Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Thioctic Acid · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Drug: Thioctic Acid | EXPERIMENTAL | 600mg tablet Thioctic Acid (alpha-lipoic acid) once daily throughout the trial |
| Drug: Placebo | PLACEBO_COMPARATOR | 1 tablet once daily throughout the trial |
| Name | Type | Description |
|---|---|---|
| Thioctic Acid | DRUG | - |
| Placebo | DRUG | 1 tablet once daily 4 years double-blind treatment period |
Inclusion Criteria: 1. Diabetes mellitus (Type I or II), as defined by the American Diabetes Association, 1997, lasting 1 year. 2. Patient must have a symmetric sensory-motor peripheral polyneuropathy of at least stage 2 attributable to diabetes mellitus following a thorough evaluation for other ca...
Thioctic Acid is an investigational small molecule being developed for the treatment of diabetic polyneuropathy, a nerve disorder caused by diabetes. It is currently in Phase 3 clinical development and has not been approved by the FDA.
Thioctic Acid is a small molecule being studied for diabetic polyneuropathy. It has been evaluated in placebo-controlled, double-blind, randomized Phase 3 trials. The specific molecular target has not been disclosed.
Thioctic Acid is being developed by Viatris Inc., a pharmaceutical company traded on the NASDAQ under the ticker symbol VTRS. The drug is currently in Phase 3 clinical development for diabetic polyneuropathy.
Thioctic Acid is in Phase 3 clinical development. It has completed two Phase 3 trials for diabetic polyneuropathy, with a total of 630 participants enrolled across both studies. The drug remains investigational and is not yet approved.
Thioctic Acid has completed two Phase 3 trials: NCT00328601, known as SYDNEY 2, enrolled 170 participants in Israel and Russia, and NCT00977483 enrolled 460 participants across the United States, Croatia, Denmark, France, Italy, Netherlands, Spain, Sweden, and the United Kingdom. Both trials studied the drug in diabetic polyneuropathy.
Thioctic Acid is also known as alpha-lipoic acid, a naturally occurring compound with antioxidant properties. In clinical trials, it has been studied as an oral treatment for diabetic polyneuropathy, with two completed Phase 3 studies.