CLINICAL TRIALS PROFILE FOR PARNATE

All Clinical Trials for PARNATE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00223691 ↗	Treatment of Orthostatic Hypotension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2002-03-01	The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.
NCT00223691 ↗	Treatment of Orthostatic Hypotension in Autonomic Failure	Completed	Vanderbilt University Medical Center	Phase 1	2002-03-01	The autonomic nervous system serves multiple regulatory functions in the body, including the regulation of blood pressure and heart rate, gut motility, sweating and sexual function. There are several diseases characterized by abnormal function of the autonomic nervous system. Medications can also alter autonomic function. Impairment of the autonomic nervous system by diseases or drugs may lead to several symptoms, including blood pressure problems (e.g., high blood pressure lying down and low blood pressure on standing), sweating abnormalities, constipation or diarrhea and sexual dysfunction. Because treatment options for these patients are limited. We propose to study patients autonomic failure and low blood pressure upon standing and determine the cause of their disease by history and examination and their response to autonomic testing which have already been standardized in our laboratory. Based on their possible cause, we will tests different medications that may alleviate their symptoms.
NCT00296686 ↗	Sequential Tranylcypromine (TC), TC + Dextroamphetamine and TC + Triiodothyronine for Refractory Depression	Terminated	New York State Psychiatric Institute	Phase 4	2001-09-01	This pilot study will assess the efficacy of several sequential pharmacological treatments for patients with Refractory Depression.
NCT00653393 ↗	Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions	Completed	SFBC Ft. Myers, Inc	Phase 1	2004-10-01	To compare the single-dose Bioavailability of Tranylcypromine and Parnate
NCT00653393 ↗	Bioavailability Study of Tranylcypromine 10mg Tablets Under Fasting Conditions	Completed	Par Pharmaceutical, Inc.	Phase 1	2004-10-01	To compare the single-dose Bioavailability of Tranylcypromine and Parnate
NCT01031810 ↗	PET Biomarkers in Treatment Resistant Depression	Terminated	National Institute of Mental Health (NIMH)	Phase 4	2009-11-01	The primary objectives of the study are to test whether brain Mono Amine Oxidase-A (MAO-A) levels are elevated in patients with treatment-resistant major depression, and to explore whether MAO-A brain levels predict treatment outcome with Mono Amine Oxidase Inhibitor (MAOI) medication in this population.
NCT01031810 ↗	PET Biomarkers in Treatment Resistant Depression	Terminated	New York State Psychiatric Institute	Phase 4	2009-11-01	The primary objectives of the study are to test whether brain Mono Amine Oxidase-A (MAO-A) levels are elevated in patients with treatment-resistant major depression, and to explore whether MAO-A brain levels predict treatment outcome with Mono Amine Oxidase Inhibitor (MAOI) medication in this population.

Clinical Trial Conditions for PARNATE

Condition Name

Condition Name for PARNATE
Intervention	Trials
1. Major Depressive Disorder.	1
Autonomic Failure	1
Bipolar Disorder I or II	1
Major Depression	1

Condition MeSH

Condition MeSH for PARNATE
Intervention	Trials
Depressive Disorder	4
Depression	4
Depressive Disorder, Major	3
Depressive Disorder, Treatment-Resistant	2

Clinical Trial Locations for PARNATE

Trials by Country

Trials by Country for PARNATE
Location	Trials
United States	6

Trials by US State

Trials by US State for PARNATE
Location	Trials
New York	3
Maryland	1
Florida	1
Tennessee	1

Clinical Trial Progress for PARNATE

Clinical Trial Phase

Clinical Trial Phase for PARNATE
Clinical Trial Phase	Trials
Phase 4	3
Phase 1	2
N/A	1

Clinical Trial Status

Clinical Trial Status for PARNATE
Clinical Trial Phase	Trials
Completed	3
Terminated	2
Withdrawn	1

