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ADX48621 · 2 trials · 2 indications
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.
This is composite
| Arm | Type | Description |
|---|---|---|
| ADX48621 | EXPERIMENTAL | - |
| ADX48621 Matching Placebo | PLACEBO_COMPARATOR | - |
| Part 1 | EXPERIMENTAL | A receptor occupancy dose curve will be obtained by using an adaptive design in this arm. |
| Part 2 | EXPERIMENTAL | In this arm, the time course of the receptor occupancy will be studied for the dose which gives 70% receptor occupancy as determined in Part 1. |
| Name | Type | Description |
|---|---|---|
| ADX48621 | DRUG | oral administration |
| Placebo | DRUG | oral administration |
| [18F]FPEB | RADIATION | radiotracer used for PET scanning |
Inclusion Criteria: * outpatient with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBCDC) * experiences moderately disabling dyskinesia (screening visit UPDRS 33 score≥2) * has an mAIMS score at baseline ≥ 7 with a score ≥ 3 in at least ...
ADX48621 is an investigational small molecule being studied for the treatment of levodopa induced dyskinesia in patients with Parkinson's Disease. It has also been evaluated in healthy volunteers in a PET imaging study to assess mGlu5r occupancy. The drug is currently in clinical development and is not approved.
ADX48621 targets the metabotropic glutamate receptor 5 (mGlu5r). This was evaluated in a Phase 1 PET imaging study (NCT02447640) that measured mGlu5r occupancy following administration of the drug. The mechanism is relevant to its potential use in Parkinson's Disease.
ADX48621 is being developed by Addex Therapeutics Ltd, a biopharmaceutical company. The company's stock is listed under the ticker ADXN. Addex is conducting clinical trials to evaluate the drug's safety and efficacy in Parkinson's Disease and healthy volunteers.
ADX48621 is in Phase 1 clinical development. It has completed a Phase 1 PET imaging study in healthy volunteers (NCT02447640) and a Phase 2 study in Parkinson's Disease (NCT01336088). The drug is investigational and has not been approved by regulatory authorities.
ADX48621 has been studied in two completed clinical trials. NCT01336088 was a Phase 2 study in patients with Parkinson's Disease and levodopa induced dyskinesia, enrolling 83 participants in the US, Austria, France, and Germany. NCT02447640 was a Phase 1 PET imaging study in 12 healthy volunteers in the US.
Yes, ADX48621 is also known as dipraglurant. The Phase 1 PET imaging study (NCT02447640) refers to ADX48621 (Dipraglurant) administration. Both names refer to the same investigational drug being developed by Addex Therapeutics.