CLINICAL TRIALS PROFILE FOR REMERON

All Clinical Trials for REMERON

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00249444 ↗	Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	2006-05-01	Many substance dependent individuals also suffer from depression. Past research suggests that antidepressant medication is helpful in treating such individuals. This study will determine the effectiveness of mirtazapine, an antidepressant medication, in treating cocaine dependent individuals who also suffer from depression. This study includes free treatment for cocaine dependence that includes medication and a behavioral intervention.
NCT00249444 ↗	Mirtazapine for Treating Cocaine Dependent Individuals Who Also Suffer From Depression	Completed	New York State Psychiatric Institute	Phase 2	2006-05-01	Many substance dependent individuals also suffer from depression. Past research suggests that antidepressant medication is helpful in treating such individuals. This study will determine the effectiveness of mirtazapine, an antidepressant medication, in treating cocaine dependent individuals who also suffer from depression. This study includes free treatment for cocaine dependence that includes medication and a behavioral intervention.
NCT00288782 ↗	PET Neuroimaging of [11C]Mirtazapine	Completed	Fund for Advancement of Medical Science	Phase 4	2006-02-01	Recent studies show that 25 - 30% of depressed patients never fully recover, resulting in a treatment-resistant condition. Thus, depression is a major cause of human suffering. We are interested in finding new ways of identifying and alleviating treatment-resistant depression, and we believe that recent advances in brain imaging can contribute to achieving that goal. In this project, we will use a novel compound ([N-methyl-11C]mirtazapine) that we invented for examining the neurochemistry of brain receptors involved in antidepressant actions. Our compound, [N-methyl-11C]mirtazapine, is closely related to the clinically effective antidepressant drug mirtazapine (Remeron®). It labels several types of noradrenergic receptors that have often been implicated in "stress reactions" as well as depressive disorders. We believe that our compound can identify specific molecular brain dysfunctions that are causally related to treatment-resistant depression. The purpose of this study is to determine whether there is a reliable relationship between the level of mirtazapine in the bloodstream and the occupancy of neuroreceptors by mirtazapine in the brain. We will apply our standard procedures of PET brain scanning and region-of-interest data analysis, using healthy volunteers who will receive a daily dose of mirtazapine (double-blind design with placebo, 7.5 mg or 15 mg daily for 5 days). We believe that this project could provide a procedure for assessing brain function in treatment-resistant depression, with the aim of improving the guidelines for successful, evidence-based treatment of depression.
NCT00288782 ↗	PET Neuroimaging of [11C]Mirtazapine	Completed	Max Woerzner's Research Award	Phase 4	2006-02-01	Recent studies show that 25 - 30% of depressed patients never fully recover, resulting in a treatment-resistant condition. Thus, depression is a major cause of human suffering. We are interested in finding new ways of identifying and alleviating treatment-resistant depression, and we believe that recent advances in brain imaging can contribute to achieving that goal. In this project, we will use a novel compound ([N-methyl-11C]mirtazapine) that we invented for examining the neurochemistry of brain receptors involved in antidepressant actions. Our compound, [N-methyl-11C]mirtazapine, is closely related to the clinically effective antidepressant drug mirtazapine (Remeron®). It labels several types of noradrenergic receptors that have often been implicated in "stress reactions" as well as depressive disorders. We believe that our compound can identify specific molecular brain dysfunctions that are causally related to treatment-resistant depression. The purpose of this study is to determine whether there is a reliable relationship between the level of mirtazapine in the bloodstream and the occupancy of neuroreceptors by mirtazapine in the brain. We will apply our standard procedures of PET brain scanning and region-of-interest data analysis, using healthy volunteers who will receive a daily dose of mirtazapine (double-blind design with placebo, 7.5 mg or 15 mg daily for 5 days). We believe that this project could provide a procedure for assessing brain function in treatment-resistant depression, with the aim of improving the guidelines for successful, evidence-based treatment of depression.

