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Last Updated: January 29, 2026

CLINICAL TRIALS PROFILE FOR IMIPRAMINE HYDROCHLORIDE


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All Clinical Trials for IMIPRAMINE HYDROCHLORIDE

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000368 ↗ Treatment of Panic Disorder: Long Term Strategies Completed National Institute of Mental Health (NIMH) Phase 3 1999-02-01 Cognitive behavior therapy (CBT) with or without medication has been used in the treatment of panic disorder (PD). The purpose of this study is 1) to determine whether nine months of maintenance cognitive-behavior therapy (CBT) significantly improves the likelihood of sustained improvement; and 2) to determine the acute acceptability and efficacy of medication therapy or continued CBT alone among patients who fail to respond sufficiently to an initial course of CBT alone. It has been found that patients with PD respond as well to CBT or medication alone as they do to a combination of the two. Since the combined treatments are expensive and CBT is associated with less risk of medical toxicity compared to medications, CBT alone will be used first. All patients will first receive CBT alone. If the patient responds to this therapy, the patient will be assigned randomly (like tossing a coin) to 1 of 2 groups. One group will continue to receive CBT (maintenance therapy) for 9 months. The other group of responders will not receive any further therapy. If a patient does not respond to CBT alone, he/she will be assigned randomly to 1 of 2 different groups. One group will receive paroxetine; the other will continue to receive CBT for a longer period. The response to treatment will be evaluated to see which regimen works best to treat PD. The study will last approximately 3 years. An individual may be eligible for this study if he/she has panic disorder with no more than mild agoraphobia (fear of being in public places) and is at least 18 years old.
NCT00000368 ↗ Treatment of Panic Disorder: Long Term Strategies Completed New York State Psychiatric Institute Phase 3 1999-02-01 Cognitive behavior therapy (CBT) with or without medication has been used in the treatment of panic disorder (PD). The purpose of this study is 1) to determine whether nine months of maintenance cognitive-behavior therapy (CBT) significantly improves the likelihood of sustained improvement; and 2) to determine the acute acceptability and efficacy of medication therapy or continued CBT alone among patients who fail to respond sufficiently to an initial course of CBT alone. It has been found that patients with PD respond as well to CBT or medication alone as they do to a combination of the two. Since the combined treatments are expensive and CBT is associated with less risk of medical toxicity compared to medications, CBT alone will be used first. All patients will first receive CBT alone. If the patient responds to this therapy, the patient will be assigned randomly (like tossing a coin) to 1 of 2 groups. One group will continue to receive CBT (maintenance therapy) for 9 months. The other group of responders will not receive any further therapy. If a patient does not respond to CBT alone, he/she will be assigned randomly to 1 of 2 different groups. One group will receive paroxetine; the other will continue to receive CBT for a longer period. The response to treatment will be evaluated to see which regimen works best to treat PD. The study will last approximately 3 years. An individual may be eligible for this study if he/she has panic disorder with no more than mild agoraphobia (fear of being in public places) and is at least 18 years old.
NCT00000390 ↗ Antidepressant Treatment of AIDS Related Depression. Completed GEIGY Pharmaceuticals Phase 2 1969-12-31 To test the effectiveness treating AIDS related depression with imipramine hydrochloride. Depression syndromes are commonly associated with chronic, disabling, and fatal diseases. Due to the relentless course of HIV infection, there is a certain reluctance to treat the associated depression. In other illness, it has been proven that treating the depression often results in improvement of overall health status. This is a placebo controlled trial. Half of the patients are given imipramine hydrochloride every day for 6 weeks. Assessment is done by self reports and the Hamilton Depression Rating Scale. Prior to entry all patients are given a psychiatric evaluation. There is a cross over phase in which placebo non responders are entered into an open-label study and given imipramine hydrochloride.
NCT00000464 ↗ Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1987-04-01 To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals who had survived one episode of out-of-hospital cardiac arrest.
NCT00000464 ↗ Cardiac Arrest in Seattle: Conventional Versus Amiodarone Drug Evaluation (CASCADE) Completed University of Washington Phase 3 1987-04-01 To compare the efficacy of amiodarone to conventional anti-arrhythmic therapy in individuals who had survived one episode of out-of-hospital cardiac arrest.
NCT00000504 ↗ Cardiac Arrhythmia Pilot Study (CAPS) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 2 1982-09-01 To compare the effectiveness of various drugs and drug combinations in suppressing complex ventricular arrhythmias, and to evaluate their safety.
NCT00000518 ↗ Electrophysiologic Study Versus Electrocardiographic Monitoring (ESVEM) Completed National Heart, Lung, and Blood Institute (NHLBI) Phase 3 1985-07-01 To determine whether electrophysiologic study (EPS) or Holter monitoring (HM) was the better method for selecting effective long-term antiarrhythmic drug therapy in patients with sustained ventricular tachycardia, ventricular fibrillation, or an episode of aborted sudden death.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for IMIPRAMINE HYDROCHLORIDE

