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Also known as Dipraglurant
ADX48621 · 2 trials · 3 indications
The primary outcome will be testing the safety and tolerability of dipraglurant in patients with blepharospasm based on the incidence of adverse events reported by patients and/or as identified by the Investigator based on clinical assessments conducted during the study.
Video analysis, by an independent rater, of the mean proportion of eye closure time, severity of periocular spasms, and blink rate. Decreased eye closure time, severity of periocular spasms and blink rate indicates improvement of blepharospasm symptoms.
Analysis of blinking activity as recorded on the Skintronics wearable device. Decreased blink activity indicates improvement of blepharospasm symptoms.
Physical and neurological examination, heart rate and blood pressure, 12-lead ECG, hematology and biochemistry assessments, use of concomitant medications, adverse events and serious adverse events.
| Arm | Type | Description |
|---|---|---|
| Dipraglurant 50 mg | EXPERIMENTAL | - |
| Dipraglurant 100 mg | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| ADX48621 | EXPERIMENTAL | - |
| ADX48621 Matching Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Dipraglurant | DRUG | Oral tablet |
| Placebo | DRUG | Oral matching placebo tablet |
| ADX48621 | DRUG | oral administration |
Inclusion Criteria: * Patients with an established diagnosis of idiopathic benign essential blepharospasm * Must have had prior response to to botulinum toxin (BoNT) reported on last 2 consecutive injection cycles * Last injection of BoNT at least 8 weeks prior to Screening assessments * Patient is...
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 |
ADX48621 is an investigational small molecule being developed for Parkinson's disease, specifically for levodopa induced dyskinesia in patients with Parkinson's disease. It is in Phase 2 clinical development and is not approved for any indication.
ADX48621 targets mGluR5, a metabotropic glutamate receptor. By acting on this receptor, the drug is designed to modulate glutamate signaling, which is being studied as a way to reduce levodopa induced dyskinesia in Parkinson's disease patients.
ADX48621 is being developed by Addex Therapeutics Ltd, a biopharmaceutical company whose ticker symbol is ADXN. Addex Therapeutics is the sponsor of the clinical program for this asset.
ADX48621 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency for marketing.
ADX48621 has been studied in one completed Phase 2 trial, NCT01336088, titled ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease. The trial enrolled 83 patients across the United States, Austria, France, and Germany.
Yes, the Phase 2 trial NCT01336088 for ADX48621 was randomized, double blind, and placebo controlled. It enrolled 83 patients with Parkinson's disease and levodopa induced dyskinesia and has been completed.