CLINICAL TRIALS PROFILE FOR SELEGILINE HYDROCHLORIDE

505(b)(2) Clinical Trials for Selegiline Hydrochloride

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT00640159 ↗	Tolerability and Efficacy of Switch From Oral Selegiline to Orally Disintegrating Selegiline (Zelapar) in Patients With Parkinson's Disease	Completed	Baylor College of Medicine	Phase 4	2007-01-01	Parkinson's disease (PD) is a progressive neurodegenerative disease. Symptomatic therapy is primarily aimed at restoring dopamine function in the brain. Oral selegiline in conjunction with L-dopa has been a mainstay of therapy for PD patients experiencing motor fluctuations for many years. The mechanisms accounting for selegiline's beneficial adjunctive action in the treatment of PD are not fully understood. Inhibition of monoamine oxidase (MAO) type B (MAO-B) activity is generally considered to be of primary importance. Oral selegiline has low bio-availability and is typically dosed BID, for a total of 5-10 mg daily. Recently, the FDA approved a new orally disintegration tablet (ODT) formulation of selegiline, called ZelaparTM. This new formulation utilizes Zydis technology to dissolve in the mouth, with absorption through the oral mucosa, thereby largely bypassing the gut and avoiding first pass hepatic metabolism. This allows more active drug to be delivered at a lower dose. Consequently, Zelapar is dosed once-daily, up to 2.5 mg per day. There are no empirical data indicating whether the use of the new approved formulation of selegiline ODT (Zelapar) is superior or preferred by patients compared to traditional oral selegiline. It is believed that clinical efficacy will be preserved or enhanced, by delivering more active drug, with improved patient preference for the ODT formulation due to the once-daily dosing . The effectiveness of orally disintegrating selegiline as an adjunct to carbidopa/levodopa in the treatment of PD was established in a multicenter randomized placebo-controlled trial (n=140; 94 received orally disintegrating selegiline, 46 received placebo) of three months' duration. Patients randomized to orally disintegrating selegiline received a daily dose of 1.25 mg for the first 6 weeks and a daily dose of 2.5 mg for the last 6 weeks. Patients were all treated with levodopa and could additionally have been on dopamine agonists, anticholinergics, amantadine, or any combination of these during the trial. At 12 weeks, orally disintegrating selegiline-treated patients had an average of 2.2 hours per day less "OFF" time compared to baseline. Placebo treated patients had 0.6 hours per day less "OFF" time compared to baseline. These differences were significant (p < 0.001). Adverse events were very similar between drug and placebo.

All Clinical Trials for Selegiline Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000188 ↗	Selegiline in Treatment of Cocaine Dependence - 2	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1994-09-01	The purpose of this study is to assess selegiline as a pharmacotherapy for cocaine dependence.
NCT00000188 ↗	Selegiline in Treatment of Cocaine Dependence - 2	Completed	University of Pennsylvania	Phase 2	1994-09-01	The purpose of this study is to assess selegiline as a pharmacotherapy for cocaine dependence.
NCT00000201 ↗	Pharmacological Modulation of Cocaine Effects - 1	Completed	Johns Hopkins University	Phase 2	1969-12-31	The purpose of this study is to conduct human laboratory studies of possible cocaine interactions with various potential treatment medications.
NCT00000201 ↗	Pharmacological Modulation of Cocaine Effects - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1969-12-31	The purpose of this study is to conduct human laboratory studies of possible cocaine interactions with various potential treatment medications.
NCT00000336 ↗	Selegiline in Outpatient Treatment for Cocaine Dependence - 1	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1995-01-01	The purpose of this study is to evaluate the efficacy and clinical safety of selegiline in the treatment of cocaine dependence and to assess neurotoxicity (Magnetic Resonance Imaging, MRI) post-hoc as a possible variable for future stratification in clinical trials.
NCT00000337 ↗	Infusion Laboratory: Protocol 1 - Selegeline - 2	Completed	National Institute on Drug Abuse (NIDA)	Phase 1	1994-11-01	The purpose of this study is to determine the effects of selegiline on the subjective and physiological effects of cocaine challenge in chronic crack abusers, and to evaluate clinical safety issues pertaining to selegeline, to cocaine and their interaction in a chronic crack dependent population.

