Nexium
(esomeprazole)ApprovedSmall molecule
Esomeprazole reduces stomach acid to treat heartburn, acid reflux, and ulcers. It helps protect the stomach lining and allows it to heal.[2] Nexium is currently approved and in use across 49 indications[4].[1]
Nexium is one of 840 small molecule programs targeting Granuloma. It is currently in Approved.
49
Indications
289
Total Trials
14
Active Trials
839
Competitors
7
FDA Applications
NDA/BLA/ANDA regulatory filings
1
Patents
Pipeline
Status by Indication[4][1]
Indication
Showing 10 of 48 indications
Competition
Competitive Landscape
1050 competitors in Asthma
#DrugCompanyPhaseTrials
1Nexium
DDexcel Pharma Technologies Ltd.
Approved
Nucala
GGlaxo Dba Glaxosmithkline
Preclinical
Cinqair
TevaPreclinical
Asmanex
NovartisPreclinical
Solu-Medrol
MMassachusetts Eye and Ear Infirmary
Preclinical
Blood Withdrawn
Emergent BioSolutionsPreclinical
Vit D
PPost Graduate Institute of Medical Education and Research, Chandigarh
Preclinical
Ozone
TTanta University
Preclinical
Biological Drug
UUniversitaire Ziekenhuizen KU Leuven
Preclinical
Inhaled Corticosteroids
Boehringer IngelheimPreclinical
Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.
Timeline
Expected Milestones
Clinical
Trials by Indication[1]
Helicobacter Pylori15 trials
Show 12 more trials
Keverprazan Combined with Amoxicillin for the Treatment of Helicobacter Pylori
Not yet recruiting·KKey Laboratory for Gastrointestinal Diseases of Gansu Province·N/A·NCT06851468·264 enrolled
Effect of Vitamin D on Drug Resistant Helicobacter Pylori (HP) Eradication Study
Unknown status·—·Phase 3·NCT03142620·96 enrolled
Gastroesophageal Reflux Disease15 trials
Show 12 more trials
Symptomatic Gastroesophageal Reflux Disease: Double Blind Randomized Controlled Study of On-demand Therapy Versus Maintenance Therapy
Completed·—·Phase 3·NCT00164840·244 enrolled
Gastroesophageal Reflux Disease (GERD)/Nighttime Heartburn and Driving Performance
Completed·—·N/A·NCT01079884·18 enrolled
Esophagitis11 trials
Show 8 more trials
Rate of Complete Symptom Relief, Prevention of Symptom Relapse: Grades A and B Esophagitis of Esomeprazole Therapy
Completed·—·Phase 4·NCT01874535·408 enrolled
Vonaprazan Versus Esomeprazole for Healing of LA Grade B or Higher Esophagitis After POEM
Recruiting·—·N/A·NCT06955520·300 enrolled
Efficacy and Safety8 trials
Show 5 more trials
Peptic ulcer7 trials
Oral vs Intravenous and Proton Pump Inhibitor (PPI）for Peptic Ulcer Bleeding (PUB)
Withdrawn·—·Phase 4·NCT01123031
Show 4 more trials
Compare Efficacy of Gastric Acid Suppression by Oral and Intravenous Administration of Esomeprazole in Patients With Peptic Ulcer
Unknown status·—·Phase 4·NCT00471029·20 enrolled
Effect of IV and Oral Esomeprazole in Prevention of Recurrent Bleeding From Peptic Ulcers After Endoscopic Therapy
Completed·—·Phase 3·NCT01142245·263 enrolled
70 more indications
Helicobacter Pylori Infection7 trials
Helicobacter Pylori Eradication6 trials
Vonoprazan for Helicobacter Pylori Eradication in Adolescents
Completed·—·Phase 3·NCT06162949·242 enrolled
Show 3 more trials
Comparison of the Efficacies of Two Novel Dose Dual Therapies in the First-line Helicobacter Pylori Eradication
Unknown status·—·Phase 3·NCT06811207·300 enrolled
Dyspepsia6 trials
Show 3 more trials
BRAVO Study for Functional Dyspepsia
