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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
Also known as Zoloft
Sertraline · 2 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Sertraline Hydrochloride tablets 100 mg | EXPERIMENTAL | Sertraline Hydrochloride tablets 100 mg of Dr.Reddy's Laboratories Limited |
| Zoloft 100 mg Tablets | ACTIVE_COMPARATOR | Zoloft 100 mg Tablets of Pfizer |
| Name | Type | Description |
|---|---|---|
| Sertraline | DRUG | Sertraline Hydrochloride Tablets 100 mg |
Inclusion Criteria: 1. Healthy human subjects ages 18 and 45 years (including both). 2. Subjects weight within the normal range according to normal values for the body mass index (18.5 to 24.9 kg/m2) with minimum of 50 kg weight. 3. Subjects with normal health as determined by personal medical hist...
Sertraline is a small molecule drug developed by Dr. Reddy's Laboratories Ltd. It is being studied in Phase 1 clinical development. The specific therapeutic indication for this program has not been disclosed. Sertraline is identified by the ChEMBL ID CHEMBL809.
Sertraline targets SLC6A4, also known as the serotonin transporter. It acts as an inhibitor of this target. SLC6A4 is a membrane transport protein involved in serotonin reuptake. By inhibiting SLC6A4, sertraline modulates serotonergic signaling.
Sertraline is being developed by Dr. Reddy's Laboratories Ltd, which trades under the ticker RDY. The company is the sponsor of the clinical program for this asset.
Sertraline is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The program has completed two Phase 1 trials to date.
Sertraline has been evaluated in two completed Phase 1 trials: NCT01267396, a bioequivalence study of sertraline hydrochloride 100 mg tablets under fasting conditions, and NCT01267383, a bioequivalence study of the same tablets under fed conditions. Both enrolled 32 healthy male volunteers in India.