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Last Updated: March 30, 2025

CLINICAL TRIALS PROFILE FOR TRIMETHOBENZAMIDE HYDROCHLORIDE


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All Clinical Trials for TRIMETHOBENZAMIDE HYDROCHLORIDE

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT01770145 ↗ Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT) Completed Cape Cod Clinical Research Inc. Phase 4 2012-12-01 This study is designed to assess the effect of APOKYN treatment in rapid and reliable improvement of motor symptoms in Parkinson's disease (PD) subjects suffering from delayed or unreliable onset of levodopa (L-dopa) action.
NCT01770145 ↗ Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT) Completed ClinData Services, Inc. Phase 4 2012-12-01 This study is designed to assess the effect of APOKYN treatment in rapid and reliable improvement of motor symptoms in Parkinson's disease (PD) subjects suffering from delayed or unreliable onset of levodopa (L-dopa) action.
NCT01770145 ↗ Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT) Completed US WorldMeds LLC Phase 4 2012-12-01 This study is designed to assess the effect of APOKYN treatment in rapid and reliable improvement of motor symptoms in Parkinson's disease (PD) subjects suffering from delayed or unreliable onset of levodopa (L-dopa) action.
NCT00489255 ↗ Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment Completed INC Research Limited Phase 4 2007-05-01 The purposes of the study are to determine: i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy iii. To assess the safety of Tigan® in combination with Apokyn® iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated concomitantly with and without Tigan®
NCT00489255 ↗ Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment Completed Ipsen Phase 4 2007-05-01 The purposes of the study are to determine: i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy iii. To assess the safety of Tigan® in combination with Apokyn® iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated concomitantly with and without Tigan®
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 5 of 5 entries

Clinical Trial Conditions for TRIMETHOBENZAMIDE HYDROCHLORIDE

Condition Name

21110-0.200.20.40.60.811.21.41.61.822.2Parkinson's DiseaseHealthyHypomobilityMotor Symptoms[disabled in preview]
Condition Name for TRIMETHOBENZAMIDE HYDROCHLORIDE
Intervention Trials
Parkinson's Disease 2
Healthy 1
Hypomobility 1
Motor Symptoms 1
[disabled in preview] 0
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Condition MeSH

21110-0.200.20.40.60.811.21.41.61.822.2Parkinson DiseaseGastroparesisVomitingNausea[disabled in preview]
Condition MeSH for TRIMETHOBENZAMIDE HYDROCHLORIDE
Intervention Trials
Parkinson Disease 2
Gastroparesis 1
Vomiting 1
Nausea 1
[disabled in preview] 0
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Clinical Trial Locations for TRIMETHOBENZAMIDE HYDROCHLORIDE

Trials by Country

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Trials by Country for TRIMETHOBENZAMIDE HYDROCHLORIDE
Location Trials
United States 23
Belgium 1
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Trials by US State

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Trials by US State for TRIMETHOBENZAMIDE HYDROCHLORIDE
Location Trials
Michigan 2
Illinois 2
Florida 2
California 2
Texas 2
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Clinical Trial Progress for TRIMETHOBENZAMIDE HYDROCHLORIDE

Clinical Trial Phase

50.0%25.0%25.0%0-0.200.20.40.60.811.21.41.61.822.2Phase 4Phase 2Phase 1[disabled in preview]
Clinical Trial Phase for TRIMETHOBENZAMIDE HYDROCHLORIDE
Clinical Trial Phase Trials
Phase 4 2
Phase 2 1
Phase 1 1
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Clinical Trial Status

75.0%25.0%000.511.522.53CompletedWithdrawn[disabled in preview]
Clinical Trial Status for TRIMETHOBENZAMIDE HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 3
Withdrawn 1
[disabled in preview] 0
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Clinical Trial Sponsors for TRIMETHOBENZAMIDE HYDROCHLORIDE

Sponsor Name

trials000111112222IpsenCape Cod Clinical Research Inc.ClinData Services, Inc.[disabled in preview]
Sponsor Name for TRIMETHOBENZAMIDE HYDROCHLORIDE
Sponsor Trials
Ipsen 1
Cape Cod Clinical Research Inc. 1
ClinData Services, Inc. 1
[disabled in preview] 2
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Sponsor Type

75.0%25.0%00123456IndustryOther[disabled in preview]
Sponsor Type for TRIMETHOBENZAMIDE HYDROCHLORIDE
Sponsor Trials
Industry 6
Other 2
[disabled in preview] 0
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Trimethobenzamide Hydrochloride: Clinical Trials, Market Analysis, and Projections

Introduction

Trimethobenzamide hydrochloride, known by its CAS number 554-92-7, is a medication primarily used to treat nausea and vomiting. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Mechanism of Action and Clinical Use

Trimethobenzamide hydrochloride works by inhibiting the chemoreceptor trigger zone (CTZ) in the medulla oblongata, which is responsible for conveying emetic impulses to the vomiting center. This mechanism is crucial in managing nausea and vomiting, particularly in patients undergoing chemotherapy or experiencing postoperative nausea[4].