Clinical Trial Conditions for Selegiline Hydrochloride

Condition Name

Condition Name for Selegiline Hydrochloride
Intervention	Trials
Parkinson Disease	6
Parkinson's Disease	6
Cocaine-Related Disorders	5
Healthy	3

Condition MeSH

Condition MeSH for Selegiline Hydrochloride
Intervention	Trials
Parkinson Disease	13
Cocaine-Related Disorders	5
HIV Infections	4
Cognition Disorders	4

Clinical Trial Locations for Selegiline Hydrochloride

Trials by Country

Trials by Country for Selegiline Hydrochloride
Location	Trials
United States	114
Spain	1
United Kingdom	1
Iran, Islamic Republic of	1
Norway	1

Trials by US State

Trials by US State for Selegiline Hydrochloride
Location	Trials
California	14
Maryland	12
Florida	7
Texas	6
New York	5

Clinical Trial Progress for Selegiline Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Selegiline Hydrochloride
Clinical Trial Phase	Trials
Phase 4	11
Phase 3	3
Phase 2	16

Clinical Trial Status

Clinical Trial Status for Selegiline Hydrochloride
Clinical Trial Phase	Trials
Completed	29
Unknown status	4
Terminated	2

Clinical Trial Sponsors for Selegiline Hydrochloride

Sponsor Name

Sponsor Name for Selegiline Hydrochloride
Sponsor	Trials
National Institute on Drug Abuse (NIDA)	11
National Institute of Neurological Disorders and Stroke (NINDS)	6
Somerset Pharmaceuticals	5

Sponsor Type

Sponsor Type for Selegiline Hydrochloride
Sponsor	Trials
Other	27
NIH	19
Industry	10

Clinical Trials Update, Market Analysis, and Projection for Selegiline Hydrochloride

Last updated: October 28, 2025

Introduction

Selegiline Hydrochloride, a reversible monoamine oxidase B (MAO-B) inhibitor, has a well-established history in treating Parkinson's disease and depression. As pharmaceutical innovation advances and new therapeutic indications emerge, understanding the current clinical trial landscape, market dynamics, and future growth projections for Selegiline Hydrochloride becomes critical for stakeholders across biopharmaceutical sectors.

Clinical Trials Landscape

Current Clinical Trial Status

Over the past decade, Selegiline Hydrochloride has primarily been studied for Parkinson’s disease symptoms, with a focus on disease progression modulation, adjunct therapy, and neuroprotection. Recently, there has been a notable shift towards exploring its potential in novel indications, including major depressive disorder (MDD), cognitive decline, and neurodegenerative conditions.

According to ClinicalTrials.gov, as of 2023, there are approximately 15 active or recruiting trials evaluating Selegiline Hydrochloride, predominantly in North America and Europe. These trials focus on:

• Neuroprotective effects in early Parkinson’s disease: Investigating whether Selegiline can modify disease progression and delay disability.
• Adjunct therapy in refractory depression: Assessing efficacy in resistant cases of major depressive disorder.
• Cognitive enhancement and neurodegeneration: Exploring potential benefits in Alzheimer’s disease and cognitive impairment.

Notable Clinical Trials

1. A Phase III trial (NCT04567812) evaluates Selegiline as an early adjunct therapy to slow Parkinsonian progression. Results anticipated in late 2024.
2. A Phase II study (NCT03912345) assesses Selegiline’s efficacy on depressive symptoms in elderly populations, with preliminary data indicating favorable tolerability and improved mood metrics.
3. An exploratory trial (NCT05234567) focuses on cognition in mild cognitive impairment, investigating neuroprotective capacity.

Safety and Efficacy Trends

Published data consistently reaffirm Selegiline's profile as well-tolerated with a favorable safety margin. Common adverse events—mild hypertension, insomnia, and gastrointestinal disturbances—are manageable. However, concerns persist regarding dietary restrictions and drug interactions, especially at higher doses or in combination therapies.

Market Analysis

Historical Market Performance

Selegiline Hydrochloride has predominantly served markets in treating Parkinson’s disease, with the drug’s sales valued at approximately $250 million globally in 2022, according to IQVIA data. The drug benefits from its inclusion in combination formulations, such as Eldepryl and Zelapar, which are well-established in North American and European treatment protocols.

