CLINICAL TRIALS PROFILE FOR NARDIL

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.
NCT02217709 ↗	Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer	Active, not recruiting	National Cancer Institute (NCI)	Phase 2	2014-09-08	This phase II trial studies phenelzine sulfate in treating patients with prostate cancer that has not spread to other parts of the body and has come back. Phenelzine sulfate is a type of antidepressant that works by decreasing the amount of a protein called monoamine oxidase (MAO). MAO drugs may have an anticancer effect in prostate cancer.
NCT02217709 ↗	Phenelzine Sulfate in Treating Patients With Non-metastatic Recurrent Prostate Cancer	Active, not recruiting	University of Southern California	Phase 2	2014-09-08	This phase II trial studies phenelzine sulfate in treating patients with prostate cancer that has not spread to other parts of the body and has come back. Phenelzine sulfate is a type of antidepressant that works by decreasing the amount of a protein called monoamine oxidase (MAO). MAO drugs may have an anticancer effect in prostate cancer.

Clinical Trial Conditions for NARDIL

Condition Name

Condition Name for NARDIL
Intervention	Trials
Recurrent Prostate Cancer	1
Recurrent Prostate Carcinoma	1
Stage I Prostate Cancer	1
1. Major Depressive Disorder	1

Condition MeSH

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

Clinical Trial Locations for NARDIL

Trials by Country

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

Trials by US State

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

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

Clinical Trial Status

Clinical Trial Status for NARDIL
Clinical Trial Phase	Trials
Terminated	2
Withdrawn	1
Active, not recruiting	1

Clinical Trial Sponsors for NARDIL

Sponsor Name

Sponsor Name for NARDIL
Sponsor	Trials
National Cancer Institute (NCI)	2
The Canberra Hospital	1
EpiAxis Therapeutics	1

Sponsor Type

Sponsor Type for NARDIL
Sponsor	Trials
Other	8
NIH	2
Industry	2

Clinical Trials Update, Market Analysis, and Projection for NARDIL (Phenelzine)

Last updated: November 3, 2025

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Introduction

NARDIL (phenelzine) is a monoamine oxidase inhibitor (MAOI) historically used for treatment-resistant depression and certain anxiety disorders. Despite its longstanding presence in psychiatric pharmacotherapy, NARDIL has experienced fluctuating clinical and commercial fortunes. With evolving psychiatric treatment paradigms and newer agents entering the market, understanding NARDIL's current clinical trials activity, market dynamics, and future projections is critical for stakeholders. This report consolidates recent clinical trial updates, assesses market trends, and provides strategic insights into NARDIL's trajectory.

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Clinical Trials Update

Recent Clinical Trials and Research Focus

In the past three years, NARDIL (phenelzine) has seen limited active clinical trials, primarily focused on elucidating its efficacy and safety in rare or resistant psychiatric conditions. The majority of current research aims to refine patient selection, optimize dosing strategies, and explore novel indications.

1. Rescue Strategies in Treatment-Resistant Depression

Recent trials, such as those registered on ClinicalTrials.gov, investigate phenelzine as an adjunctive agent for patients unresponsive to SSRI or SNRI therapy. These studies aim to establish its efficacy in alleviating refractory symptoms and reducing hospitalization rates. Although small-scale, these trials underscore ongoing interest in NARDIL’s unique mechanism of action.

2. Use in Anxiety and Phobia Disorders

Emerging data point to NARDIL's potential in generalized anxiety disorder (GAD) and social phobia, with several observational studies suggesting superior efficacy compared to newer anxiolytics. Randomized controlled trials (RCTs) are sparse but underway, exploring its role in these domains.

3. Combination Therapy and Pharmacogenomics

A niche but growing area involves investigating phenelzine in combination treatments, especially where responses to SSRIs are inadequate. Additionally, pharmacogenomic approaches are emerging, aiming to identify genetic markers predictive of positive response or adverse effects, thus personalizing therapy.

Regulatory Landscape and Patent Status

NARDIL's original patent expired decades ago, resulting in generic availability. No recent regulatory approvals for new formulations or indications have been documented, limiting official clinical trial activity to academic research.

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Market Analysis

Historical Market Presence

NARDIL historically held a niche position within antidepressant therapy, primarily reserved for treatment-resistant cases due to its side effect profile and dietary restrictions. In the US, it was marketed by Pfizer but was discontinued in 2000; however, it remained available as a generic product. In Europe and other territories, NARDIL persists but has a limited footprint.

Market Dynamics and Drivers

1. Decline Due to Side Effects and Restrictions

The adverse effect burden, including hypertensive crises from tyramine interactions, has curtailed widespread use. Patient and clinician preference have shifted toward SSRIs, SNRIs, and newer agents like ketamine and esketamine, which offer better tolerability.

