Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ropinirole · 8 trials · 6 indications
Cmax, AUC (0-24), AUC(0-inf)
| Arm | Type | Description |
|---|---|---|
| Open Label | EXPERIMENTAL | All subjects will receive ropinirole XR in this study. The total daily dose range of ropinirole XR will be 0.5mg to 6.0mg daily |
| Subjects receiving ropinirole | EXPERIMENTAL | Eligible subjects will receive single and multiple oral dose of ropinirole prolonged release tablet in sequence over 14 days without dosing on washout period from Day 2 to Day 7. |
| Name | Type | Description |
|---|---|---|
| ropinirole Extended Release (XR) | DRUG | - |
| Ropinirole | DRUG | - |
| Ropinirole (+ physical therapy) | DRUG | - |
| (vs.) Placebo + physical therapy | DRUG | - |
Inclusion Criteria: * Diagnosis of primary RLS according to RLS Diagnostic Clinical Interview and International Restless Legs Syndrome Study Group Diagnostic Criteria. * Disturbed sleep, with both evening (between 5:00 pm and 8:00 pm) and night time (between 8:00 pm and 8:00 am) symptoms requiring ...
Top 15 of 23 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 2 | PHASE3 | Onapgo (SPN-830) |
| Prothena Corp. Plc | PRTA | 3 | PHASE3 | Prasinezumab |
| Denali Therapeutics Inc. | DNLI | 1 | PHASE2 | BIIB122 |
| Bayer | BAYRY | 4 | PHASE3 | bemdaneprocel, AB-1005 |
| Biohaven Ltd. | BHVN | 1 | PHASE2 | BHV-8000 |
| AC Immune SA | ACIU | 2 | PHASE2 | ACI-7104.056 |
| Eli Lilly and Company | LLY | 4 | PHASE1 | LY3884961, LY4006896, LY3962681 |
| Gain Therapeutics, Inc. | GANX | 2 | PHASE2 | GT-02287 |
| Annovis Bio Inc | ANVS | 1 | PHASE2 | Buntanetap |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE1 | ALN-SNCA |
| MeiraGTx Holdings Plc | MGTX | 1 | PHASE1 | AAV-GAD |
| Serina Therapeutics, Inc. | SER | 1 | PHASE1 | SER-252 |
| Ardelyx, Inc. | ARDX | 1 | PHASE2 | Tenapanor |
| Hoffmann-La Roche | RHHBY | 1 | PHASE1 | RO7568282 |
| Merck & Co., Inc. | MRK | 1 | EARLY_PHASE1 | MK-0947 |
Ropinirole is a small molecule studied in neurology for Parkinson disease, fibromyalgia syndrome, and cerebrovascular accident. It has been investigated in completed clinical trials, including a Phase 3 study in Parkinson disease patients not well controlled on L-dopa and a Phase 2 study in adults with fibromyalgia. It is not described as approved for these uses.
Ropinirole targets the dopamine receptors DRD2, DRD3, and DRD4, where it acts as an agonist. By activating these receptors, it is designed to influence dopamine signaling, which is relevant to neurological conditions such as Parkinson disease. This mechanism is the basis for its study in the indications listed.
Ropinirole is developed by GSK plc, which trades under the ticker GSK. GSK is the company associated with the clinical development program for this small molecule across Parkinson disease, fibromyalgia syndrome, and cerebrovascular accident.
Ropinirole is in Phase 2 development overall, with completed trials spanning Phase 1 to Phase 3. The program includes three completed trials with a total enrollment of 445 participants. No active trials are ongoing. It is investigational and not described as approved.
Ropinirole has been studied in completed trials including NCT01435915, a Phase 1 pharmacokinetics study in Chinese healthy subjects; NCT00460148, a Phase 2 absorption, distribution, metabolism, and excretion study in Parkinson disease; NCT00381472, a Phase 3 trial in Parkinson disease patients not well controlled on L-dopa; and NCT00256893, a Phase 2 fibromyalgia study in adults.