urinary incontinence (UUI) up to 48 weeks post-dose. The trial is currently in recruiting stage with an estimated enrollment of 78 participants and expected to be completed in September 2022.

• Solabegron: Velicept Therapeutics

Solabegron is a highly potent and selective beta-3 adrenoceptor agonist that is being developed for Overactive Bladder treatment. Solabegron has been tested in over 800 study subjects in a twice-a-day formulation and demonstrated efficacy in treating OAB and Irritable bowel syndrome (IBS). A once-daily formulation designed to optimise patient convenience and effectiveness has been developed and is currently being evaluated in phase 2b dose-ranging clinical trials.

Research and Development
Phase II 
NCT03594058: In July 2018, Velicept Therapeutics initiated a phase IIb, multicenter, randomised, double-blind, placebo-controlled, parallel-group study to assess the efficacy and safety of oral solabegron modified-release tablets in the treatment of Overactive Bladder in adult female subjects. The trial enrolled 1413 participants and was completed in May 2019.

Results 
Velicept Therapeutics announced that its next-generation beta-3 adrenoceptor agonist solabegron met the primary endpoint in VEL-2002, a phase IIb study in Overactive Bladder patients. In the study, twice-daily administration of solabegron showed a statistically major improvement compared to placebo at week 12, as measured by the mean change in the number of micturitions per day, the study’s primary endpoint. Solabegron also showed statistical significance across various secondary endpoints, comprising a percent reduction of urge urinary incontinence episodes, dry rate, and urgency episodes.

For further information, refer to the detailed report @ Overactive Bladder Pipeline Therapeutics 

Scope of Overactive Bladder Pipeline Drug Insight    

• Coverage: Global 
• Major Players: 15+  Key Players
• Prominent Players: AbbVie, Medytox, Velicept Therapeutics, Sumitovant Biopharma, Hugel, Imbrium Therapeutics, Taiho Pharmaceutical, Bayer, DelNova, Johnson &Johnson, Lipella Pharmaceuticals, Bayer, Sumitovant Biopharma, Aetas Pharma, and many others.   
• Key Drugs Profiles: 15+  Products
• Phases:  

• Overactive Bladder Therapies Late-stage (Phase III)  
• Overactive Bladder Therapies Mid-stage (Phase II)
• Overactive Bladder Therapies Early-stage (Phase I) 
• Overactive Bladder Pre-clinical stage and Discovery candidates     
• Discontinued and Inactive candidates 

• Mechanism of Action:

• Neuromuscular blocking agents
• Calcium-activated potassium channel openers
• Beta 3 adrenergic receptor agonists
• Purinergic P2X3 receptor antagonists
• Nociceptin receptor agonists 

• Molecule Types:   

• Stem gene therapy 
• Small molecule
• Gene therapy

• Route of Administration:

• Oral
• Inhalation
• Intravenous 
• Subcutaneous 

• Product Types:

• Monotherapy
• Combination
• Mono/Combination 

Key Questions regarding Current Overactive Bladder Treatment Landscape and Emerging Therapies Answered in the Pipeline Report  

• What are the current options for Overactive Bladder treatment?
• How many companies are developing therapies for the treatment of the Overactive Bladder? 
• How many are Overactive Bladder emerging therapies in the early-stage, mid-stage, and late development stages to treat Overactive Bladder? 
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and significant licensing activities that will impact the Overactive Bladder market? 
• Which are the dormant and discontinued products and the reasons for the same?
• What is the unmet need for current therapies for the treatment of the Overactive Bladder?  
• What are the current novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing Overactive Bladder therapies? 
• What are the critical designations that have been granted for the emerging therapies for the Overactive Bladder? 
• How many patents are granted and pending for the emerging therapies to treat the Overactive Bladder?   

Table of Contents

Get a customised pipeline report @ Overactive Bladder Drugs Pipeline Report  

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