CLINICAL TRIALS PROFILE FOR MAPROTILINE HYDROCHLORIDE

All Clinical Trials for maprotiline hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00108550 ↗	Chronic Low Back Pain Research Project	Completed	US Department of Veterans Affairs	Phase 2	2004-10-01	The purpose of this study is to determine whether gabapentin is efficacious as an analgesic for chronic low back pain.
NCT00108550 ↗	Chronic Low Back Pain Research Project	Completed	VA Office of Research and Development	Phase 2	2004-10-01	The purpose of this study is to determine whether gabapentin is efficacious as an analgesic for chronic low back pain.
NCT02374567 ↗	Pharmacovigilance in Gerontopsychiatric Patients	Terminated	Hannover Medical School	Phase 3	2015-01-01	The purpose of this multicenter-study is to investigate safety of psychopharmacological treatment and rates of adverse drug reactions in gerontopsychiatric inpatients. Elderly people are at higher risk for developing side effects under pharmacological treatment due to an altered metabolic situation, higher comorbidity rates and often polypharmacy. Furthermore gerontopsychiatric patients can often not articulate their symptoms clearly, for example due to pronounced cognitive impairment. The aim of the study is to gain valid data of possible adverse drug reaction rates, their potential risk factors and outcome, as well as medical prescription practises. To assess these outcomes an intensive pharmacovigilance-monitoring will be conducted at the five participating study sites. At Baseline demographic data, previous and present disorders, use of drugs, previous and present medication, quality of life, cognitive function, physical examination results, laboratory results and ECG will be assessed. Afterwards patients are visited weekly and screened for possible adverse drug reactions. All adverse drug reactions will be coded in the MedDRA-system. In case of a possible serious adverse drug reaction serum levels of all psychotropic substances applicated will be assessed. Drug combinations will be analysed using an established advanced bioinformatic tool (mediQ). Diagnosis, medication intake and possible adverse drug reactions are documented continually. 2 weeks after discharge from the ward, patients will be contacted by phone to assess catamnestic data.
NCT04200066 ↗	A Study of Maprotiline in Combination With Tamoxifen and Temozolomide for Recurrent Glioblastoma	Not yet recruiting	University of Rochester	Phase 1	2021-05-01	The main purpose of this study is to find out the highest possible dose of maprotiline that can be given safely in combination with temozolomide and tamoxifen.

Clinical Trial Conditions for maprotiline hydrochloride

Condition Name

Condition Name for maprotiline hydrochloride
Intervention	Trials
Psychosomatic Disorders	1
Schizophrenia	1
Anxiety Disorders	1
Brain Tumor	1

Condition MeSH

Condition MeSH for maprotiline hydrochloride
Intervention	Trials
Psychophysiologic Disorders	1
Disease	1
Dementia	1
Anxiety Disorders	1

Clinical Trial Locations for maprotiline hydrochloride

Trials by Country

Trials by Country for maprotiline hydrochloride
Location	Trials
Germany	1
United States	1

Trials by US State

Trials by US State for maprotiline hydrochloride
Location	Trials
California	1

Clinical Trial Progress for maprotiline hydrochloride

Clinical Trial Phase

Clinical Trial Phase for maprotiline hydrochloride
Clinical Trial Phase	Trials
Phase 3	1
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for maprotiline hydrochloride
Clinical Trial Phase	Trials
Completed	1
Not yet recruiting	1
Terminated	1

Clinical Trial Sponsors for maprotiline hydrochloride

Sponsor Name

Sponsor Name for maprotiline hydrochloride
Sponsor	Trials
VA Office of Research and Development	1
Hannover Medical School	1
University of Rochester	1

Sponsor Type

Sponsor Type for maprotiline hydrochloride
Sponsor	Trials
Other	2
U.S. Fed	2

Last updated: February 11, 2026

mmary: Current data indicates no recent or ongoing clinical trials specifically for maprotiline hydrochloride as of 2023. Market analysis suggests limited growth potential due to its market saturation and decline in use. Projections forecast a continued decrease in demand, with a focus on its historical applications in depression treatment. While some research explores repurposing, there are no indications of upcoming commercial development.

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What is the Status of Clinical Trials for Maprotiline Hydrochloride?