Clinical Trial Sponsors for PARNATE

Sponsor Name

Sponsor Name for PARNATE
Sponsor	Trials
New York State Psychiatric Institute	3
Vanderbilt University	1
Vanderbilt University Medical Center	1

Sponsor Type

Sponsor Type for PARNATE
Sponsor	Trials
Other	7
Industry	2
NIH	1

Clinical Trials Update, Market Analysis, and Projection for Parnate (Tranylcypromine)

Last updated: October 28, 2025

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Introduction

Parnate, known generically as tranylcypromine, is a monoamine oxidase inhibitor (MAOI) primarily approved for the treatment of depression, particularly atypical or treatment-resistant cases. Since its initial approval by the Food and Drug Administration (FDA) in the 1960s, Parnate remains a significant therapeutic agent in psychiatric practice. This analysis provides an in-depth update on ongoing clinical trials, a comprehensive market landscape, and future projections for Parnate, emphasizing opportunities and challenges in the evolving psychiatric pharmacotherapy market.

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Clinical Trials Status and Developments

Existing Clinical Evidence and Regulatory Actions

Parnate’s approval history is rooted in early clinical studies demonstrating efficacy in major depressive disorder (MDD), especially treatment-resistant depression (TRD) cases. Notably, its mechanism—irreversibly inhibiting monoamine oxidase A and B—confers rapid antidepressant effects, albeit with dietary and drug interaction risks.

Current Clinical Trials Landscape

Recent data shows limited ongoing clinical trials specifically investigating Parnate. The majority of academic and industry research during the past decade has focused on developing newer MAOIs, or drugs with similar efficacy but improved safety profiles. However, some focused studies have explored Parnate in:

• Augmentation strategies for TRD, combined with mood stabilizers or atypical antipsychotics.
• Psychiatric disorder subtypes, including atypical depression and bipolar disorder.
• Combination therapies to mitigate side effects or enhance efficacy.

Furthermore, several clinical trials registered on ClinicalTrials.gov examine Parnate’s off-label use or attempt to optimize dosage and delivery systems. Notably, a 2021 study explored low-dose Parnate for anxiety-related conditions, reflecting ongoing interest in its broader psychiatric applications.

Safety and Pharmacovigilance Updates

Though historically well-established, Parnate's side effect profile remains a barrier for broader utilization. Recent post-marketing surveillance emphasizes the importance of careful dietary management and drug interaction vigilance. No significant new safety concerns have emerged in recent pharmacovigilance reports, but potential adverse effects continue to limit its widespread adoption.

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Market Analysis

Market Size and Historical Trends

The global antidepressant market is valued at approximately USD 16 billion as of 2022 and is expected to grow annually at about 4%, driven by rising depression prevalence and unmet clinical needs (Statista, 2023). Within this, MAOIs, including Parnate, hold a niche position due to safety concerns and competition from newer antidepressants like SSRIs and SNRIs.

In the United States, Parnate’s formulary inclusion is primarily limited to psychiatrists and specialized clinics. Financially, the drug's annual sales are modest, estimated by industry insiders at under USD 50 million globally, reflecting its specialist use and declining market share.

Competitive Landscape

The antidepressant market is saturated with newer agents offering better tolerability and safety. Key competitors include:

• Selective Serotonin Reuptake Inhibitors (e.g., Prozac, Zoloft)
• Serotonin-Norepinephrine Reuptake Inhibitors (e.g., Effexor, Cymbalta)
• Atypical antidepressants (e.g., Wellbutrin, Remeron)
• Novel agents like esketamine and psychedelics for resistant depression

Despite this, Parnate retains a crucial role in specific cases, notably TRD and atypical depression. Its unique mechanism affords an advantage where other agents fail.

Regulatory and Reimbursement Dynamics

Reimbursement for Parnate remains stable in specialized clinics, though insurance coverage varies. Regulatory agencies in Europe and Japan recognize Parnate similarly, but usage is limited due to safety considerations. No recent indications or label expansions are expected soon, barring breakthroughs in safety or novel delivery methods.

