Nexium, Nexium control(esomeprazole)
Esomeprazole, Esomeprazole Magnesium, Nexium (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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Esomeprazole, Esomeprazole magnesium, Nexium (discontinued: Esomeprazole, Esomeprazole magnesium, Nexium)
CombinationsNaproxen esomeprazole magnesium (discontinued: Naproxen esomeprazole magnesium, Vimovo)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Esomeprazole strontium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ESOMEPRAZOLE STRONTIUM | Belcher Pharmatech | N-202342 DISCN | 2013-08-06 | 2 products, RLD |
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Esomeprazole sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NEXIUM IV | AstraZeneca | N-021689 DISCN | 2005-03-31 | 2 products, RLD |
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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 Therapeutics Public | N-022511 DISCN | 2010-04-30 | 2 products, RLD |
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Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acid reducer | ANDA | 2024-11-01 |
| basic care esomeprazole magnesium | ANDA | 2024-07-25 |
| basic care omeprazole and sodium bicarbonate | ANDA | 2021-07-22 |
| berkley and jensen heartburn treatment | ANDA | 2024-07-31 |
| careone esomeprazole magnesium | ANDA | 2019-12-18 |
| dg health esomeprazole magnesium | ANDA | 2024-08-02 |
| equaline esomeprazole magnesium | ANDA | 2024-08-01 |
| equate omeprazole and sodium bicarbonate | ANDA | 2021-05-04 |
| esomeprazole | ANDA | 2023-11-03 |
| esomeprazole dr | ANDA | 2023-08-23 |
Show 41 more
Indications
FDA
EMA
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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
540 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 | 9 | 19 | 29 | 36 | 24 | 114 |
| Infections | D007239 | EFO_0000544 | — | 2 | 5 | 9 | 61 | 33 | 107 |
| Healthy volunteers/patients | — | — | — | 56 | 1 | 1 | 6 | 2 | 65 |
| Helicobacter infections | D016481 | EFO_1000961 | — | 2 | 5 | 9 | 25 | 20 | 58 |
| Peptic esophagitis | D004942 | EFO_1001095 | — | 1 | 7 | 14 | 8 | 10 | 39 |
| Ulcer | D014456 | MPATH_579 | — | 2 | 2 | 17 | 10 | 6 | 37 |
| Gastritis | D005756 | EFO_0000217 | K29.7 | 3 | 1 | 5 | 19 | 6 | 34 |
| Communicable diseases | D003141 | — | — | 1 | 3 | 4 | 15 | 13 | 34 |
| Esophagitis | D004941 | HP_0100633 | K20 | 2 | 8 | 12 | 6 | 4 | 31 |
| Peptic ulcer | D010437 | HP_0004398 | K27 | 3 | 1 | 4 | 16 | 6 | 30 |
Show 72 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Duodenal ulcer | D004381 | EFO_0004607 | K26 | 1 | — | 5 | — | 5 | 11 |
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | 2 | 1 | — | 1 | 3 |
| Recurrence | D012008 | — | — | 1 | 1 | 1 | — | 1 | 3 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 1 | — | 2 | — | — | 3 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 2 | 1 | — | — | 3 |
| Esophageal neoplasms | D004938 | — | C15 | — | 1 | 1 | — | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | — | 1 | 2 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | 1 | — | 1 | 2 |
| Gastrinoma | D015408 | — | — | — | — | 1 | — | 1 | 2 |
| Zollinger-ellison syndrome | D015043 | — | E16.4 | — | — | 1 | — | 1 | 2 |
Show 27 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 1 | — | — | — | 2 |
| Dermatitis | D003872 | HP_0011123 | L30.9 | — | 2 | — | — | — | 2 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | 1 | 1 | — | — | — | 2 |
| Head and neck neoplasms | D006258 | — | — | — | 1 | — | — | 1 | 2 |
| Replacement arthroplasty knee | D019645 | — | — | — | 1 | — | — | — | 1 |
| Neuralgia | D009437 | EFO_0009430 | — | — | 1 | — | — | — | 1 |
| Chronic pain | D059350 | HP_0012532 | — | — | 1 | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | — | — | 1 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 1 | — | — | — | 1 |
| Heart valve diseases | D006349 | EFO_0009551 | I08 | — | 1 | — | — | — | 1 |
Show 12 more
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 | — | — | 4 | — | — | — | — | 4 |
| Hepatitis b | D006509 | — | — | 2 | — | — | — | — | 2 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 2 | — | — | — | — | 2 |
| Pharmacological phenomena | D000069437 | — | — | 2 | — | — | — | — | 2 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 1 | — | — | — | — | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | — | — | — | — | 1 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | — | — | — | — | 1 |
| Pulmonary arterial hypertension | D000081029 | — | — | 1 | — | — | — | — | 1 |
Show 16 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Drug-related side effects and adverse reactions | D064420 | — | T88.7 | — | — | — | — | 4 | 4 |
| Pneumonia | D011014 | EFO_0003106 | — | — | — | — | — | 2 | 2 |
| Gastrointestinal microbiome | D000069196 | — | — | — | — | — | — | 2 | 2 |
| Shoulder injuries | D000070599 | — | — | — | — | — | — | 1 | 1 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | — | — | — | 1 | 1 |
| Pyloromyotomy | D000074882 | — | — | — | — | — | — | 1 | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | — | — | — | 1 | 1 |
| Calcium metabolism disorders | D002128 | EFO_0005769 | E83.5 | — | — | — | — | 1 | 1 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | — | — | 1 | 1 |
Show 27 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Esomeprazole |
| INN | esomeprazole |
| Description | (R)-omeprazole is a 5-methoxy-2-{[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulfinyl}-1H-benzimidazole that has R configuration at the sulfur atom. It is an enantiomer of an esomeprazole. |
| 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 | — |
| ChEMBL ID | CHEMBL1201320 |
| ChEBI ID | 50275 |
| PubChem CID | 9579578 |
| 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
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Variants
No data
Financial
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Vimovo – Horizon Therapeutics Public
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Nexium – AstraZeneca
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Estimated US medical usage
Esomeprazole
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Refill frequency
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Esomeprazole
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Naproxen
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Naproxen and esomeprazole magnesium, Vimovo
Adverse Events
Top Adverse Reactions
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118,878 adverse events reported
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