Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as paroxetine hydrochloride hydrate
paroxetine hydrate · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| Paroxetine hydrochloride hydrate | DRUG | - |
Inclusion criteria: * Diagnosis of Social Anxiety Disorder (SAD) (300.23 Social Phobia/Social Anxiety Disorder) according to DSM-IV-TR criteria. * Must give a written informed consent. But if the patient is under 20, both the patient himself/herself and his/her proxy consenter must give written inf...
Paroxetine hydrate is a small molecule drug developed by GSK plc (ticker GSK) for social phobia, also called social anxiety disorder. It is an inhibitor of SLC6A4, the serotonin transporter. It has been studied in a Phase 3 clinical trial conducted in Japan.
Paroxetine hydrate is used for the treatment of social phobia, also known as social anxiety disorder, which falls within the psychiatry therapeutic area. Its clinical development has focused on this indication, with a Phase 3 trial in Japan enrolling 390 adult participants aged 18 years and older.
Paroxetine hydrate targets SLC6A4, the serotonin transporter, and acts as an inhibitor of this target. By inhibiting SLC6A4, it affects serotonin signaling in the brain, which is the mechanism underlying its use in social phobia and related psychiatric conditions.
Paroxetine hydrate is developed by GSK plc, which trades under the ticker GSK. GSK is the sponsor associated with the clinical development of this small molecule for social phobia, including the Phase 3 study conducted in Japan.
Paroxetine hydrate is in Phase 3 clinical development for social phobia. It is an investigational small molecule and is not described as approved. One Phase 3 trial has been completed, with no active trials currently listed.
Paroxetine hydrate has been evaluated in the Phase 3 trial NCT00318669, titled Social Anxiety Disorder Study Of Paroxetine. The trial enrolled 390 participants with social phobia in Japan, included adults aged 18 years and older of all sexes, was randomized and double blind, and has been completed.
Yes, paroxetine hydrate is also known as paroxetine hydrochloride hydrate. These names refer to the same drug substance developed by GSK plc for social phobia, so searches using either name point to the same asset and the same Phase 3 clinical program.