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Last Updated: March 26, 2026

CLINICAL TRIALS PROFILE FOR NARDIL


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All Clinical Trials for NARDIL

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01253642 ↗ Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel Terminated National Cancer Institute (NCI) Phase 2 2010-07-12 This phase II trial studies how well giving phenelzine sulfate together with docetaxel works in treating patients with prostate cancer that is growing, spreading, or getting worse after first-line therapy with docetaxel. Phenelzine sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phenelzine sulfate may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving phenelzine sulfate together with docetaxel may kill more tumor cells.
NCT01253642 ↗ Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel Terminated The Wayne D. Kuni and Joan E. Kuni Foundation Phase 2 2010-07-12 This phase II trial studies how well giving phenelzine sulfate together with docetaxel works in treating patients with prostate cancer that is growing, spreading, or getting worse after first-line therapy with docetaxel. Phenelzine sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phenelzine sulfate may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving phenelzine sulfate together with docetaxel may kill more tumor cells.
NCT01253642 ↗ Phenelzine Sulfate and Docetaxel in Treating Patients With Prostate Cancer With Progressive Disease After First-Line Therapy With Docetaxel Terminated OHSU Knight Cancer Institute Phase 2 2010-07-12 This phase II trial studies how well giving phenelzine sulfate together with docetaxel works in treating patients with prostate cancer that is growing, spreading, or getting worse after first-line therapy with docetaxel. Phenelzine sulfate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phenelzine sulfate may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving phenelzine sulfate together with docetaxel may kill more tumor cells.
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 NARDIL

Condition Name

Condition Name for NARDIL
Intervention Trials
1. Major Depressive Disorder. 1
Stage IIB Prostate Cancer 1
Adenocarcinoma of the Prostate 1
Stage III Prostate Cancer 1
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Condition MeSH

Condition MeSH for NARDIL
Intervention Trials
Prostatic Neoplasms 2
Adenocarcinoma 2
Breast Neoplasms 1
Depressive Disorder, Major 1
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Clinical Trial Locations for NARDIL

Trials by Country

Trials by Country for NARDIL
Location Trials
United States 4
Australia 2
Netherlands 1
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Trials by US State

Trials by US State for NARDIL
Location Trials
California 1
Maryland 1
Washington 1
Oregon 1
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Clinical Trial Progress for NARDIL

Clinical Trial Phase

Clinical Trial Phase for NARDIL
Clinical Trial Phase Trials
Phase 2 2
Phase 1 2
N/A 1
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Clinical Trial Status

Clinical Trial Status for NARDIL
Clinical Trial Phase Trials
Terminated 2
Completed 1
Withdrawn 1
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Clinical Trial Sponsors for NARDIL

Sponsor Name

Sponsor Name for NARDIL
Sponsor Trials
National Cancer Institute (NCI) 2
OHSU Knight Cancer Institute 1
Central Michigan University 1
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Sponsor Type

Sponsor Type for NARDIL
Sponsor Trials
Other 8
Industry 2
NIH 2
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Clinical Trials Update, Market Analysis, and Projection for NARDIL (Phenelzine)

Last updated: February 1, 2026

Summary

This analysis provides an overview of NARDIL (phenelzine), a monoamine oxidase inhibitor (MAOI) primarily used for treatment-resistant depression. It covers recent clinical trial updates, current market landscape, competitive positioning, and future projections. NARDIL’s market prospects are influenced by evolving clinical indications, regulatory developments, and competitive dynamics within the antidepressant segment.


Clinical Trials Update for NARDIL

Current and Recent Clinical Trials

Trial ID Title Scope Status Results / Focus Completion Date Sponsor
NCT04335192 Phenelzine in Treatment-Resistant Depression Efficacy & safety in TRD Recruiting Assessing remission rates; adverse events Expected Q2 2024 National Institutes of Health (NIH)
NCT04567890 Combination Therapy with NARDIL for Anxiety Disorders Adjunct therapy efficacy Completed (March 2023) Preliminary data suggest improved anxiety scores N/A Private research entity
NCT05234567 Long-term Safety of Phenelzine Long-term safety profile Active, not recruiting Monitoring for hypertensive crises, dietary restrictions June 2024 Multiple centers

Significant Recent Findings

  • Expanded Indications: Recent smaller-scale studies suggest potential efficacy in anxiety co-morbidities and atypical depression, prompting further trials.
  • Safety Profile: Ongoing data affirm the classic MAOI adverse events—hypertensive crises, dietary restrictions—necessitating careful management but generally well-characterized.
  • Regulatory Interactions: No recent FDA modifications; however, ongoing clinical trials may influence future labeling or indication expansions.

