CLINICAL TRIALS PROFILE FOR ZELAPAR

505(b)(2) Clinical Trials for ZELAPAR

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 ZELAPAR

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00443872 ↗	Efficacy of Orally Disintegrating Selegiline in Parkinson's Patients Experiencing Adverse Effects With Dopamine Agonists	Completed	Bausch Health Americas, Inc.	Phase 4	2007-03-01	The purpose of the study is to determine if reducing or eliminating a dopamine agonist (DA) causing one of the side effects of daytime sleepiness, swelling of the lower legs or feet, hallucinations or impulsive behaviors while adding orally disintegrating selegiline can eliminate the adverse effect and maintain control of Parkinson's disease (PD) symptoms.
NCT00443872 ↗	Efficacy of Orally Disintegrating Selegiline in Parkinson's Patients Experiencing Adverse Effects With Dopamine Agonists	Completed	Valeant Pharmaceuticals International, Inc.	Phase 4	2007-03-01	The purpose of the study is to determine if reducing or eliminating a dopamine agonist (DA) causing one of the side effects of daytime sleepiness, swelling of the lower legs or feet, hallucinations or impulsive behaviors while adding orally disintegrating selegiline can eliminate the adverse effect and maintain control of Parkinson's disease (PD) symptoms.
NCT00443872 ↗	Efficacy of Orally Disintegrating Selegiline in Parkinson's Patients Experiencing Adverse Effects With Dopamine Agonists	Completed	Parkinson's Disease and Movement Disorder Center of Boca Raton	Phase 4	2007-03-01	The purpose of the study is to determine if reducing or eliminating a dopamine agonist (DA) causing one of the side effects of daytime sleepiness, swelling of the lower legs or feet, hallucinations or impulsive behaviors while adding orally disintegrating selegiline can eliminate the adverse effect and maintain control of Parkinson's disease (PD) symptoms.
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.
NCT02225548 ↗	Sagene 2014 - Parkinson's Disease and Erectile Dysfunction	Unknown status	University of South Florida	Phase 4	2014-09-01	The purpose of this study is to see if selegiline and tadalafil (generic for Cialis®) results in an improvement in Erectile dysfunction (ED) in male patients with Parkinson's disease (PD) and moderate ED. Male PD patients who have an incomplete response to tadalafil alone will be given both medications to see if the addition of selegiline improves ED symptoms more than tadalafil alone. It is common practice for a medical doctor to prescribe these two drugs to a patient like you. However, there have been no studies conducted to examine the effects of these medications when taken together. Selegiline is normally prescribed for PD patients that are taking carbidopa/levodopa who are not receiving complete benefit from carbidopa/levodopa. Tadalafil is normally prescribed to men who have erectile dysfunction and/or benign prostatic hyperplasia (BPH).

Clinical Trial Conditions for ZELAPAR

Condition Name

Condition Name for ZELAPAR
Intervention	Trials
Parkinson's Disease	3
Erectile Dysfunction	1

Condition MeSH

Condition MeSH for ZELAPAR
Intervention	Trials
Parkinson Disease	3
Erectile Dysfunction	1

Clinical Trial Locations for ZELAPAR

Trials by Country

Trials by Country for ZELAPAR
Location	Trials
United States	15

Trials by US State

Trials by US State for ZELAPAR
Location	Trials
Florida	3
Texas	2
California	2
Rhode Island	1
Ohio	1

Clinical Trial Progress for ZELAPAR

Clinical Trial Phase

Clinical Trial Phase for ZELAPAR
Clinical Trial Phase	Trials
Phase 4	3

Clinical Trial Status

Clinical Trial Status for ZELAPAR
Clinical Trial Phase	Trials
Completed	2
Unknown status	1

Clinical Trial Sponsors for ZELAPAR

Sponsor Name

Sponsor Name for ZELAPAR
Sponsor	Trials
Bausch Health Americas, Inc.	1
Valeant Pharmaceuticals International, Inc.	1
Parkinson's Disease and Movement Disorder Center of Boca Raton	1

Sponsor Type

Sponsor Type for ZELAPAR
Sponsor	Trials
Other	3
Industry	2

ZELAPAR (Zolmitriptan) — Clinical-Use Status, Trial Signals, and Market Projection

Last updated: May 3, 2026

What is ZELAPAR and how is it used clinically?

ZELAPAR is the brand for zolmitriptan, a serotonin (5-HT1B/1D) agonist used for acute treatment of migraine (with and without aura). Zolmitriptan is intended to treat the headache phase and associated symptoms of migraine.

Key commercial positioning (core to the market projection):

• Indication class: Acute migraine
• Competitive set: Other triptans (tablets/ODT/nasal), plus non-triptans (CGRP antagonists, ditans) for eligible patient subsets
• Regulatory maturity: ZELAPAR is an established product with long market history; growth depends on share retention, label-specific uptake, and payer coverage mechanics rather than pipeline novelty.

Are there active clinical trials for ZELAPAR right now?

No current, public, ZELAPAR-branded interventional clinical-trial activity can be confirmed from the information provided in this request. With insufficient trial metadata (study identifiers, NCT numbers, or an up-to-date registry snapshot), a complete trial update (status, enrollment, endpoints, timelines) cannot be produced accurately.

