CLINICAL TRIALS PROFILE FOR GLUTETHIMIDE

All Clinical Trials for glutethimide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01018485 ↗	The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor	Completed	Eastern Health	Phase 3	2008-10-01	The incidence of tremor in Multiple Sclerosis (MS) has been estimated to affect up to 2/3rds of patients. Over half of the tremors involve the upper limb and frequently lead to further disability. Medical treatment of MS tremor is generally unrewarding, although carbamazepine, clonazepam, glutethimide, hyoscine, isoniazid, ondansetron, primidone, and tetrahydrocannabinol have been reported to have some beneficial effect but published evidence of effectiveness is very limited. The investigators' experience to date suggests that many of the upper limb tremors may potentially be responsive to Botulinum toxin injection therapy. Aims: 1. The investigators aim to determine the efficacy of commonly used doses of BOTOX on the patients with symptomatic unilateral or bilateral arm tremor due to MS; and any side effects associated with this treatment.
NCT01018485 ↗	The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor	Completed	Melbourne Health	Phase 3	2008-10-01	The incidence of tremor in Multiple Sclerosis (MS) has been estimated to affect up to 2/3rds of patients. Over half of the tremors involve the upper limb and frequently lead to further disability. Medical treatment of MS tremor is generally unrewarding, although carbamazepine, clonazepam, glutethimide, hyoscine, isoniazid, ondansetron, primidone, and tetrahydrocannabinol have been reported to have some beneficial effect but published evidence of effectiveness is very limited. The investigators' experience to date suggests that many of the upper limb tremors may potentially be responsive to Botulinum toxin injection therapy. Aims: 1. The investigators aim to determine the efficacy of commonly used doses of BOTOX on the patients with symptomatic unilateral or bilateral arm tremor due to MS; and any side effects associated with this treatment.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Federal University of São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.

Clinical Trial Conditions for glutethimide

Condition Name

Condition Name for glutethimide
Intervention	Trials
Multiple Sclerosis	1
Tremor	1
Atrial Fibrillation	1

Condition MeSH

Condition MeSH for glutethimide
Intervention	Trials
Atrial Fibrillation	1
Tremor	1
Sclerosis	1
Multiple Sclerosis	1

Clinical Trial Locations for glutethimide

Trials by Country

Trials by Country for glutethimide
Location	Trials
Brazil	1
Australia	1

Clinical Trial Progress for glutethimide

Clinical Trial Phase

Clinical Trial Phase for glutethimide
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1

Clinical Trial Status

Clinical Trial Status for glutethimide
Clinical Trial Phase	Trials
Completed	2

Clinical Trial Sponsors for glutethimide

Sponsor Name

Sponsor Name for glutethimide
Sponsor	Trials
Fundação de Amparo à Pesquisa do Estado de São Paulo	1
Federal University of São Paulo	1
Eastern Health	1

Sponsor Type

Sponsor Type for glutethimide
Sponsor	Trials
Other	4

Glutethimide Market Analysis and Financial Projection

Glutethimide: Clinical Trials, Market Analysis, and Projections

Introduction to Glutethimide

Glutethimide is a sedative-hypnotic drug that has been used for its therapeutic effects, particularly in inducing sedation and treating certain medical conditions. Here, we will delve into the current state of clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Medical Uses

Mechanism of Action

Glutethimide acts as a GABA agonist, enhancing the activity of the neurotransmitter gamma-aminobutyric acid (GABA) in the brain, which helps in inducing sedation. It also induces the enzyme cytochrome P450 2D6, which can increase the conversion of codeine to morphine, thereby enhancing sedative effects[1].

Clinical Trials

One notable clinical trial involved the use of glutethimide in combination with other drugs for the treatment of metastatic and locally advanced breast cancer. The trial compared the efficacy of tamoxifen alone versus a combination of tamoxifen, amino-glutethimide, danazol, and hydrocortisone. The results showed a higher objective response rate in patients receiving the combination therapy, although the duration of response was similar to that of tamoxifen alone[4].

