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
Brazil	2
Canada	2
Egypt	2

Trials by US State

Trials by US State for REMERON
Location	Trials
North Dakota	4
New York	3
Pennsylvania	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
Withdrawn	3
Recruiting	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
Actavis Inc.	2

Sponsor Type

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

REMERON Market Analysis and Financial Projection

Last updated: May 2, 2026

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

Remeron is the brand name for mirtazapine, a tetracyclic antidepressant marketed by Organon in multiple countries. The drug is fully out of patent in most major markets, so the commercial outcome is dominated by generic penetration, tender pricing, formulary access, and safety/side-effect positioning rather than exclusivity-led launch economics.

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What is Remeron (mirtazapine) and what is the current clinical-trial activity level?

Current development landscape

Mirtazapine is a legacy antidepressant. Public registries show limited new late-stage development for the base molecule versus ongoing work in:

• New indications (small studies)
• Special populations (e.g., geriatric, comorbidities)
• Formulation and regimen optimization (bioavailability, tolerability, adherence)
• Comparative effectiveness studies (often non-commercial, academic, or post-marketing)

What typically drives new trials for mirtazapine now

Across legacy antidepressants, trial activity tends to concentrate in:

• Head-to-head or pragmatic studies where clinicians need comparative outcomes
• Safety monitoring and tolerability endpoints (weight gain, sedation, sleep quality)
• Real-world evidence protocols that measure continuation rates and switching

Clinical implication for R&D planning: for a compound like mirtazapine, upside comes less from discovering “new efficacy” and more from niche differentiation (patient segment, dosing schedule, comedication strategy, and access).

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Which regulatory and market realities shape Remeron’s sales?

Exclusivity status

Mirtazapine predates modern IP timelines and has been widely genericized. In practice, brand Remeron performance depends on:

• Generic substitution rates in ambulatory care
• Hospital formulary rules and reimbursement structures
• Tender dynamics in government-funded systems
• Patient preference where brand loyalty persists

Safety and differentiation (commercially relevant)

The commercial profile remains anchored in known class behavior:

• Sedation is often used clinically for patients with insomnia or anxiety-related sleep disruption
• Weight gain is a major consideration and a key reason some patients switch away, while others switch toward it (appetite and tolerability in low-weight patients)

Commercial implication: Remeron’s brand value concentrates in segments where prescribers actively balance sleep benefit vs. weight gain risk.

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How is Remeron positioned versus alternatives in antidepressant markets?

Competitive set

Remeron competes primarily against:

• SSRIs/SNRIs (first-line in many guidelines due to tolerability in long-term use)
• TCAs (in select settings due to efficacy and older safety trade-offs)
• Other “sedating” antidepressants used when insomnia is prominent

Practical prescribing reality

Even when efficacy differences are small across many antidepressants, real-world choice often hinges on:

• Sleep symptoms
• Previous treatment response
• Side-effect management (weight, sexual dysfunction, discontinuation tolerance)

Brand implications: Remeron tends to hold ground when sedation is clinically desirable and when patients poorly tolerate SSRI/SNRI adverse effect profiles.

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What is the current market size and how should you project Remeron’s trajectory?

Market method (how projection should be framed for a legacy branded drug)

For a mature antidepressant brand with generic competition, projections should be built on:

• Share drift caused by generic substitution
• Formulary retention (where the brand remains listed even if not first-line)
• Price erosion and tender frequency
• Demographic demand growth (depression prevalence and aging populations)

Projection outlook (base-case)

For Remeron specifically, the most likely market path is:

• Flat to declining volumes over time in markets with high generic penetration
• Gradual revenue erosion driven by lower net price
• Local persistence where brand tenders or reimbursement rules limit substitution

A reasonable planning range for a legacy branded antidepressant under sustained generic pressure is:

• Low single-digit revenue decline annually in mature generic-heavy markets
• More stable revenue in markets with slower substitution, brand-restricted formularies, or national procurement structures

Projection outlook (bull-case levers)

Upside typically requires one of:

• A regulatory or reimbursement change that improves brand access
• A stronger clinician preference cycle driven by patient experience (sedation, sleep)
• Competitive disadvantage of generics due to supply or pricing shocks (less common, more episodic)

Projection outlook (bear-case levers)

Downside typically follows:

• Increased generic substitution due to new tender cycles
• Greater restriction of brand reimbursement
• Loss of formulary position in hospital systems

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What does this mean for investors and R&D strategists?

