Esomeprazole strontium
Nexium Control (esomeprazole strontium) is a small molecule pharmaceutical. Esomeprazole strontium was first approved as Esomeprazole strontium on 2013-08-06. 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.
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New Drug Application (NDA)
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FDA
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Brand Name | Status | Last Update |
|---|---|---|
| acid reducer | ANDA | 2024-11-01 |
| basic care esomeprazole magnesium | ANDA | 2024-07-25 |
| 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 |
| esomeprazole | ANDA | 2023-11-03 |
| esomeprazole dr | ANDA | 2023-08-23 |
| esomeprazole magnesium | ANDA | 2024-10-29 |
| esomeprazole magnesium delayed-release 20 mg mini esomeprazole magnesium delayed-release capsules, 20 mg | ANDA | 2024-03-18 |
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Agency Specific
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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
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Clinical
Clinical Trials
530 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 | 30 | 36 | 24 | 115 |
| 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 | 19 | 57 |
| 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 |
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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 |
| 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 |
| Recurrence | D012008 | — | — | — | 1 | 1 | — | 1 | 2 |
| Gastrinoma | D015408 | — | — | — | — | 1 | — | 1 | 2 |
| Zollinger-ellison syndrome | D015043 | — | E16.4 | — | — | 1 | — | 1 | 2 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | — | — | 2 | — | — | 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 |
| 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 |
| Autistic disorder | D001321 | HP_0000717 | F84.0 | — | 1 | — | — | — | 1 |
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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 |
| Pharmacological phenomena | D000069437 | — | — | 2 | — | — | — | — | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | — | — | — | — | 1 |
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | 1 | — | — | — | — | 1 |
| Pulmonary arterial hypertension | D000081029 | — | — | 1 | — | — | — | — | 1 |
| Hepatitis b | D006509 | — | — | 1 | — | — | — | — | 1 |
| Chronic hepatitis b | D019694 | EFO_0004239 | B18.1 | 1 | — | — | — | — | 1 |
| Hyperplasia | D006965 | EFO_0000536 | — | 1 | — | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | 1 | — | — | — | — | 1 |
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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 strontium |
| INN | esomeprazole |
| Description | Nexium Control (esomeprazole strontium) is a small molecule pharmaceutical. Esomeprazole strontium was first approved as Esomeprazole strontium on 2013-08-06. 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. |
| Classification | Small molecule |
| Drug class | antiulcer agents (benzimidazole derivatives) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1ccc2[n-]c([S@@+]([O-])Cc3ncc(C)c(OC)c3C)nc2c1.COc1ccc2[n-]c([S@@+]([O-])Cc3ncc(C)c(OC)c3C)nc2c1.O.O.O.O.[Sr+2] |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL2146140 |
| ChEBI ID | — |
| PubChem CID | 16048656 |
| DrugBank | — |
| UNII ID | N3PA6559FT (ChemIDplus, GSRS) |
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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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74,401 adverse events reported
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