CLINICAL TRIALS PROFILE FOR ROPINIROLE HYDROCHLORIDE

505(b)(2) Clinical Trials for ROPINIROLE 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	NCT00363727 ↗	Onset Motor Complications Using REQUIP CR (Ropinirole Controlled-release) As Add-on Therapy To L-dopa In Parkinson's	Completed	GlaxoSmithKline	Phase 3	2003-12-01	This study evaluates how effective a new formulation of a marketed drug is in increasing the time to onset of dyskinesia (abnormal twisting, writhing movements) in patients with Parkinson's Disease who have been taking levodopa for less than 2 years.
New Formulation	NCT03250117 ↗	Relative Bioavailability Study of Ropinirole Implants in Parkinson's Patients on L-Dopa Switched From Oral Ropinirole	Terminated	Titan Pharmaceuticals	Phase 1/Phase 2	2017-10-10	Subjects stable on L-Dopa and oral ropinirole will have their ropinirole replaced with the Ropinirole Implant(s). The Ropinirole Implant was designed using the ProNeura™ implant technology where the implant is inserted under the skin. This study will measure how much ropinirole is released in the blood during 3 months of treatment, and evaluate the side effects of this new formulation.

All Clinical Trials for ROPINIROLE HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00036218 ↗	Study Evaluating Sumanirole for the Treatment of the Signs and Symptoms of Early Parkinson's Disease.	Completed	Pfizer	Phase 3	2001-12-01	The primary purpose of this study is to determine whether sumanirole is effective and safe in the treatment of the signs and symptoms of early Parkinson's disease.
NCT00086294 ↗	ACP-103 to Treat Parkinson's Disease	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2004-06-25	This study will evaluate the effects of an experimental drug called ACP-103 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term levodopa treatment. ACP-103 changes the spread of certain brain signals that are affected in patients with Parkinson's disease. Patients with relatively advanced Parkinson's disease and dyskinesias who are between 30 and 80 years of age may be eligible for this study. Candidates are screened with a complete medical history and physical examination, neurological evaluation, blood and urine tests, and electrocardiogram (ECG). A brain magnetic resonance imaging (MRI) scan, CT scan, and chest x-ray may be done if medically indicated. Patients enrolled in the study will, if possible, stop taking all antiparkinsonian medications for one month (2 months for Selegiline) before the study begins and throughout its duration. Exceptions are Sinemet (levodopa/carbidopa), Mirapex (pramipexole) and Requip (ropinirole). Levodopa Dose Finding After the screening evaluations, patients are admitted to the NIH Clinical Center for 2 to 3 days to undergo a levodopa "dose-finding" procedure. For this test, patients stop taking Sinemet and instead have levodopa infused through a vein. During the infusion, the drug dose is increased slowly until either 1) parkinsonian symptoms improve, 2) unacceptable side effects occur, or 3) the maximum study dose is reached. Side effects are monitored closely during the infusions, and parkinsonian symptoms are evaluated frequently during and after the infusions. The infusions usually begin early in the morning and continue until evening. Once the infusion is finished, patients resume taking their regular oral Sinemet dose. The infusions are repeated once a week during 1-day inpatient evaluations. Treatment Patients are randomly assigned to take either ACP-103 followed by placebo (a look-alike pill with no active ingredient) once a week for 10 weeks or vice versa (placebo followed by ACP-103). Patients are admitted to the Clinical Center for each dose. During this admission they have a brief medical examination, blood and urine tests, ECG, and review of symptoms or changes in their condition. They also have an infusion of levodopa (see above) at the previously determined optimal rate. Parkinsonism symptoms and dyskinesias are evaluated every 30 minutes for about 6 hours. At the end of the infusions and ratings, patients are discharged home with their regular Parkinson's medications until the following visit. Two weeks after their final dose of ACP-103 or placebo, patients are contact by telephone for a follow-up safety check. At that time, the investigator may ask the patient to return to the clinic for closer evaluation.
NCT00140712 ↗	Ropinirole Tablets In Young Patients With Restless Legs Syndrome	Completed	GlaxoSmithKline	Phase 1	2005-06-10	This is a two-period dose rising study of Ropinirole Immediate Release in adolescent patients with restless legs syndrome (RLS) in order to determine the starting dose for the ropinirole titration regimen for this age group. Patients will receive two single doses unless poor tolerability is observed following the first dose.
NCT00144300 ↗	Ophthalmologic Safety Study of Pramipexole Immediate Release (IR) Versus Ropinirole in Early Parkinson's Disease (PD) Patients	Completed	Boehringer Ingelheim	Phase 4	2005-01-01	To determine if there is any difference in the presence of retinal deterioration in PD patients treated with pramipexole IR versus ropinirole as monitored by comprehensive ophthalmologic assessments from baseline to the end of study at two years.
NCT00197080 ↗	Ropinirole XR (Extended Release) In Patients With Restless Legs Syndrome	Completed	GlaxoSmithKline	Phase 3	2005-06-01	The purpose of this study is to assess the efficacy and safety of ropinirole XR in the treatment of adults with Restless Legs Syndrome (RLS).

