Nexium, Nexium control(esomeprazole)
Nexium, Vimovo (esomeprazole) is a small molecule pharmaceutical. Esomeprazole was first approved as Nexium on 2001-02-20. It is used to treat duodenal ulcer, esophagitis, gastroesophageal reflux, heartburn, and helicobacter infections amongst others in the USA. It has been approved in Europe to treat gastroesophageal reflux. The pharmaceutical is active against potassium-transporting ATPase alpha chain 1.
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Commercial
Trade Name
FDA
EMA
Nexium (generic drugs available since 2013-03-18)
CombinationsVimovo (generic drugs available since 2013-03-18)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Esomeprazole magnesium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NEXIUM | AstraZeneca | N-021153 RX | 2001-02-20 | 2 products, RLD, RS |
| NEXIUM | AstraZeneca | N-021957 RX | 2006-10-20 | 4 products, RLD, RS |
| NEXIUM | AstraZeneca | N-022101 RX | 2008-02-27 | 1 products, RLD |
| NEXIUM 24HR | AstraZeneca | N-204655 OTC | 2014-03-28 | 1 products, RLD, RS |
| NEXIUM 24HR | AstraZeneca | N-207920 OTC | 2015-11-23 | 1 products, RLD, RS |
Show 1 discontinued
Esomeprazole magnesium
+
Naproxen
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VIMOVO | Horizon Pharmaceutical | N-022511 RX | 2010-04-30 | 2 products, RLD |
Esomeprazole sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NEXIUM IV | AstraZeneca | N-021689 RX | 2005-03-31 | 1 products, RLD, RS |
Show 1 discontinued
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| duodenal ulcer | EFO_0004607 | D004381 | K26 |
| esophagitis | HP_0100633 | D004941 | K20 |
| gastroesophageal reflux | EFO_0003948 | D005764 | K21 |
| heartburn | — | D006356 | R12 |
| helicobacter infections | EFO_1000961 | D016481 | — |
| zollinger-ellison syndrome | — | D015043 | E16.4 |
Agency Specific
FDA
EMA
No data
ATC Codes
A: Alimentary tract and metabolism drugs
— A02: Drugs for acid related disorders
— A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
— A02BC: Proton pump inhibitors for peptic ulcer and gord
— A02BC05: Esomeprazole
— A02BD: Combinations for eradication of helicobacter pylori
— A02BD06: Esomeprazole, amoxicillin and clarithromycin
M: Musculo-skeletal system drugs
— M01: Antiinflammatory and antirheumatic products
— M01A: Antiinflammatory and antirheumatic products, non-steroids
— M01AE: Propionic acid derivatives, antiinflammatory and antirheumatic products
— M01AE52: Naproxen and esomeprazole
HCPCS
No data
Clinical
Clinical Trials
365 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Gastroesophageal reflux | D005764 | EFO_0003948 | K21 | 8 | 13 | 21 | 31 | 12 | 82 |
| Infections | D007239 | EFO_0000544 | 1 | — | 2 | 32 | 11 | 46 | |
| Healthy volunteers/patients | — | 35 | 1 | 1 | 5 | — | 41 | ||
| Dyspepsia | D004415 | EFO_0008533 | K30 | 2 | 6 | 4 | 10 | 1 | 21 |
| Stomach ulcer | D013276 | K25 | — | — | 12 | 2 | 1 | 15 | |
| Esophagitis | D004941 | HP_0100633 | K20 | 1 | 2 | 7 | 5 | — | 15 |
| Gastritis | D005756 | EFO_0000217 | K29.7 | 2 | 1 | 3 | 5 | 3 | 14 |
| Peptic ulcer | D010437 | HP_0004398 | K27 | 3 | 1 | 2 | 6 | 1 | 13 |
| Heartburn | D006356 | R12 | 1 | 1 | 3 | 7 | — | 11 | |
| Barrett esophagus | D001471 | EFO_0000280 | K22.7 | 1 | 1 | — | 3 | 2 | 7 |
Show 30 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | 1 | 2 | — | 2 | 5 |
| Duodenal ulcer | D004381 | EFO_0004607 | K26 | — | — | 3 | — | 1 | 4 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 2 | 1 | — | — | 3 |
| Gastrointestinal hemorrhage | D006471 | K92.2 | — | 1 | 2 | — | — | 3 | |
| Gastrointestinal diseases | D005767 | 1 | — | 2 | — | — | 3 | ||
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | 1 | 1 | — | 1 | 2 |
| Esophageal neoplasms | D004938 | C15 | — | 1 | 1 | — | — | 2 | |
| Arthritis | D001168 | EFO_0005856 | M05-M14 | 1 | — | 1 | — | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | — | 1 | 2 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 2 | — | — | 2 |