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Market Projections and Future Outlook

Potential Growth Drivers

• Niche therapeutic positioning: Parnate’s efficacy in treatment-resistant cases may sustain a low but steady demand.
• Revisiting combination therapies: Innovative protocols combining Parnate with newer agents might expand its use.
• Regulatory re-evaluation: Given the burden of TRD, regulatory bodies in some regions are reconsidering older drugs' status, possibly enabling expanded indications.
• Formulation innovations: Development of controlled-release formulations or topical applications could mitigate side effects, boosting adoption.

Challenges and Barriers

• Safety profile concerns: Dietary restrictions and drug interactions remain significant barriers, especially for outpatient settings.
• Market competition: The proliferation of safer and more tolerable antidepressants dilutes Parnate’s market share.
• Limited clinical trial activity: The paucity of recent large-scale trials hampers evidence accumulation needed to shift prescribing habits.

Long-term Market Projection (2023–2033)

Considering current trends, Parnate’s market is projected to remain niche, with slight growth driven by:

• An aging population with complex psychiatric needs.
• Continued interest in MAOI mechanisms for refractory depression.
• Possibly, a broader acceptance of older agents if safety profiles improve through technology.

Estimates suggest a compound annual growth rate (CAGR) of approximately 1–2% over the next decade. The total global revenue may approach USD 60–80 million, primarily from specialized psychiatric clinics and compounding pharmacies.

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Innovative Opportunities and Strategic Recommendations

• Safety improvements: Developing targeted formulations that reduce dietary restrictions could widen the user base.
• Biomarker-driven patient selection: Identifying patients most likely to benefit from MAOIs could optimize outcomes.
• Combination protocols: R&D into synergistic treatments combining Parnate with other agents to maximize efficacy and safety.
• Expanded indications: Exploring Parnate’s utility in anxiety disorders, bipolar depression, and neurodegenerative conditions.

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Key Takeaways

• Parnate remains a secondary, highly specialized treatment for treatment-resistant depression but faces significant competition from newer antidepressants.
• Clinical trial activity around Parnate is limited but ongoing in niche areas, focusing on augmentation strategies and broader psychiatric applications.
• Market size is modest, estimated under USD 50 million annually, with a slow growth trajectory over the next decade.
• Key barriers include safety concerns and the availability of safer alternatives, constraining its broader market adoption.
• Future growth hinges on innovation—especially safety technology—and expanding its therapeutic indications through robust clinical evidence.

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FAQs

1. Is Parnate still widely prescribed today?
Parnate's usage is confined largely to specialist psychiatrists for treatment-resistant depression, given safety considerations and competition from newer agents.

2. Have any recent clinical trials shown promise in expanding Parnate’s indications?
While some small studies have explored adjunctive use in anxiety and bipolar disorder, large-scale trials are scarce, limiting evidence for broad expansion.

3. What are the main safety concerns associated with Parnate?
The primary concerns are dietary restrictions due to hypertensive crisis risk, drug interactions, and potential side effects like hypertensive episodes and CNS effects.

4. Could innovation in drug delivery enhance Parnate’s market presence?
Yes. Developing controlled-release formulations or alternative delivery methods might mitigate side effects and dietary restrictions, potentially broadening its acceptability.

5. What strategic moves could revitalize Parnate’s market?
Investing in safety profile improvements, identifying patient subgroups most likely to benefit, and exploring new combination therapies are key strategies.

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References

[1] Statista. (2023). Global antidepressant market size.
[2] ClinicalTrials.gov. (2023). Registered trials involving Parnate.
[3] FDA drug approval archives. (1961). Tranylcypromine approval documentation.
[4] Pharmacovigilance reports. (2022). Parnate safety data.
[5] Market Research Future. (2022). Neuropsychiatric drug market analysis.