CLINICAL TRIALS PROFILE FOR REQUIP XL

505(b)(2) Clinical Trials for REQUIP XL

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 REQUIP XL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00040209 ↗	JP-1730 to Treat Parkinson's Disease	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2002-06-01	This study will evaluate the effects of an experimental drug called JP-1730 on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. JP-1730 affects chemical messengers believed to affect Parkinson's disease symptoms. Patients between 30 and 80 years of age with relatively advanced Parkinson's disease may be eligible for this 3-phase study. - Phase 1 - Baseline evaluation Participants will be evaluated with a medical history, physical examination, detailed neurologic evaluation, routine blood tests, urinalysis and an electrocardiogram. They will also have a 24-hour holter monitor (heart monitoring) and cardiology consultation. A chest X-ray and MRI or CT scan of the brain will be done if needed. Patients will, if possible, stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month before the study begins and throughout its duration. (If necessary, patients may use short-acting dopamine agonists, such as Mirapex and Requip.) - Phase 2 - Dose Finding Phase For 2 to 3 days, patients will be admitted to the NIH Clinical Center for a levodopa (a dopamine agonist) dose-finding procedure. For this procedure, patients stop taking Sinemet and instead have levodopa, and subsequently apomorphine, infused through a vein. During the infusions, 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. Symptoms are monitored frequently to find the optimal dose. (Patients who have had dosing infusions in the last 3 months will not have to undergo this phase of the study.) - Phase 3 - Active Study Phase Within 3 months of the dose-finding phase, treatment will begin. Patients will receive seven doses of JD-1730 or placebo (an inactive substance) via puffs from an oral spray together with levodopa infusions over a 3-week period. The doses are given on days 1, 2, and 3 of the first week and then approximately twice a week for the next 2 weeks. For these doses, patients are hospitalized 4 days the first week and 2 days each for the next 2 weeks. All participants will receive placebo at some time during the study, and a few patients, selected at random, will receive only placebo the entire 3 weeks. The procedure for the infusions is the same as that for the dose-finding phase, with frequent evaluation of symptoms. Also, small blood samples are drawn up to three times each study day. At the end of the third week, patients will be discharged from the hospital. Their anti-parkinsonian medications may be readjusted, as needed. Patients will be contacted 2 weeks after the end of the study for a check on side effects and, if necessary, will be scheduled for a follow-up evaluation at the clinic. In addition to the above procedures, patients will be asked to have an optional lumbar a puncture (spinal tap) on the first and last days of the study to measure various brain chemicals and drug levels that cannot be measured in blood and urine. For this procedure, a local anesthetic is given and a needle is inserted in the space between the bones (vertebrae) in the lower back. About 2 tablespoons of fluid is collected through the needle.
NCT00076674 ↗	Levetiracetam Treatment of L-dopa Induced Dyskinesias	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2004-01-01	This study will evaluate the effects of levetiracetam (Keppra (Trademark) on Parkinson's disease symptoms and on dyskinesias (involuntary movements) that develop as a result of long-term treatment with levodopa. Levetiracetam blocks certain protein receptors on brain cells and thus can change the spread of brain signals believed to be affected in patients with Parkinson's disease. Patients between 30 and 80 years of age with relatively advanced Parkinson's disease and dyskinesias due to levodopa therapy may be eligible for this 6-week study. Screening and baseline evaluation - Participants are evaluated with a medical history, physical examination and neurologic evaluation, blood tests, urinalysis, electrocardiogram (EKG), 24-hour holter monitor (heart monitoring), and cardiology consultation. A chest x-ray and MRI or CT scan of the brain are done if needed. If possible, patients stop taking all antiparkinsonian medications except levodopa (Sinemet) for one month (2 months if taking Selegiline) before the study begins and throughout its duration. (If necessary, patients may use short-acting agents, such as Mirapex, Requip or Amantadine.) Dose-finding phase - Patients are admitted to the NIH Clinical Center for 2 to 3 days for a levodopa "dose-finding" procedure. For this test, patients stop taking Sinemet and instead have levodopa infused through a vein. During the infusions, the drug dose is increased slowly until parkinsonian symptoms improve or unacceptable side effects occur or the maximum study dose is reached. Symptoms are monitored frequently. (Patients who have had dosing infusions in the last 3 months do not have to undergo this phase of the study.) Active study phase - Patients are randomly assigned to take levetiracetam or placebo ("sugar pill") twice a day for 6 weeks. At the end of weeks 1, 2 4, and 5, patients come to the clinic for blood tests, an EKG, and a review of adverse side effects. At the end of weeks 3 and 6, patients are hospitalized to study the response to treatment. They again stop taking Sinemet and selegiline and their ability to perform motor tasks is evaluated. They are then placed on an L-dopa infusion for 10 hours. Placebo may be infused at various times instead of L-dopa. Motor symptoms are evaluated several times during the infusion. Blood is drawn once during the infusion for research studies. Lumbar puncture - Patients undergo a lumbar puncture (spinal tap) at the end of weeks 1 and 4 to measure certain brain chemicals and drug levels. For this test, a local anesthetic is given and a needle is inserted in the space between the vertebrae in the lower back. About 2 tablespoons of fluid is collected through the needle. Magnetic resonance imaging (MRI) - Patients with changing disease activity may undergo MRIs at baseline, at the end of week 1 and at the end of the study to show changes in the brain. The patient lies in a narrow cylinder (the scanner) that uses radio waves and a magnetic field to produce images of the brain, which show structural and chemical changes. Follow-up - 2 weeks after the study ends, patients are contacted by phone for a review of side effects or they return to the clinic for an evaluation.
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.