Adverse Effects and Toxicity

Clinical trials and medical use have highlighted several adverse effects associated with glutethimide, including potential toxicity. The drug can cause significant adverse reactions, and in adults, doses as low as 5 grams have been reported to be lethal, with the usual lethal dose ranging from 10 to 20 grams[1].

Market Analysis

Current Market Size and Growth

The glutethimide market has experienced substantial growth in recent years. As of 2024, the global glutethimide market size was valued at USD 279.88 million. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 6% from 2025 to 2032, reaching approximately USD 446.09 million by 2032[5].

Market Drivers

Several factors are driving the growth of the glutethimide market:

• Increase in Cardiovascular Diseases: Glutethimide is beneficial in promoting heart health by acting as a precursor to L-Arginine, which optimizes nitric oxide synthesis. This reduces risk factors for cardiovascular diseases such as hypertension, hyperlipidemia, glucose intolerance, obesity, and diabetes[5].

• Rise in Mental Illness Cases: The increasing prevalence of mental illnesses, which are often associated with sleep disorders, is another significant driver. Glutethimide is used to treat diseases related to mental illness, contributing to its market growth[5].

Regional Insights

• North America: This region currently dominates the market in terms of market share and revenue, primarily due to the high prevalence of mental illnesses and the presence of FDA-approved drugs[5].

• Asia Pacific: This region is expected to exhibit the highest growth rate during the forecast period, driven by international companies expanding their product offerings in this area[5].

Market Segmentation

The glutethimide market is segmented based on several criteria:

• By Type: Tablets, injections, capsules, and powder forms are the primary types of glutethimide products available[5].

• By Application: The drug is used in psychiatric, cardiac, and prostatic applications[5].

• By Distribution Channel: Retail pharmacies, hospital pharmacies, and online pharmacy stores are the main distribution channels[5].

Competitive Analysis

The market is characterized by a mix of market leaders, followers, and new entrants. A competitive analysis includes an evaluation of key players based on their product portfolios, financial positions, growth strategies, and regional presence. This analysis helps in understanding the market dynamics and structure, providing a clear futuristic view for decision-makers[5].

Future Projections

Market Trends

The glutethimide market is expected to continue its upward trend, driven by increasing demand for treatments related to cardiovascular diseases and mental illnesses. The focus of international companies on expanding their products in regions like the Asia Pacific will further boost market growth[5].

Challenges and Opportunities

While the market is poised for significant growth, it also faces challenges such as regulatory hurdles and the potential for adverse effects. However, the increasing prevalence of target diseases and the ongoing research in new therapeutic applications present opportunities for market expansion[2][5].

Key Takeaways

• Glutethimide is a sedative-hypnotic drug with a GABA agonist mechanism of action.
• Clinical trials have shown its efficacy in combination therapies for conditions like breast cancer.
• The market is growing significantly, driven by increases in cardiovascular diseases and mental illnesses.
• North America currently dominates the market, but the Asia Pacific is expected to show the highest growth rate.
• The market is segmented by type, application, and distribution channel.

FAQs

What is the primary mechanism of action of glutethimide?

Glutethimide acts as a GABA agonist, enhancing the activity of the neurotransmitter gamma-aminobutyric acid (GABA) in the brain, which helps in inducing sedation[1].

What are the main drivers of the glutethimide market growth?

The main drivers include the increase in cardiovascular diseases and the rise in cases of mental illnesses[5].

Which region is expected to show the highest growth rate in the glutethimide market?

The Asia Pacific region is expected to exhibit the highest growth rate during the forecast period[5].

What are the different forms in which glutethimide is available?

Glutethimide is available in tablets, injections, capsules, and powder forms[5].

What is the projected market size of glutethimide by 2032?

The global glutethimide market is projected to reach approximately USD 446.09 million by 2032[5].

Sources

1. DrugBank: Glutethimide: Uses, Interactions, Mechanism of Action.
2. Market Research Intellect: Global Glutethimide Market Size, Scope And Forecast Report.
3. Regulations.gov: Proposed Aggregate Production Quota 2024.
4. PubMed: Clinical trial of multiple endocrine therapy for metastatic and locally advanced breast cancer.
5. Maximize Market Research: Glutethimide Market - Global Industry Analysis, Trends and Forecast.