Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ADX48621
Dipraglurant · 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...
Dipraglurant is being studied for the treatment of blepharospasm, a focal dystonia involving involuntary eyelid spasms. It is an investigational small molecule in Phase 2 development and is not approved for any indication. Addex Therapeutics Ltd is developing it as a potential treatment in the neurology therapeutic area.
Dipraglurant targets GRM5, also known as the metabotropic glutamate receptor 5. It acts as a modulator of this receptor. GRM5 modulation is the proposed mechanism by which Dipraglurant is designed to influence the neurological signaling underlying blepharospasm and other dystonias.
Dipraglurant is being developed by Addex Therapeutics Ltd, which trades under the ticker ADXN. The company is advancing the small molecule as a Phase 2 candidate for blepharospasm, a neurological movement disorder. Addex Therapeutics is the sponsor of the clinical program for this asset.
Dipraglurant is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The completed Phase 2 study evaluated the drug in patients with blepharospasm and dystonia, and no active trials are currently listed for the program.
Dipraglurant has been studied in one completed Phase 2 trial, NCT05027997, titled an exploratory study of Dipraglurant (ADX48621) for the treatment of patients with blepharospasm. The trial enrolled 15 participants in the United States, was randomized, double-blind, and placebo-controlled, and included patients aged 18 years and older.
Yes, Dipraglurant is also known as ADX48621. The two names refer to the same investigational small molecule developed by Addex Therapeutics Ltd. The completed Phase 2 blepharospasm trial, NCT05027997, lists the drug under the name Dipraglurant (ADX48621), confirming they are the same compound.