Approval Probability
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Adjusted LOA
ML Risk
Also known as Ropinirole XL (formerly CR)
Ropinirole XL · 3 trials · 2 indications
AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. SAEs, defined as AEs that are fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.
The UPDRS is a clinician-based scale used to assess the longitudinal course of PD. Two of the six sections were assessed (Part II, Activities of Daily Living (ADL); Part III, Motor Examination). Both consist of a number of items (ADL, 13 items; Motor Exam., 17 items), and each item has a choice of 5 responses that are numerically scored 0-4, with 0 as the least severe response and 4 as the most severe response. ADL final score is a sum of the 13 items and may have a value between 0 (no impairment of overall activities) and 52 (severe impairment of overall activities). LTT, long-term treatment.
AEs, defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, were collected to obtain data on the safety, tolerability, and benefit of ropinirole XL. Serious Adverse Events (SAEs), defined as AEs that are either fatal, life threatening, disabling/incapacitating, resulting in hospitalization or prolongation of a hospital stay, a congenital abnormality/birth defect, or any important medical occurrence that the investigator regards as serious based on medical judgment, were also collected. st. med., study medication.
PK parameters used to measure this change : AUC(0-infinity), AUC(0-t), Cmax, tmax, lambda - z and t1/2
| Arm | Type | Description |
|---|---|---|
| Ropinirole XL (formerly CR) | ACTIVE_COMPARATOR | Ropinirole XL (formerly CR) |
| Active | ACTIVE_COMPARATOR | Open label medication - Ropinirole CR |
| Session 1 | OTHER | Ropinirole manufactued at Crawley will be compared to that manufactured at Aranda |
| Session 2 | OTHER | Ropinirole manufactured at Crawley will be compared to that manufactured at Aranda. |
| Name | Type | Description |
|---|---|---|
| Ropinirole XL (formerly CR) | DRUG | - |
| Ropinirole XL | DRUG | Ropinirole XL manufactured at Crawley will be compared to that manufactued at Aranda. |
Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: * Subjects must have completed REQUIP studies 165 or 168, or must have completed at least 12 weeks of randomised treatment in study 169 (and must have completed the one-week down...
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 XL is used for the treatment of Parkinson Disease. It is an extended release oral small molecule developed by GSK plc. The clinical program includes three completed trials in Parkinson Disease, with a combined enrollment of 545 participants across Phase 1 and Phase 3 studies.
Ropinirole XL targets the dopamine receptors DRD2, DRD3, and DRD4, where it acts as an agonist. By stimulating these dopamine receptors, the drug is designed to address the dopaminergic deficit associated with Parkinson Disease. It is a small molecule administered as an extended release formulation.
Ropinirole XL is developed by GSK plc, which trades under the ticker GSK. GSK conducted the clinical development program for the extended release formulation in Parkinson Disease, including the long-term extension and continuation studies that make up the trial record for this asset.
Ropinirole XL has been studied in Phase 3 clinical development for Parkinson Disease. Three trials are recorded for the program, all of which are completed, and none are currently active. The studies include one Phase 1 bioequivalence trial and two Phase 3 trials.
The Ropinirole XL program includes NCT01371682, a Phase 1 bioequivalence study in healthy subjects, plus two completed Phase 3 trials: NCT00650104, a long-term extension study with 76 patients, and NCT00632736, an open-label continuation study with 419 patients evaluating long-term safety in Parkinson Disease.
Yes. Ropinirole XL was formerly referred to as Ropinirole CR, and the two names describe the same extended release formulation. The Phase 3 trials NCT00650104 and NCT00632736 are listed under the Ropinirole XL name with the former CR designation noted in their titles.