Clinical Trial Conditions for REMERON

Condition Name

Condition Name for REMERON
Intervention	Trials
Major Depressive Disorder	8
Depression	4
Healthy	4
Cocaine Dependence	3

Condition MeSH

Condition MeSH for REMERON
Intervention	Trials
Depression	14
Depressive Disorder	13
Depressive Disorder, Major	11
Disease	7

Clinical Trial Locations for REMERON

Trials by Country

Trials by Country for REMERON
Location	Trials
United States	24
China	5
Canada	2
Egypt	2
Brazil	2

Trials by US State

Trials by US State for REMERON
Location	Trials
North Dakota	4
Pennsylvania	3
New York	3
Virginia	2
California	2

Clinical Trial Progress for REMERON

Clinical Trial Phase

Clinical Trial Phase for REMERON
Clinical Trial Phase	Trials
Phase 4	12
Phase 3	4
Phase 2	12

Clinical Trial Status

Clinical Trial Status for REMERON
Clinical Trial Phase	Trials
Completed	27
Recruiting	3
Unknown status	3

Clinical Trial Sponsors for REMERON

Sponsor Name

Sponsor Name for REMERON
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	5
Capital Medical University	3
University of Pittsburgh	2

Sponsor Type

Sponsor Type for REMERON
Sponsor	Trials
Other	47
NIH	11
Industry	5

Clinical Trials Update, Market Analysis, and Projection for Remeron (Mirtazapine)

Last updated: October 30, 2025

Introduction

Remeron, the brand name for mirtazapine, is a tetracyclic antidepressant primarily prescribed for major depressive disorder (MDD). Approved by the U.S. Food and Drug Administration (FDA) in 1996, Remeron has gained widespread use for its efficacy and unique pharmacological profile. This comprehensive analysis details recent developments from clinical trials, evaluates market dynamics, and projects future growth trajectories to inform industry stakeholders and investors.

Clinical Trials Update

Recent and Ongoing Clinical Trials

Despite Remeron's longstanding approval, current research emphasizes optimizing its therapeutic profile, addressing side effects, and exploring new indications. According to ClinicalTrials.gov, as of 2023, there are no large-scale, Phase III trials actively recruiting for Remeron specifically. However, ongoing investigations aim to expand its application scope and improve patient outcomes.

Key Areas of Focus

• Adjunctive Use in Treatment-Resistant Depression (TRD): Several Phase II and III trials explore mirtazapine as an adjunct therapy in TRD. These studies suggest potential benefits in combined regimens with SSRIs and SNRIs, potentially enhancing remission rates (see [1]).

• Off-Label Applications: Trials investigate mirtazapine's efficacy in addressing sleep disorders, anxiety, and weight management, often as off-label uses outside the primary indication. Results demonstrate promising efficacy but await regulatory endorsement.

• Pharmacogenomics and Personalized Medicine: Emerging studies explore genetic markers influencing drug response, aiming to tailor mirtazapine therapy better and mitigate adverse effects (see [2]).

Safety and Efficacy Data

Recent meta-analyses reaffirm mirtazapine’s efficacy in reducing depressive symptoms with a tolerable side effect profile. Notably, weight gain and sedation remain prominent adverse events but are sometimes perceived as therapeutic benefits in addressing co-morbid conditions like insomnia and cachexia ([3]).

Regulatory Developments

While no significant recent label expansions have emerged, regulatory agencies continue to review real-world evidence supporting mirtazapine’s safety profile. There is speculation about potential approvals for new indications, such as Alzheimer’s-related depression or opioid-induced depression, based on evolving clinical data.

Market Analysis

Current Market Landscape

Remeron remains a prominent antidepressant within the global market, with an estimated valuation of approximately $1.2 billion in 2022, according to IQVIA. The drug benefits from off-patent status, increasing generic availability, which enhances accessibility but pressures brand-name pricing.

Key Market Players

• AbbVie (original developer): Retained rights before genericization.
• Generics Manufacturers: Numerous firms produce mirtazapine, including Teva, Mylan, and Sandoz, driving price competition (~10-20% reductions annually).

