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Label indication Sertraline hydrochloride oral solution is indicated for the treatment of the following [See Clinical Studies (14) ] : • Major depressive disorder (MDD) • Obsessive-compulsive disorder (OCD) • Panic disorder (PD) • Posttraumatic stress disorder (PTSD) • Social anxiety disorder (SAD) • Premenstrual dysphoric disorder (PMDD) Sertraline hydrochloride oral solution is a selective serotonin reuptake inhibitor (SSRI)… FDA label
Sertraline · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | Sertraline Hydrochloride Tablets 100 mg |
| 2 | ACTIVE_COMPARATOR | Zoloft® Tablets 100 mg |
| Name | Type | Description |
|---|---|---|
| Sertraline Hydrochloride Tablets 100 mg | DRUG | 100mg, single dose fed |
| Zoloft® Tablets 100 mg | DRUG | 100mg, single dose fed |
Inclusion Criteria: 1. Age: 18 years and older. 2. Sex: Male and/or non-pregnant, non-lactating female. 1. Women of childbearing potential must have negative serum beta-human chorionic gonadotropin (HCG) pregnancy tests performed within 14 days prior to the start of the study and on the evening...
Sertraline is a small molecule drug developed by Viatris Inc. (ticker: VTRS). It is also known as Sertraline Hydrochloride Tablets 100 mg. The drug is in Phase 1 clinical development, with two completed trials in healthy volunteers.
Sertraline targets SLC6A4, also known as the serotonin transporter. It acts as an inhibitor of this target. This mechanism is characteristic of selective serotonin reuptake inhibitors.
Sertraline is developed by Viatris Inc., which trades under the ticker symbol VTRS. Viatris is the company responsible for the clinical development of Sertraline Hydrochloride Tablets 100 mg.
Sertraline is in Phase 1 clinical development. Two Phase 1 trials have been completed, and there are currently no active trials. The drug is investigational and has not been approved by the FDA for any indication.
Sertraline has been studied in two completed Phase 1 trials: NCT00650325 and NCT00648856. Both trials enrolled healthy adult volunteers in the United States and compared Sertraline Hydrochloride Tablets 100 mg with Zoloft tablets 100 mg.