TheraRadar
Data updated: May 26, 2026

ZOLOFT (sertraline hydrochloride)

Trial Activity: Mature
CNS Approved 1991-12-30
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. conducting 2 trials (40%)
5 indications explored (Moderate)
→ healthy (2 trials)
→ covid-19 vaccine adverse reaction (1 trials)
→ obsessive-compulsive disorder (1 trials)
12
Indications
--
Phase 3 Trials
34
Years on Market

Details

Status
Discontinued
First Approved
1991-12-30
Routes
ORAL
Dosage Forms
TABLET, CONCENTRATE

Companies

Viatris
Active Ingredient: SERTRALINE HYDROCHLORIDE

ZOLOFT Approval History

1992
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Original
New Indication
New Form
Label Update
388 FDA actions from 1991 to 2023 · 11 indication expansions
Aug 2023 SUPPL
Label · Labeling
FDA Letter Label
Jan 2023 SUPPL
Label · Labeling
FDA Letter Label
Sep 2021 SUPPL
Label · Labeling
FDA Letter Label

What ZOLOFT Treats

12 FDA approvals

Originally approved for its first indication in 1991 . Covers 12 distinct patient populations.

  • Other (12)
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Clinical Trial Registry

4 trials
Trial Sponsor ID Phase Status Title
NCT06357104 SCI-CT-0001 Ph 4 completed Detoxification From the Lipid Tract
NCT03068429 FEARCON 0182/11 Ph 4 completed Fear Conditioned Response in Healthy Subjects and in OCD Patients Pre and Post Treatment With Sertraline.
NCT01235195 results posted A0501097 Ph 1 completed A Study Comparing the Drug Exposure in Humans After Administration of a 50 mg Tablet of Sertraline Hydrochloride as Compared to a 50 mg Capsule of Sertraline Hydrochloride Under Fasted (Nonfed) Conditions
NCT02185547 MAGDALENA KWMP001 Ph 4 terminated Effects and Consequences for Mother and Child From Treatment for Depression
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ZOLOFT FDA Label Details

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Data Sources

FDA Approval: NDA019839 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment