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Also known as Adentri, BG9928
tonapofylline · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | .03 mg/kg |
| 2 | EXPERIMENTAL | .15 mg/kg |
| 3 | EXPERIMENTAL | .3 mg/kg |
| 4 | PLACEBO_COMPARATOR | Placebo |
| Name | Type | Description |
|---|---|---|
| tonapofylline | DRUG | IV |
| Placebo | DRUG | IV |
| BG9928 | DRUG | Oral 75 mg single dose |
Inclusion Criteria: * Previous diagnosis of heart failure. * Must have ADHF, requiring hospitalization, with clinical evidence for volume overload Exclusion Criteria: * History of an allergic reaction to any xanthine-containing substance. * History of seizure * History of stroke * Myocardial infa...
Tonapofylline was studied for the treatment of patients with acute decompensated heart failure who also have renal insufficiency. It was administered intravenously in a Phase 3 clinical trial that enrolled 420 participants. The drug is an investigational small molecule and is not described as approved for any indication.
Tonapofylline targets ADORA1, the adenosine A1 receptor, and acts as an antagonist. By blocking this receptor, the drug was designed to influence adenosine-mediated signaling relevant to cardiovascular and renal function. This mechanism was the basis for its evaluation in heart failure patients with renal insufficiency.
Tonapofylline is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen sponsored the Phase 3 clinical trial of intravenous tonapofylline in patients with acute decompensated heart failure and renal insufficiency.
Tonapofylline has been evaluated in a Phase 3 clinical trial. That trial, NCT00709865, is listed as completed, and there are no active trials of tonapofylline. The drug is investigational and is not described as FDA approved for any indication.
Tonapofylline was studied in one clinical trial, NCT00709865, titled a study to assess the safety and tolerability of IV tonapofylline in subjects with acute decompensated heart failure and renal insufficiency. It was a Phase 3, randomized, double-blind, placebo-controlled trial that enrolled 420 participants across the United States, Argentina, Australia, Brazil, Bulgaria, Canada, Czechia, Finland, France, Germany, India, Israel, Italy, Netherlands, Poland, Romania, Russia, and Sweden.