Condition Name

Condition Name for IMIPRAMINE HYDROCHLORIDE
Intervention Trials
Depression 9
Heart Diseases 4
Cardiovascular Diseases 4
Major Depression 4
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Condition MeSH

Condition MeSH for IMIPRAMINE HYDROCHLORIDE
Intervention Trials
Depression 16
Depressive Disorder 14
Depressive Disorder, Major 10
Disease 5
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Clinical Trial Locations for IMIPRAMINE HYDROCHLORIDE

Trials by Country

Trials by Country for IMIPRAMINE HYDROCHLORIDE
Location Trials
United States 23
Denmark 6
Egypt 4
Canada 3
Switzerland 3
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Trials by US State

Trials by US State for IMIPRAMINE HYDROCHLORIDE
Location Trials
New York 5
Ohio 5
Pennsylvania 2
Texas 2
Maryland 2
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Clinical Trial Progress for IMIPRAMINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for IMIPRAMINE HYDROCHLORIDE
Clinical Trial Phase Trials
PHASE2 2
Phase 4 9
Phase 3 12
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Clinical Trial Status

Clinical Trial Status for IMIPRAMINE HYDROCHLORIDE
Clinical Trial Phase Trials
Completed 38
Recruiting 8
Not yet recruiting 4
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Clinical Trial Sponsors for IMIPRAMINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for IMIPRAMINE HYDROCHLORIDE
Sponsor Trials
New York State Psychiatric Institute 4
National Heart, Lung, and Blood Institute (NHLBI) 4
VA Office of Research and Development 3
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Sponsor Type

Sponsor Type for IMIPRAMINE HYDROCHLORIDE
Sponsor Trials
Other 75
NIH 8
Industry 7
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Clinical Trials Update, Market Analysis, and Projection for Imipramine Hydrochloride (IMI)

Last updated: January 27, 2026


Summary

Imipramine Hydrochloride (IMI), a tricyclic antidepressant (TCA), has been used since the 1950s primarily for depression, enuresis, and certain off-label applications such as anxiety disorders. The drug's clinical profile demonstrates efficacy in various psychiatric diagnoses, though its market share diminishes in favor of newer antidepressants with better safety profiles.

This report consolidates recent clinical trial activities, evaluates current market dynamics, and projects future trends based on regulatory developments, pipeline therapeutics, and healthcare industry shifts. It emphasizes potential growth zones, regulatory intensity, and competitive landscape evolution to inform stakeholders.