Clinical Trial Conditions for REQUIP XL

Condition Name

Condition Name for REQUIP XL
Intervention	Trials
Parkinson Disease	13
Parkinson's Disease	11
Healthy	4

Condition MeSH

Condition MeSH for REQUIP XL
Intervention	Trials
Parkinson Disease	21
Restless Legs Syndrome	5
Dyskinesias	3

Clinical Trial Locations for REQUIP XL

Trials by Country

Trials by Country for REQUIP XL
Location	Trials
United States	92
China	16
Italy	12
United Kingdom	8
Germany	7

Trials by US State

Trials by US State for REQUIP XL
Location	Trials
Maryland	7
Texas	7
Georgia	6
Florida	5
New York	5

Clinical Trial Progress for REQUIP XL

Clinical Trial Phase

Clinical Trial Phase for REQUIP XL
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	8
Phase 2	7

Clinical Trial Status

Clinical Trial Status for REQUIP XL
Clinical Trial Phase	Trials
Completed	29
Unknown status	4
Terminated	2

Clinical Trial Sponsors for REQUIP XL

Sponsor Name

Sponsor Name for REQUIP XL
Sponsor	Trials
GlaxoSmithKline	13
National Institute of Neurological Disorders and Stroke (NINDS)	4
Lupin Ltd.	3

Sponsor Type

Sponsor Type for REQUIP XL
Sponsor	Trials
Industry	27
Other	13
NIH	4

Requip XL (ropinirole extended-release): Clinical Trials Update, Market Analysis, and Projection

Last updated: April 28, 2026

What is Requip XL and what does the clinical development picture look like?

Requip XL is ropinirole extended-release, a dopamine agonist used for restless legs syndrome (RLS) in the US and for Parkinson’s disease (PD) in many markets depending on label structure. In the US, the extended-release formulation is marketed for RLS, with additional ropinirole products positioned across PD indications.

Clinical trials update (state of play):

• No major late-stage (Phase 3) new-drug development program is actively reported for Requip XL in public trial registries at a level that would change market exclusivity status.
• Publicly visible activity for ropinirole extended-release tends to cluster around:
  • Formulation/quality work and bioequivalence studies rather than pivotal efficacy trials.
  • Post-marketing observational and safety monitoring studies that do not typically expand indication scope in a way that materially alters addressable market.

Implication for investors and R&D strategists:

• The near-term clinical impact on market growth is likely to come from label maintenance, adherence programs, payer access, and competitive dynamics, not from new Phase 3 readouts that reset growth curves.

What is the current market structure for ropinirole extended-release?

Requip XL competes in chronic movement-disorder treatment channels where payer behavior and formulary design matter as much as clinical differentiation.

Core competitive set (practical substitute landscape)

Requip XL’s substitution risk comes from:

• Immediate-release ropinirole and other dopamine agonists where payer tiers allow switching.
• Alpha-2-delta ligands (notably gabapentinoids) that often serve as alternative first-line or add-on choices depending on region and guideline positioning.
• Levodopa strategies in PD subsets that do not directly mirror RLS economics but shape prescriber preferences and treatment sequencing.

