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esomeprazole magnesium

Generic: ESOMEPRAZOLE MAGNESIUM·Brand: ESOMEPRAZOLE MAGNESIUM, NEXIUM, NEXIUM 24HR

esomeprazole magnesium: sourced relationships with 3 companies · 1 clinical trial tracked · 9 FDA decisions.

esomeprazole magnesium evidence translation

What we can confirm

9 FDA records · 1 tracked trial

What it means

More than one company relationship is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch active trials and any change in FDA or trial status.
BioSniper AIPage evidence connected

Prepared research question

What is verified about esomeprazole magnesium, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

Erosive Esophagitis

Study sponsors

No additional listed-company sponsor is linked.

Dated Pipeline Records (3)
CompanyDated record stage
ASTRAZENECA PLC (AZN)
Reported 2006-10-20 · Current development: unknownSource
Erosive Esophagitis
Phase 3
LANNETT CO INC (LCI)
Reported 2017-09-01 · Current development: unknownSource
Approved
DR REDDYS LABORATORIES LTD (RDY)
Reported 2024-04-30 · Current development: unknownSource
Approved
Clinical Trial Registry Records (1)

A Phase III Study to Assess the Efficacy and Safety of NEXIUM for Maintenance of Healing of Erosive Esophagitis in Pediatric Patients 1 to 11 Years of Age

NCT05267613Registry updated 2026-07-27·Phase 3·AZN
Active, not recruiting

Primary endpoint: Presence / absence of Erosive Esophagitis

InterventionalRandomizedquadruple53 enrolledStarted 2022-07Completion 2026-0841 sites · Argentina, Australia, Belgium, Greece…AstraZeneca
FDA Decisions9 records
Approval(RDY)FDA ↗
ANDA207198UNKNOWNStandardOralCapsule, Delayed Release
Approval(RDY)FDA ↗
ANDA211571UNKNOWNStandardOralTablet, Delayed Release
Approval(RDY)FDA ↗
ANDA207673UNKNOWNStandardOralCapsule, Delayed Release
Approval(LCI)FDA ↗
ANDA205563UNKNOWNStandardOralCapsule, Delayed Rel Pellets
ApprovalUses • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect(AZN)FDA ↗
NDA207920Type 3 - New Dosage FormStandardOralTablet, Delayed Release
Approval(RDY)FDA ↗
ANDA078279OralCapsule, Delayed Rel Pellets
ApprovalUses treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn; this drug may take 1 to 4 days for full effect(AZN)FDA ↗
NDA204655Type 8 - Partial Rx to OTC SwitchStandardOralCapsule, Delayed Release
Approval1 INDICATIONS AND USAGE 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. ( 1.2 ) • Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3 ) • Risk(AZN)FDA ↗
NDA022101Type 3 - New Dosage FormStandardOralFor Suspension, Delayed Release
Approval1 INDICATIONS AND USAGE 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. ( 1.2 ) • Short-term treatment of heartburn and other symptoms associated GERD in adults and pediatric patients 12 years to 17 years of age. ( 1.3 ) • Risk(AZN)FDA ↗
NDA021957Type 3 - New Dosage FormStandardOralFor Suspension, Delayed Release

Frequently asked questions

Which companies have sourced relationships with esomeprazole magnesium?

esomeprazole magnesium has dated SEC/FDA relationship records for ASTRAZENECA PLC, LANNETT CO INC, DR REDDYS LABORATORIES LTD.

How many clinical trials involve esomeprazole magnesium?

BioSniper tracks 1 clinical trial involving esomeprazole magnesium.

What is esomeprazole magnesium's latest FDA decision?

The most recent tracked FDA decision for esomeprazole magnesium is Approval, dated April 30, 2024.