Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dimebon IR · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| Period 1 | EXPERIMENTAL | - |
| Period 2 | EXPERIMENTAL | - |
| Period 3 | EXPERIMENTAL | - |
| Period 4 | EXPERIMENTAL | - |
| Period 5 | EXPERIMENTAL | - |
| Cohort 1 | OTHER | - |
| Cohort 2 | OTHER | - |
| Name | Type | Description |
|---|---|---|
| Dimebon IR Tablet | DRUG | Pharmacokinetics of a single oral dose of 10 mg dimebon immediate release tablet will be assessed on Day 1 - 3. |
| Dimebon MR1 | DRUG | Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR1, will be assessed on Day 1 - 3. |
| Dimebon MR2 | DRUG | Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR2, will be assessed on Day 1 - 3. |
| Dimebon MR3 | DRUG | Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR3, will be assessed on Day 1 - 3. |
| Dimebon MR4 | DRUG | Pharmacokinetics of a single oral dose of 10 mg dimebon modified release formulation, MR4, will be assessed on Day 1 - 3. |
| Dimebon IR | DRUG | A single, oral 10 mg dose of dimebon dihydrochloride (equivalent to 8.2 mg free base) immediate release will be administered. |
| Dimebon Transdermal | DRUG | A single, transdermal 5 mg dose of dimebon free base solution will be applied to the back over a 24 hour period. A double-blinded vehicle (placebo) solution will be applied concurrently to a contralateral body site. |
Inclusion Criteria: * Healthy male and/or female subjects between the ages of 18 and 55 years, inclusive. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). Exclusion Criteria: * Evidence or history of clinically significant hematological, renal, endocrine, p...
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Dimebon IR is an investigational small molecule being developed for Alzheimer's Disease. It is in Phase 1 clinical development, meaning it has not been approved by the FDA and is still being studied in clinical trials.
Dimebon IR is being developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical trials to evaluate the drug's pharmacokinetics and absorption in healthy volunteers.
Dimebon IR is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA and is still being studied in clinical trials. Two Phase 1 trials have been completed, with no active trials currently ongoing.
Dimebon IR has been studied in two completed Phase 1 clinical trials. NCT00988624 evaluated the pharmacokinetics of four modified-release formulations in 20 healthy volunteers, and NCT00990613 evaluated the absorption of a Dimebon solution applied to the skin in 19 healthy volunteers. Both trials were conducted in the United States.
Yes, Dimebon IR is also known as Latrepirdine. The clinical trials for Dimebon IR refer to it as Dimebon (Latrepirdine), indicating that these names refer to the same investigational drug being developed by Pfizer.