Market drivers

Growth and share retention depend on:

• Chronicity: RLS and PD are long-duration conditions; therapy continuity supports base demand.
• Switching dynamics: Conversion between ropinirole formulations and between classes is driven by tolerance, sleep outcomes, and insurance policy constraints.
• Generic pressure: Where ropinirole molecules are generic, branded extended-release value depends on formulary placement and patient-level adherence (less dosing friction can reduce discontinuation in real-world practice).

How large is the addressable opportunity and how is it likely to evolve?

Demand model (projection framework)

Given the absence of a visible late-stage expansion, projections should be built around:

1. Epidemiology and treated prevalence for RLS and relevant PD segments.
2. Share of prescription vs competitors within the dopamine agonist and adjacent-class buckets.
3. Net price erosion due to generic mix and payer tiering.
4. Utilization stability driven by adherence and chronic treatment patterns.

Market direction (what the numbers tend to do for this category)

For older, branded chronic neurology agents with generic availability of the active ingredient:

• Volume growth usually tracks modestly with population and diagnosis/treatment rates.
• Value growth is typically slower than volume due to net price compression.
• Extended-release formulations can defend share better than immediate-release when adherence advantages are recognized by payers and clinicians, but they do not typically prevent pricing pressure.

What is the likely revenue outlook for Requip XL through the next 5 years?

Base-case projection (directional, market-mechanics based)

Because Requip XL’s clinical pipeline is not visibly poised to create a new exclusivity event, revenue trajectories generally follow:

• Stable-to-slightly-declining revenue under sustained generic/payer pressure
• Resilient volume but shrinking net sales if branded share continues to erode
• Potential stabilization if payer systems treat extended-release as preferred within a class

Scenario projection (annual directionality)

Base case (most likely):

• 2026-2028: gradual revenue softness; volume stabilizes, net price declines.
• 2029-2031: further modest declines unless the product keeps preferred status in formularies.

Bear case:

• faster net price erosion and share loss from broader formulary substitution into other ropinirole formulations and adjacent-class therapies.

Bull case:

• improved formulary position and better persistence outcomes sustain share longer than expected; price erosion slows.

What do payers and competition imply for near-term growth?

Formulary behavior

Extended-release products are most resilient when:

• they are placed on a preferred tier for RLS and when prior authorization criteria are light relative to alternatives;
• they are supported by outcomes evidence that improves persistence and reduces symptom rebound.

Switching and adherence

Real-world persistence for chronic movement disorders often drives outcomes. Extended-release can help by:

• reducing dosing complexity,
• smoothing symptom control across the dosing interval,
• supporting fewer discontinuations in patients who struggled with immediate-release schedules.

Key clinical and regulatory facts relevant to the market

Requip XL is part of the ropinirole extended-release franchise and is already approved and marketed in the US; growth does not depend on trial completion cycles. The strategic question is whether payers view it as cost-effective versus generics and adjacent-class competitors.

Key Takeaways

• Requip XL’s public clinical development profile shows no visible late-stage expansion that would materially change market trajectory.
• Market outlook is governed by generic/payer economics, not by new pivotal efficacy readouts.
• Base case: modest revenue softness with volume stability possible if extended-release remains preferred in RLS formularies.
• Upside depends on payer access and persistence benefits; downside tracks faster net price erosion and substitution.

FAQs

1) Is there an active Phase 3 trial pipeline that could expand Requip XL’s indications?
Public trial visibility does not indicate a new pivotal Phase 3 program that would expand indications in a way that changes exclusivity or addressable market.

2) What is the main driver of Requip XL revenue changes?
Net price compression and formulary tiering, driven by generic substitution and payer substitution rules.

3) How does extended-release positioning affect competitiveness?
It can improve adherence and persistence, which supports share defense when payers treat extended-release as preferred.

4) What competitor classes most affect share?
Other dopaminergic options including ropinirole formulations and adjacent-class therapies such as alpha-2-delta ligands used in chronic symptom control.

5) What is the most likely 5-year revenue pattern?
Stable-to-declining value with possible volume resilience, absent new label-expanding trial results.

References

[1] ClinicalTrials.gov. (n.d.). Search results for ropinirole extended-release (Requip XL). https://clinicaltrials.gov/
[2] FDA. (n.d.). Drug approvals and labeling database for ropinirole extended-release. https://www.accessdata.fda.gov/scripts/cder/daf/
[3] DailyMed. (n.d.). Requip XL (ropinirole hydrochloride extended-release) label information. https://dailymed.nlm.nih.gov/