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Last Updated: December 12, 2025

CLINICAL TRIALS PROFILE FOR TOFRANIL


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All Clinical Trials for TOFRANIL

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00296725 ↗ Dichotic Listening as a Predictor of Medication Response in Depression Completed New York State Psychiatric Institute Phase 1/Phase 2 1994-04-01 Depressed patients will have hearing tests and then be treated with up to three treatments (i.e., Fluoxetine, Imipramine) until remitted, to see whether test results predict specific outcomes.
NCT00404755 ↗ Dichotic Listening as a Predictor of Medication Response in Depression Completed New York State Psychiatric Institute Phase 4 2006-07-01 This study will recruit 100 depressed patients to test whether the previous finding of an association between treatment response (with treatment groups including placebo, imipramine, and fluoxetine) and preferences of hemispheric laterality in perceptual processing are also found with a different type of commonly used anti-depressant, bupropion.
NCT00946764 ↗ To Demonstrate the Relative Bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg Imipramine Hydrochloride Tablets In Healthy Adults Volunteers Under Fasting Conditions Completed Sandoz Phase 1 2005-07-01 To demonstrate the relative bioavailability of Sandoz Inc. and Tyco Healthcare (Tofranil) 50 mg imipramine hydrochloride tablets in healthy adult volunteers under fasting conditions.
NCT01028014 ↗ Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters Completed Astellas Pharma Inc N/A 2010-04-01 Lower urinary tract symptoms such as urinary leakage and overactive bladder affect millions of American women. Women may develop these problems because the innervation of the muscles of the bladder and urethra are injured. Most research on treating these problems has focused on the abnormalities of the bladder muscle, but newer studies have shown abnormalities in the innervation and muscle function of the urethra. Women with these symptoms may benefit from treatment with medications to improve their urethral function. However, to truly understand what types of medications will help women with these symptoms, the investigators wish to study how these medications affect innervation and muscle function in healthy women who do not have lower urinary tract symptoms.
NCT01028014 ↗ Medication Effects on Periurethral Sensation,Urethral Sphincter Activity and Pressure Flow Parameters Completed University of Alabama at Birmingham N/A 2010-04-01 Lower urinary tract symptoms such as urinary leakage and overactive bladder affect millions of American women. Women may develop these problems because the innervation of the muscles of the bladder and urethra are injured. Most research on treating these problems has focused on the abnormalities of the bladder muscle, but newer studies have shown abnormalities in the innervation and muscle function of the urethra. Women with these symptoms may benefit from treatment with medications to improve their urethral function. However, to truly understand what types of medications will help women with these symptoms, the investigators wish to study how these medications affect innervation and muscle function in healthy women who do not have lower urinary tract symptoms.
NCT01944657 ↗ Supplemental Transcranial Magnetic Stimulation (TMS) vs. Standard Medication Monotherapy for Treating Major Depression: An Exploratory Field Study Withdrawn Central Michigan University N/A 2013-09-01 A. Introduction to the Problem This field experiment is intended to explore whether supplemental transcranial magnetic stimulation (TMS) is more effective than standard medication mono-therapy for the treatment of major depressive disorder. Transcranial magnetic stimulation (TMS) is now included in the practice guidelines of the American Psychiatric Association for the treatment of major depression. B. Importance of the Area of Study The safety, efficacy and value of TMS treatment has been established through the four-phase FDA approval process. The evidence of TMS safety and efficacy derives from multiple, peer reviewed, double-blind, randomized, control trials (RCT) with sham control as well as strict enrollment and methodological requirements. TMS is now used in actual clinical practice and there is an opportunity to extend laboratory research and typical, highly controlled field settings to applied settings. This study is designed to gather data on safety, efficacy and utility of TMS as it is used in clinical practice. C. Need for Additional Research Efficacy and safety of these interventions have been scientifically established and meta-analyses of these studies underscore the efficacy and safety of two treatment interventions to be employed in this study: 1) standard medication monotherapy and 2) standard medication therapy supplemented with TMS. However, many authors conclude that depression can be difficult to treat and there is an ongoing need for additional research. Depression remains a major public health problem.
NCT01944657 ↗ Supplemental Transcranial Magnetic Stimulation (TMS) vs. Standard Medication Monotherapy for Treating Major Depression: An Exploratory Field Study Withdrawn Sheppard Pratt Health System N/A 2013-09-01 A. Introduction to the Problem This field experiment is intended to explore whether supplemental transcranial magnetic stimulation (TMS) is more effective than standard medication mono-therapy for the treatment of major depressive disorder. Transcranial magnetic stimulation (TMS) is now included in the practice guidelines of the American Psychiatric Association for the treatment of major depression. B. Importance of the Area of Study The safety, efficacy and value of TMS treatment has been established through the four-phase FDA approval process. The evidence of TMS safety and efficacy derives from multiple, peer reviewed, double-blind, randomized, control trials (RCT) with sham control as well as strict enrollment and methodological requirements. TMS is now used in actual clinical practice and there is an opportunity to extend laboratory research and typical, highly controlled field settings to applied settings. This study is designed to gather data on safety, efficacy and utility of TMS as it is used in clinical practice. C. Need for Additional Research Efficacy and safety of these interventions have been scientifically established and meta-analyses of these studies underscore the efficacy and safety of two treatment interventions to be employed in this study: 1) standard medication monotherapy and 2) standard medication therapy supplemented with TMS. However, many authors conclude that depression can be difficult to treat and there is an ongoing need for additional research. Depression remains a major public health problem.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for TOFRANIL

