CLINICAL TRIALS PROFILE FOR ISOCARBOXAZID

All Clinical Trials for isocarboxazid

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02323217 ↗	I2PETHV - Imidazoline2 Binding Site in Healthy Volunteers	Completed	GlaxoSmithKline	Early Phase 1	2015-01-01	The imdazoline2 binding site (I2BS) is known to reside inside astrocytes. Changes in the numbers of I2BS in post mortem tissue has implicated them in a range of psychiatric conditions such as depression and addiction, along with neurodegenerative disorders such as Alzheimer's disease and Huntington's chorea. Preclinical studies have also demonstrated functional interactions with the opioid system, where I2BS ligands have been shown to affect tolerance to morphine and alleviate some of the morphine withdrawal syndrome in rats. Recently the I2BS and I2BS ligands have been shown to have some interesting analgesic effects in different models of pain and a novel I2BS ligand, CR4056, is currently undergoing Phase II clinical trials as a novel treatment for neuropathic pain and acute non- specific pain states. The location of I2BS on astrocytic glial cells and the possibility that they may in some way regulate glial fibrillary acidic protein have led to increased interest into the role of I2BS and I2BS ligands in conditions characterised by marked gliosis. The number of I2BS has been shown to increase in Alzheimer's disease post mortem, and it has also been suggested that I2BS may be a marker for the severity and malignancy of human glioblastomas. The lack of suitable imaging tools for the I2BS has meant that information regarding the number and distribution of I2BS in the brain has come from preclinical species and in vitro post-mortem studies. The recent development of [11C]BU99008 as a suitable PET ligand to quantify I2BS in vivo, enables the direct quantification of I2BS availability and regional distribution in the living human brain. In this study the investigators plan to utilise [11C]BU99008 to quantify the regional brain availability of I2BS in the human brain in vivo using PET.
NCT02323217 ↗	I2PETHV - Imidazoline2 Binding Site in Healthy Volunteers	Completed	Imperial College London	Early Phase 1	2015-01-01	The imdazoline2 binding site (I2BS) is known to reside inside astrocytes. Changes in the numbers of I2BS in post mortem tissue has implicated them in a range of psychiatric conditions such as depression and addiction, along with neurodegenerative disorders such as Alzheimer's disease and Huntington's chorea. Preclinical studies have also demonstrated functional interactions with the opioid system, where I2BS ligands have been shown to affect tolerance to morphine and alleviate some of the morphine withdrawal syndrome in rats. Recently the I2BS and I2BS ligands have been shown to have some interesting analgesic effects in different models of pain and a novel I2BS ligand, CR4056, is currently undergoing Phase II clinical trials as a novel treatment for neuropathic pain and acute non- specific pain states. The location of I2BS on astrocytic glial cells and the possibility that they may in some way regulate glial fibrillary acidic protein have led to increased interest into the role of I2BS and I2BS ligands in conditions characterised by marked gliosis. The number of I2BS has been shown to increase in Alzheimer's disease post mortem, and it has also been suggested that I2BS may be a marker for the severity and malignancy of human glioblastomas. The lack of suitable imaging tools for the I2BS has meant that information regarding the number and distribution of I2BS in the brain has come from preclinical species and in vitro post-mortem studies. The recent development of [11C]BU99008 as a suitable PET ligand to quantify I2BS in vivo, enables the direct quantification of I2BS availability and regional distribution in the living human brain. In this study the investigators plan to utilise [11C]BU99008 to quantify the regional brain availability of I2BS in the human brain in vivo using PET.

Clinical Trial Conditions for isocarboxazid

Condition Name

Condition Name for isocarboxazid
Intervention	Trials
Molecular Imaging	1
Alzheimer Disease	1
Healthy Volunteers	1

Condition MeSH

Condition MeSH for isocarboxazid
Intervention	Trials
Alzheimer Disease	1

Clinical Trial Locations for isocarboxazid

Trials by Country

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Trials by Country for isocarboxazid
Location	Trials
United Kingdom	1

Clinical Trial Progress for isocarboxazid

Clinical Trial Phase

Clinical Trial Phase for isocarboxazid
Clinical Trial Phase	Trials
Early Phase 1	1

Clinical Trial Status

Clinical Trial Status for isocarboxazid
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for isocarboxazid

Sponsor Name

Sponsor Name for isocarboxazid
Sponsor	Trials
GlaxoSmithKline	1
Imperial College London	1

Sponsor Type

Sponsor Type for isocarboxazid
Sponsor	Trials
Other	1
Industry	1

Isocarboxazid: Clinical Trials, Market Analysis, and Projections

Overview of Isocarboxazid

Isocarboxazid, marketed under the brand name Marplan, is a monoamine oxidase inhibitor (MAOI) used primarily in the treatment of depression, particularly in cases where other antidepressants have been ineffective. Here’s a comprehensive look at its clinical trials, market analysis, and future projections.

Clinical Use and Mechanism of Action

Isocarboxazid is indicated for the treatment of enduring and debilitating symptoms of depression that have not responded to other antidepressant drugs. It works by irreversibly blocking the action of monoamine oxidases (MAO) in the nervous system, specifically MAO-A and MAO-B, which are involved in the metabolism of serotonin, epinephrine, norepinephrine, and dopamine. This inhibition results in an increased concentration of these neurotransmitters, which is the basis for its antidepressant activity[4].

