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.

Clinical Trial Conditions for NARDIL

Condition Name

Condition Name for NARDIL
Intervention	Trials
Metastatic Breast Cancer	1
Metastatic Prostatic Adenocarcinoma	1
Prostate Adenocarcinoma	1
Recurrent Prostate Cancer	1

Condition MeSH

Condition MeSH for NARDIL
Intervention	Trials
Prostatic Neoplasms	2
Adenocarcinoma	2
Depressive Disorder	1
Depression	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
University of Southern California	1
Liverpool Cancer Therapy Centre	1

Sponsor Type

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

NARDIL (phenelzine) Clinical Trials Update, Market Analysis, and Projection (2026)

Last updated: April 25, 2026

What is NARDIL and what is its regulatory status?

NARDIL is the brand name for phenelzine (a monoamine oxidase inhibitor, MAOI), used for treatment-resistant depression and related depressive disorders depending on jurisdiction labeling.

Because NARDIL is an established, off-patent medicine in most major markets, the dominant market dynamics come from:

• Generic penetration
• Safety-driven prescribing constraints (MAOI dietary and drug interaction burden)
• Shift of depression treatment standards toward SSRIs/SNRIs and newer agents

What is the clinical trials update for phenelzine (NARDIL)?

A complete, current “clinical trials update” requires a study-by-study accounting across registries (ClinicalTrials.gov and major global registries) with status, phase, endpoints, and dates. That information is not provided in the input, and producing it without live registry verification would risk factual errors.

No trials can be credibly enumerated here without an exact registry snapshot and identifiers.

What does the depression market landscape imply for NARDIL?

Even without adding trial-specific claims, phenelzine faces structurally unfavorable commercial forces versus newer depression classes:

1) Class competition

• SSRIs and SNRIs remain first-line in most markets.
• Atypical antidepressants and ketamine/esketamine ecosystems capture portions of treatment-resistant pathways.
• MAOIs retain a niche, with prescribing constrained by:
  • high interaction management needs
  • dietary restrictions
  • monitoring and education requirements

2) Niche positioning mechanics

Phenelzine tends to perform commercially when:

• multiple prior antidepressant failures exist
• clinicians are comfortable managing MAOI interactions
• payers allow access after step therapy

3) Generic economics

Phenelzine’s market share is heavily influenced by:

• low-cost generics
• physician switching away from brands unless a payer or formulary requires or favors a specific NDC

How big is the addressable market for NARDIL?

A market projection for NARDIL requires at minimum:

• the relevant geography set
• the forecast horizon and unit basis (sales $ or units)
• whether the analysis includes only branded NARDIL or total phenelzine (brand plus generics)

The input does not specify any of these; producing numeric forecasts would require external market sizing and formulary data that are not supplied.

What are the key demand drivers and risks for NARDIL?

These drivers apply to phenelzine’s real-world utilization irrespective of any single trial program.

Demand drivers (commercial)

• Treatment-resistant depression pools remain large globally, providing a persistent niche for older agents when newer options fail.
• Clinician familiarity in certain care settings keeps MAOIs in back-up pathways.
• Formulary access in markets where MAOIs are not strictly restricted supports steady baseline demand.

Risks (commercial)

• Safety and interaction burden reduces rapid adoption and can trigger step-therapy barriers.
• Brand-to-generic conversion typically compresses branded revenue unless brand-specific contracts exist.
• Treatment standard drift reduces the number of patients escalated into MAOI pathways over time.

What is a defensible market projection framework for NARDIL?

Given brand compression risk and niche demand, a projection should be modeled using:

• Base demand tied to depression prevalence and treatment-resistant sub-population
• Share-of-therapeutic-niche constrained by MAOI prescribing rates
• Share erosion from generics (for brand) and from newer treatment modalities (for class)
• Price and access impacts via reimbursement and formulary rules

However, producing an actual forecast with numbers requires data that is not present in the request.

Clinical development outlook: what is likely to matter next for phenelzine?

For an old MAOI like phenelzine, “future value” usually depends less on blockbuster label expansion and more on:

• targeted studies in subpopulations where MAOIs remain rational
• protocol refinements that reduce interaction friction
• evidence for combination strategies that fit real-world care pathways

But the current trial status and publication record must be verified against registry and literature databases to be stated as facts.

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Key Takeaways

• NARDIL (phenelzine) is an established depression MAOI with market dynamics dominated by generic economics, safety-driven prescribing constraints, and niche use in treatment-resistant depression.
• A clinical trials update with phase/status/endpoints cannot be produced accurately without a verified registry snapshot.
• A market analysis and projection for NARDIL must specify whether it targets branded NARDIL only or total phenelzine, plus geography and forecast horizon; numeric forecasts are not supportable from the provided input.

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FAQs

1. Is NARDIL still prescribed for depression in major markets?
   Yes, but largely within niche pathways, especially treatment-resistant cases, constrained by MAOI interaction management.

2. What most affects NARDIL revenue versus phenelzine generics?
   Brand versus generic pricing and formulary placement, plus conversion over time.

3. Do newer depression drugs reduce MAOI usage long term?
   They typically reduce the rate of escalation into MAOIs, but they do not eliminate a treatment-resistant niche.

4. What types of trials would most plausibly extend phenelzine’s use?
   Studies that reduce safety friction, define responder subgroups, or fit combination and sequence-of-therapy practice.

5. What is the minimum data needed to forecast NARDIL market value?
   Geography, forecast horizon, and whether the forecast is branded NARDIL only or total phenelzine, plus current baseline sales and unit trends.

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References

[1] Not available. No external clinical registry or market-source inputs were provided in the request.