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.

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

Condition MeSH

Condition MeSH for ropinirole hydrochloride
Intervention	Trials
Parkinson Disease	35
Restless Legs Syndrome	24
Psychomotor Agitation	20

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
Terminated	4
Unknown status	4

Clinical Trial Sponsors for ropinirole hydrochloride

Sponsor Name

Sponsor Name for ropinirole hydrochloride
Sponsor	Trials
GlaxoSmithKline	38
UCB Pharma	4
Otsuka Pharmaceutical Co., Ltd.	3

Sponsor Type

Sponsor Type for ropinirole hydrochloride
Sponsor	Trials
Industry	64
Other	25
NIH	2

Ropinirole Hydrochloride Clinical Trials Update, Market Analysis, and Forecast (2026–2035)

Last updated: July 25, 2026

Ropinirole hydrochloride is an established, oral non-ergot dopamine agonist for Parkinson’s disease (PD) and Restless Legs Syndrome (RLS). The asset base is commoditizing: most products are already off original patent protection in major markets, while near-term growth depends on generic mix, dosing-form differentiation (IR vs ER), and uptake in RLS/PD segments rather than new disease-modifying mechanisms.

What clinical trials for ropinirole hydrochloride are ongoing, recruiting, or completed?

Answer: Publicly tracked ropinirole studies are mostly incremental: formulation/bioequivalence, comparative efficacy in RLS and PD, and switching or adjunct regimens. The bulk of sponsor activity in practice is not new single-agent “breakthrough” phase 3 for novel mechanisms, because ropinirole is mature and genericized.

Which trial types dominate the pipeline?

1. Bioequivalence and formulation work
   • Immediate-release (IR) vs extended-release (ER) comparability
   • Food-effect and pharmacokinetic (PK) bridging
2. RLS and PD effectiveness/safety comparisons
   • Symptom control in RLS severity ladders
   • Motor fluctuation and “off” symptom management in PD, often as add-on therapy
3. Long-term tolerability studies
   • Dopaminergic adverse event monitoring: nausea, orthostasis, somnolence
   • Impulse control disorder (ICD) screening and real-world-like follow-up

Phase distribution: what to expect by trial intent

• Phase 1–2: Mostly PK/bridging and tolerance characterization for reformulated products
• Phase 3: Limited in count for new ropinirole mechanisms; more commonly comparative designs, sometimes region-specific
• Phase 4: Post-marketing comparative and adherence/tolerability investigations

How to read “activity” for ropinirole

For mature generics, trial “signal” is often driven by:

• Regulatory requirements (bioequivalence)
• Switching studies for patient segments (titration and ER adherence)
• Contract research organization (CRO) sponsored comparative projects, including local-market replications

How large is the ropinirole hydrochloride market and what segments drive demand?

Answer: Demand is tied to total RLS prevalence diagnosed and treated, plus PD patient volumes with ongoing oral dopaminergic therapy needs. In both segments, ropinirole is one of multiple oral dopamine agonist options, so share depends on payer preference, generic penetration, and ER formulation selection.

Key commercial segments

• By indication
  • Restless Legs Syndrome: chronic symptom control with long-term dosing
  • Parkinson’s disease: monotherapy or adjunct for motor symptom control
• By formulation
  • Immediate-release (IR) ropinirole hydrochloride tablets
  • Extended-release (ER), typically the higher-execution product for adherence and once-daily use
• By geography
  • Developed markets: stable demand, strong generic presence
  • Emerging markets: growth from treatment rates and formulary adoption, offset by pricing pressure

Pricing pressure and mix shift

Ropinirole’s market math is dominated by:

• Competitive generic price compression
• Forced brand erosion where original product exclusivity ended
• Continued ER differentiation, which slows but does not stop margin decline

What is the market forecast for ropinirole hydrochloride through 2035?

Answer: Base-case forecast is low-single-digit value growth in developed markets, with growth driven by patient pool expansion, ER mix, and incremental uptake in RLS diagnosis. Volume growth is more credible than value growth due to ongoing generic competition.

Forecast framework that matches ropinirole reality

• Volume drivers
  • RLS screening and diagnosis expansion
  • PD incidence aging demographics
  • Long treatment duration
• Value drivers
  • ER share shift and payer acceptance
  • Formulary placement relative to competing dopamine agonists
• Value headwinds
  • Further price erosion from generic entry and tender cycles
  • Substitution by alternative agents (other dopamine agonists, adjunct strategies)

Scenario set (directional)

• Base case: modest value growth, stable volume growth; ER maintains a premium within generic frameworks
• Downside: accelerated price compression and share loss to competing dopaminergics
• Upside: improved RLS diagnosis and persistent ER adherence gains

What is the patent and exclusivity landscape for ropinirole hydrochloride, and when does it lose exclusivity?

Answer: Ropinirole hydrochloride is an established small molecule with historical brand origins. In practical terms, exclusivity-driven barriers for new competitors are largely expired across major jurisdictions. New entries are typically driven by ANDA/bioequivalence, not patent hold-ups.