Competitive Dynamics

While SSRIs and SNRIs dominate current treatment algorithms, mirtazapine retains niche advantages for patients with co-morbid insomnia or weight issues. Market share shifts are influenced by:

• Side effect profiles: Preference for agents with fewer sedative effects.
• Emerging evidence: Favoring combination therapies for treatment-resistant patients.
• Patient adherence: Sedation and weight gain may hinder compliance, prompting recommendations for alternative medications in some cases.

Regional Market Trends

• North America: Stable but mature; growth driven by off-label uses and polypharmacy.
• Europe: Slight decline due to preference for newer antidepressants with better tolerability.
• Emerging Markets: Rapid uptake, with increased access in Asia-Pacific and Latin America, driven by price and healthcare infrastructure expansion.

Market Drivers and Challenges

• Drivers:

  • High prevalence of depression globally.
  • Off-label expanding uses, including sleep disorders.
  • Generic competition improving affordability.

• Challenges:

  • Side effect management—particularly weight gain and sedation.
  • Competition from newer agents with more favorable side effect profiles.
  • Regulatory scrutiny on off-label claims.

Market Projection

Forecast Overview (2023-2028)

The global mirtazapine market is projected to grow at a compound annual growth rate (CAGR) of approximately 3-4% over the next five years, reaching $1.4 billion by 2028. Growth factors include:

• Increasing recognition of mirtazapine’s role in treatment-resistant depression.
• Expansion into adjunctive therapies for sleep and anxiety.
• Rising medication access in developing economies.

Key Influencers

• Clinical Validation: Positive trial outcomes for additional indications could expand market size.
• Regulatory Approvals: Potential approvals for new uses would catalyze sales.
• Generics and Pricing: Reduced costs will sustain demand, especially in cost-sensitive markets.
• Alignment with Personalized Medicine: Pharmacogenomics may favor targeted use, optimizing efficacy and tolerability, and fostering sustained demand.

Risks to Growth

• Competition from novel antidepressants with superior side-effect profiles.
• Market saturation in developed countries.
• Regulatory uncertainties regarding off-label use and safety concerns.

Conclusion

Remeron (mirtazapine) maintains its position as a valuable agent in the depression treatment landscape, supported by ongoing clinical research, real-world evidence, and market dynamics favoring its niche applications. The upcoming years present opportunities for expanded use, particularly if regulatory pathways facilitate approval for new indications. Nevertheless, market growth hinges on balancing its efficacy with addressing side effects, innovation in personalized approaches, and navigating competitive pressures.

Key Takeaways

• Stable Clinical Profile: Despite numerous newer antidepressants, mirtazapine remains relevant due to its efficacy in treatment-resistant cases and adjunctive therapy.
• Market Growth: The global market is projected to grow modestly, driven by expanding access in emerging markets and off-label applications.
• Upcoming Opportunities: Potential regulatory approvals for broader indications could significantly impact demand.
• Challenges: Side effects and competition necessitate ongoing innovation and personalized treatment strategies.
• Investment Consideration: Continued generic availability, positive clinical data, and emerging research make mirtazapine a compelling asset in the antidepressant segment.

FAQs

1. What are the primary clinical indications for Remeron?
   Mirtazapine is mainly prescribed for major depressive disorder and as an adjunct for treatment-resistant depression, with off-label use for anxiety and sleep disorders.

2. Are there ongoing trials exploring new uses for mirtazapine?
   Yes. Current research investigates its potential in Alzheimer’s depression, opioid addiction comorbidities, and personalized medicine, though large-scale phase III trials are limited.

3. How does remron market competition impact its sales?
   Generic mirtazapine's affordability sustains its market share; however, newer agents with better side effect profiles challenge its dominance, especially in developed markets.

4. What are the major side effects associated with mirtazapine?
   Weight gain and sedation are common and may lead to discontinuation, particularly in long-term use or vulnerable populations.

5. What future market trends could influence mirtazapine’s growth?
   Advancements in pharmacogenomics, expanded approved indications, and increased access in emerging markets are expected to drive future growth.

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Sources
[1] ClinicalTrials.gov. Mirtazapine trials catalog.
[2] Pharmacogenomics Journal, 2022. Role of genetics in mirtazapine response.
[3] Meta-analysis of antidepressant efficacy, Journal of Clinical Psychiatry, 2023.