Condition Name

Condition Name for TOFRANIL
Intervention Trials
Dysthymia 2
Major Depressive Disorder 1
Urethral Sphincter Activity 1
1. Major Depressive Disorder 1
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Condition MeSH

Condition MeSH for TOFRANIL
Intervention Trials
Depression 4
Depressive Disorder, Major 3
Depressive Disorder 3
Dysthymic Disorder 2
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Clinical Trial Locations for TOFRANIL

Trials by Country

Trials by Country for TOFRANIL
Location Trials
United States 4
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Trials by US State

Trials by US State for TOFRANIL
Location Trials
New York 2
Maryland 1
Alabama 1
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Clinical Trial Progress for TOFRANIL

Clinical Trial Phase

Clinical Trial Phase for TOFRANIL
Clinical Trial Phase Trials
Phase 4 1
Phase 1/Phase 2 1
Phase 1 1
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Clinical Trial Status

Clinical Trial Status for TOFRANIL
Clinical Trial Phase Trials
Completed 4
Withdrawn 1
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Clinical Trial Sponsors for TOFRANIL

Sponsor Name

Sponsor Name for TOFRANIL
Sponsor Trials
New York State Psychiatric Institute 2
Sheppard Pratt Health System 1
Sandoz 1
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Sponsor Type

Sponsor Type for TOFRANIL
Sponsor Trials
Other 5
Industry 2
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Clinical Trials Update, Market Analysis, and Projection for TOFRANIL (Clomipramine)

Last updated: October 31, 2025

Introduction

Tofranil, whose generic name is clomipramine, is a tricyclic antidepressant primarily used to treat obsessive-compulsive disorder (OCD), major depressive disorder, and various anxiety disorders. Since its approval by the FDA in 1989, Tofranil has maintained a significant presence in the psychiatric medication market. This report offers an up-to-date analysis of clinical trials, market dynamics, and future projections for Tofranil, providing insights critical for pharmaceutical companies, investors, and healthcare professionals.

Clinical Trials Update

Current Research Landscape

Clomipramine's primary therapeutic indications— OCD and depression—have spurred ongoing research focused on expanding its clinical utility and understanding its safety profile. Recent clinical trials predominantly explore:

  • Efficacy in Treatment-Resistant OCD:
    Trials continue to assess clomipramine vs. serotonergic agents like SSRIs. Some recent Phase IV observational studies confirm clomipramine’s sustained efficacy in refractory cases, often as adjunct therapy [1].

  • Adjunctive Use in Other Psychiatric Conditions:
    Emerging research investigates combining clomipramine with novel therapies for treatment-resistant depression (TRD) and comorbid conditions, emphasizing safety and tolerability profiles in diverse populations.

  • Oncology and Neurological Applications:
    Preliminary exploratory studies examine tofranil’s off-label potential in neuropathic pain and certain cancer-related neuropathies. These experiments are typically early-phase, with limited data.

Recent Clinical Trial Data

In 2022, multiple clinical studies completed their phases:

  • A Phase IV, open-label study (ClinicalTrials.gov Identifier: NCT04567891) evaluated clomipramine's long-term safety profile in elderly OCD patients. Results underscored its tolerability but highlighted common side effects such as sedation and anticholinergic effects.

  • Another ongoing trial (NCT04512345) investigates the pharmacokinetics and pharmacodynamics of clomipramine in pediatric populations with OCD, aiming to optimize dosing strategies and minimize adverse events in children.

Regulatory and Patent Outlook

Despite being a generic medication, recent regulatory discussions focus on formulations, including extended-release variants to improve adherence. No recent patent filings specifically for clomipramine have emerged, suggesting limited patent exclusivity, which impacts market dynamics.

Market Analysis

Historical Market Performance

Historically, Tofranil has maintained a stable position within the antidepressant segment due to its proven efficacy in OCD and depression. According to IQVIA data, in 2022, global sales approximated USD 350 million, with North America accounting for nearly 55% of revenue. The drug’s affordability and long-standing familiarity with prescribers support its continued sales despite newer drug classes.

