Polyethylene glycol 3350
Clenz-lyte, Colyte With Flavor Packs, Golytely, Halflytely, Miralax, Moviprep, Nulytely, Ocl, Plenvu, Suclear (polyethylene glycol 3350) is a small molecule pharmaceutical. Polyethylene glycol 3350 was first approved as Golytely on 1984-07-13. It is used to treat constipation in the USA.
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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Miralax (generic drugs available since 2009-06-01, discontinued: Glycolax)
CombinationsColyte with flavor packs, Golytely, Moviprep, Nulytely, Plenvu (generic drugs available since 2009-06-01, discontinued: Clenz-lyte, Co-lav, Colovage, Colyte, E-z-em prep lyte, Glycoprep, Go-evac, Halflytely, Lax-lyte with flavor packs, Ocl, Peg-lyte, Suclear, Trilyte)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Ascorbic acid
+
Polyethylene glycol 3350
+
Potassium chloride
+
Sodium ascorbate
+
Sodium chloride
+
Sodium sulfate
Bisacodyl
+
Polyethylene glycol 3350
+
Potassium chloride
+
Sodium bicarbonate
+
Sodium chloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| HALFLYTELY | Braintree Laboratories | N-021551 DISCN | 2010-07-16 | 1 products, RLD |
Hide discontinued
Magnesium sulfate
+
Polyethylene glycol 3350
+
Potassium chloride
+
Potassium sulfate
+
Sodium bicarbonate
+
Sodium chloride
+
Sodium sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SUCLEAR | Braintree Laboratories | N-203595 DISCN | 2013-01-18 | 1 products, RLD |
Hide discontinued
Polyethylene glycol 3350
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| MIRALAX | Bayer | N-022015 OTC | 2006-10-06 | 1 products, RLD, RS |
Polyethylene glycol 3350
+
Potassium chloride
+
Sodium bicarbonate
+
Sodium chloride
Polyethylene glycol 3350
+
Potassium chloride
+
Sodium bicarbonate
+
Sodium chloride
+
Sodium sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| OCL | Hospira | N-019284 DISCN | 1986-04-30 | 1 products |
Hide discontinued
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| constipation | HP_0002019 | D003248 | K59.0 |
Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Ascorbic Acid / Polyethylene Glycol 3350 / Potassium Chloride / Sodium Ascorbate / Sodium Chloride / Sodium Sulfate, Plenvu, Salix | |||
| 8999313 | 2033-09-10 | DP | |
| 9326969 | 2033-09-10 | U-2310 | |
| 9707297 | 2033-09-10 | DP | |
| 10016504 | 2033-09-10 | DP | |
| 10918723 | 2033-09-10 | U-2310 | |
| 9592252 | 2032-08-11 | DP | U-2310 |
| 10646512 | 2032-03-25 | DP | |
| 10780112 | 2032-03-09 | DP | |
| 10792306 | 2032-03-09 | DP | U-2310 |
| 11529368 | 2032-03-09 | DP | U-2310 |
| Ascorbic Acid / Polyethylene Glycol 3350 / Potassium Chloride / Sodium Ascorbate / Sodium Chloride / Sodium Sulfate, Moviprep, Salix Pharms | |||
| 7169381 | 2024-09-01 | DS, DP | |
| 7658914 | 2024-09-01 | DS, DP | |
HCPCS
No data
Clinical
Clinical Trials
37 clinical trials
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Venous insufficiency | D014689 | — | — | 1 | — | 1 | 2 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Melanoma | D008545 | — | 1 | — | — | — | 1 | ||
| Neoplasm metastasis | D009362 | EFO_0009708 | — | 1 | — | — | — | 1 | |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | 1 | — | — | — | 1 |
| Tennis elbow | D013716 | EFO_1001896 | M77.1 | — | 1 | — | — | — | 1 |
| Snoring | D012913 | R06.83 | 1 | 1 | — | — | — | 1 | |
| Apnea | D001049 | HP_0002104 | R06.81 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Esophageal and gastric varices | D004932 | EFO_0009545 | I85 | — | — | — | — | 4 | 4 |
| Portal hypertension | D006975 | EFO_0000666 | K76.6 | — | — | — | — | 1 | 1 |
| Neuroendocrine tumors | D018358 | EFO_1001901 | D3A.8 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | POLYETHYLENE GLYCOL 3350 |
| INN | macrogol |
| Description | Macrogol, also known as polyethylene glycol (PEG), is used as a medication to treat constipation in children and adults. It is also used to empty the bowels before a colonoscopy. It is taken by mouth. Benefits usually occur within three days. Generally it is only recommended for up to two weeks. It is also used as an excipient.
|
| Classification | Small molecule |
| Drug class | Osmotic laxative |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | — |
| RxCUI | — |
| ChEMBL ID | CHEMBL1201479 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | DB09287 |
| UNII ID | 3WJQ0SDW1A (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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820 adverse events reported
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