TheraRadar
Data updated: Jul 17, 2026

ZANTAC (ranitidine hydrochloride) · GSK

Trial Activity: Declining
Gastrointestinal Approved 1984-10-19

ZANTAC is FDA-approved to treat 7 conditions (same as RANITIDINE HYDROCHLORIDE).

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Sanofi conducting 3 trials (16%)
59 indications explored (Broad Platform)
→ healthy (2 trials)
→ gastroesophageal reflux disease (gerd) (2 trials)
→ pharmacokinetics (2 trials)
4
Indications
--
Phase 3 Trials
41
Years on Market

Details

Status
Discontinued
First Approved
1984-10-19
Routes
ORAL, INJECTION
Dosage Forms
SYRUP, INJECTABLE

Companies

GSK PAI HOLDINGS
Active Ingredient: RANITIDINE HYDROCHLORIDE

ZANTAC Approval History

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Original
New Indication
New Form
Label Update
74 FDA actions from 1984 to 2009 · 2 indication expansions
Sep 2009 SUPPL
Label · Labeling
FDA Letter Label
Feb 2009 SUPPL
Label · Labeling
FDA Letter Label
Feb 2009 SUPPL
Label · Labeling
FDA Letter Label

What ZANTAC Treats

7 indications

ZANTAC is approved for 7 conditions since its original approval in 1984. These indications span multiple therapeutic areas including oncology, immunology, and more.

Same approved indications as RANITIDINE HYDROCHLORIDE (same active ingredient).

Source: FDA Label
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Clinical Trial Registry

1 trials
Trial Sponsor ID Phase Status Title
NCT02195804 1144.3 Ph 1 completed Bioavailability Study of Ranitidine Hydrochloride (Maximum Strength ZANTAC 150®) Compared to Two Different 150 mg Ranitidine Hydrochloride Oral Disintegrating Tablet (ODT) in Fasting, Healthy Male Volunteers
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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.

ZANTAC FDA Label Details

Indications & Usage

FDA Label (PDF)

ZANTAC is FDA-approved to treat 7 conditions — same approved indications as RANITIDINE HYDROCHLORIDE.

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Data Sources

FDA Approval: NDA019675 → 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