Completed·—·Phase 4·NCT01349413·130 enrolled
Interaction5 trials
Oral5 trials
Prevention4 trials
Intravenous4 trials
Show 1 more trial
A Comparison of Gastric pH Control With High Dose Intravenous or Oral Esomeprazole
Terminated·—·Phase 2·NCT00164788·7 enrolled
Tics4 trials
Adult4 trials
Barrett's esophagus3 trials
Preeclampsia3 trials
Metformin and Esomeprazole in Treatment of Early Onset Preeclampsia
Unknown status·—·N/A·NCT03717701·120 enrolled
Esomeprazole in Treatment of Early Onset Preeclampsia (ESOPE Trial)
Completed·—·Phase 2/3·NCT03213639·205 enrolled
ESS3 trials
MPA3 trials
Randomized3 trials
Clopidogrel3 trials
Gastro-oesophageal Reflux Disease2 trials
Helicobacter2 trials
AIN2 trials
Medication2 trials
Bismuth Quadruple Therapy2 trials
GERD2 trials
Gastrointestinal2 trials
Duodenal Ulcer2 trials
Heartburn2 trials
Double-blind2 trials
Laryngopharyngeal Reflux2 trials
Non-Allergic Rhinitis1 trial
Reflux Episodes1 trial
SLE1 trial
Peptic Ulcer Disease1 trial
Drug Interactions1 trial
Function1 trial
Gastric Functions & Proton Pump Inhibitor( PPI) Study
Completed·—·Phase 4·NCT00951431·155 enrolled
Thyroid Associated Ophthalmopathy1 trial
Chronic Gastritis1 trial
Schizophrenia1 trial
Pneumonia1 trial
Proton Pump Inhibitors and Risk of Community-acquired Pneumonia
Completed·CCanadian Network for Observational Drug Effect Studies, CNODES··NCT02555852·4,238,504 enrolled
ART1 trial
Intraoperative Bleeding1 trial
Infusion1 trial
Trial1 trial
Allergy1 trial
Bariatric Surgery1 trial
Advanced Solid Tumors1 trial
Rescue Therapy for Helicobacter Pylori1 trial
Gastritis1 trial
A RCT of Triple Therapy With Proton Pump Inhibitor vs Vonoprazan for Helicobacter Pylori Gastritis
Unknown status·—·Phase 4·NCT03908619·252 enrolled
First-line Treatment1 trial
Antiplatelet1 trial
Bone pain1 trial
Non Steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy
Not yet recruiting·—·Phase 2·NCT06903585·385 enrolled
Type 2 Diabetes1 trial
The Effect of Esomeprazole on Type 2 Diabetes
Completed·—·N/A·NCT03598738·32 enrolled
Intensive Care Unit1 trial
Head and Neck Cancer1 trial
Cirrhosis1 trial
Heart Disease1 trial
Unspecified15 trials
Show 12 more trials
Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations
Completed·—·Phase 2·NCT01983774·21 enrolled
Regulatory
FDA Approval Timeline[5]
Feb 20, 2001
NEXIUM
NDA NDA021153
Mar 31, 2005
NEXIUM IV
NDA NDA021689
Feb 27, 2008
NEXIUM
NDA NDA022101
Dec 15, 2011
NEXIUM
NDA NDA021957
Mar 28, 2014
NEXIUM 24HR
NDA NDA204655
Nov 23, 2015
NEXIUM 24HR
NDA NDA207920
Oct 20, 2020
ESOMEPRAZOLE MAGNESIUM
NDA NDA214278
Sources
References
- [1]
- [2]MedlinePlus Drug Information — Nexium drug information. U.S. National Library of Medicine, National Institutes of Health.
- [3]
- [4]Open Targets Platform — Drug–disease associations for esomeprazole. EMBL-EBI & Wellcome Sanger Institute.
- [5]
- [6]FDA Orange Book — Patent and exclusivity data for Nexium. U.S. Food & Drug Administration.
- [7]
Details
Drug Info
Quick Facts
- Mechanism of Action
- Potassium-Transporting Atpase Inhibitor[3]
- Modality
- Small molecule[3]
- Highest Phase
- Approved[1]
- Company
- DDexcel Pharma Technologies Ltd.
Patent Landscape[6]
Patent Cliff
Dec 8, 2036
Earliest patent expiration — generic entry possible after this date
Patent #Expires
10076494Dec 8, 2036