Clinical Trials and Regulatory Status

As of the latest updates, there are no ongoing or upcoming clinical trials specifically focused on trimethobenzamide hydrochloride that have been highlighted in recent pharmaceutical reports. However, it is important to note that the FDA has previously taken action against unapproved suppository formulations of this drug due to a lack of evidence of effectiveness. Companies were required to cease manufacturing and marketing these unapproved products, and any future formulations would need to obtain an approved New Drug Application (NDA)[5].

Market Analysis

Global Market Overview

The market for antiemetic drugs, which includes trimethobenzamide hydrochloride, is influenced by various factors such as the prevalence of conditions requiring antiemetic treatment, technological advancements, and regulatory environments.

  • Regional Markets: North America, particularly the U.S. and Canada, dominates the market for antiemetic drugs due to the presence of major industry players and favorable reimbursement policies. The Asia Pacific region is expected to grow at a significant CAGR due to increasing healthcare investments and a growing patient population[3].

Market Size and Growth

While specific data on trimethobenzamide hydrochloride is not readily available, the broader oncology clinical trials market, which includes antiemetic treatments, is projected to grow significantly. The oncology clinical trials market is expected to reach USD 22.11 billion by 2033, with the phase III segment growing at a CAGR of 5.7% due to its critical role in long-term safety studies and registration commitments[3].

Pricing and Supply

The prices of trimethobenzamide hydrochloride vary by region. In Europe, Asia, and North America, the prices are influenced by production costs, market demand, and regulatory factors. Detailed pricing information can be found in comprehensive market research reports that analyze regional markets and supplier dynamics[2].

Applications and End-Use Sectors

Trimethobenzamide hydrochloride is primarily used in the treatment of nausea and vomiting associated with various conditions, including:

  • Chemotherapy-Induced Nausea and Vomiting: It is often prescribed to patients undergoing chemotherapy to manage emesis.
  • Postoperative Nausea and Vomiting: The drug is used to prevent and treat nausea and vomiting in postoperative patients.
  • Other Medical Conditions: It may also be used in other scenarios where nausea and vomiting are significant concerns, such as in gastroenteritis or radiation therapy[4].

Manufacturing and Suppliers

The manufacturing of trimethobenzamide hydrochloride involves several global and regional producers. The report by BAC Reports lists various manufacturers and suppliers across Europe, Asia, and North America, providing contact details and market insights[2].

Market Forecast

The market for trimethobenzamide hydrochloride is expected to be influenced by several factors:

  • Increasing Prevalence of Cancer: The growing number of cancer cases will drive the demand for antiemetic drugs.
  • Technological Advancements: Improvements in cell and gene therapies and personalized medicine will impact the broader antiemetic market.
  • Regulatory Environment: Strict regulatory requirements, such as the need for approved NDAs, will shape the market dynamics[3].

Challenges and Opportunities

Regulatory Challenges

The FDA's actions against unapproved suppository formulations highlight the regulatory challenges faced by manufacturers. Ensuring compliance with regulatory requirements is crucial for market presence[5].

Market Opportunities

The growing demand for antiemetic treatments, especially in the oncology sector, presents opportunities for manufacturers to develop and market effective and approved formulations of trimethobenzamide hydrochloride.

Key Takeaways

  • Clinical Trials: There are no recent or upcoming clinical trials specifically focused on trimethobenzamide hydrochloride.
  • Market Size and Growth: The broader oncology clinical trials market is expected to grow significantly, driven by phase III trials and technological advancements.
  • Regional Markets: North America dominates the market, with the Asia Pacific region expected to grow rapidly.
  • Applications: Primarily used in treating chemotherapy-induced and postoperative nausea and vomiting.
  • Regulatory Environment: Strict FDA regulations require approved NDAs for any new formulations.

FAQs

What is the primary use of trimethobenzamide hydrochloride?

Trimethobenzamide hydrochloride is primarily used to treat nausea and vomiting associated with chemotherapy, postoperative care, and other medical conditions.

Are there any ongoing clinical trials for trimethobenzamide hydrochloride?

As of the latest updates, there are no specific ongoing or upcoming clinical trials focused on trimethobenzamide hydrochloride.

Why did the FDA take action against trimethobenzamide hydrochloride suppositories?

The FDA took action due to a lack of evidence of effectiveness for the unapproved suppository formulations of trimethobenzamide hydrochloride.

What regions dominate the market for antiemetic drugs?

North America, particularly the U.S. and Canada, dominates the market, with the Asia Pacific region expected to grow significantly.

What are the key factors driving the growth of the antiemetic market?

The growth is driven by the increasing prevalence of cancer, technological advancements in cell and gene therapies, and favorable reimbursement policies.

Sources

  1. AstraZeneca Clinical Trials Appendix - Q1 2024 Results[1].
  2. Trimethobenzamide hydrochloride Market Research Report 2024 - BAC Reports[2].
  3. Oncology Clinical Trials Market Size Expected to Reach USD 22.11 BN by 2033 - Biospace[3].
  4. Tigan Injection: Package Insert / Prescribing Information - Drugs.com[4].
  5. FDA calls on companies to end marketing of unapproved suppositories - MMM Online[5].

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