CLINICAL TRIALS PROFILE FOR SOLIFENACIN SUCCINATE

505(b)(2) Clinical Trials for SOLIFENACIN SUCCINATE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT01565707 ↗	A Study to Investigate How Effective and Safe Solifenacin Succinate Suspension is in Treating Children/Adolescents Aged 5 to Less Than 18 Years With Symptoms of Overactive Bladder (OAB) Compared to a Non-active Drug	Completed	Astellas Pharma Europe B.V.	Phase 3	2012-06-07	Solifenacin succinate as a tablet formulation is already on the market for the treatment of symptoms of overactive bladder in adults. For the use in children and adolescent patients a new formulation of solifenacin has been developed. This study investigated the effect and safety of solifenacin succinate liquid suspension compared to a non-active drug (placebo) over a 12-week period. The 2 weeks prior to the double blind period was a single-blind placebo run-in period in combination with behavioral urotherapy (Non-interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB), followed by a 12 week daily treatment period. The study also investigated how well solifenacin succinate suspension is taken-up by the body and how long it stays in the body during this time.

All Clinical Trials for SOLIFENACIN SUCCINATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00333112 ↗	A Study to Evaluate Solifenacin Succinate in Combination With Tamsulosin for the Treatment of Residual Overactive Bladder Symptoms (OAB) in Men.	Completed	Astellas Pharma Inc	Phase 4	2006-05-01	A study to evaluate solifenacin succinate in combination with tamsulosin for the treatment of residual OAB symptoms in men.
NCT00337558 ↗	A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)	Completed	Astellas Pharma Europe B.V.	Phase 4	2006-05-01	This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessing patient diaries and other patient reported outcomes.
NCT00337558 ↗	A Study of Solifenacin With Bladder Training Versus Solifenacin Alone in Patients With Overactive Bladder (SOLAR)	Completed	Astellas Pharma Inc	Phase 4	2006-05-01	This study will look at a drug for OAB (solifenacin) in combination with a non drug treatment (bladder training) compared to the drug on its own. The study will compare the symptoms of OAB by assessing patient diaries and other patient reported outcomes.
NCT00189800 ↗	A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder	Completed	Astellas Pharma Korea, Inc.	Phase 3	1969-12-31	The purpose of this study is to ascertain the clinical results of solifenacin succinate of PIII study conducted in the original country using Korean patients with an overactive bladder.
NCT00189800 ↗	A Study of Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder	Completed	Astellas Pharma Inc	Phase 3	1969-12-31	The purpose of this study is to ascertain the clinical results of solifenacin succinate of PIII study conducted in the original country using Korean patients with an overactive bladder.

Clinical Trial Conditions for SOLIFENACIN SUCCINATE

Condition Name

Condition Name for SOLIFENACIN SUCCINATE
Intervention	Trials
Overactive Bladder	17
Urinary Bladder, Overactive	15
Healthy Subjects	5
Urinary Incontinence	5

Condition MeSH

Condition MeSH for SOLIFENACIN SUCCINATE
Intervention	Trials
Urinary Bladder, Overactive	39
Prostatic Hyperplasia	6
Hyperplasia	6
Urinary Incontinence	5

Clinical Trial Locations for SOLIFENACIN SUCCINATE

Trials by Country

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−

Trials by Country for SOLIFENACIN SUCCINATE
Location	Trials
United States	261
United Kingdom	21
Canada	21
Germany	20
Netherlands	19

Trials by US State

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−

Trials by US State for SOLIFENACIN SUCCINATE
Location	Trials
New York	13
Florida	11
Texas	10
Pennsylvania	9
Ohio	9

Clinical Trial Progress for SOLIFENACIN SUCCINATE

Clinical Trial Phase

Clinical Trial Phase for SOLIFENACIN SUCCINATE
Clinical Trial Phase	Trials
Phase 4	19
Phase 3	17
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for SOLIFENACIN SUCCINATE
Clinical Trial Phase	Trials
Completed	48
Unknown status	4
Terminated	2

Clinical Trial Sponsors for SOLIFENACIN SUCCINATE

Sponsor Name

Sponsor Name for SOLIFENACIN SUCCINATE
Sponsor	Trials
Astellas Pharma Inc	23
Astellas Pharma Europe B.V.	17
Astellas Pharma Korea, Inc.	3

Sponsor Type

Sponsor Type for SOLIFENACIN SUCCINATE
Sponsor	Trials
Industry	51
Other	23

Solifenacin Succinate: Clinical Trials, Market Analysis, and Projections

Introduction to Solifenacin Succinate

Solifenacin succinate, marketed under the brand name VESIcare®, is a small molecule drug used primarily for the treatment of overactive bladder (OAB) symptoms, including urgency, urinary frequency, and urge urinary incontinence. Here, we will delve into the recent clinical trials, market analysis, and future projections for this medication.

Clinical Trials Update

SYNERGY I, SYNERGY II, and BESIDE Trials

Significant clinical trials have been conducted to evaluate the efficacy and safety of solifenacin succinate, particularly in combination with mirabegron (Myrbetriq®). The SYNERGY I and SYNERGY II trials, along with the BESIDE study, were pivotal in assessing the combination therapy.

