Approval Probability
TA Base Rate
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ADX10059 · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| ADX10059 50 mg | EXPERIMENTAL | twice-daily |
| ADX10059 100 mg | EXPERIMENTAL | twice-daily |
| ADX10059 150 mg | EXPERIMENTAL | twice-daily |
| ADX10059 Matching Placebo | PLACEBO_COMPARATOR | twice-daily |
| ADX10059 120 mg | EXPERIMENTAL | Twice-daily |
| Name | Type | Description |
|---|---|---|
| ADX10059 | DRUG | oral administration |
| ADX10059 Matching Placebo | DRUG | oral administration |
Inclusion Criteria: * diagnosis of typical GERD * partial responder to a stable standard clinical symptoms control dose of PPI therapy * body mass index ≤ 32 kg/m2 Exclusion Criteria: * exclusively atypical symptoms of GERD * symptoms that have been shown not to be associated with GERD * erosive ...
ADX10059 is an investigational small molecule being studied for gastroesophageal reflux disease, or GERD. It has been tested both as a monotherapy and as an add-on therapy to proton pump inhibitors in adults with GERD. It is not approved and remains in clinical development.
ADX10059 targets mGluR5, the metabotropic glutamate receptor 5. mGluR5 is a receptor, and ADX10059 is a small molecule that acts on it. This receptor target is the basis for its investigation in gastrointestinal conditions such as gastroesophageal reflux disease.
ADX10059 is being developed by Addex Therapeutics Ltd, which trades under the ticker ADXN. The company has advanced the compound into Phase 2 clinical testing in gastroesophageal reflux disease.
ADX10059 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. Two Phase 2 trials in gastroesophageal reflux disease have been completed, and no trials are currently active.
ADX10059 has been studied in two completed Phase 2 trials. NCT00820079 evaluated ADX10059 as a monotherapy in patients with gastroesophageal reflux and enrolled 120 patients. NCT00810485 evaluated ADX10059 as an add-on therapy to proton pump inhibitors and enrolled 298 patients.
Both ADX10059 Phase 2 trials were randomized, double-blind, and placebo-controlled. They enrolled a combined total of 418 adults aged 18 years and older with gastroesophageal reflux disease. NCT00820079 ran in Austria, Belgium, France, and Germany, while NCT00810485 ran in the United States, France, Germany, the Netherlands, and Switzerland.