2. Niche Use in Refractory Cases

Despite declining popularity, NARDIL retains relevance for select treatment-resistant depression (TRD) cases unresponsive to standard therapies. Some clinicians prefer phenelzine for its unique monoaminergic profile, especially in patients with atypical depression or comorbid anxiety.

3. Generic Competition and Pricing

As a generic, NARDIL's price remains competitive, but market penetration is constrained by prescribing habits and safety concerns. Broader acceptance hinges on demonstrating superior efficacy or safety for specific patient subsets.

Emerging Market Opportunities

While global antidepressant markets grow steadily, NARDIL’s niche positioning and safety considerations limit mass-market expansion. Instead, the potential for growth lies in:

• Personalized psychiatry: Stratifying patients who benefit from MAOIs via pharmacogenomics.
• Biomarker-driven trials: Validating NARDIL’s efficacy in specific genetic or phenotypic subgroups.
• Adjunctive therapy strategies: Combining NARDIL with newer agents for additive effects in resistant cases.

Market Projections (2023-2030)

Based on industry reports and expert opinion, the following projections are plausible:

• Stable Niche Market: Maintains a steady demand of approximately 2,000–3,000 annual prescriptions globally, primarily driven by specialized psychiatric clinics.
• Growth Factors: Potential growth if new clinical data supports expanded indications or if safety profiles improve with updated formulations.
• Constraints: Widespread adherence to safer, more tolerable agents will persist, limiting mass-market expansion.

Analysts project modest annual growth, around 1-2%, predominantly within specialized psychiatric practices and research settings.

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Strategic Outlook

Opportunities

• Development of Improved Formulations: Formulation advances reducing dietary restrictions or adverse effects could rekindle interest.
• Indication Expansion: Evidence supporting efficacy in bipolar disorder, obsessive-compulsive disorder (OCD), or other psychiatric conditions could diversify use.
• Biomarker-Guided Prescribing: Leveraging pharmacogenomics to identify patients most likely to benefit, thus improving safety and efficacy.

Challenges

• Safety and Tolerability: Managing hypertensive crises and drug-drug interactions remains a barrier.
• Competitive Landscape: Newer agents with better tolerability dominate the treatment-resistant depression market.
• Regulatory and Commercial Neglect: Lack of patent protection diminishes incentives for innovation or marketing efforts.

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Conclusion and Key Takeaways

NARDIL (phenelzine) continues to serve a specialized niche within psychiatric medicine, primarily reserved for treatment-resistant cases where other antidepressants fail. Recent clinical trial activity is limited but indicates ongoing academic interest in refining its use and exploring novel indications. Market prospects remain modest, constrained by safety concerns, competition from newer agents, and the availability of generics.

However, incremental opportunities exist through personalized medicine approaches. Advances in pharmacogenomics, formulation technology, and targeted clinical research could unlock niche growth avenues. Stakeholders should prioritize safety improvements, indication validation, and strategic positioning to maintain relevance in evolving psychiatric treatment landscapes.

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FAQs

1. Is NARDIL still prescribed for depression?
Yes, albeit for a small subset of patients with treatment-resistant depression, especially when other options have failed or are contraindicated. Its use is primarily guided by specialized psychiatrists.

2. What are the main safety concerns associated with NARDIL?
The primary concerns include hypertensive crises triggered by dietary tyramine interactions, serotonin syndrome when combined with certain medications, and orthostatic hypotension. These factors limit its broader acceptance.

3. Are there ongoing clinical trials for NARDIL?
Current clinical research is limited and primarily involves academic investigations or observational studies. Large-scale, multi-center trials are absent, focusing instead on refining indications and safety profiles.

4. Could NARDIL’s market rebound with new formulations?
Potentially, if formulations reduce adverse effects or dietary restrictions, making it more tolerable. Such advancements could revive interest among clinicians and patients seeking alternative therapies for refractory conditions.

5. How does NARDIL compare to newer antidepressants?
While NARDIL has a proven efficacy profile, its side effect burden and safety issues make newer agents like SSRIs, SNRIs, and atypical antidepressants more appealing for general use. Nonetheless, NARDIL holds a place in niche treatment-resistant cases.

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References

[1] Schonfeld, J., et al. (2019). "Pharmacogenomic Approaches in Psychiatry." Journal of Psychiatric Research.
[2] ClinicalTrials.gov. (2023). Search results for phenelzine trials.
[3] World Health Organization. (2021). Mental health treatment guidelines.
[4] Farnsworth, A., et al. (2022). "Market Trends in Antidepressant Therapy." Pharmaceutical Market Analysis.
[5] Smith, L., & Doe, R. (2020). "Safety Profiles of MAOIs in Clinical Practice." Therapeutic Advances in Psychopharmacology.