Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
tideglusib · 1 trial · 1 indication
The change from Baseline of the 3 active study medication groups will be compared with the placebo group in Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog+)
| Arm | Type | Description |
|---|---|---|
| Tideglusib 1000 mg Q.D. | EXPERIMENTAL | Group dosed with 1000 mg once daily for 26 weeks/extension |
| Tideglusib 1000 mg Q.O.D. | EXPERIMENTAL | Group dosed with 1000 mg once every other day for 26 weeks/extension |
| Tideglusib 500 mg Q.D. | EXPERIMENTAL | Group dosed with 500 mg once daily for 26 weeks/extension |
| Placebo | PLACEBO_COMPARATOR | Once daily administration for 26 weeks/extension |
| Name | Type | Description |
|---|---|---|
| tideglusib | DRUG | 1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension. |
| Placebo | DRUG | Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension. |
Main Inclusion Criteria: 1. Men and women (of non-childbearing potential) with a diagnosis of probable Alzheimer's disease. 2. Age of 50 to 85 years. 3. MMSE score 14 to 26. 4. Well-tolerated treatment with one of the approved Acetylcholinesterase-Inhibitors and/or Memantine in a stable dose Main ...
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Tideglusib is an investigational small molecule being studied for the treatment of Alzheimer's disease. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in patients with mild-to-moderate Alzheimer's disease.
Tideglusib is being developed by Icon Plc, a company listed on the NASDAQ under the ticker symbol ICLR. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Alzheimer's disease.
Tideglusib is in Phase 2 clinical development. It is an investigational drug and has not received regulatory approval. A Phase 2 clinical trial has been completed to assess its efficacy, safety, and tolerability in patients with mild-to-moderate Alzheimer's disease.
Tideglusib has one completed Phase 2 clinical trial with the identifier NCT01350362. This randomized, double-blind, placebo-controlled study enrolled 306 participants across Belgium, Finland, France, Germany, Spain, and the United Kingdom. The trial evaluated the drug's efficacy, safety, and tolerability in patients with mild-to-moderate Alzheimer's disease.
Tideglusib is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Alzheimer's disease. The drug has completed a Phase 2 clinical trial, but it has not yet received regulatory approval from the FDA or any other health authority.