CLINICAL TRIALS PROFILE FOR RASAGILINE

505(b)(2) Clinical Trials for RASAGILINE

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 RASAGILINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00104273 ↗	Rasagiline 1 mg and 2 mg Added to Aricept 10 mg Daily in Patients With Mild to Moderate Alzheimer's Disease (AD)	Completed	Eisai Inc.	Phase 2	2004-08-01	The purpose of this study is to evaluate the safety, tolerability, and efficacy of two dose levels of rasagiline mesylate versus placebo in patients with mild-to-moderate Alzheimer's Disease who are taking Aricept.
NCT00104273 ↗	Rasagiline 1 mg and 2 mg Added to Aricept 10 mg Daily in Patients With Mild to Moderate Alzheimer's Disease (AD)	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	Phase 2	2004-08-01	The purpose of this study is to evaluate the safety, tolerability, and efficacy of two dose levels of rasagiline mesylate versus placebo in patients with mild-to-moderate Alzheimer's Disease who are taking Aricept.
NCT00104273 ↗	Rasagiline 1 mg and 2 mg Added to Aricept 10 mg Daily in Patients With Mild to Moderate Alzheimer's Disease (AD)	Completed	Teva Pharmaceutical Industries	Phase 2	2004-08-01	The purpose of this study is to evaluate the safety, tolerability, and efficacy of two dose levels of rasagiline mesylate versus placebo in patients with mild-to-moderate Alzheimer's Disease who are taking Aricept.
NCT00203034 ↗	Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations	Completed	Teva Branded Pharmaceutical Products R&D, Inc.	Phase 3	2000-05-01	Study for patients currently using Levodopa/Carbidopa who will be assigned to receive either Rasagiline or Placebo
NCT00203034 ↗	Multicenter Study of Rasagiline in Parkinson's Disease Patients Using Levodopa and Experiencing Motor Fluctuations	Completed	Teva Pharmaceutical Industries	Phase 3	2000-05-01	Study for patients currently using Levodopa/Carbidopa who will be assigned to receive either Rasagiline or Placebo

Clinical Trial Conditions for RASAGILINE

Condition Name

Condition Name for RASAGILINE
Intervention	Trials
Parkinson's Disease	31
Parkinson Disease	7
Parkinson´s Disease	2
Alzheimer's Disease	2

Condition MeSH

Condition MeSH for RASAGILINE
Intervention	Trials
Parkinson Disease	45
Sclerosis	3
Motor Neuron Disease	3
Amyotrophic Lateral Sclerosis	3

Clinical Trial Locations for RASAGILINE

Trials by Country

Trials by Country for RASAGILINE
Location	Trials
United States	234
Germany	27
Canada	15
Spain	8
Israel	5

Trials by US State

Trials by US State for RASAGILINE
Location	Trials
California	16
New York	13
Florida	12
Texas	12
Illinois	11

Clinical Trial Progress for RASAGILINE

Clinical Trial Phase

Clinical Trial Phase for RASAGILINE
Clinical Trial Phase	Trials
PHASE4	1
PHASE1	1
Phase 4	19

Clinical Trial Status

Clinical Trial Status for RASAGILINE
Clinical Trial Phase	Trials
Completed	40
Terminated	6
Unknown status	5

Clinical Trial Sponsors for RASAGILINE

Sponsor Name

Sponsor Name for RASAGILINE
Sponsor	Trials
Teva Branded Pharmaceutical Products R&D, Inc.	17
Teva Pharmaceutical Industries	16
H. Lundbeck A/S	10

Sponsor Type

Sponsor Type for RASAGILINE
Sponsor	Trials
Other	67
Industry	64
NIH	2

Last updated: May 2, 2026

Rasagiline Clinical Trials Update, Market Analysis, and Projection

What is the current clinical-stage landscape for rasagiline?

Rasagiline (brand: Azilect; other regional brands) is an established, marketed monoamine oxidase-B (MAO-B) inhibitor. Public, registrable pipeline activity in the last several years is limited relative to new chemical entities, with most recent “clinical trials updates” concentrated in comparative studies, lifecycle trials (e.g., special populations, switching strategies), and label-adjacent studies rather than late-stage, registration-driving programs for a new indication.

From a practical investment and R&D standpoint, rasagiline’s near-term clinical profile is best described as mature product with incremental evidence generation, not a late-stage growth pipeline.

Which registrational indications are most relevant to the market thesis?

Rasagiline is primarily positioned in Parkinson’s disease:

• Adjunct therapy in Parkinson’s disease
• Monotherapy for early Parkinson’s disease (where approved per local label)
• Advanced Parkinson’s disease as adjunct to levodopa (where approved per local label)

Clinical development and trial activity typically map to Parkinson’s disease management strategies:

• Maintenance vs. add-on use
• Off-state management approaches
• Tolerability and adherence in real-world dosing patterns

(For regulatory context and baseline clinical positioning, see FDA label and EMA product documentation cited below.) [1], [2]

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What is the current market structure for rasagiline?

How the product is sold

Rasagiline is sold globally as a branded prescription medicine and also faces generic competition in many jurisdictions.

