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Data updated: Mar 10, 2026

NEXIUM

ESOMEPRAZOLE MAGNESIUM
Immunology Approved 2001-02-20
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
8
Indications
--
Phase 3 Trials
4
Priority Reviews
25
Years on Market

Details

Status
Prescription
First Approved
2001-02-20
Routes
ORAL
Dosage Forms
FOR SUSPENSION, DELAYED RELEASE, CAPSULE, DELAYED REL PELLETS

Companies

AstraZeneca
Active Ingredient: ESOMEPRAZOLE MAGNESIUM

NEXIUM Approval History

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What NEXIUM Treats

7 indications

NEXIUM is approved for 7 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Erosive Esophagitis
  • Heartburn
  • Gastroesophageal Reflux Disease
  • Gastric Ulcer
  • Duodenal Ulcer
  • Zollinger-Ellison Syndrome
  • Pathological Hypersecretory Conditions
Source: FDA Label

Drugs Similar to NEXIUM

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ESOMEPRAZOLE MAGNESIUM
ESOMEPRAZOLE MAGNESIUM
7 shared
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Erosive EsophagitisHeartburnGastroesophageal Reflux Disease +4 more
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Baxter
Shared indications:
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OMEPRAZOLE MAGNESIUM
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ALEMBIC
Shared indications:
Erosive EsophagitisHeartburnGastroesophageal Reflux Disease
ARTHROTEC
DICLOFENAC SODIUM
2 shared
Pfizer
Shared indications:
Gastric UlcerDuodenal Ulcer
DICLOFENAC SODIUM AND MISOPROSTOL
DICLOFENAC SODIUM
2 shared
MICRO LABS
Shared indications:
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VOQUEZNA
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PHATHOM PHARMACEUTICALS INC
Shared indications:
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Shared indications:
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BISMUTH SUBSALICYLATE, METRONIDAZOLE AND TETRACYCLINE HYDROCHLORIDE
BISMUTH SUBSALICYLATE
1 shared
AILEX PHARMS LLC
Shared indications:
Heartburn
CARAFATE
SUCRALFATE
1 shared
AbbVie
Shared indications:
Duodenal Ulcer
CLARITHROMYCIN
CLARITHROMYCIN
1 shared
Teva
Shared indications:
Duodenal Ulcer
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Active Pipeline

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Key Completed Trials

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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.

NEXIUM FDA Label Details

Pro

Indications & Usage

FDA Label (PDF)

NEXIUM is a proton pump inhibitor (PPI). NEXIUM delayed-release capsules and NEXIUM for delayed-release oral suspension are indicated for the: • Short-term treatment in the healing of erosive esophagitis (EE) in adults and pediatric patients 12 years to 17 years of age. • Maintenance of healing of EE in adults. • Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. • Risk reduction of nonsteroidal anti-inflammatory drugs (NSAID)-associated gastric ulcer in adults at risk for developing gastric ulcers due to age (60 y...

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Data Sources

FDA Approval: NDA022101 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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