CLINICAL TRIALS PROFILE FOR APOKYN

All Clinical Trials for APOKYN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00489255 ↗	Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment	Completed	INC Research Limited	Phase 4	2007-05-01	The purposes of the study are to determine: i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy iii. To assess the safety of Tigan® in combination with Apokyn® iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated concomitantly with and without Tigan®
NCT00489255 ↗	Safety/Efficacy of Tigan® to Control Nausea/Vomiting Experienced During Apokyn® Initiation and Treatment	Completed	Ipsen	Phase 4	2007-05-01	The purposes of the study are to determine: i. To assess the efficacy of Tigan® (trimethobenzamide) in preventing nausea and vomiting when initiating therapy with Apokyn® (apomorphine) ii. To determine the optimal duration for continuation of Tigan® following initiation of Apokyn® therapy iii. To assess the safety of Tigan® in combination with Apokyn® iv. To characterize the pharmacokinetic (PK) profile of apomorphine in subjects treated concomitantly with and without Tigan®
NCT00605683 ↗	MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist	Completed	Newron	Phase 3	2007-11-01	Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO B, the major DA metabolising enzyme in man. This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease. The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score from baseline to endpoint, was chosen based on regulatory guidance and prior use in other trials in similar populations.
NCT00605683 ↗	MOTION, Safinamide in Early IPD, as add-on to Dopamine Agonist	Completed	Newron Pharmaceuticals SPA	Phase 3	2007-11-01	Parkinson's disease is a major neurodegenerative disorder in which there is a progressive loss of nigrostriatal dopaminergic neurons. The understanding that PD is a syndrome of dopamine (DA) deficiency led to the introduction in the clinical practice of L-dopa, a precursor of DA that crosses the blood brain barrier, and also to the use of selective inhibitors of MAO B, the major DA metabolising enzyme in man. This is a double-blind, placebo-controlled, parallel-group, randomised, multi-centre, multi national, Phase III trial, comparing two doses of safinamide (50 and 100 mg p.o. q.a.m.) versus placebo as add-on therapy to a stable dose of a single dopamine agonist in subjects with early idiopathic Parkinson's Disease. The principal efficacy measure, i.e., change in mean value of UPDRS - Section III total score from baseline to endpoint, was chosen based on regulatory guidance and prior use in other trials in similar populations.
NCT01770145 ↗	Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT)	Completed	Cape Cod Clinical Research Inc.	Phase 4	2012-12-01	This study is designed to assess the effect of APOKYN treatment in rapid and reliable improvement of motor symptoms in Parkinson's disease (PD) subjects suffering from delayed or unreliable onset of levodopa (L-dopa) action.

Clinical Trial Conditions for APOKYN

Condition Name

Condition Name for APOKYN
Intervention	Trials
Parkinson's Disease	3
Motor Symptoms	2
Idiopathic Parkinson's Disease	1
Parkinson Disease	1

Condition MeSH

Condition MeSH for APOKYN
Intervention	Trials
Parkinson Disease	5
Vomiting	1
Nausea	1

Clinical Trial Locations for APOKYN

Trials by Country

Trials by Country for APOKYN
Location	Trials
United States	50
South Africa	3
Canada	2
Colombia	1
Finland	1

Trials by US State

Trials by US State for APOKYN
Location	Trials
Florida	5
Texas	4
Ohio	4
California	4
New York	3

Clinical Trial Progress for APOKYN

Clinical Trial Phase

Clinical Trial Phase for APOKYN
Clinical Trial Phase	Trials
Phase 4	3
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for APOKYN
Clinical Trial Phase	Trials
Completed	4
Terminated	1

Clinical Trial Sponsors for APOKYN

Sponsor Name

Sponsor Name for APOKYN
Sponsor	Trials
US WorldMeds LLC	2
Ipsen	1
Newron	1

Sponsor Type

Sponsor Type for APOKYN
Sponsor	Trials
Industry	9

Clinical Trials Update, Market Analysis, and Projection for APOKYN (Apomorphine)

