Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Dimebon+ Dextromethorphan · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| Regimen A (Reference) | OTHER | - |
| Regimen B (Test) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Dimebon | DRUG | 20 mg Dimebon orally TID |
| Placebo | OTHER | Orally TID |
| Dextromethorphan | DRUG | Dextromethorphan HCl 30 syrup single dose |
| Dimebon + Dextromethorphan | DRUG | Dimebon 20 mg tablets given three times daily for 14 days plus Dextromethorphan HCl 30 syrup single dose administered on Day 12 |
Inclusion Criteria: * Healthy adult subjects. * Extensive or ultra-rapid metabolizers of CYP2D6 substrates, predicted by genotype. Exclusion Criteria: * Existence of significant medical conditions that would impact study results or pose unacceptable risks to study subjects. * Pregnant or nursing ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Novartis AG Sponsored ADR | NVS | 2 | PHASE3 | Votoplam |
| Neurocrine Biosciences, Inc. | NBIX | 1 | PHASE3 | Valbenazine |
| Alnylam Pharmaceuticals, Inc | ALNY | 1 | PHASE1 | ALN-HTT02 |
| uniQure N.V. | QURE | 2 | PHASE1 | intra-striatal rAAV5-miHTT |
| Sarepta Therapeutics, Inc. | SRPT | 1 | PHASE1 | SRP-1005 |
Dimebon is an investigational small molecule being studied for Huntington's Disease and Alzheimer's Disease. It has also been evaluated in healthy volunteers and in subjects with hepatic failure. All nine clinical trials listed for Dimebon have been completed.
Dimebon is being developed by Pfizer, Inc., which trades under the ticker symbol PFE on the New York Stock Exchange. Pfizer has sponsored clinical trials of Dimebon in the United States.
Dimebon is in Phase 3 clinical development for neurology indications. It is an investigational drug and is not approved by the FDA. All nine trials listed for Dimebon have been completed, with no active trials currently ongoing.
Dimebon has been studied in several completed Phase 1 trials, including NCT00824590, NCT00825084, NCT00827034, and NCT00975481. These trials evaluated the drug's pharmacokinetics, safety, tolerability, and potential for abuse in healthy subjects and in patients with Alzheimer's or Huntington's disease.
Yes, Dimebon is also known as Latrepirdine. In clinical trials, it has been referred to by the code name PF-01913539. The drug has been studied under these names in trials for Alzheimer's Disease and Huntington's Disease.