• SYNERGY I Trial: This Phase 3 trial enrolled 6,991 patients across 435 study locations in 42 countries. It compared the combination of mirabegron and solifenacin succinate with each drug as monotherapy and placebo in patients with symptoms of "wet" OAB[1].
• SYNERGY II Trial: This 52-week, Phase 3 trial involved 2,084 patients across 251 sites in 32 countries. It evaluated the combination of mirabegron 50 mg and solifenacin succinate 5 mg compared to each drug as monotherapy in patients with "wet" OAB symptoms[1].
• BESIDE Trial: The Phase 3b BESIDE study enrolled 3,815 patients across 281 sites in 36 countries. It focused on the efficacy, safety, and tolerability of the combination therapy in OAB patients who had an inadequate response to solifenacin succinate monotherapy[1].

These trials demonstrated the efficacy and safety of the combination therapy, leading to a supplemental New Drug Application (sNDA) submission to the FDA for approval.

Bioequivalence Studies

Recent bioequivalence studies have also been conducted to compare different formulations of solifenacin succinate. For example, a study aimed to determine the bioequivalence of solifenacin succinate and mirabegron from Mirfenacin MR 5/50 mg Extended Release Tablets (Hikma Pharma) versus Vesicare 5 mg Film Coated Tablets and Betmiga 50 mg Prolonged-Release Tablets (Astellas Pharma Europe B.V)[3].

Market Analysis

Global Market Size and Growth

The global solifenacin succinate market is experiencing significant growth driven by increasing healthcare investments, rising awareness and diagnosis of urinary disorders, and the growing prevalence of chronic conditions.

• Global Market Size: The market size was estimated at USD 102151.2 million in 2024 and is projected to expand at a compound annual growth rate (CAGR) of 50.90% from 2024 to 2031, reaching USD 1819986.4 million by 2031[2].
• Regional Markets: North America, Europe, Asia Pacific, Latin America, and the Middle East and Africa are key regions contributing to the market growth. Europe held more than 30% of the global revenue in 2024, while Asia Pacific accounted for around 23%[2].

Market Segmentation and Trends

The solifenacin succinate market is segmented based on type, application, and region. High-purity solifenacin succinate (above 99% purity) is expected to dominate the market due to its improved bioavailability and stability, as well as stringent quality standards set by regulatory agencies like the FDA and EMA[2].

Competitive Landscape

The market is competitive, with several pharmaceutical companies involved in the production and distribution of solifenacin succinate. Astellas Pharma, the originator of VESIcare®, plays a significant role in the market, along with other manufacturers like Hikma Pharma[1][3].

Market Projections

Future Growth

The solifenacin succinate market is anticipated to grow substantially over the next few years. Here are some key projections:

• Global Growth: The market is expected to grow from USD 102151.2 million in 2024 to USD 1819986.4 million by 2031, with a CAGR of 50.90%[2].
• Regional Growth: North America and Europe are expected to maintain significant market shares, while the Asia Pacific region is projected to grow at a CAGR of 52.9% from 2024 to 2031[2].

Drivers and Challenges

• Drivers: Increasing healthcare investments, rising awareness of urinary disorders, and the growing prevalence of chronic conditions are key drivers of the market[2].
• Challenges: Regulatory hurdles, competition from generic versions, and the need for continuous innovation to meet stringent quality standards are some of the challenges the market may face[2].

Key Takeaways

• Clinical Trials: The SYNERGY I, SYNERGY II, and BESIDE trials have established the efficacy and safety of solifenacin succinate in combination with mirabegron.
• Market Growth: The global solifenacin succinate market is projected to grow significantly, driven by increasing healthcare investments and rising awareness of urinary disorders.
• High-Purity Demand: High-purity solifenacin succinate is expected to dominate the market due to its improved bioavailability and stability.
• Regional Markets: Europe, North America, and Asia Pacific are key regions contributing to the market growth.

FAQs

What is the primary use of solifenacin succinate?

Solifenacin succinate is primarily used to treat overactive bladder (OAB) symptoms, including urgency, urinary frequency, and urge urinary incontinence.

What are the key clinical trials for solifenacin succinate?

The SYNERGY I, SYNERGY II, and BESIDE trials are significant clinical trials that evaluated the efficacy and safety of solifenacin succinate, particularly in combination with mirabegron.

What is the projected global market size for solifenacin succinate by 2031?

The global solifenacin succinate market is projected to reach USD 1819986.4 million by 2031, growing at a CAGR of 50.90% from 2024 to 2031[2].

Which regions are expected to drive the market growth?

North America, Europe, and the Asia Pacific region are expected to be key drivers of the market growth, with the Asia Pacific region growing at a CAGR of 52.9% from 2024 to 2031[2].

Why is high-purity solifenacin succinate preferred?

High-purity solifenacin succinate (above 99% purity) is preferred due to its improved bioavailability and stability, as well as the stringent quality standards set by regulatory agencies like the FDA and EMA[2].

Sources

1. Astellas Pharma Inc. - News: Submission of sNDA for Mirabegron in Combination with Solifenacin Succinate for OAB Treatment[1].
2. Cognitive Market Research - Solifenacin Succinate Market Report 2024[2].
3. ClinicalTrials.gov - Bioequivalence Study of Solifenacin Succinate & Mirabegron[3].