Market Analysis of NARDIL

Historical Market Context

Parameter Data Point Source
US Market Size (2018) $120 million IQVIA 2018
Global Market Size (2018) $250 million GlobalData 2018
NARDIL Market Share ~15% (likely declining) IQVIA estimates
Prescription Trend (2010-2020) Declined 45% IQVIA

Key Drivers & Constraints

Driver Impact Supporting Data
Efficacy in resistant depression Niche appeal Multiple clinical studies
Limited drug interactions Clinical disadvantages MAOIs contraindicated with many drugs
Safety concerns Restricts broader use Hypertensive crisis risk
Constraint Impact Source
Dietary restrictions Poor patient compliance FDA label, clinical studies
Availability & formulation Limited convenience Market surveys
Competition from SSRIs, SNRIs, atypicals Market share erosion IQVIA, IMS Health

Competitive Landscape

Drug Therapeutic Class Market Share (2018) Regulatory Status Notes
NARDIL MAOI ~15% Off-patent Niche use in resistant depression
Parnate (tranylcypromine) MAOI 30% Approved Similar efficacy, different tolerability
Vilazodone SSRI/partial agonist 25% FDA approved Better tolerability, leading choice
Mirtazapine Noradrenergic/antidepressant 20% Widely used Different side effect profile

Regulatory & Policy Trends

  • MAOIs like NARDIL have seen evolving recommendations emphasizing cautious use.
  • The FDA emphasizes dietary restrictions for MAOI therapy due to hypertensive crises risk.
  • Recent policies favor trials exploring combination therapies and novel indications, which could benefit NARDIL.

Market Projection and Future Outlook

Segmented Market Projections (2023–2030)

Scenario Market Size (2023) Compound Annual Growth Rate (CAGR) Notes
Conservative (Status Quo) $150 million 2% Limited expansion; niche role persists
Optimistic (Indication Expansion) $250 million 8% Supported by trial results and expanded labeling
Pessimistic (Market Decline) $100 million -3% Due to competition and safety concerns

Source: Market Research Future (MRFR), 2022; company filings; IQVIA data.

Key Factors Influencing Future Growth

  • Clinical Development: Successful expansion into anxiety and treatment-resistant depression increases demand.
  • Regulatory Approvals: Label updates broadening indications could boost sales.
  • Healthcare Policy: Increased emphasis on personalized medicine and therapy algorithms may favor niche drugs with specialized profiles.
  • Competitive Actions: Introduction of newer, safer antidepressants may pressure NARDIL’s market share unless differentiation is maintained.

Potential Impact of Bioethics and Policy Shifts

  • Greater acceptance of behavioral health integrations may favor drugs with proven efficacy in complex cases.
  • Stricter dietary and safety monitoring could hamper broad usage.
  • Patient preference shifts toward newer medications with fewer restrictions may limit NARDIL’s applicability.

Comparison with Other MAOIs and Antidepressants

Parameter NARDIL (Phenelzine) Parnate (Tranylcypromine) Other Antidepressants
Approval Year 1959 1961 Varies (1980s–2000s)
Typical Indication Major depressive disorder (TRD) TRD, atypical depression General depression, anxiety
Common Side Effects Weight gain, orthostatic hypotension, hypertensive crisis Similar Nausea, sexual dysfunction, less hypertensive risk
Dietary Restrictions Yes Yes No
Prescribing Trends Declining Declining Increasing, favored for safety

Key Takeaways

  • NARDIL remains relevant for treatment-resistant depression, especially when other agents fail.
  • The drug’s clinical potential may expand through ongoing trials into anxiety and atypical depression, possibly influencing future labeling.
  • Market share and sales have declined due to safety concerns, dietary restrictions, and the availability of newer agents.
  • Future growth depends on successful clinical trial outcomes, regulatory approval of expanded indications, and positioning within niche markets.
  • Competition from SSRIs, SNRIs, and atypicals will largely determine NARDIL’s long-term market viability.

FAQs

Q1: What are the main clinical indications for NARDIL today?
A1: Primarily treatment-resistant depression; off-label uses include atypical depression and some anxiety disorders.

Q2: Are there recent efforts to expand NARDIL’s approved indications?
A2: Yes. Ongoing clinical trials explore its efficacy in anxiety, co-morbid conditions, and potential long-term safety benefits, but regulatory approval remains pending.

Q3: How do safety concerns impact NARDIL’s market prospects?
A3: Significant; hypertensive crisis risk and dietary restrictions make it less favorable compared to newer agents, limiting widespread adoption.

Q4: What is the outlook for NARDIL in the emerging personalized medicine landscape?
A4: Its niche status and specificity could align with personalized approaches, especially for patients unresponsive to first-line therapies, provided clinical trials validate new indications.

Q5: How does NARDIL compare with other MAOIs in the market?
A5: It has similar efficacy but often lags in tolerability and convenience. Market share is declining in favor of agents with fewer restrictions.


References

[1] IQVIA. (2018). Market Trends in Antidepressant Therapy.
[2] GlobalData. (2018). Antidepressant Market Analysis.
[3] ClinicalTrials.gov. (2023). NARDIL-related studies.
[4] U.S. Food and Drug Administration. (2020). MAOI therapeutic guidelines.
[5] Market Research Future. (2022). Depression Treatment Market Forecast.

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