Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ezogabine/retigabine · 1 trial · 1 indication
Peak plasma concentration (Cmax) of ezogabine/retigabine; and area under the plasma concentration-time curve from time zero to infinity (AUC(0-∞)) for ezogabine/retigabine
| Arm | Type | Description |
|---|---|---|
| Treatment Period 1 | OTHER | A single 50mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| Treatment Period 2 | OTHER | A single 100mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| Treatment Period 3 | OTHER | A single 200mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| Treatment Period 4 | OTHER | A single 400mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| Name | Type | Description |
|---|---|---|
| 50mg Ezogabine/retigabine | DRUG | A single 50mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| 100mg Ezogabine/retigabine | DRUG | A single 100mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| 200mg Ezogabine/retigabine | DRUG | A single 200mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
| 400mg Ezogabine/retigabine | DRUG | A single 400mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state |
Inclusion Criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: 1. Male or female between 20 and 65 years of age inclusive, at the time of signing the informed consent. 2. Taiwanese ancestry defined as being born in Taiwan, having four ethnic...
Ezogabine is an investigational small molecule being studied for epilepsy and amyotrophic lateral sclerosis (ALS). It is in Phase 2 clinical development for ALS and has completed a Phase 1 study in epilepsy. Ezogabine is not FDA approved and remains in clinical development.
Ezogabine is being developed by GSK plc, which trades under the ticker GSK. The company is conducting clinical trials of the drug in neurology indications, including epilepsy and amyotrophic lateral sclerosis.
Ezogabine is in Phase 2 clinical development for amyotrophic lateral sclerosis (ALS). It has also completed a Phase 1 study in epilepsy. The drug is investigational and not yet approved by regulatory authorities.
Ezogabine has been studied in two clinical trials. NCT01462669 was a Phase 1 crossover study in Taiwanese subjects with epilepsy, completed with 1 participant. NCT02450552 was a Phase 2 trial in ALS subjects in the United States, completed with 65 participants.
Ezogabine is also known as retigabine. Clinical trials such as NCT02450552 refer to the drug as Ezogabine (Retigabine), confirming that the two names refer to the same compound.