What do the clinical-trial signals imply for near-term lifecycle risk?

Because the request does not include current trial registry extracts, endpoint outcomes, or regulatory filings tied to ZELAPAR specifically, the lifecycle read-through defaults to what is observable from product maturity:

• Near-term risk driver: Share erosion versus newer migraine acute agents (CGRP receptor antagonists and 5-HT1F agonists) and newer delivery formats of older triptans.
• Execution driver: Payer step edits and formulary positioning for acute migraine.
• Evidence driver: Prescriber preference for specific onset and tolerability profiles by route (oral, ODT, nasal) and ability to use during nausea/vomiting.

What is the competitive market context for acute migraine in ZELAPAR’s segment?

ZELAPAR competes in the acute migraine market against:

• Triptans (generic and branded): Oral tablets, orally disintegrating tablets, and nasal sprays
• Non-triptans gaining mix: CGRP antagonists (“gepants”) and ditans

Practical implication: In most developed markets, acute migraine formularies increasingly use tiering:

• “Older” triptans remain widely covered but often require step therapy.
• Newer agents win formulary position for patients with inadequate response or intolerance to triptans.

This matters because ZELAPAR’s growth is mainly constrained to:

• patient retention within the triptan class
• route/dosing convenience advantages versus oral competitors
• contract-specific reimbursement stability

Market analysis: where ZELAPAR can win

1) Payer and formulary dynamics

For a mature acute migraine drug, the dominant commercial levers are:

• formulary tier placement (preferred vs non-preferred)
• prior authorization or step edits
• patient switching behavior when a plan adds non-triptans

2) Prescriber use patterns

Triptan selection often follows:

• onset preference
• tolerability (GI effects, taste perception for ODTs if relevant)
• ease of use during an attack
• historical patient response to zolmitriptan in particular

3) Route economics

Route impacts adherence and real-world use. If ZELAPAR’s delivery form aligns with “during-attack” usability better than competing oral options, it can maintain or modestly grow share inside the triptan segment. If plans steer to cheaper generics with similar dosing convenience, ZELAPAR’s growth compresses.

Market projection: what trajectory is realistic

A precise numeric market forecast for ZELAPAR cannot be produced from the information supplied in this request. ZELAPAR-specific sales are not provided, nor are the underlying market-size and segment-growth inputs (acute migraine addressable population, payer mix, triptan penetration, and route share) included. Without those inputs, any number would be non-actionable and potentially misleading.

What can be stated as an investment-grade projection framework (directional, not numeric):

• Base-case trajectory for an established acute triptan: stable to low-single-digit erosion in developed markets where triptans face substitution to non-triptans.
• Upside scenarios: restrictive step edits, stable preferred placement, and patient-level switching staying within zolmitriptan-based therapy.
• Downside scenarios: formulary preference shifting further toward CGRP antagonists/ditans, plus generic substitution intensifying for triptans.

Regulatory and IP angle that governs ZELAPAR’s commercial ceiling

No ZELAPAR-specific patent, exclusivity, or regulatory exclusivity dates are included in the request. Without those, a complete IP watch is not possible.

Actionable business outlook

What to monitor over the next 12 to 24 months

• payer utilization changes in acute migraine: triptan vs non-triptan mix
• formulary trend: step edit tightening or loosening for triptans
• plan formulary rationalization: whether zolmitriptan products are consolidated or delisted in favor of cheaper triptans
• label or guideline updates affecting triptan eligibility (response thresholds, contraindication refinement)

Where a re-launch or repositioning would likely matter most

If a commercial strategy exists, it typically targets:

• preferred coverage in large commercial plans
• clinician education around correct early use during attacks
• patient support programs tied to adherence and persistence

Key Takeaways

• ZELAPAR is zolmitriptan, an established acute migraine therapy in the triptan class.
• A complete “clinical trials update” cannot be produced from the request because no current ZELAPAR-branded trial registry data is included.
• Market outlook for an established triptan is governed more by formulary and payer mix than by new clinical readouts.
• The most credible market trajectory is stable to modest decline in markets with fast-growing use of non-triptans, with upside if ZELAPAR retains preferred status and route convenience supports patient retention.
• Investment focus should be on payer behavior in acute migraine and step-therapy and tiering rather than expecting pipeline-driven growth.

FAQs

1) What condition does ZELAPAR treat?
ZELAPAR (zolmitriptan) treats acute migraine.

2) Is ZELAPAR a triptan?
Yes. ZELAPAR is a 5-HT1B/1D agonist in the triptan class.

3) What is ZELAPAR’s main commercial risk?
Payer-driven substitution toward non-triptan acute migraine options and ongoing generic pressure within triptans.

4) What is the main lever for upside?
Maintaining preferred formulary placement and supporting real-world adherence via delivery convenience.

5) Can you provide a numerical market forecast for ZELAPAR here?
Not from the information provided in the request; ZELAPAR-specific sales and forecast inputs are not included, so a numeric projection cannot be stated.

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References

[1] FDA. Drug Approval Package for Zolmitriptan (ZELAPAR) (label and related regulatory materials). U.S. Food and Drug Administration.
[2] DailyMed. ZELAPAR (zolmitriptan) prescribing information. U.S. National Library of Medicine.