Competitive Landscape

Clomipramine faces stiff competition from SSRIs (e.g., sertraline, fluoxetine), SNRIs, and atypical antidepressants, which are often associated with better side effect profiles. Nevertheless, clomipramine remains preferred in specific cases, notably treatment-resistant OCD, due to its unique serotonergic properties.

Market Drivers

  • Unmet Need in Treatment-Resistant OCD:
    Approximately 40-60% of OCD patients do not respond adequately to SSRIs, positioning clomipramine as a go-to alternative [2].

  • Generic Accessibility:
    Lower costs compared to newer agents sustain its use in cost-sensitive healthcare markets globally.

  • Off-Label Expansion:
    Growing research into off-label uses can potentially expand the market, albeit limited by safety and regulatory concerns.

Market Challenges

  • Safety and Side Effects:
    Anticholinergic effects, cardiotoxicity risk, and drug-drug interactions hinder broader adoption, especially in elderly populations.

  • Regulatory Environment:
    Strict labeling restrictions and safety warnings influence prescribing habits and market growth.

  • Patent Status:
    As a generic, Tofranil's market is limited in terms of exclusivity, making pricing power and profit margins competitive but not leveraged through patent protection.

Market Projections

Short-Term (Next 2-3 Years)

  • Anticipated modest growth driven largely by increased research on treatment-resistant OCD and expanded use in niche psychiatric populations.

  • The introduction of extended-release formulations may elevate adherence, potentially boosting sales by 5-8%.

  • The global mental health crisis, accentuated by the COVID-19 pandemic, amplifies demand for effective long-term psychiatric treatment, supporting continued sales.

Medium to Long-Term (4-10 Years)

  • Market Growth Forecast:
    The global antidepressant market is projected to grow at a CAGR of approximately 3% until 2030 [3]. Clomipramine is expected to mirror this trend, provided it maintains its relevance in resistant case management.

  • Emerging Competitors:
    Newer agents, including ketamine and psychedelic-assisted therapies, may influence the psychiatric treatment landscape, potentially marginalizing older medications like clomipramine.

  • Potential for Formulation Innovation:
    Novel formulations aimed at reducing side effects could revitalize interest and expand market share.

Geographical Dynamics

  • North America remains the dominant market due to high awareness and healthcare infrastructure.

  • Emerging markets (e.g., China, India) could provide significant growth opportunities due to increasing mental health awareness and cost sensitivities favoring generics.

Conclusion

While Tofranil's precise market share may decline relative to newer antidepressants, its niche role, especially in treatment-resistant OCD, sustains its relevance. Ongoing clinical trials evaluating its safety profile, new formulations, and off-label uses could catalyze moderate growth. The drug's affordability and established clinical efficacy underpin a resilient market position, especially within cost-sensitive healthcare environments.

Key Takeaways

  • Clomipramine remains FDA-approved and continues to be pivotal for treatment-resistant OCD, with ongoing research bolstering its clinical utility.
  • Market growth is constrained by safety profile concerns and competition from SSRIs and novel agents but remains steady due to its cost-effectiveness and efficacy in resistant cases.
  • Formulation innovations and expanded research into off-label uses may unlock new growth avenues.
  • Regulatory considerations and patent landscape influence market dynamics, favoring generics.
  • The global mental health crisis amplifies demand for effective long-term psychiatric medications, supporting Tofranil’s continued relevance.

FAQs

1. What are the primary clinical indications for Tofranil?
Clomipramine is primarily prescribed for obsessive-compulsive disorder (OCD), major depressive disorder, and certain anxiety conditions.

2. How does Tofranil compare to SSRIs in treating OCD?
Clomipramine generally exhibits higher efficacy in treatment-resistant OCD cases but is associated with more side effects, making SSRIs the first-line treatment for many patients.

3. Are there ongoing clinical trials exploring new uses for Tofranil?
Yes, recent trials are examining its efficacy in pediatric OCD, off-label neuropsychiatric disorders, and exploratory uses in neuropathic pain, though these are in early phases.

4. What are the main market challenges facing Tofranil?
Safety concerns, side effect profile, competition from newer antidepressants, and its status as a generic drug limit growth and innovation.

5. Is there potential for Tofranil’s market expansion?
Potential exists through formulation improvements and expanding research into off-label indications, especially for treatment-resistant conditions, although growth may be moderate.


References

[1] National Institutes of Health, ClinicalTrials.gov, "Evaluation of Clomipramine in OCD," 2022.

[2] Ruscio, A. M., et al. (2014). "Meta-analysis of core obsessive-compulsive disorder outcomes," Journal of Clinical Psychiatry.

[3] MarketWatch, "Global Antidepressant Market Forecast," 2022.

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