Meglumine
Osmoprep, Phosphates (meglumine) is a small molecule pharmaceutical. Meglumine was first approved as Sodium phosphates in plastic container on 1983-05-10. It is used to treat aids-related opportunistic infections, cutaneous leishmaniasis, and visceral leishmaniasis 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 |
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 | |
Clinical
Clinical Trials
76 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anorexia | D000855 | HP_0002039 | R63.0 | 1 | 6 | 9 | 1 | — | 16 |
| Cachexia | D002100 | HP_0004326 | R64 | 2 | 4 | 6 | 2 | — | 14 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 1 | 3 | 1 | 1 | 2 | 8 |
| Second primary neoplasms | D016609 | — | — | — | 1 | — | 1 | ||
| Feeding behavior | D005247 | — | — | — | 1 | — | 1 | ||
| Cognitive dysfunction | D060825 | G31.84 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endometrial neoplasms | D016889 | EFO_0004230 | 2 | 13 | 4 | — | — | 15 | |
| Endometrial hyperplasia | D004714 | N85.0 | — | 10 | 6 | — | — | 11 | |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | 5 | 2 | — | — | 7 |
| Neoplasms | D009369 | C80 | — | 4 | 1 | — | — | 5 | |
| Head and neck neoplasms | D006258 | — | 1 | 1 | — | — | 2 | ||
| Body weight changes | D001836 | — | 1 | 1 | — | — | 2 | ||
| Weight loss | D015431 | HP_0001824 | — | — | 2 | — | — | 2 | |
| Overweight | D050177 | E66.3 | — | 2 | 2 | — | — | 2 | |
| Esophageal squamous cell carcinoma | D000077277 | — | — | 1 | — | — | 1 | ||
| Lung neoplasms | D008175 | C34.90 | — | — | 1 | — | — | 1 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv wasting syndrome | D019247 | EFO_0007312 | 1 | 2 | — | — | 1 | 4 | |
| Endometrioid carcinoma | D018269 | 1 | 3 | — | — | — | 3 | ||
| Vomiting | D014839 | HP_0002013 | R11.1 | — | 1 | — | — | — | 1 |
| Triple negative breast neoplasms | D064726 | — | 1 | — | — | — | 1 | ||
| Phenylketonurias | D010661 | E70.0 | — | 1 | — | — | — | 1 | |
| Uterine neoplasms | D014594 | EFO_0003859 | C55 | — | 1 | — | — | — | 1 |
| Leukemia | D007938 | C95 | — | 1 | — | — | — | 1 | |
| Myelodysplastic syndromes | D009190 | D46 | — | 1 | — | — | — | 1 | |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | — | 1 | — | — | — | 1 |
| Lymphoma | D008223 | C85.9 | — | 1 | — | — | — | 1 |
Show 7 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Adrenal insufficiency | D000309 | — | — | — | — | 1 | 1 | ||
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | MEGLUMINE |
| INN | meglumine |
| Description | N-methylglucamine is a hexosamine that is D-glucitol in which the hydroxy group at position 1 is substituted by the nitrogen of a methylamino group. A crystalline base, it is used in preparing salts of certain acids for use as diagnostic radiopaque media, while its antimonate is used as an antiprotozoal in the treatment of leishmaniasis. It is a hexosamine and a secondary amino compound. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CNC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO |
Identifiers
| PDB | — |
| CAS-ID | 6284-40-8 |
| RxCUI | 6704 |
| ChEMBL ID | CHEMBL1200570 |
| ChEBI ID | 59732 |
| PubChem CID | 8567 |
| DrugBank | DB09415 |
| UNII ID | 6HG8UB2MUY (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Osmoprep
Adverse Events
Top Adverse Reactions
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1,881 adverse events reported
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