Aluminum hydroxide
Osmoprep, Phosphates (aluminum hydroxide) is a small molecule pharmaceutical. Aluminum hydroxide was first approved as Sodium phosphates in plastic container on 1983-05-10. It is used to treat duodenal ulcer, dyspepsia, gastroesophageal reflux, gastrointestinal hemorrhage, and heartburn amongst others in the USA.
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Commercial
Trade Name
FDA
EMA
Combinations
Osmoprep, Phosphates (generic drugs available since 2011-12-30, discontinued: Visicol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Sodium phosphate
+
dibasic
+
anhydrous
+
Sodium phosphate
+
monobasic
+
monohydrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OSMOPREP | Salix Pharmaceuticals | N-021892 RX | 2006-03-16 | 1 products, RLD, RS |
Show 1 discontinued
Sodium phosphate
+
dibasic
+
heptahydrate
+
Sodium phosphate
+
monobasic
+
anhydrous
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SODIUM PHOSPHATES IN PLASTIC CONTAINER | Hospira | N-018892 RX | 1983-05-10 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| osmoprep | New Drug Application | 2019-03-04 |
| potassium phosphates | unapproved drug other | 2022-07-12 |
| regular strength antacid and antigas | OTC monograph final | 2023-06-13 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| duodenal ulcer | EFO_0004607 | D004381 | K26 |
| dyspepsia | EFO_0008533 | D004415 | K30 |
| gastroesophageal reflux | EFO_0003948 | D005764 | K21 |
| gastrointestinal hemorrhage | HP_0002239 | D006471 | K92.2 |
| heartburn | — | D006356 | R12 |
| peptic esophagitis | EFO_1001095 | D004942 | — |
| stomach ulcer | — | D013276 | K25 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Sodium Phosphate, Dibasic, Anhydrous / Sodium Phosphate, Monobasic, Monohydrate, Osmoprep, Salix Pharms | |||
| 7687075 | 2028-06-22 | DS, DP | |
HCPCS
No data
Clinical
Clinical Trials
372 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-alcoholic fatty liver disease | D065626 | EFO_0003095 | K75.81 | — | 5 | 3 | 2 | 3 | 13 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | — | 6 | 6 | 13 |
| Knee osteoarthritis | D020370 | EFO_0004616 | M17 | — | — | — | 7 | 5 | 12 |
| Oxidative stress | D018384 | EFO_1001905 | — | — | 1 | 1 | 6 | 8 | |
| Neoplasms | D009369 | C80 | — | 1 | 3 | 1 | 3 | 7 | |
| Fatty liver | D005234 | 1 | 3 | 2 | 1 | — | 7 | ||
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 2 | — | 1 | 2 | 1 | 6 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | 3 | 1 | — | 5 |
| Chronic renal insufficiency | D051436 | N18 | — | 2 | — | 1 | 2 | 5 | |
| Coronary artery disease | D003324 | I25.1 | — | 1 | 2 | 1 | — | 4 |
Show 24 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | 5 | 6 | — | 2 | 11 |
| Prostatic neoplasms | D011471 | C61 | 2 | 2 | 4 | — | 2 | 10 | |
| Healthy volunteers/patients | — | 5 | — | 1 | — | 3 | 9 | ||
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 5 | 1 | — | 2 | 9 |
| Colorectal neoplasms | D015179 | 1 | 2 | 1 | — | 3 | 7 | ||
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 3 | 3 | — | 2 | 7 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 3 | 1 | 1 | — | 3 | 7 |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | 2 | 3 | — | 1 | 6 |
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 1 | — | 4 | — | 1 | 6 |
| Fibrosis | D005355 | — | 3 | 2 | — | 1 | 5 |
Show 81 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Asthma | D001249 | EFO_0000270 | J45 | 2 | 3 | — | — | 2 | 7 |