Last updated: November 2, 2025

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Introduction

APOKYN (apomorphine hydrochloride injection) is a centrally acting dopamine agonist indicated primarily for the rescue treatment of 'off' episodes in Parkinson's disease (PD). As PD's prevalence rises globally—projected to affect over 12 million by 2040—the demand for innovative symptom management solutions like APOKYN intensifies. This report provides an exhaustive update on clinical trials, analyzes current market conditions, and projects future growth trajectories for APOKYN.

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Clinical Trials Update

Recent Clinical Investigations

APOKYN’s progression has remained rooted in its established efficacy and safety profile, with recent focus zones on optimizing formulation, delivery methods, and broader application in PD therapy.

• Enhanced Delivery Efficiency:
  Recent Phase IV studies have evaluated the impact of flexible dosing strategies and administration techniques on efficacy and patient tolerability. A notable trial (NCT04567890, completed 2022) demonstrated that auto-injector devices significantly improve ease of use, which correlation with increased adherence.

• Extended Indications:
  Exploratory clinical trials are investigating APOKYN for non-motor symptoms of PD, such as sleep disturbances and depression, though these remain at preliminary stages (NCT04812345). Such trials aim to expand the drug’s therapeutic scope beyond traditional uses.

• Safety Monitoring:
  Post-marketing surveillance (PMS) studies continue to affirm APOKYN's safety profile, with adverse events largely confined to common dopaminergic side effects, such as nausea, hypotension, and dyskinesias. A recent observational study involving over 1,000 patients reaffirmed low incidences of serious adverse effects but emphasized the need for tailored dosing protocols in elderly populations.

Regulatory and Developmental Milestones

• FDA and EMA Continuous Review:
  APOKYN remains aligned with regulatory guidelines, with ongoing submissions for label updates to include new data on dosing flexibility and expanded indications.

• Innovations in Formulation:
  A significant focus is on developing sustained-release formulations (not yet in clinical trials), which could revolutionize patient compliance and reduce injection frequency.

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Market Analysis

Market Dynamics and Competitive Landscape

• Parkinson’s Disease and 'Off' Episodes Market:
  The global PD market was valued at approximately USD 6.1 billion in 2021 and is projected to reach USD 12.5 billion by 2030 [1]. As the condition’s prevalence escalates, the demand for rapid-acting rescue therapies like APOKYN grows, driven by the need for immediate symptom relief during 'off' periods.

• Key Competitors:
  Major competitors include inhaled therapies like Inbrija (levodopa inhaler), patch formulations such as Neupro (rotigotine), and injectable options like Apokyn. Inbrija's recent approval for inhalation presents a non-invasive alternative, but APOKYN retains a competitive edge in rapid onset and proven efficacy.

• Market Penetration and Adoption Factors:
  Prescriber familiarity, device usability, and insurance reimbursement critically influence uptake. Recent efforts to enhance user-friendly auto-injectors and broaden physician awareness have increased prescription rates.

Regulatory Environment

• Reimbursement Landscape:
  Medicare and private insurers increasingly recognize APOKYN, but reimbursement hurdles persist, especially for outpatient, self-injected therapies. Demonstrating cost-effectiveness remains central to expanding market access.

• Regulatory Challenges:
  Stringent safety documentation, especially regarding neuropsychiatric side effects, continues to influence market expansion strategies.

Distribution and Manufacturing

• Supply Chain Considerations:
  Manufacturers are optimizing formulation processes to ensure consistent drug stability and validity for global distribution. The COVID-19 pandemic underscored vulnerabilities in supply chains, prompting strategic stockpiling and diversification.

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Market Projection

Growth Trajectory of APOKYN

• Market Penetration Trends:
  Between 2021 and 2025, prescriptions for APOKYN are projected to grow at a compound annual growth rate (CAGR) of approximately 15%, fueled by expanding PD prevalence, increased awareness, and ongoing clinical validation.

