Esomeprazole strontium, Nexium control(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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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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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| esomeprazole strontium | NDA authorized generic | 2021-01-25 |
| nexium | New Drug Application | 2022-03-04 |
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
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Patent Expiration
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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
HCPCS
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Clinical
Clinical Trials
514 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Major depressive disorder | D003865 | EFO_0003761 | F22 | 11 | 24 | 30 | 51 | 20 | 129 |
| Depression | D003863 | F33.9 | 5 | 16 | 19 | 50 | 35 | 117 | |
| Healthy volunteers/patients | — | 24 | — | — | 4 | 4 | 32 | ||
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | 3 | 2 | 6 | 8 | 4 | 22 |
| Depressive disorder | D003866 | EFO_1002014 | F32.A | 4 | 1 | 6 | 2 | 3 | 15 |
| Anxiety | D001007 | EFO_0005230 | F41.1 | — | 1 | 3 | 5 | 6 | 14 |
| Schizophrenia | D012559 | EFO_0000692 | F20 | — | — | 2 | 8 | 1 | 11 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | 1 | 3 | 4 | 2 | 10 |
| Bipolar disorder | D001714 | EFO_0000289 | F30.9 | 1 | 2 | 3 | 2 | 2 | 9 |
| Obsessive-compulsive disorder | D009771 | EFO_0004242 | F42 | — | — | 1 | 6 | 1 | 8 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Treatment-resistant depressive disorder | D061218 | 1 | — | 7 | — | 1 | 9 | ||
| Neoplasms | D009369 | C80 | 1 | 1 | 4 | — | 1 | 7 | |
| Cocaine-related disorders | D019970 | F14 | 1 | 5 | 1 | — | — | 6 | |
| Mood disorders | D019964 | EFO_0004247 | F30-F39 | — | 1 | 1 | — | 2 | 4 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | — | 2 | 2 | — | 1 | 4 |
| Hot flashes | D019584 | — | — | 1 | — | 3 | 4 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 1 | 1 | — | 1 | 3 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | — | 1 | 1 | — | — | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | — | 2 | — | — | 2 |
| Fibromyalgia | D005356 | EFO_0005687 | M79.1 | — | 1 | 1 | — | 1 | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Menopause | D008593 | EFO_0003922 | N95 | — | 1 | — | — | 1 | 2 |
| Ischemic stroke | D000083242 | 1 | 2 | — | — | — | 2 | ||
| Male infertility | D007248 | EFO_0004248 | N46 | — | 1 | — | — | — | 1 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | — | 1 | — | — | — | 1 |
| Aphasia | D001037 | HP_0002381 | R47.01 | — | 1 | — | — | — | 1 |
| Glioma | D005910 | EFO_0000520 | — | 1 | — | — | — | 1 | |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 1 | — | — | — | 1 |
| Bereavement | D001601 | — | 1 | — | — | — | 1 | ||
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | — | 1 | — | — | — | 1 |
| Neurodevelopmental disorders | D065886 | F89 | — | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Spinal cord injuries | D013119 | EFO_1001919 | 2 | — | — | — | 1 | 3 | |
| Substance-related disorders | D019966 | EFO_0003890 | F13 | 1 | — | — | — | 1 | 2 |
| Autism spectrum disorder | D000067877 | F84.0 | 1 | — | — | — | 1 | 2 | |
| Stress urinary incontinence | D014550 | HP_0010992 | 1 | — | — | — | — | 1 | |
| Fecal incontinence | D005242 | R15 | 1 | — | — | — | — | 1 | |
| Hepacivirus | D016174 | 1 | — | — | — | — | 1 | ||
| Premature ejaculation | D061686 | HP_0012876 | F52.4 | 1 | — | — | — | — | 1 |
| Respiratory insufficiency | D012131 | HP_0002093 | J96.9 | 1 | — | — | — | — | 1 |
| Hypercapnia | D006935 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 4 | 4 |
| Pharmacokinetics | D010599 | — | — | — | — | 2 | 2 | ||
| Cognition | D003071 | EFO_0003925 | — | — | — | — | 2 | 2 | |
| Perimenopause | D047648 | — | — | — | — | 1 | 1 | ||
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Wounds and injuries | D014947 | T14.8 | — | — | — | — | 1 | 1 | |
| Chronic disease | D002908 | — | — | — | — | 1 | 1 | ||
| Brain injuries | D001930 | S06.9 | — | — | — | — | 1 | 1 | |
| Alcohol-related disorders | D019973 | F10 | — | — | — | — | 1 | 1 | |
| Suicidal ideation | D059020 | EFO_0004320 | R45.851 | — | — | — | — | 1 | 1 |
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Epidemiology
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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 | 934714-36-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL2146140 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | N3PA6559FT (ChemIDplus, GSRS) |
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Safety
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27,453 adverse events reported
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