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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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Nexium (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 DISCN | 2010-04-30 | 2 products, RLD |
Hide discontinued
Esomeprazole sodium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NEXIUM IV | AstraZeneca | N-021689 RX | 2005-03-31 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| acid reducer | ANDA | 2023-10-25 |
| basic care esomeprazole magnesium | ANDA | 2020-08-19 |
| basic care omeprazole and sodium bicarbonate | ANDA | 2021-07-22 |
| berkley and jensen heartburn treatment | ANDA | 2020-01-29 |
| careone esomeprazole magnesium | ANDA | 2019-12-18 |
| dg health esomeprazole magnesium | ANDA | 2021-12-09 |
| equate omeprazole and sodium bicarbonate | ANDA | 2021-05-04 |
| esomeprazole | ANDA | 2023-11-03 |
| esomeprazole dr | ANDA | 2023-08-23 |
| esomeprazole magnesium | ANDA | 2024-01-18 |
Show 39 more
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
527 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 | 17 | 23 | 33 | 19 | 97 |
| Infections | D007239 | EFO_0000544 | — | 1 | 1 | 3 | 43 | 21 | 69 |
| Healthy volunteers/patients | — | — | — | 43 | 1 | 1 | 6 | 1 | 51 |
| Dyspepsia | D004415 | EFO_0008533 | K30 | 3 | 6 | 4 | 12 | 1 | 24 |
| Stomach ulcer | D013276 | — | K25 | 1 | — | 13 | 2 | 5 | 21 |
| Gastritis | D005756 | EFO_0000217 | K29.7 | 2 | 1 | 3 | 8 | 4 | 18 |
| Peptic ulcer | D010437 | HP_0004398 | K27 | 3 | 1 | 2 | 9 | 1 | 16 |
| Esophagitis | D004941 | HP_0100633 | K20 | 1 | 2 | 7 | 5 | 1 | 16 |
| Heartburn | D006356 | — | R12 | 1 | 1 | 3 | 7 | 1 | 12 |
| Peptic esophagitis | D004942 | EFO_1001095 | — | 1 | 2 | 4 | 2 | 2 | 11 |
Show 39 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 | — | 4 | — | 5 | 10 |
| Arthritis | D001168 | HP_0001369 | M05-M14 | 4 | — | 2 | — | — | 6 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | 1 | 2 | — | 2 | 5 |
| Gastrointestinal diseases | D005767 | — | — | 1 | — | 2 | — | 2 | 5 |
| Non-erosive reflux disease | D000096663 | — | — | — | 1 | 1 | — | 2 | 4 |
| Asthma | D001249 | EFO_0000270 | J45 | — | 2 | 1 | — | — | 3 |
| Gastrointestinal hemorrhage | D006471 | HP_0002239 | K92.2 | — | 1 | 2 | — | — | 3 |
| Eosinophilic esophagitis | D057765 | EFO_0004232 | K20.0 | — | 1 | 1 | — | 1 | 2 |
| Esophageal neoplasms | D004938 | — | C15 | — | 1 | 1 | — | — | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | — | 1 | — | 1 | 2 |
Show 19 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 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | 1 | 1 | — | — | — | 2 |
| Replacement arthroplasty knee | D019645 | — | — | — | 1 | — | — | — | 1 |
| Neuralgia | D009437 | EFO_0009430 | — | — | 1 | — | — | — | 1 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | — | — | — | 1 |
| Heart valve diseases | D006349 | EFO_0009551 | I08 | — | 1 | — | — | — | 1 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | 1 | — | — | — | 1 |
| Autistic disorder | D001321 | HP_0000717 | F84.0 | — | 1 | — | — | — | 1 |
| Deglutition disorders | D003680 | HP_0002015 | R13.1 | — | 1 | — | — | — | 1 |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 1 | — | — | — | 1 |
Show 3 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 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 2 | — | — | — | — | 2 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | — | — | — | — | 1 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | — | — | — | — | 1 |
| Pulmonary arterial hypertension | D000081029 | — | — | 1 | — | — | — | — | 1 |
| Sickle cell anemia | D000755 | EFO_0000697 | D57 | 1 | — | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | 1 | — | — | — | — | 1 |
| Homeostasis | D006706 | — | — | 1 | — | — | — | — | 1 |
| Chronic pancreatitis | D050500 | EFO_0000342 | K86.1 | 1 | — | — | — | — | 1 |
Show 5 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 | — | — | — | — | 2 | 2 |
| Drug interactions | D004347 | — | — | — | — | — | — | 1 | 1 |
| Pyloromyotomy | D000074882 | — | — | — | — | — | — | 1 | 1 |
| Calcium metabolism disorders | D002128 | EFO_0005769 | E83.5 | — | — | — | — | 1 | 1 |
| Covid-19 | D000086382 | — | U07.1 | — | — | — | — | 1 | 1 |
| Radiotherapy | D011878 | — | — | — | — | — | — | 1 | 1 |
| Mortality | D009026 | EFO_0004352 | — | — | — | — | — | 1 | 1 |
| Hemostasis | D006487 | — | — | — | — | — | — | 1 | 1 |
| Sudden death cardiac | D016757 | EFO_0004278 | — | — | — | — | — | 1 | 1 |
| Thrombocytopenic purpura idiopathic | D016553 | EFO_0007160 | D69.3 | — | — | — | — | 1 | 1 |
Show 8 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
No data
Variants
No data
Financial
Revenue by drug
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Nexium – AstraZeneca
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Vimovo – Horizon Therapeutics Public
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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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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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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,811 documents
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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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111,126 adverse events reported
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