Golytely, Mircera(polyethylene glycol)
Clenz-lyte, Colyte With Flavor Packs, Golytely, Halflytely, Miralax, Mircera, Moviprep, Nulytely, Ocl, Plenvu, Suclear (polyethylene glycol) is a small molecule pharmaceutical. Polyethylene glycol was first approved as Golytely on 1984-07-13. It has been approved in Europe to treat anemia and chronic kidney failure.
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Novartis Pharmaceuticals
Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| urogenital diseases | D000091642 |
| hemic and lymphatic diseases | D006425 |
| 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
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| golytely | New Drug Application | 2021-05-28 |
| miralax | New Drug Application | 2022-12-22 |
| mircera | Biologic Licensing Application | 2019-08-05 |
| moviprep | New Drug Application | 2021-05-01 |
| nulytely | New Drug Application | 2021-05-28 |
| peg-3350 and electrolytes | NDA authorized generic | 2023-06-20 |
| plenvu | New Drug Application | 2021-05-05 |
Indications
FDA
EMA
No data
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
361 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Anemia | D000740 | EFO_0004272 | D64.9 | — | 8 | 39 | 11 | 4 | 62 |
| Colonoscopy | D003113 | — | 2 | 11 | 12 | 15 | 40 | ||
| Constipation | D003248 | HP_0002019 | K59.0 | 1 | 5 | 5 | 21 | 2 | 33 |
| Dry eye syndromes | D015352 | H04.12 | — | 2 | — | 5 | 7 | 14 | |
| Colonic neoplasms | D003110 | C18 | 1 | 2 | 5 | 2 | 4 | 13 | |
| Chronic renal insufficiency | D051436 | N18 | — | 3 | 2 | 1 | 6 | 12 | |
| Colorectal neoplasms | D015179 | 2 | 1 | 4 | 3 | 2 | 12 | ||
| Colonic polyps | D003111 | K63.5 | — | — | 1 | 2 | 3 | 6 | |
| Hepatic encephalopathy | D006501 | K72.91 | — | — | — | 3 | 2 | 5 | |
| Colonic diseases | D003108 | — | — | — | 3 | 1 | 4 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | 5 | — | 1 | — | 1 | 7 | ||
| Inflammatory bowel diseases | D015212 | EFO_0003767 | 1 | — | 2 | — | 4 | 7 | |
| Mucocutaneous lymph node syndrome | D009080 | EFO_0004246 | M30.3 | — | — | 1 | — | — | 1 |
| Critical illness | D016638 | — | — | 1 | — | — | 1 | ||
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | 1 | — | — | 1 |
| Pregnancy complications | D011248 | — | 1 | 1 | — | — | 1 | ||
| Shock | D012769 | R57.1 | — | — | 1 | — | — | 1 | |
| Systemic inflammatory response syndrome | D018746 | EFO_1001478 | R65.10 | — | — | 1 | — | — | 1 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | 1 | — | — | 1 |
| Endometrial hyperplasia | D004714 | N85.0 | — | 1 | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Crohn disease | D003424 | EFO_0000384 | K50 | 1 | 3 | — | — | — | 3 |
| Autism spectrum disorder | D000067877 | F84.0 | 1 | 3 | — | — | — | 3 | |
| Lung neoplasms | D008175 | C34.90 | 1 | 1 | — | — | — | 2 | |
| Radiodermatitis | D011855 | L58 | — | 1 | — | — | 1 | 2 | |
| Peripheral nerve injuries | D059348 | 2 | 1 | — | — | — | 2 | ||
| Inferior wall myocardial infarction | D056989 | EFO_1000983 | — | 1 | — | — | — | 1 | |
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | — | 1 | — | — | — | 1 |
| Diarrhea | D003967 | HP_0002014 | R19.7 | — | 1 | — | — | — | 1 |
| Adenomatous polyps | D018256 | D28 | — | 1 | — | — | — | 1 | |
| Klebsiella pneumoniae | D007711 | NCBITaxon_573 | B96.1 | 1 | 1 | — | — | — | 1 |
Show 2 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sarcoma | D012509 | 1 | — | — | — | — | 1 | ||
| Reticulocyte count | D017701 | 1 | — | — | — | — | 1 | ||
| Pharmacokinetics | D010599 | 1 | — | — | — | — | 1 | ||
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | — | — | — | — | 1 |
| Malaria | D008288 | EFO_0001068 | B54 | 1 | — | — | — | — | 1 |
| Surgical wound infection | D013530 | 1 | — | — | — | — | 1 | ||
| Diverticulitis | D004238 | EFO_1001460 | K57 | 1 | — | — | — | — | 1 |
| Gastric emptying | D005746 | 1 | — | — | — | — | 1 | ||
| Hyperuricemia | D033461 | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | — | — | — | 2 | 2 |
| Hemolytic-uremic syndrome | D006463 | D59.3 | — | — | — | — | 1 | 1 | |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | — | — | — | — | 1 | 1 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | — | — | — | 1 | 1 | |
| Type 1 diabetes mellitus | D003922 | EFO_0001359 | E10 | — | — | — | — | 1 | 1 |
| Microbiota | D064307 | — | — | — | — | 1 | 1 | ||
| Polyps | D011127 | EFO_0000662 | — | — | — | — | 1 | 1 | |
| Urinary bladder neoplasms | D001749 | C67 | — | — | — | — | 1 | 1 | |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | — | — | — | 1 | 1 |
| Rectal neoplasms | D012004 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | POLYETHYLENE GLYCOL |
| INN | macrogol |
| Description | Polyethylene glycol (PEG; /ˌpɒliˈɛθəlˌiːn ˈɡlaɪˌkɒl, -ˈɛθɪl-, -ˌkɔːl/) is a polyether compound derived from petroleum with many applications, from industrial manufacturing to medicine. PEG is also known as polyethylene oxide (PEO) or polyoxyethylene (POE), depending on its molecular weight. The structure of PEG is commonly expressed as H−(O−CH2−CH2)n−OH.
|
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | — |
Identifiers
| PDB | — |
| CAS-ID | 25322-68-3 |
| RxCUI | 8516 |
| ChEMBL ID | CHEMBL1201478 |
| 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
Mircera - Roche
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 112,518 documents
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Safety
Black-box Warning
Black-box warning for: Mircera
Adverse Events
Top Adverse Reactions
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13,799 adverse events reported
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