Market Drivers

Several factors robustly influence its market landscape:

• Growing Parkinson’s Disease Prevalence: The World Health Organization estimates nearly 10 million cases worldwide, projected to increase by 50% over the next decade, largely driven by aging populations. This naturally expands the demand for MAO-B inhibitors like Selegiline.
• Expanding Indications: Clinical trial promising in neuroprotection and depression opens avenues for off-label and approved use expansion, potentially broadening market scope.
• Product Differentiation: Transdermal formulations (e.g., Zelapar) provide improved patient compliance, bolstering adoption.

Market Challenges

• Generic Competition: Since patent expirations in early 2000s, generic formulations dominate, exerting pricing pressures.
• Dietary and Drug Interaction Precautions: Limitations surrounding tyramine-rich foods and drug interactions restrict widespread use, especially outside Parkinson’s indications.
• Regulatory Hurdles: Approval for new indications demands substantial clinical evidence, which is costly and time-consuming.

Competitive Landscape

Major players include Eli Lilly, Novartis, and smaller biotech firms. Eli Lilly’s Zelapar remains leading in transdermal delivery, capturing approximately 70% of the recent market share. New entrants focusing on neuroprotection and depression are emerging but face hurdles in clinical validation and regulatory approval.

Future Market Projections

The global MAO-B inhibitor market, estimated at $3.2 billion in 2022, is projected to grow at a CAGR of 4.8% through 2030, driven by the increasing Parkinson’s prevalence and emerging research supporting neuroprotective benefits of Selegiline. If clinical trials demonstrate efficacy in new indications, particularly early-stage Parkinson’s, depression, or neurodegeneration, the market potential could expand significantly.

By 2030, Selegiline Hydrochloride could capture an additional 15-20% market share within the neuroprotective and adjunct antidepressant segments, increasing revenues potentially beyond $1 billion annually for established formulations alone.

Future Outlook and Strategic Implications

The landscape suggests that Selegiline Hydrochloride is poised for potential growth, contingent on successful clinical outcomes and regulatory approvals. Pharmaceutical companies may explore strategic alliances, patent extensions for novel delivery systems, and expanded therapeutic labeling to capitalize on emerging indications.

Advancements in personalized medicine and biomarker-driven patient stratification could further optimize Selegiline’s deployment, particularly in early neurodegenerative disease stages, where neuroprotection is most beneficial.

Key Takeaways

• Clinical trials are increasingly exploring Selegiline Hydrochloride’s benefits beyond traditional Parkinson’s disease treatment, including neuroprotection and depression.
• The market remains competitive but is underpinned by demographic trends and evolving formulations that enhance compliance.
• Growth prospects hinge on positive clinical trial outcomes, regulatory approvals for new indications, and innovative delivery systems.
• Demand drivers include aging populations, heightened awareness of neurodegenerative conditions, and potential repositioning of Selegiline as a neuroprotective agent.
• Challenges include dietary restrictions, drug interactions, generic competition, and regulatory pathways.

FAQs

1. What are the key therapeutic indications for Selegiline Hydrochloride?
Traditionally, Selegiline is approved for Parkinson’s disease and depression, functioning as an MAO-B inhibitor that boosts dopaminergic activity and elevates mood.

2. Are there ongoing efforts to expand Selegiline’s approved uses?
Yes. Numerous trials are evaluating its neuroprotective role in Parkinson’s progression, Alzheimer’s disease, and refractory depression, potentially broadening its therapeutic landscape.

3. How does Selegiline’s formulation impact market potential?
Transdermal formulations like Zelapar improve adherence and reduce dietary restrictions, potentially increasing market share among patients with compliance challenges.

4. What are the main barriers to market expansion?
Key obstacles include safety considerations related to dietary restrictions, drug interactions, patent expirations leading to generics, and stringent regulatory requirements for new indications.

5. What is the long-term market outlook for Selegiline Hydrochloride?
Pending favorable clinical trial outcomes, Selegiline is poised to leverage growth driven by demographic trends, expanding indications, and formulation innovations, potentially exceeding $1 billion in global revenues by 2030.

References

1. ClinicalTrials.gov records, 2023.
2. IQVIA data, 2022.
3. World Health Organization statistics, 2022.
4. Market research reports, 2023.
5. Peer-reviewed literature on Selegiline’s pharmacology and clinical trials.

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Disclaimer: This analysis is for informational purposes only and does not constitute investment advice. Readers should consult relevant professionals before making decisions based on this report.