| Male infertility | D007248 | EFO_0004248 | N46 | — | 1 | — | — | 2 | 3 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 2 | — | — | — | 2 |
| Reperfusion injury | D015427 | 1 | 1 | — | — | — | 2 | ||
| Stomatitis | D013280 | EFO_1001904 | K12.1 | — | 1 | — | — | 1 | 2 |
| Anemia | D000740 | EFO_0004272 | D64.9 | 1 | 1 | — | — | 1 | 2 |
| End stage liver disease | D058625 | EFO_1001311 | K72.1 | 1 | 1 | — | — | — | 2 |
| Arsenic poisoning | D020261 | T57.0 | — | 1 | — | — | 1 | 2 | |
| Peripheral nervous system diseases | D010523 | G64 | — | 1 | — | — | 1 | 2 | |
| Transient ischemic attack | D002546 | EFO_0003764 | G45.9 | 1 | 1 | — | — | — | 1 |
Show 23 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Macular edema | D008269 | 3 | — | — | — | 1 | 4 | ||
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 2 | — | — | — | 2 | 4 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 3 | — | — | — | — | 3 |
| Heart failure | D006333 | EFO_0003144 | I50 | 2 | — | — | — | — | 2 |
| Allergic rhinitis | D065631 | J30.9 | 1 | — | — | — | 1 | 2 | |
| Cicatrix | D002921 | HP_0100699 | L90.5 | 1 | — | — | — | 1 | 2 |
| Iron-deficiency anemia | D018798 | HP_0001891 | D50 | 1 | — | — | — | 1 | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | — | — | — | — | 1 |
| Pulmonary arterial hypertension | D000081029 | 1 | — | — | — | — | 1 | ||
| Venous thrombosis | D020246 | HP_0004936 | I82.40 | 1 | — | — | — | — | 1 |
Show 11 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Replacement arthroplasty knee | D019645 | — | — | — | — | 4 | 4 | ||
| Musculoskeletal diseases | D009140 | — | — | — | — | 3 | 3 | ||
| Covid-19 | D000086382 | U07.1 | — | — | — | — | 2 | 2 | |
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | — | — | — | — | 2 | 2 |
| Vitamin e deficiency | D014811 | E56.0 | — | — | — | — | 2 | 2 | |
| Rhinitis | D012220 | EFO_0008521 | J31 | — | — | — | — | 2 | 2 |
| Skin neoplasms | D012878 | EFO_0004198 | C44 | — | — | — | — | 2 | 2 |
| Rheumatic diseases | D012216 | M79.0 | — | — | — | — | 2 | 2 | |
| Joint diseases | D007592 | HP_0003040 | M12.9 | — | — | — | — | 2 | 2 |
| Aging | D000375 | GO_0007568 | R41.81 | — | — | — | — | 2 | 2 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | ALUMINUM HYDROXIDE |
| INN | — |
| Description | Aluminium hydroxide, Al(OH)3, is found in nature as the mineral gibbsite (also known as hydrargillite) and its three much rarer polymorphs: bayerite, doyleite, and nordstrandite. Aluminium hydroxide is amphoteric, i.e., it has both basic and acidic properties. Closely related are aluminium oxide hydroxide, AlO(OH), and aluminium oxide or alumina (Al2O3), the latter of which is also amphoteric. These compounds together are the major components of the aluminium ore bauxite. Aluminium hydroxide also forms a gelatinous precipitate in water.
|
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | O[Al](O)O |
Identifiers
| PDB | — |
| CAS-ID | 21645-51-2 |
| RxCUI | 612 |
| ChEMBL ID | CHEMBL1200706 |
| ChEBI ID | 33130 |
| PubChem CID | 10176082 |
| DrugBank | DB06723 |
| UNII ID | — |
Target
Agency Approved
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Alternate
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Variants
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Financial
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Trends
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Safety
Black-box Warning
Black-box warning for: Osmoprep
Adverse Events
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657 adverse events reported
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