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Last Updated: July 8, 2025

CLINICAL TRIALS PROFILE FOR MYOBLOC


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All Clinical Trials for MYOBLOC

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00125203 ↗ Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS) Completed ALS Association Phase 2/Phase 3 2003-07-01 The purpose of this study is to determine the safety and efficacy of Myobloc in ALS patients who are having excessive drooling. The primary goal of the study is to determine if the patient perceives a benefit from the Myobloc in controlling excessive drooling.
NCT00125203 ↗ Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS) Completed Carolinas MDA Neuromuscular/ALS Center-Carolinas Medical System Phase 2/Phase 3 2003-07-01 The purpose of this study is to determine the safety and efficacy of Myobloc in ALS patients who are having excessive drooling. The primary goal of the study is to determine if the patient perceives a benefit from the Myobloc in controlling excessive drooling.
NCT00125203 ↗ Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS) Completed University of Kansas Phase 2/Phase 3 2003-07-01 The purpose of this study is to determine the safety and efficacy of Myobloc in ALS patients who are having excessive drooling. The primary goal of the study is to determine if the patient perceives a benefit from the Myobloc in controlling excessive drooling.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for MYOBLOC

Condition Name

Condition Name for MYOBLOC
Intervention Trials
Sialorrhea 4
Stroke 2
Low Back Pain 2
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Condition MeSH

Condition MeSH for MYOBLOC
Intervention Trials
Sialorrhea 4
Muscle Spasticity 4
Brain Injuries 2
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Clinical Trial Locations for MYOBLOC

Trials by Country

Trials by Country for MYOBLOC
Location Trials
United States 48
Russian Federation 4
Ukraine 2
Belarus 1
Lebanon 1
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Trials by US State

Trials by US State for MYOBLOC
Location Trials
California 4
Texas 3
Tennessee 3
Florida 3
Maryland 3
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Clinical Trial Progress for MYOBLOC

Clinical Trial Phase

Clinical Trial Phase for MYOBLOC
Clinical Trial Phase Trials
Phase 4 4
Phase 3 4
Phase 2/Phase 3 3
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Clinical Trial Status

Clinical Trial Status for MYOBLOC
Clinical Trial Phase Trials
Completed 8
Terminated 2
Unknown status 2
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Clinical Trial Sponsors for MYOBLOC

Sponsor Name

Sponsor Name for MYOBLOC
Sponsor Trials
Supernus Pharmaceuticals, Inc. 5
US WorldMeds LLC 3
Solstice Neurosciences 3
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Sponsor Type

Sponsor Type for MYOBLOC
Sponsor Trials
Industry 12
Other 11
U.S. Fed 3
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MYOBLOC: Clinical Trials, Market Analysis, and Projections

Last updated: January 4, 2025

Introduction to MYOBLOC

MYOBLOC, also known as rimabotulinumtoxinB, is a botulinum toxin type B injectable medication used to manage various neurological and muscular conditions. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Upper Limb Spasticity

A Phase 2/3, randomized, double-blind, placebo-controlled, multicenter trial is currently underway to assess the efficacy and safety of MYOBLOC in treating adult upper limb spasticity. This trial involves comparing two doses of MYOBLOC against a placebo, followed by an open-label extension safety trial where participants will receive multiple treatments of MYOBLOC over several months. The trial excludes patients with severe dysphagia, prior surgery for spasticity, or those planning any major surgery during the study period[1].

Cervical Dystonia

MYOBLOC has been extensively studied for its efficacy in treating cervical dystonia. Two Phase 3 trials involving 186 adults with cervical dystonia showed significant improvements in the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores, indicating reduced severity and impact of uncontrolled neck movements. Patients treated with MYOBLOC showed improvements of 9.3 to 11.7 points, whereas those given the placebo showed improvements of less than five points[3].

Sialorrhea

Clinical trials have also focused on MYOBLOC's effectiveness in managing sialorrhea (excessive drooling) in patients, particularly those with Parkinson’s disease. The MYSTICOL trial and another study involving 187 and 54 patients, respectively, demonstrated that MYOBLOC significantly reduced saliva flow and improved clinician-rated impressions of overall efficacy compared to the placebo[3].