Show 15 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Autism spectrum disorder | D000067877 | F84.0 | 1 | 1 | — | — | — | 2 | |
| Replacement arthroplasty knee | D019645 | — | 1 | — | — | — | 1 | ||
| Neuralgia | D009437 | EFO_0009430 | — | 1 | — | — | — | 1 | |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | 1 | — | — | — | 1 |
| Deglutition disorders | D003680 | HP_0002015 | R13.1 | — | 1 | — | — | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 1 | — | — | — | 1 |
| Gram-negative bacterial infections | D016905 | — | 1 | — | — | — | 1 | ||
| Tooth erosion | D014077 | K03.2 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pharmacokinetics | D010599 | 4 | — | — | — | 1 | 5 | ||
| Therapeutic equivalency | D013810 | 2 | — | — | — | — | 2 | ||
| Neoplasms | D009369 | C80 | 2 | — | — | — | — | 2 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | — | — | — | — | 1 |
| Pulmonary arterial hypertension | D000081029 | 1 | — | — | — | — | 1 | ||
| Chronic hepatitis b | D019694 | EFO_0004197 | B18.1 | 1 | — | — | — | — | 1 |
| Lymphoma | D008223 | C85.9 | 1 | — | — | — | — | 1 | |
| Homeostasis | D006706 | 1 | — | — | — | — | 1 | ||
| Chronic pancreatitis | D050500 | EFO_0000342 | K86.1 | 1 | — | — | — | — | 1 |
Show 4 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pyloromyotomy | D000074882 | — | — | — | — | 1 | 1 | ||
| Calcium metabolism disorders | D002128 | EFO_0005769 | E83.5 | — | — | — | — | 1 | 1 |
| Radiotherapy | D011878 | — | — | — | — | 1 | 1 | ||
| Mortality | D009026 | EFO_0004352 | — | — | — | — | 1 | 1 | |
| Hemostasis | D006487 | — | — | — | — | 1 | 1 | ||
| Vasomotor rhinitis | D012223 | EFO_0007533 | J30.0 | — | — | — | — | 1 | 1 |
| Esophageal achalasia | D004931 | HP_0002571 | K22.0 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ESOMEPRAZOLE |
| INN | esomeprazole |
| Description | Esomeprazole is a 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole that has S configuration at the sulfur atom. An inhibitor of gastric acid secretion, it is used (generally as its sodium or magnesium salt) for the treatment of gastro-oesophageal reflux disease, dyspepsia, peptic ulcer disease, and Zollinger-Ellison syndrome. It has a role as a histamine antagonist, an EC 3.6.3.10 (H(+)/K(+)-exchanging ATPase) inhibitor, an anti-ulcer drug and an EC 1.4.3.4 (monoamine oxidase) inhibitor. It is a conjugate acid of an esomeprazole(1-). It is an enantiomer of a (R)-omeprazole. |
| Classification | Small molecule |
| Drug class | antiulcer agents (benzimidazole derivatives) |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | COc1ccc2[nH]c([S@@+]([O-])Cc3ncc(C)c(OC)c3C)nc2c1 |
Identifiers
| PDB | — |
| CAS-ID | 119141-88-7 |
| RxCUI | 283742 |
| ChEMBL ID | CHEMBL1201320 |
| ChEBI ID | 50275 |
| PubChem CID | 9568614 |
| DrugBank | DB00736 |
| UNII ID | N3PA6559FT (ChemIDplus, GSRS) |
Target
Agency Approved
ATP4A
ATP4A
Organism
Homo sapiens
Gene name
ATP4A
Gene synonyms
NCBI Gene ID
Protein name
potassium-transporting ATPase alpha chain 1
Protein synonyms
ATPase H+/K+ transporting alpha subunit, ATPase, H+/K+ exchanging, alpha polypeptide, ATPase, H+/K+ transporting, alpha polypeptide, epididymis secretory sperm binding protein, Gastric H(+)/K(+) ATPase subunit alpha, gastric H+/K+ ATPase alpha subunit, gastric H,K-ATPase catalytic subunit, gastric hydrogen-potassium ATPase, Proton pump
Uniprot ID
Mouse ortholog
Atp4a (11944)
potassium-transporting ATPase alpha chain 1 (Q9CV46)
Alternate
No data
Variants
Clinical Variant
No data
Financial
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Nexium - AstraZeneca
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Trends
PubMed Central
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Additional graphs summarizing 6,658 documents
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Safety
Black-box Warning
Black-box warning for: Vimovo
Adverse Events
Top Adverse Reactions
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2,145 adverse events reported
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