Clinical Trial Conditions for ROPINIROLE HYDROCHLORIDE

Condition Name

Condition Name for ROPINIROLE HYDROCHLORIDE
Intervention	Trials
Restless Legs Syndrome	22
Parkinson Disease	22
Parkinson's Disease	14
Restless Legs Syndrome (RLS)	5

Condition MeSH

Condition MeSH for ROPINIROLE HYDROCHLORIDE
Intervention	Trials
Parkinson Disease	35
Restless Legs Syndrome	24
Psychomotor Agitation	20
Syndrome	18

Clinical Trial Locations for ROPINIROLE HYDROCHLORIDE

Trials by Country

Trials by Country for ROPINIROLE HYDROCHLORIDE
Location	Trials
United States	324
Germany	47
Italy	26
United Kingdom	20
Canada	17

Trials by US State

Trials by US State for ROPINIROLE HYDROCHLORIDE
Location	Trials
Florida	18
California	18
Georgia	17
New York	16
Texas	15

Clinical Trial Progress for ROPINIROLE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for ROPINIROLE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	28
Phase 2	11

Clinical Trial Status

Clinical Trial Status for ROPINIROLE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	63
Unknown status	4
Terminated	4

Clinical Trial Sponsors for ROPINIROLE HYDROCHLORIDE

Sponsor Name

Sponsor Name for ROPINIROLE HYDROCHLORIDE
Sponsor	Trials
GlaxoSmithKline	38
UCB Pharma	4
Lupin Ltd.	3

Sponsor Type

Sponsor Type for ROPINIROLE HYDROCHLORIDE
Sponsor	Trials
Industry	64
Other	25
NIH	2

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

Last updated: October 28, 2025

Introduction

Ropinirole Hydrochloride, marketed under brand names such as Requip and Requip XL, is a dopamine agonist primarily indicated for Parkinson’s disease and restless legs syndrome (RLS). As the Parkinson’s disease treatment paradigm evolves and new therapeutic alternatives emerge, ongoing clinical trials and market dynamics influence its positioning globally. This report provides a comprehensive update on current clinical trials, analyzes market trends, and projects future outlooks for Ropinirole Hydrochloride.

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Clinical Trials Update

Recent and Ongoing Clinical Research

As of 2023, Ropinirole Hydrochloride remains a focal point in Parkinson’s disease management, with several ongoing clinical studies aimed at expanding its indications and optimizing its efficacy.

• Parkinson’s Disease Progression and Symptom Management: Multiple phase IV trials evaluate the long-term safety and effectiveness of Ropinirole in early versus advanced Parkinson’s. For instance, NCT04215510 examines the neuroprotective potential when used in combination with other agents. These studies aim to demonstrate disease-modifying effects, which, if validated, could significantly alter its therapeutic role.

• Restless Legs Syndrome (RLS): Continued research explores higher dosages and extended-release formulations to improve patient adherence. The pivotal trials (e.g., NCT03292498) assess the safety of Ropinirole in pediatric populations, aligning with expanded indications. However, regulatory agencies remain cautious due to the association of dopamine agonists with impulse control disorders.

• Novel Delivery Systems and Formulations: Innovative formulations, including transdermal patches and implantable devices, are under examination to mitigate side effects like hypotension and impulsivity. Preclinical studies have demonstrated promising pharmacokinetic profiles, but clinical validation remains pending.

Safety and Efficacy Data

Recent meta-analyses underscore Ropinirole’s substantial efficacy in symptom control but reaffirm the risk profile concerning neuropsychiatric side effects. The FDA’s post-marketing surveillance continues to monitor adverse events, including compulsive behaviors and sudden sleep episodes, shaping guidelines for safer use.

Regulatory Developments

While no major regulatory amendments have occurred specifically for Ropinirole, emerging data from ongoing trials could influence future label expansions. Notably, regulatory agencies maintain strict criteria for RLS and Parkinson’s to approve novel formulations and combination therapies.

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Market Analysis

Current Market Landscape

The global Parkinson’s disease therapeutics market was valued at approximately USD 4.92 billion in 2021 and is projected to reach USD 8.8 billion by 2028, growing at a compound annual growth rate (CAGR) of about 8.56% [1].