Long-Term Safety and Efficacy

An ongoing Phase IV study at Stanford Health Care aims to evaluate the safety and effect of repeat doses of MYOBLOC over time in patients with cervical dystonia. This open-label safety and immunogenicity study involves administering MYOBLOC injections every three months, with doses ranging from 2500 to 25000 units[4].

Market Analysis

Global Market Size and Growth

The global botulinum toxin market, which includes MYOBLOC, is projected to experience significant growth. From $8.74 billion in 2024, the market is expected to reach $16.01 billion by 2032, growing at a CAGR of 7.9% during this period[2].

Therapeutic Segment Dominance

The therapeutics segment, which includes treatments for conditions like cervical dystonia, chronic migraine, overactive bladder, and spasticity, holds a dominant share of the botulinum toxin market. This segment is driven by increasing investments in R&D and the expansion of therapeutic uses for botulinum toxins. MYOBLOC, being a botulinum toxin type B, is expected to contribute to this growth, especially after strategic acquisitions and focus on new therapeutic indications[2].

End-User Preferences

Specialty and dermatology clinics account for the largest market share in terms of end-users. This is due to the high number of procedures performed in these clinics compared to hospitals. The increasing demand for aesthetic treatments and other therapeutic applications further supports the growth of this segment[2].

Market Projections

Botulinum Toxin Type B Segment

While botulinum toxin type A remains the major revenue contributor, the botulinum toxin type B segment, which includes MYOBLOC, is projected to exhibit the fastest market growth. This is attributed to the expansion of therapeutic indications, such as chronic sialorrhea, and growing research and development efforts to explore other potential uses of MYOBLOC[5].

Geographic and Regulatory Factors

The market growth will also be influenced by regulatory approvals and the adoption of MYOBLOC in emerging regions. As more countries approve the use of MYOBLOC for various therapeutic indications, the market is expected to expand further[5].

Key Takeaways

  • Clinical Trials: MYOBLOC is undergoing extensive clinical trials for upper limb spasticity, cervical dystonia, and sialorrhea, showing promising results in efficacy and safety.
  • Market Growth: The global botulinum toxin market is projected to grow significantly, with the therapeutics segment driving this growth.
  • Therapeutic Uses: MYOBLOC is expanding its therapeutic indications, contributing to the market's growth, especially in areas like cervical dystonia and sialorrhea.
  • End-User Preferences: Specialty and dermatology clinics are key end-users, driving the demand for botulinum toxin treatments.

FAQs

What is MYOBLOC used for?

MYOBLOC is used to manage conditions such as cervical dystonia, sialorrhea (excessive drooling), and upper limb spasticity.

What are the current clinical trials for MYOBLOC?

Current trials include a Phase 2/3 trial for upper limb spasticity, ongoing studies for cervical dystonia, and trials for managing sialorrhea.

How is the global botulinum toxin market projected to grow?

The global botulinum toxin market is expected to grow from $8.74 billion in 2024 to $16.01 billion by 2032, at a CAGR of 7.9%.

Which segment dominates the botulinum toxin market?

The therapeutics segment dominates the market, driven by increasing R&D and the expansion of therapeutic uses.

What is the outlook for the botulinum toxin type B segment?

The botulinum toxin type B segment, including MYOBLOC, is expected to exhibit the fastest market growth due to expanding therapeutic indications and growing R&D efforts.

Sources

  1. Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity. CTV Veeva.
  2. Botulinum Toxin Market Size | Global Growth Report [2032]. Fortune Business Insights.
  3. Myobloc (rimabotulinumtoxinB) for Parkinson's disease. Parkinson's News Today.
  4. Myobloc Study - Stanford Health Care. Stanford Health Care.
  5. Botulinum Toxin Market Size, Share | Growth Report - 2031. Allied Market Research.

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