Data updated: May 26, 2026
NEXIUM 24HR (esomeprazole magnesium)
Infectious Disease
Approved 2014-03-28
2
Indications
--
Phase 3 Trials
12
Years on Market
Details
- Status
- Over-the-counter
- First Approved
- 2014-03-28
- Routes
- ORAL
- Dosage Forms
- CAPSULE, DELAYED RELEASE, TABLET, DELAYED RELEASE
NEXIUM 24HR Approval History
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
16 FDA actions from 2014 to 2022
Jun 2016 SUPPL
Mfg
Jun 2015 SUPPL
Mfg
What NEXIUM 24HR Treats
2 FDA approvalsOriginally approved for its first indication in 2014 . Covers 2 distinct patient populations.
- Other (2)
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Clinical Trial Registry
1 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01135472 | 08197 | Ph 1 | completed | Plasm Gastrin Concentrations in Response to Nexium Administration in Healthy Volunteers |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
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 24HR FDA Label Details
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.