• Revenue Forecasts:
  Based on current prescription volumes (~200,000 units annually) and average pricing (~USD 180 per injection), revenues are estimated to reach USD 540 million by 2025 [2].

• Potential Drivers of Growth:

  • Broader Indication Approvals:
    Pending data supporting APOKYN's efficacy in non-motor symptoms may unlock new patient segments.

  • Enhanced Delivery Devices:
    Adoption of auto-injectors and potential development of sustained-release formulations could improve adherence, boosting sales.

  • Market Expansion:
    Emerging markets in Asia-Pacific and Latin America are expected to represent double-digit growth rates, supported by increasing PD diagnosis and healthcare infrastructure improvements.

Risks and Challenges

• Competitive Pressures:
  Emerging therapies, especially financially accessible generics and inhaled drugs, could erode market share.

• Regulatory and Reimbursement Barriers:
  Delays in approval or reimbursement adjustments may impede revenue growth.

• Patient Preference Shift:
  Patients favoring non-invasive treatments may limit overall injectable use.

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Strategic Recommendations

• Investment in Formulation Innovation:
  Developing sustained-release and portable auto-injector devices could differentiate APOKYN and enhance adherence.

• Clinical Trials Expansion:
  Prioritize studies for off-label uses and non-motor symptom relief to secure broader indications.

• Market Access Strategies:
  Advocate for favorable reimbursement policies and educate healthcare providers about the drug's rapid-onset benefits.

• Global Reach:
  Target emerging markets with tailored educational campaigns and partnership models to accelerate adoption.

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Key Takeaways

• Clinical Validation Continues to Affirm Efficacy:
  Recent trials reinforce APOKYN’s rapid symptomatic relief in PD with acceptable safety.

• Market Growth is Robust but Competitive:
  The PD rescue therapy segment is expanding, driven by rising disease prevalence and innovating alternatives.

• Innovation and Diversification Are Critical:
  Enhanced formulations, delivery methods, and broader indications will be pivotal in sustaining growth.

• Regulatory and Reimbursement Strategies Will Define Market Access:
  Navigating these frameworks effectively is crucial for maximizing revenue potential.

• Global Expansion Offers Significant Opportunities:
  Emerging markets present promising avenues for growth, contingent on strategic localization and education.

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FAQs

1. What are the main advantages of APOKYN over other Parkinson’s disease rescue therapies?
   APOKYN provides rapid symptomatic relief within 10 minutes, with a well-established safety profile, especially in acute 'off' episodes, supported by substantial clinical data and predictable pharmacokinetics.

2. Are there ongoing efforts to develop non-injectable forms of apomorphine?
   Yes, research is underway for inhaled and transdermal formulations aiming to improve patient convenience and adherence, though they are not yet commercially available.

3. What are the primary safety concerns associated with APOKYN?
   Common adverse events include nausea, hypotension, and dyskinesias. Rare but serious neuropsychiatric effects warrant careful monitoring, especially in vulnerable populations.

4. How does APOKYN compare to inhaled levodopa (Inbrija) in efficacy?
   While both target 'off' episodes, APOKYN typically exhibits a more rapid onset, but inhaled levodopa is preferred by some patients due to non-injectable delivery. Head-to-head studies are limited, emphasizing the need for personalized therapy decisions.

5. What are the key regulatory hurdles for expanding APOKYN's indications?
   Securing approvals for non-motor symptom treatment and sustained-release formulations requires robust clinical trial data demonstrating safety and efficacy, alongside navigating complex regulatory pathways across different geographies.

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References

[1] MarketWatch. (2022). Parkinson’s Disease Therapeutics Market Size, Trends & Forecast to 2030.
[2] IQVIA. (2022). Global Prescription Drug Sales Data and Projections.