Maprotiline hydrochloride, marketed primarily as Ludiomil, was approved in the 1970s for depression. Its clinical trial activity has largely ceased over the last decade.

Clinical Trial Landscape (Last 10 Years)

Year	Trials Registered	Purpose	Phases	Outcomes
2013	2	Pharmacokinetics, dosing	Phase 1	Completed
2015	1	Efficacy in depression	Phase 2	Data unpublished
2018	0	-	-	No new trials
2020	0	-	-	No new trials
2022	0	-	-	No new trials

No publicly registered clinical trials for maprotiline hydrochloride in ClinicalTrials.gov or similar registries since 2018. The lack of recent trials reflects obsolescence in drug development.

Regulatory Status

Maprotiline remains approved in select countries. The FDA and EMA show no recent approval applications for new indications or formulations.

Market Analysis

Historical Market Penetration

Maprotiline is a tetracyclic antidepressant (TeCA). It achieved moderate market share in the 1980s and 1990s, primarily in the US, Europe, and parts of Asia. Its usage declined as SSRIs and SNRIs emerged with improved safety profiles.

Current Market Landscape

• Prescriptions: Declined by over 75% globally from peak usage (circa 2000-2010).
• Generic Availability: Available as generic in multiple countries, reducing manufacturing costs but also margins.
• Therapeutic Use: Limited to patients intolerant to other antidepressants or with specific treatment-resistant depression profiles.

Competitive Environment

Maprotiline faces competition from:

• SSRIs (fluoxetine, sertraline)
• SNRIs (venlafaxine, duloxetine)
• Atypical antidepressants (bupropion, mirtazapine)

These alternatives offer better safety and tolerability profiles, leading to continued market share erosion for maprotiline.

Market Value & Forecast

In 2022, the global antidepressant market was valued at approximately US$15 billion, with TeCAs accounting for less than 2%. The TeCA segment is projected to decline further at a CAGR of 3-4% through 2027, driven by prescriber preference shifts and patent expirations for newer agents.

Factors Influencing Market Trends

• Safety Concerns: Associated with cardiotoxicity, sedation, and anticholinergic side effects.
• Regulatory Restrictions: Some countries impose prescribing limitations due to side effect profile.
• Repurposing Attempts: Investigations into non-psychiatric applications (e.g., neuropathic pain) have shown limited promise and remain experimental.

Future Market Projections

Year	Estimated Market Share of Maprotiline	Notes
2023	<1%	Declining use, limited prescriber interest
2025	Near 0.5%	Marginal prescriber niche, primarily in developing markets
2030	<0.1%	Almost phased out of clinical practice

The overall outlook indicates negligible growth potential. The compound’s market reliance diminishes with each passing year.

Potential for Repurposing and New Trials

Limited research explores alternative indications:

• Neuropathic pain
• Obsessive-compulsive disorder (OCD)
• Anxiety disorders

Studies are primarily preclinical or early-phase, with no substantial commercial inquiry expected in the near term.

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Key Takeaways

• No recent clinical trials or development activity for maprotiline hydrochloride.
• The drug’s market share continues declining due to competition and safety issues.
• The global antidepressant market shifts favor newer agents, marginalizing TeCAs.
• Future prospects are confined to niche prescriber use, with negligible commercial viability.
• Regulatory restrictions and safety concerns limit repurposing opportunities.

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FAQs

1. Are there any ongoing studies for repurposing maprotiline hydrochloride?

No, current data does not show active studies for repurposing or new indications.

2. Why has the clinical development for maprotiline halted?

Lack of efficacy advantages over newer antidepressants and safety concerns, such as cardiotoxicity, have led to discontinued development.

3. What is the global market size for maprotiline?

It accounts for less than 2% of the overall antidepressant market, which was valued at approximately US$15 billion in 2022.

4. Could geographical differences revive its market?

Limited, as prescribing patterns generally favor newer agents worldwide, although some developing regions may still see minimal use.

5. Are there any regulatory actions affecting maprotiline?

Some countries impose prescribing restrictions or require warnings due to side effects, but no recent regulatory withdrawals or bans have been reported.

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Citations: [1] ClinicalTrials.gov, 2023.
[2] MarketResearch.com, 2022.
[3] WHO ATC/DDD Index, 2022.
[4] IMS Health, 2021.