NEXIUM (esomeprazole magnesium) · AstraZeneca
Nexium is a proton pump inhibitor (PPI) indicated for the treatment of acid-related gastrointestinal disorders in adults and pediatric patients (as young as one month for erosive esophagitis). It is used for the short-term healing and maintenance of healing of erosive esophagitis (EE) and the symptomatic treatment of GERD. In adults, Nexium is also indicated for the risk reduction of NSAID-associated gastric ulcers in patients at increased risk (age ≥60 or history of gastric ulcer), the eradication of H. pylori (in combination with amoxicillin and clarithromycin) to reduce duodenal ulcer recurrence, and the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome.
How NEXIUM Works
Esomeprazole is a proton pump inhibitor (PPI) that suppresses gastric acid secretion by specifically inhibiting the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. As a substituted benzimidazole, esomeprazole is a prodrug that is protonated and converted within the acidic compartment of the parietal cell to its active form, an achiral sulphenamide. This active moiety blocks the final step of acid production, inhibiting both basal and stimulated gastric acid secretion regardless of the stimulus.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2001-02-20
- Routes
- ORAL
- Dosage Forms
- FOR SUSPENSION, DELAYED RELEASE, CAPSULE, DELAYED REL PELLETS
NEXIUM Approval History
What NEXIUM Treats
7 indicationsNEXIUM 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
NEXIUM Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Other CDER-designated drugs from the same sponsor (2016–2025).
Clinical Trial Registry
8 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05038969 | GRC/1/20/868 | Ph 1 | completed | Bioequivalence Study of Esomeprazole From Stomopral 40 mg Capsules Contain Enteric Coated Pellets (Future Pharmaceuticals Industries, Egypt) and Nexium 40 mg Delayed Release Capsules (AstraZeneca Sweden, Product of France) |
| NCT03558477 | YYPCT_YYD601_P1 | Ph 1 | completed | PK/PD Clinical Trial of YYD601 in Healthy Adult Male |
| NCT03211143 | 173HPS16024 | Ph 1 | completed | A Study to Compare PK, PD and Safety of CKD-381 in Healthy Subjects |
| NCT02711176 | 22/52/1662 | Ph 4 | completed | Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection |
| NCT02543606 | YSP-RFH3002-01 | Ph 4 | completed | Bioequivalence of Two Formulations of Esomeprazole |
| NCT01921647 YH4808-108 | YH4808-108 | Ph 1 | completed | The PK and PD Interaction Between YH4808, Amoxicillin and Clarithromycin in Healthy Subjects |
| NCT01135472 | 08197 | Ph 1 | completed | Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers |
| NCT00699426 Nexium | EudraCT: 2007-00405237 | Ph 3 | completed | The Effect of Nexium and Probiotics on Insulin Secretion and Cardiovascular Risk Factors in Patients With Type 2 Diabetes |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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
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
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