Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-639 · 2 trials · 1 indication
Spontaneous activity in peripheral c-nociceptor measured through microneurography
Daily questions asked on a hand held diary
| Arm | Type | Description |
|---|---|---|
| ABT-639 | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Lidocaine | ACTIVE_COMPARATOR | - |
| pregabalin | ACTIVE_COMPARATOR | pregabalin starting dose twice daily for week one then titrated up to maintenance dose twice daily for duration of the study |
| Name | Type | Description |
|---|---|---|
| ABT-639 | DRUG | two 50 mg oral capsules |
| Placebo | DRUG | 2 placebo capsules |
| Lidocaine | DRUG | 3mg/kg infusion over 30 minutes |
| pregabalin | DRUG | pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study. |
Inclusion Criteria * Subject is between the ages of 18 to 75 years with a diagnosis of diabetes mellitus and must have a diagnosis of painful distal symmetric diabetic polyneuropathy and presence of ongoing pain due to diabetic peripheral neuropathy for at least 6 months. * Subject must have an ave...
ABT-639 is an investigational small molecule being developed for diabetic neuropathic pain. It is a Phase 2 drug candidate studied in patients with diabetic neuropathic pain, also referred to as diabetic peripheral neuropathy. ABT-639 is not approved and remains in clinical development.
ABT-639 is being developed by AbbVie Inc., traded on the New York Stock Exchange under the ticker ABBV. The company is conducting clinical trials to evaluate the drug's analgesic effects and safety in patients with diabetic neuropathic pain.
ABT-639 is in Phase 2 clinical development. Two Phase 2 trials have been completed, both involving patients with diabetic neuropathic pain. The drug is investigational and has not been approved by regulatory authorities.
ABT-639 has completed two Phase 2 trials. NCT01345045 enrolled 193 participants across the United States, Czechia, France, Germany, and Mexico. NCT01589432 enrolled 39 participants in the United Kingdom. Both trials were randomized, double-blind, and placebo-controlled, with a combined enrollment of 232 patients.
ABT-639 is the primary name for this investigational compound. No alternative names have been reported for this drug candidate. It is being studied specifically for diabetic neuropathic pain and is not known to be marketed under any other designation.