Why exclusivity is not the main growth lever

• Original compound and early process/polymorph claims have largely run out.
• Current competitive differentiation is formulation (IR vs ER) and dosing convenience, not mechanism-level exclusivity.

What to expect from competitive entry timing

• Generic market entry continues where any remaining secondary patents (formulation/process) are weaker or already designed around.
• Settlement agreements, if they occurred historically, mainly affect earlier launch windows and do not stop ongoing substitution cycles in later years.

What Orange Book status applies to ropinirole hydrochloride and its ER/IR versions?

Answer: In the US, ropinirole products are typically represented in the FDA’s Orange Book as multiple approved applications (generics and branded entries). The core brand exclusivity windows are not the limiting factor for current procurement.

How to interpret the Orange Book for ropinirole

• Multiple listing apps indicate broad generic coverage.
• The controlling patents for each application tend to be weaker at this stage, with the market dominated by bioequivalent generics.
• ER vs IR typically show distinct application and dosing form listings, affecting substitution rules.

What patent litigation or Paragraph IV challenges affect ropinirole hydrochloride?

Answer: Litigation exists historically for ropinirole-related patents, but the mature market profile means ongoing Paragraph IV disputes are less likely to be the primary determinant of near-term pricing. The market is more sensitive to tender cycles and generic availability than to active court outcomes.

Commercial implication

• Even when litigation occurs, settlements usually shift launch dates rather than eliminate generic competition.
• By the time ropinirole is already widely genericized, new disputes typically have limited long-run market impact.

How does ropinirole compare with other dopamine agonists for RLS and Parkinson’s disease?

Answer: Ropinirole competes in a class that includes other oral dopamine agonists (and non-agonist pathways). Its differentiator is formulation convenience, especially ER once-daily dosing, rather than unique mechanism.

Competitive axes

• Efficacy: symptom control in RLS and motor symptoms in PD
• Tolerability: nausea, dizziness/orthostasis, somnolence
• Adherence: ER dosing convenience
• Formulary positioning: payer preference and step therapy rules
• Substitution ease: generic availability for both IR and ER

What tends to win share

• ER formulations with strong payer preference
• Local tender economics and wholesaler contracting
• Patient familiarity and stable dosing routines

What manufacturing and IP barriers exist for new ropinirole hydrochloride entrants?

Answer: Barriers are mostly regulatory and formulation-level rather than deep process IP. Entrants typically need strong bioequivalence packages and stable manufacturing controls for IR or ER release profiles.

Barrier map

• Regulatory: BA/BE studies, dissolution matching for ER
• Quality system: consistent release kinetics across batches
• Formulation know-how: controlling rate-limiting steps in ER matrix
• Less often: residual patents tied to specific release technologies

What regulatory pathway dynamics affect ropinirole hydrochloride (ANDA vs 505(b)(2))?

Answer: Most new entries for ropinirole are ANDA-driven via bioequivalence to a reference listed drug. 505(b)(2) is less central for an established generic-like molecule unless the product changes substantially (e.g., distinct delivery system, dosing strengths, or formulation that is not straightforward for an ANDA).

What matters to timelines

• BE study scheduling
• Strength/food-effect bridging needs
• Stability and dissolution data for ER products

Market projection: revenue exposure and how RLS/PD mix changes outlook

Answer: Revenue exposure is most sensitive to two levers: (1) ER share and (2) RLS diagnosis/treatment penetration. PD volume contributes steady demand, but the PD segment is more vulnerable to switching toward other regimens when payers tighten.

Sensitivity drivers

• ER adoption in chronic RLS
• GERD, falls, and somnolence management affecting adherence
• Patient age shifts: older populations increase both RLS and PD treatment demand but also tolerability constraints

Key Takeaways

• Ropinirole hydrochloride is a mature, largely genericized market where growth is driven by patient volume and ER mix, not new clinical breakthroughs.
• Clinical activity is dominated by formulation, PK/BE, comparative efficacy, and long-term tolerability studies.
• Forecast favors volume stability with modest value growth in most geographies, constrained by ongoing price compression.
• IP and exclusivity barriers are not the main determinant of near-term competitive dynamics; availability and payer economics dominate.

FAQs

1. Which ropinirole hydrochloride formulation (IR vs ER) has better payer acceptance and why?
2. How do bioequivalence requirements typically differ for ropinirole ER tablets compared with IR tablets?
3. What adverse events most affect discontinuation rates for ropinirole in RLS and PD?
4. How does generic substitution impact ropinirole pricing during tender cycles in major markets?
5. What competitive risks arise if payers prefer other dopamine agonists over ropinirole ER?

References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. ClinicalTrials.gov. (n.d.). Ropinirole hydrochloride studies. U.S. National Library of Medicine.
3. EMA. (n.d.). EPARs and product information for ropinirole-containing medicines. European Medicines Agency.