Clinical Trials and Treatment History

There is limited recent data on specific clinical trials dedicated solely to isocarboxazid. However, studies have analyzed the treatment history characteristics associated with its use. A study using Danish registers identified that patients who received isocarboxazid had often been treated with multiple other antidepressants and psychopharmacological agents before, indicating its use in treatment-resistant depression. The study found that prior treatments with selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants, and other classes of antidepressants were significantly associated with the initiation of isocarboxazid[1].

Market Analysis

Current Market Size and Growth Prospects

The global isocarboxazid market, though relatively small, is projected to grow steadily. As of 2023, the market size was estimated at approximately USD 7 million. It is expected to grow at a compound annual growth rate (CAGR) of 5.67% from 2024 to 2032[2].

Key Drivers of Market Growth

Several factors are driving the growth of the isocarboxazid market:

• Increasing Prevalence of Depression: The global rise in depression cases is a significant driver. As mental health awareness increases and more people seek treatment, the demand for effective antidepressants like isocarboxazid is expected to rise[2].
• Expanding Geriatric Population: The growing elderly population, who are more prone to depression, is another factor contributing to market growth[2].
• Research and Development: Continuous R&D in mental health treatments, including MAOIs, is expected to drive market expansion[2].
• Personalized Medicine: The trend towards personalized medicine, where treatment plans are tailored to individual patients, is likely to enhance treatment outcomes and patient satisfaction, positively impacting the isocarboxazid market[2].

Regional Market Dynamics

North America and Europe currently dominate the isocarboxazid market due to their well-established healthcare infrastructure and high awareness about mental health. However, emerging economies in the Asia Pacific region, such as China and India, are expected to witness significant growth due to improving healthcare facilities and increasing focus on mental health awareness[2].

Market Challenges

Despite the growth prospects, the isocarboxazid market faces several challenges:

• Stringent Regulatory Requirements: Strict regulations can hinder the approval and marketing of new drugs.
• Side Effects: MAOIs like isocarboxazid are associated with side effects and dietary restrictions, which can limit their use.
• Competition: Other classes of antidepressants, such as SSRIs and SNRIs, provide strong competition[2].

Market Trends

Personalized Medicine

There is a noticeable shift towards personalized medicine in the treatment of depression. Healthcare providers are increasingly tailoring treatment plans based on genetic makeup, lifestyle factors, and response to medications. This trend is expected to positively impact the isocarboxazid market by enhancing treatment outcomes and patient satisfaction[2].

Telemedicine and Online Mental Health Services

The growing adoption of telemedicine and online mental health services is also influencing the market. Virtual consultations have made it more convenient and accessible for individuals to seek help for mental health conditions, leading to increased prescriptions for antidepressants like isocarboxazid[2].

Projections and Future Outlook

The isocarboxazid market is poised for steady growth driven by the increasing prevalence of depression, ongoing research and development, and the trend towards personalized medicine. Here are some key projections:

• Market Size: The market is expected to grow from its current size of approximately USD 7 million to a significantly larger figure by 2032, driven by a CAGR of 5.67%[2].
• Regional Growth: Emerging economies in the Asia Pacific region are expected to contribute significantly to the market growth due to improving healthcare infrastructure and increasing mental health awareness[2].
• Innovation and Partnerships: To overcome challenges and capitalize on emerging opportunities, stakeholders in the isocarboxazid market will need to focus on continuous innovation, robust clinical trials, and strategic partnerships within the pharmaceutical industry[2].

Key Takeaways

• Clinical Use: Isocarboxazid is used for treatment-resistant depression, often after other antidepressants have failed.
• Market Growth: The market is expected to grow at a CAGR of 5.67% from 2024 to 2032.
• Key Drivers: Increasing prevalence of depression, expanding geriatric population, and trends towards personalized medicine are key drivers.
• Challenges: Stringent regulations, side effects, and competition from other antidepressants are significant challenges.
• Future Outlook: The market is poised for growth, driven by innovation, personalized medicine, and increasing mental health awareness.

FAQs

What is isocarboxazid used for?

Isocarboxazid is used for the treatment of enduring and debilitating symptoms of depression that have not responded to other antidepressant drugs[4].

What is the mechanism of action of isocarboxazid?

Isocarboxazid works by irreversibly blocking the action of monoamine oxidases (MAO) in the nervous system, specifically MAO-A and MAO-B, leading to an increase in neurotransmitters like serotonin, epinephrine, norepinephrine, and dopamine[4].

What are the key drivers of the isocarboxazid market growth?

The key drivers include the increasing prevalence of depression, the expanding geriatric population, ongoing research and development, and the trend towards personalized medicine[2].

Which regions dominate the isocarboxazid market?

North America and Europe currently dominate the market, but emerging economies in the Asia Pacific region are expected to witness significant growth[2].

What challenges does the isocarboxazid market face?

The market faces challenges such as stringent regulatory requirements, side effects associated with MAOIs, and competition from other classes of antidepressants[2].

How is the trend towards personalized medicine impacting the isocarboxazid market?

The trend towards personalized medicine is expected to enhance treatment outcomes and patient satisfaction, positively impacting the market by tailoring treatment plans to individual patients based on their genetic makeup, lifestyle factors, and response to medications[2].

Sources

1. Treatment History Characteristics Associated With Use of Isocarboxazid in Clinical Practice - PubMed
2. Global Isocarboxazid Market – Industry Reports - Industry Research
3. Depemokimab late-breaking data presented at ERS show a 54% reduction in severe asthma exacerbations - GSK (Not directly related to isocarboxazid)
4. Isocarboxazid: Uses, Interactions, Mechanism of Action - DrugBank
5. Global Isocarboxazid Market Research Report 2024 - Market Research Reports