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Label indication 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. ( 1.1 ) • Maintenance of healing of EE in adults. FDA label
Also known as Esomeprazole magnesium (Nexium), Nexium
esomeprazole magnesium · 3 trials · 4 indications
Presence/absence of Erosive Esophagitis for all patients by assessment of Esophagogastroduodenoscopy at the end of the 16-week maintenance phase
| Arm | Type | Description |
|---|---|---|
| Nexium - high dose | ACTIVE_COMPARATOR | Arm 1 (High dose = Healing dose) |
| Nexium - Low dose | ACTIVE_COMPARATOR | Arm 2 (Low dose = ½ healing dose) |
| 1 | EXPERIMENTAL | esomeprazole magnesium 5 mg, weight 8 kg to \< 20kg |
| 2 | EXPERIMENTAL | esomeprazole magnesium 10 mg, weight 8 kg to \< 20kg |
| 3 | EXPERIMENTAL | esomeprazole magnesium 10 mg, weight \> 20 kg |
| 4 | EXPERIMENTAL | esomeprazole magnesium 20 mg, weight \> 20 kg |
| Name | Type | Description |
|---|---|---|
| Nexium 20mg | DRUG | Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks. |
| Nexium 10mg | DRUG | Nexium® (Esomeprazole) gastro-resistant granules for oral suspension 10 or 20 mg taken once daily for 8 weeks, and then 10 or 5 mg taken once daily for 16 weeks. |
| Esomeprazole magnesium (Nexium) | DRUG | - |
| esomeprazole magnesium | DRUG | capsules, oral, qd, one day |
Inclusion Criteria: 1. Patient must be 1 to 11 years of age 2. Patients must have a clinical history of GERD for at least 3 months before the start of study 3. For the healing phase: Patients must have confirmed presence of EE at endoscopy performed within one week of the start of the healing phase...
Esomeprazole magnesium is used for endoscopically-proven gastroesophageal reflux disease (GERD) and for gastric acid hypersecretory conditions including Zollinger-Ellison syndrome. It is a small molecule developed by AstraZeneca PLC under the ticker AZN. Clinical study NCT00687245 evaluated it in children 1 to 11 years old with endoscopically-proven GERD.
Esomeprazole magnesium targets ATP4A and ATP4B, the subunits of the gastric proton pump. It acts as an inhibitor of this target. By inhibiting the proton pump, it reduces gastric acid secretion, which is the basis for its use in acid-related conditions such as GERD and Zollinger-Ellison syndrome.
Esomeprazole magnesium is developed by AstraZeneca PLC, which trades under the ticker AZN. The company is the sponsor behind the clinical studies of this small molecule in gastrointestinal conditions, including endoscopically-proven GERD and Zollinger-Ellison syndrome.
Esomeprazole magnesium is in Phase 1 development according to its current development stage. It is an investigational small molecule and is not stated to be approved. Its clinical program includes a completed Phase 1 pharmacokinetic study and a completed Phase 3 study in gastric acid hypersecretory states.
Esomeprazole magnesium has been studied in NCT00687245, a completed Phase 1 pharmacokinetic trial in patients 1 to 11 years old with endoscopically-proven GERD, and NCT00079833, a completed Phase 3 trial in patients with gastric acid hypersecretory states including idiopathic hypersecretion and Zollinger-Ellison syndrome.
Yes, esomeprazole magnesium is also known as Nexium. Esomeprazole magnesium (Nexium) is the same active small molecule developed by AstraZeneca PLC under the ticker AZN. Both names refer to the same agent studied in GERD and Zollinger-Ellison syndrome.