Investment thesis reality check

Because Remeron is a legacy branded drug, value creation is generally not driven by:

• New MoA breakthroughs
• New IP exclusivity for the base molecule

Instead, business cases rely on:

• Working capital and distribution efficiency
• Contracting and tender execution
• Portfolio allocation toward line extensions or supportive brand strategy

R&D implications

If you are allocating R&D resources around mirtazapine economics, the highest ROI paths typically target:

• Subpopulation-defined studies where the benefit-risk balance is more favorable
• Adherence, dosing convenience, and sleep-related endpoints
• Reformulation that reduces tolerability constraints (weight gain management is usually clinical, not formulation alone)

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Clinical trials update: what is the actionable state of evidence for Remeron today?

Evidence base

Mirtazapine has a large clinical evidence base relative to newer antidepressants, and most ongoing trials are incremental rather than transformative.

Most actionable readouts to monitor

When evaluating any new trial publication or registry update involving mirtazapine, prioritize:

• Switching and augmentation outcomes in pragmatic designs
• Sleep and sedation metrics for targeted patient segments
• Weight change trajectories and discontinuation due to adverse events
• Continuation and relapse rates in longer follow-up windows

Decision-use framing

For business and portfolio planning, the critical question is whether any new trial:

• Changes prescriber behavior at the point of care, or
• Alters payer/formulary decisions via a differentiating safety or tolerability signal

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Key Takeaways

1. Remeron is a legacy brand for mirtazapine with limited room for growth based on new exclusivity; performance is primarily driven by generic penetration, pricing, contracting, and formulary access.
2. Clinical trial activity for mirtazapine now is typically incremental and oriented to special populations, pragmatic effectiveness, and tolerability endpoints rather than new mechanism-led breakthroughs.
3. Base-case market projection for a brand like Remeron under sustained generics is flat to low single-digit revenue decline annually in mature markets, with stability possible where brand access is protected by reimbursement or tender structures.

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FAQs

1) Is Remeron still relevant clinically versus SSRIs/SNRIs?

Yes. It retains clinical use where prescribers target patients who benefit from sedation and sleep improvement, while weighing weight gain risk.

2) What factors most affect Remeron revenue in generic-heavy markets?

Net pricing, tender frequency, substitution rates, and formulary position drive the outcome more than incremental efficacy updates.

3) Are there new late-stage trials that could extend exclusivity for mirtazapine?

Market and registry reality for mirtazapine is that late-stage, exclusivity-extending development is uncommon; most activity is pragmatic or population-focused.

4) What safety endpoints matter most for market positioning?

Weight gain, sedation, and discontinuation due to adverse events are the endpoints that influence clinician switching and payer acceptance.

5) Where can a branded Remeron strategy still win?

In settings where brand listing persists, substitution is limited by reimbursement rules, or patient-level tolerability benefits support continued prescribing.

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References

[1] European Medicines Agency (EMA). Mirtazapine: EPAR and product information (public assessment documents and summaries of product characteristics). EMA.
[2] U.S. FDA. Drug Approval Packages: Remeron (mirtazapine) and labeling history (where available via FDA databases). FDA.
[3] ClinicalTrials.gov. Mirtazapine clinical trial registry entries (status, results availability, and study descriptions). National Library of Medicine.
[4] WHO Collaborating Centre for Drug Statistics Methodology. ATC/DDD information for mirtazapine (for market analytics mapping). WHO.