Ropinirole holds a significant share within this domain, favored for its proven efficacy and oral administration. The majority of prescriptions are concentrated in North America and Europe, where healthcare infrastructure supports extensive use. The increasing prevalence of Parkinson’s disease, estimated to affect over 10 million individuals worldwide, propels demand for dopamine agonists like Ropinirole.

Market Drivers

• Increasing Prevalence of Parkinson’s Disease and RLS: Aging populations are primary drivers. The global demographic shift towards older age groups correlates with rising Parkinson’s and RLS cases.

• Advancements in Formulations: Extended-release and transdermal formulations enhance patient compliance, broadening usage scenarios.

• Off-label and Expanded Indications: Explorations into Ropinirole’s neuroprotective effects may open new markets, although regulatory validation is pending.

Market Challenges

• Side Effect Profile: Neuropsychiatric adverse effects and impulse control disorders diminish drug preference, especially among younger cohorts.

• Competition: The market faces fierce competition from other dopamine agonists such as pramipexole, rotigotine, and newer non-dopaminergic agents like safinamide.

• Generic Competition: Patent expirations in the late 2010s facilitated generic manufacturing, reducing prices and profit margins unless branded formulations introduced superior delivery systems.

Competitive Landscape

Major players include:

• AbbVie (formerly GlaxoSmithKline): Manufacturer of Requip and Requip XL.
• Teva Pharmaceutical Industries: Generic versions.
• Boehringer Ingelheim: Offers different dopaminergic agents with overlapping indications.
• UCB Pharma: Focused on specialized formulations and adjunct therapies.

Market Share Trends

Generic availability has decreased prices, increasing access but compressing margins for branded formulations. The shift toward personalized medicine and combination therapies is influencing market dynamics, compelling manufacturers to innovate both in drug delivery and indications.

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Market Projection

Short-term Outlook (2023–2026)

The immediate future projects sustained demand driven by existing Parkinson’s demographics. However, intense competition from generics, combined with concerns over side effects, is expected to restrain significant price increases. Ongoing trials exploring neuroprotective roles could catalyze off-label use, contingent upon regulatory approval.

Medium- to Long-term Outlook (2026–2030)

Innovations in drug delivery (transdermal patches, implants) are anticipated to command premium pricing and improve adherence, especially among elderly populations. Potential label expansions into early-stage Parkinson’s or neurodegenerative conditions could unlock new markets.

Moreover, emerging therapies, including gene-based and cell-based treatments, pose long-term threats to dopamine agonists like Ropinirole. Nonetheless, given the current trajectory, Ropinirole is expected to maintain a significant market share within dopaminergic therapies into the next decade, particularly in regions with widespread generic adoption.

Impact of Regulatory and Scientific Developments

Regulatory endorsements for new formulations or indications hinge on robust clinical data. Positive trial outcomes demonstrating neuroprotection or enhanced safety profiles could reinforce Ropinirole’s market position, potentially leading to increased penetration in pediatric RLS or off-label neurodegenerative indications.

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Key Takeaways

• Ropinirole Hydrochloride remains a cornerstone dopamine agonist for Parkinson’s and RLS, with ongoing clinical studies exploring neuroprotection and novel formulations.
• Market dynamics are influenced by demographic trends, drug innovation, competition from generics, and safety concerns.
• The product's future depends on successful clinical validation of new formulations and potential expanded indications.
• Price pressures from generic competition necessitate innovation in delivery systems to sustain profitability.
• Long-term growth prospects are promising if clinical trials confirm neuroprotective effects and regulatory approvals expand its therapeutic scope.

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FAQs

1. What are the main therapeutic indications for Ropinirole Hydrochloride?
Primarily, it treats Parkinson’s disease and restless legs syndrome, with ongoing research into broader neuroprotective applications.

2. How do safety concerns impact Ropinirole’s market positioning?
Adverse events like impulse control disorders limit its use to certain patient populations, prompting the development of safer formulations to mitigate risks.

3. Are there any new formulations of Ropinirole in development?
Yes, transdermal patches and implantable systems are under clinical evaluation to enhance adherence and reduce side effects.

4. What is the competitive landscape for Ropinirole?
It faces competition from other dopamine agonists such as pramipexole, rotigotine, and generic manufacturers, impacting pricing and market share.

5. What factors could influence the future demand for Ropinirole?
Demographic aging, clinical trial successes showing neuroprotection, regulatory approvals for new indications, and advancements in drug delivery methods are key determinants.

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Sources

1. [MarketWatch] “Global Parkinson’s Disease Therapeutics Market Size, Share & Trends Analysis Report,” 2022.