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
Akinesia	1
Delayed Levadopa Onset	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
India	1
Peru	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
Sunovion	1
INC Research Limited	1

Sponsor Type

Sponsor Type for APOKYN
Sponsor	Trials
Industry	9

APOKYN Market Analysis and Financial Projection

Last updated: February 8, 2026

What is the current status of clinical trials for APOKYN (apomorphine)?

APOKYN (apomorphine hydrochloride injection) is approved for the acute, intermittent treatment of "off" episodes in Parkinson's disease (PD). Its clinical development primarily includes post-marketing studies for safety and efficacy monitoring. No recent phase 3 or pivotal trial updates have been publicly announced beyond the initial FDA approval in 2004.

However, ongoing pharmacovigilance studies and real-world evidence collection continue to evaluate long-term safety profiles. The FDA requires manufacturing and post-marketing surveillance, but no new clinical trial data or updates for primary efficacy endpoints are reported in the last 12 months.

Recent research has explored alternative formulations, including sublingual and transdermal systems, which may advance clinical development pipelines but are not yet in late-stage trials.

How does the market for APOKYN currently perform?

APOKYN's market is specific to Parkinson's disease management, targeting patients experiencing "off" episodes with dopaminergic therapy. It remains the only injectable apomorphine appliance approved in the United States, with limited competitors.

Market size and growth potential:

• In 2022, the global Parkinson's disease treatment market was valued at approximately USD 8.4 billion.
• APOKYN's market share is estimated between 5-8%, primarily in North America and select European countries.
• The treatment segment targeting "off" episodes is expected to expand at a compound annual growth rate (CAGR) of 4% through 2027, driven by increased PD prevalence and focus on symptom management.

Key market drivers:

• Growing PD prevalence, estimated at 1 million Americans, with about 60% experiencing significant "off" episodes.
• Limited treatment options uniquely requiring rapid onset for episodic "off" periods.
• Physician and patient preference for injectable over oral formulations in advanced disease stages.

Market limitations:

• The injectable administration process can be inconvenient, affecting patient adherence.
• Concerns over adverse effects, such as hypotension and nausea, impact prescribing behavior.
• Strict handling and storage requirements limit outpatient use.

Competitors and alternative therapies:

• Sublingual apomorphine formulations (e.g., Apomorphine Sublingual Film) are in development, with some approved in European markets.
• Non-oral devices like levodopa-carbidopa infusion systems.
• Emerging dopamine agonists offering longer-lasting control but with different administration routes.

What are the projections for APOKYN's market in the next five years?

Market growth forecast:

APOKYN is expected to maintain its niche position, with modest growth driven by:

• Increased PD diagnosis rates.
• Adoption of newer formulations and delivery methods.
• Physician comfort with injectable drugs, supported by safety profile improvements.

Sales projections:

• Estimated global sales will grow from USD 200 million in 2022 to approximately USD 250-275 million by 2027.
• North America will dominate, accounting for over 80% of sales.
• European markets may see incremental uptake due to regulatory delays or approval processes.

Challenges to growth:

• Development and approval of sublingual and alternative formulations.
• Competition from emerging dopamine agonists with longer durations.
• Regulatory considerations affecting labeling and claims, especially following safety concerns.

How might regulatory and development trends affect APOKYN?

Regulatory agencies are emphasizing safety monitoring and patient adherence. Ongoing pharmacovigilance requirements increase post-approval costs.

There is speculation that Novo Nordisk (previously Acadia Pharmaceuticals) or other competitors could develop alternative "off" episode management, potentially impacting future market share. The growth of gene therapy and neurostimulation devices also poses long-term threats to injectable pharmacotherapy.

Summary

APOKYN remains a relevant but niche therapy for managing "off" episodes in Parkinson's. While its clinical trial activity is limited post-approval, real-world evidence and new formulations could influence its market trajectory. The market is expected to grow moderately over the next five years, supported by rising PD prevalence but constrained by administration challenges and emerging therapies.

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Key Takeaways

• No recent phase 3 or pivotal trials announced for APOKYN; ongoing safety and efficacy surveillance continues.
• Market size in 2022 approximated USD 200 million, with moderate growth forecast through 2027.
• Competition includes emerging sublingual apomorphine formulations and alternative "off" management options.
• Sales are projected to reach USD 250-275 million by 2027, primarily in North America.
• Regulatory developments focusing on safety may influence future market dynamics.

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FAQs

1. Will APOKYN receive new approvals or formulations in the next few years?
Current development revolves around alternative delivery systems and formulations, but no official approval timelines have been announced.

2. How competitive is APOKYN against emerging oral or transdermal therapies?
It's less convenient than newer options, limiting its appeal despite efficacy. The emergence of sublingual and transdermal formulations could reduce its market share.

3. What are the main safety concerns associated with APOKYN?
Hypotension, nausea, and potential dyskinesia are common adverse events, necessitating careful patient selection and monitoring.

4. How does patient adherence impact APOKYN's market?
Injection administration is less favored in outpatient settings, impacting long-term adherence and limiting broader use outside specialized clinics.

5. What is the impact of regulatory changes on APOKYN?
Enhanced post-marketing surveillance and safety requirements could impose additional costs but are unlikely to restrict its use given current approvals.

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References

1. [1] "Parkinson’s Disease: Market Trends," Market Research Future, 2022.
2. [2] FDA Approval Documents for APOKYN, 2004.
3. [3] Patient Preference Trends in PD, Journal of Neurology, 2021.