A workable market segmentation for projection modeling:

• Core Parkinson’s prescription demand (early and adjunct settings)
• Switching and add-on inertia (patients and clinicians staying on existing MAO-B inhibitor therapy)
• Generic price pressure in markets where patents are expired or where entry was permitted

What drives demand

Demand drivers are dominated by:

• Parkinson’s disease incidence and prevalence growth with aging populations
• Long-term pharmacotherapy patterns and clinician familiarity with MAO-B inhibitors
• Generic substitution and payer formularies in each geography
• Competitive displacement by other MAO-B inhibitors and emerging Parkinson’s therapies

Competitive set

Rasagiline competes in the MAO-B inhibitor space, most directly with:

• Selegiline
• Other MAO-B inhibitor products where available per country formularies

In broader PD management, it competes with other symptomatic therapies across levodopa, COMT inhibitors, dopamine agonists, and other classes depending on the country.

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How big is the market today and what does a projection look like?

Market size: directionally bounded by maturity and generics

Because rasagiline is an established product, the market outlook is not characterized by high-growth unit expansion typical of pipeline-stage assets. Growth is constrained by:

• Price erosion from generics
• No major label expansion that creates step-change demand in most markets
• Substitution and therapeutic switching within PD formularies

A projection framework for a mature branded-to-generic transition generally follows:

1. Unit growth tracks PD epidemiology and persistence.
2. Revenue growth (if any) tracks mix, payer contracting, and patent/generic status by geography.
3. Margin compression occurs as generic penetration rises.

Projection bands (revenue CAGR)

A defensible projection band for rasagiline revenue over the medium term for a global basket should be modeled as:

• Low single-digit growth to mild decline in nominal revenue depending on geography mix and generic penetration pace.
• Unit demand likely grows modestly with PD prevalence, while revenue per patient trends down.

This is consistent with the lifecycle profile of other established symptomatic PD medicines where no new high-impact indications are introduced. Baseline clinical and regulatory history indicate no current step-change indication expansion as the central lever. [1], [2]

Projection drivers to include in a model

Key inputs that materially move the forecast:

• Geographic patent and generic entry timeline (by country)
• Payer formulary changes affecting MAO-B inhibitor tiering
• Switch rates among MAO-B inhibitors and other first-line adjunct therapies
• Persistence and discontinuation influenced by tolerability and disease progression
• Manufacturing and supply continuity (for branded product availability in some markets)

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What recent clinical trial activity should be monitored?

Evidence types that continue to appear for mature products

For rasagiline, ongoing or periodically updated trials typically cluster into:

• Comparative effectiveness and switching studies (within PD symptom management)
• Safety and tolerability in subpopulations (elderly, comorbidities)
• Pharmacovigilance-driven studies and registry-based analyses
• Adherence and persistence evidence generation

Operational implication

These study types tend to:

• Support payer and clinician confidence in continuing use
• Maintain label credibility without changing the competitive position
• Generate incremental outcomes rather than create a new growth engine

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What is the IP and regulatory status that shapes the market path?

Regulatory anchors

• FDA: Azilect prescribing information is the baseline U.S. reference for dosing, indication language, and safety. [1]
• EMA: product information provides European label structure for EU contracting and clinical positioning. [2]

IP and lifecycle reality

The market trajectory for rasagiline is shaped by:

• Patent expiry in many jurisdictions over time
• Generic substitution and price competition
• Residual branded demand where formularies and access rules favor established medicines

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Business and R&D implications

Is rasagiline still investable as an R&D anchor?

For most investors, rasagiline is better treated as:

• A commercial cash-flow product (if owned/marketed)
• A platform for combination strategy or lifecycle studies if rights allow
• A comparator anchor for Parkinson’s endpoints in development of newer assets

Clinical development that reuses rasagiline as a backbone tends to be less capital intensive than novel MOA discovery, but it does not typically unlock major revenue step-change unless it enables label expansion or materially superior outcomes versus standard of care.

If you are modeling the market, what matters most?

A projection should not assume major clinical breakthroughs. It should assume:

• Epidemiology-driven unit demand growth
• Formularies driving mix shift between branded and generic
• Gradual revenue normalization after generic entry

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Key Takeaways

• Rasagiline is a mature, marketed MAO-B inhibitor with clinical activity concentrated in lifecycle and comparative evidence rather than a late-stage registration pipeline shift. [1], [2]
• Market growth is constrained by generic competition and substitution within Parkinson’s symptomatic therapy.
• Forecasting should model unit growth as Parkinson’s prevalence-driven and revenue as geography-mix plus price erosion dependent, producing low single-digit growth to mild decline bands for nominal revenue depending on basket composition.
• The most decision-relevant clinical updates are those that influence persistence, tolerability-based adherence, and payer/formulary favorability in Parkinson’s management.

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FAQs

1. What is rasagiline’s primary indication focus?
   Parkinson’s disease management, including early disease monotherapy and adjunct use depending on jurisdictional labeling. [1], [2]

2. Does rasagiline have a current late-stage pipeline signal that would drive a step-change market expansion?
   The clinical development posture for rasagiline is lifecycle and comparative in nature, consistent with a mature product profile rather than a late-stage breakthrough program.

3. What is the main market risk to revenue growth?
   Generic substitution and payer price pressure after entry in key geographies.

4. What drives demand in the near term?
   Parkinson’s disease prevalence trends, plus persistence and adherence in long-term pharmacotherapy patterns.

5. What endpoints matter for ongoing clinical evidence?
   Clinically relevant Parkinson’s outcomes aligned to symptomatic control and tolerability, supporting real-world continuation and formulary decisions.

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References

[1] U.S. Food and Drug Administration. (n.d.). Azilect (rasagiline) prescribing information.
[2] European Medicines Agency. (n.d.). Azilect (rasagiline): Product information (summary of product characteristics).