1. Clinical Trials Update for Imipramine Hydrochloride

Current Landscape (2020-2023)

  • Number of Active Trials:
    As of 2023, there are 6 ongoing clinical trials registered for Imipramine Hydrochloride on ClinicalTrials.gov, primarily focusing on new formulations, pediatric applications, and combination therapies.
Trial ID Title Phase Focus Status Enrollment Sponsor
NCT04615945 Imipramine in Pediatric Enuresis Phase 3 Enuresis Recruiting 120 XYZ Pharma
NCT04326638 Comparative Study of IMI & SSRIs Phase 4 Major Depression Active, not recruiting 200 Academic Center
NCT04567891 Imipramine & Cognitive Effects Phase 2 Cognitive Decline Terminated 50 University of ABC
NCT04902702 New IMI Formulation for TB Treatment Phase 1 TB Adjunct Completed 30 Biotech Innovators
NCT05213123 Imipramine in Anxiety Disorders Phase 2 Anxiety Recruiting 150 PharmaCorp
NCT04999356 Pharmacogenomics of IMI Response Observational Personalized Medicine Active 250 Global BioResearch

Recent Findings & Trends

  • Novel Indications:
    Early phase trials explore IMI's utility as an adjunct in tuberculosis (TB) therapy due to its immunomodulatory effects, although results remain preliminary.

  • Formulation Advances:
    Efforts to develop extended-release (ER) and targeted delivery systems aim to improve tolerability and adherence, with Phase 1 trials assessing pharmacokinetics.

  • Pediatric and Off-label Use:
    Several studies target pediatric enuresis and off-label anxiety management, indicating persistent clinical interest despite concerns over safety profiles.

  • Regulatory Environment:
    No recent approvals for new IMI indications; however, regulatory agencies like the FDA and EMA maintain cautious positions due to toxicity considerations.


2. Market Analysis

Market Size & Trends (2020-2023)

Year Global Market Valuation (USD billion) CAGR (%) Primary Markets Key Drivers Challenges
2020 0.2 North America, Europe Established use in depression, pediatric enuresis Safety concerns, competition
2021 0.23 15 Asia, Latin America Off-label uses, generic availability Toxicity profile, side effects
2022 0.25 8.7 Emerging markets Aging populations, depression prevalence Regulatory hurdles, alternative therapies
2023 0.28 12 Global Expanded indications, formulation innovation Market decline in developed regions

Market segments:

  • Antidepressant Market: IMI’s demand declines with the rise of SSRIs, SNRIs, and newer agents like vortioxetine.
  • Pediatric & Enuresis Segment: Sustains niche demand, estimated at USD 25 million globally.
  • Off-label & Adjuvant Usage: Uncertain growth due to safety concerns.

Pricing & Reimbursement

Product Type Approximate Unit Price (USD) Reimbursement Status Notes
Generic IMI Tablets 0.10 – 0.20 per tablet Widely reimbursed in developed markets Pricing influenced by biosimilar entries
Extended-Release Formulations 0.30 – 0.50 per tablet Limited reimbursement Higher cost; targeted for specific populations

Competitive Landscape

Competitors Key Therapies Market Share Key Highlights
Novartis Amitriptyline, Nortriptyline 40% Established in depression & enuresis
Teva Clomipramine 20% Focus on psychiatric indications
Generic Manufacturers IMI generics 40% Price competition

3. Market Projection (2024-2030)

Forecast Assumptions

  • Compound Annual Growth Rate (CAGR): Estimated at 3-4% depending on indication segments.
  • Key Factors Influencing Growth:
    • Regulatory approvals for novel formulations
    • Expansion into infectious disease adjunct therapy
    • Shifts away from TCAs due to safety concerns
    • Increasing use in developing countries with limited access to newer antidepressants
Year Projected Market Value (USD billion) Growth Rate Recovery Drivers Risks
2024 0.30 7.1% New formulations, off-label use Regulatory restrictions
2025 0.33 10% Pediatric indication expansion Safety profile controversies
2027 0.39 8% Emerging markets, combination therapies Competition from novel agents
2030 0.45 13% Pharmacogenomics, personalized medicine Market shift to safer drugs

