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Drug

Esomeprazole

Approved · EMA
Emerging researchLate-stage development
Also known as Esomeprazole Strontium, NexIUM, Omeprazole S-form, Vimovo+8 more

Esomeprazole Strontium, NexIUM, Omeprazole S-form, Vimovo, (-)-omeprazole, (S)-(-)-omeprazole, (S)-omeprazole, Perprazole, Esomeprazol, Esomeprazole Magnesium, Esomeprazole Sodium, Esomeprazolum.

RxNorm283742ChEMBLCHEMBL1201320UNIIN3PA6559FT
1
Research papers
9
Active clinical trials
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Tolerability of NX-5948 Tablets Following Single and Multiple Ascending Doses, the Relative Bioavailability of NX-5948 Tablets Compared to Capsules, the Effect of NX-5948 on the QT Interval, the Effect of Food on the Pharmacokinetics of NX-5948, Drug-Drug Interactions With NX-5948, and the Intra-Subject Variability of the Bioavailability of NX-5948 Capsules

Clinical trial2026-07-28Status changed to Completed · ClinicalTrials.gov

An Open-Label Pilot Study of Esomeprazole in Children With Autism

Clinical trial2026-06-25Results expected Q4 2028 · ClinicalTrials.gov

A Multicenter, Double-blind, Randomized, Investigator-initiated Trial to Evaluate the Degree of Symptom Relief of Zastaprazan and Esomeprazole in Patients With Erosive Reflux Disease With Night-time Heartburn Symptoms

Clinical trial2026-05-29Primary completion · ClinicalTrials.gov

A Multiple Dose Study in Healthy Participants to Investigate the Safety, Tolerability, and Pharmacokinetics of LY3502970

Clinical trial2026-05-29Results posted · ClinicalTrials.gov

Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM

Clinical trial2026-04-27Results expected Q4 2027 · ClinicalTrials.gov

A Comparison Between a High Dose PPI Intravenous Infusion and Oral Acid Pump Inhibitors After Endoscopic Haemostasis to Bleeding Peptic Ulcers

Clinical trial2026-03-18Results expected Q1 2028 · ClinicalTrials.gov

Efficacy and Safety of Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: A Prospective, Multicenter, Randomized Controlled Trial

Clinical trial2025-12-02Results expected Q3 2026 · ClinicalTrials.gov

Comparison of Effectiveness in Patients of Gastroesophageal Reflux Disease Taking Esomeprazole Versus Vonoprazan.

Clinical trial2025-09-30Completed · ClinicalTrials.gov

Study on The Efficacy and Safety of Berberine,Amoxicillin and Vonoprazan Containing Triple Therapy in Helicobacter Pylori First-Line Eradication

Clinical trial2025-06-25Completed · ClinicalTrials.gov

Use of Combination Metformin and Esomeprazole in Preterm Pre-eclampsia: a Randomized Controlled Trial

Clinical trial2025-05-08Terminated · ClinicalTrials.gov

Approval: Nexium Control (EMA)

Regulatory2013-08-26EMA

Randomised clinical trial: high-dose acid suppression for chronic cough - a double-blind, placebo-controlled study.

Research2010-11-17Alimentary pharmacology & therapeutics

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Esomeprazole
Aliases & brands
Esomeprazole StrontiumNexIUMOmeprazole S-formVimovo(-)-omeprazole(S)-(-)-omeprazole(S)-omeprazolePerprazoleEsomeprazolEsomeprazole MagnesiumEsomeprazole SodiumEsomeprazolum
RxNorm CUI
283742
ChEMBL ID
CHEMBL1201320
UNII
N3PA6559FT
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2013-08-26
Latest approval
2013-08-26
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2013-08-26Approval
Approval: Nexium Control (EMA)

Indication: Nexium Control is indicated for the short-term treatment of reflux symptoms (e.g. heartburn and acid regurgitation) in adults.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

176 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
176
registered trials across all phases
LATEST COMPLETION 2026
9
Active studies
9
Recruiting
129
Late-stage (III+)
126
Completed
41
Discontinued
PHASE DISTRIBUTIONn = 176
Early Phase 11Phase 129Phase 1 / 23Phase 214Phase 2 / 32Phase 342Phase 465Phase N / A20

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Efficacy and Safety of Vonorasan Versus Esomeprazole in the Treatment of Ulcers After Endoscopic Submucosal Dissection (ESD): a Multicentre, Parallel-design, Double-blind, Randomised Controlled Study

Not yet recruitingPH IVShicai Yen=1962029

A Comparison Between a High Dose PPI Intravenous Infusion and Oral Acid Pump Inhibitors After Endoscopic Haemostasis to Bleeding Peptic Ulcers

RecruitingPH IVChinese University of Hong Kongn=5942028

Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind, Placebo-controlled Trial

RecruitingPH IVUniversitätsklinikum Hamburg-Eppendorfn=4762028

A Multicenter, Double-blind, Randomized, Investigator-initiated Trial to Evaluate the Degree of Symptom Relief of Zastaprazan and Esomeprazole in Patients With Erosive Reflux Disease With Night-time Heartburn Symptoms

RecruitingPH IVIncheon St.Mary's Hospitaln=1602026

Efficacy and Safety of Saccharomyces Boulardii Combined With Bismuth Quadruple Therapy for Helicobacter Pylori Rescue Treatment: A Prospective, Multicenter, Randomized Controlled Trial

RecruitingPH IVKey trialYongquan Shin=1,2482026

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 1 Study in Healthy Volunteers to Evaluate the Safety and Tolerability of NX-5948 Tablets Following Single and Multiple Ascending Doses, the Relative Bioavailability of NX-5948 Tablets Compared to Capsules, the Effect of NX-5948 on the QT Interval, the Effect of Food on the Pharmacokinetics of NX-5948, Drug-Drug Interactions With NX-5948, and the Intra-Subject Variability of the Bioavailability of NX-5948 Capsules

CompletedPH INurix Therapeutics, Inc.n=2232026

Comparison of Effectiveness in Patients of Gastroesophageal Reflux Disease Taking Esomeprazole Versus Vonoprazan.

CompletedN/AMuhammad Aamir Latifn=8242025

Study on The Efficacy and Safety of Berberine,Amoxicillin and Vonoprazan Containing Triple Therapy in Helicobacter Pylori First-Line Eradication

CompletedPH IVXijing Hospital of Digestive Diseasesn=5582025

The Need of Revisiting to an Outpatient Clinic After the Prescription of Vonoprazan or Esomeprazole for 4weeks for Erosive Esophagitis Without Any Appointments

CompletedN/AShowa Inan General Hospitaln=3002024

A Multi-Center, Randomized, Open-Label Study to Evaluate Symptom Relief and Safety After Using Fexuprazan 40 Mg Compared to Esomeprazole 40 Mg in Patients With Gastroesophageal Reflux Disease (GERD)

CompletedPH IIIIndonesia Universityn=1452024

Rescue Therapy for Helicobacter Pylori Eradication: A Randomized and Non-inferiority Trail of Vonorazon and Amoxicillin Dual Therapy Versus Bismuth-containing Quadruple Therapy

CompletedPH IVYongquan Shin=6882024

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • Alimentary pharmacology & therapeutics1
Leading researchers
  • Bright SD1
  • Buckmire R1
  • Couch M1
  • Crockett SD1
  • Dellon ES1
  • Galanko JA1
  • Heidt-Davis P1
  • Henke D1
Leading institutions
free-text, unnormalised
  • Center for Esophageal Diseases and Swallowing1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.