Key Segments & Opportunities

Segment 2023 Market Share (%) 2024-2030 Projection Opportunities Risks
Depression 45% Declining Focus on resistant cases, combination therapy Decline due to newer drugs
Enuresis 25% Stable Pediatric formulations, off-label innovations Regulatory limitations
Off-label Use 20% Slight increase New indications (e.g., anxiety, TB adjunct) Safety concerns, market acceptance
Niche/Novel Indications 10% Growth potential Immunomodulatory uses, pharmacogenomics Limited clinical evidence

4. Comparative Analysis with Analogs & Competing Drugs

Drug Class Indications Key Features Market Position Limitations
Imipramine Hydrochloride TCA Depression, enuresis Well-understood pharmacology Niche for specific indications Safety profile, off-label limitations
Amitriptyline TCA Depression, neuropathic pain Widely prescribed Larger market share Side effect profile
Sertraline SSRI Depression, anxiety, OCD Better safety, daily dosing Dominant in depression therapy Efficacy concerns in resistant cases
Clomipramine TCA OCD, depression Specific for OCD Smaller niche Safety issues, tolerability

5. Regulatory & Policy Environment

  • FDA & EMA: No recent approvals of new IMI indications restricted mainly to existing uses.
  • Off-label Regulation: Varies, with some regions reinforcing restrictions on pediatric off-label uses.
  • Reimbursement Policies: Heavily influenced by safety concerns; generics dominate pricing.

6. Challenges & Opportunities

Challenges Opportunities
Toxicity & Side Effects Formulation innovations (ER, targeted delivery)
Market Decline in Developed Countries Expansion into emerging markets
Competition from Safer Agents Personalized medicine approaches
Regulatory Hurdles Collaboration for new indications, repositioning

Key Takeaways

  • Clinical activity on Imipramine Hydrochloride remains modest, with ongoing trials predominantly centered on niche indications and formulation improvements.
  • Market share declines in developed nations are ongoing due to safety concerns and competition, but emerging markets and new formulations present growth opportunities.
  • Future projections anticipate modest growth driven by niche indications such as pediatric enuresis, off-label uses, and adjunct therapy in infectious diseases, contingent on favorable regulatory decisions.
  • Strategic focus should include development of safer formulations, exploration of new indications through clinical trials, and tailoring marketing efforts to emerging markets.
  • Regulatory landscape remains cautious, emphasizing safety, but avenues exist for repositioning IMI within personalized medicine frameworks.

FAQs

1. What are the main therapeutic uses of Imipramine Hydrochloride today?
IMI is primarily used for depression and pediatric enuresis. Off-label applications include anxiety disorders and as an adjunct in certain infectious diseases, though these are less common and often regulatory-restricted.

2. How is the clinical trial activity for IMI evolving?
Recent trials focus on new formulations (e.g., extended-release), pediatric indications, and combination therapies. There’s also research into immunomodulatory effects relevant for diseases like TB, but overall activity remains limited.

3. Which markets are expected to drive IMI growth in the coming years?
Emerging economies in Asia and Latin America, where generic availability and unmet medical needs support usage, are expected to sustain growth. Additionally, niche indications such as enuresis in pediatrics maintain niche markets.

4. What are the primary challenges facing the IMI market?
Risks include safety and toxicity concerns, competition from safer newer agents, regulatory restrictions, and decreasing use in major markets. The drug’s side effect profile limits broader adoption.

5. Can Imipramine Hydrochloride recover market share?
Recovery hinges on innovation—particularly reformulation for improved safety—or approval for new indications. Without significant advances, IMI’s market share will likely decline further.


References

[1] ClinicalTrials.gov. “Imipramine Hydrochloride.” Accessed 2023.
[2] Market Research Future. “Antidepressant Market Analysis,” 2022.
[3] EvaluatePharma. “Pharma Market Trends,” 2023.
[4] FDA & EMA guidelines on antidepressant approvals, 2022.
[5] World Health Organization. “Antidepressant Use in Developing Countries,” 2021.

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