Polyethylene glycol 3350
/ Polyethylene Glycol 3350 / Potassium / / /, Clenz-lyte, Golytely, Halflytely, Miralax, Moviprep, Nulytely, Ocl, Plenvu, Polyethylene Glycol, Polyethylene Glycol 3350 / Potassium / Bicarbonate /, Polyethylene Glycol 3350 / Potassium / Bicarbonate / /, Suclear, Suflave (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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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| signs and symptoms pathological conditions | D013568 |
Trade Name
FDA
EMA
Combinations
Golytely, Moviprep, Nulytely, Peg, potassium chloride, bicarbonate,, Peg, sulfate, chloride, potassium chloride, ascorbate ascorbic acid, Plenvu, Polyethylene glycol 3350 electrolytes, Suflave (discontinued: Clenz-lyte, Co-lav, Colyte with flavor packs, Go-evac, Golytely, Halflytely, Lax-lyte with flavor packs, Ocl, Peg 3350 electrolytes, Peg, potassium chloride, bicarbonate,, Peg-lyte, Polyethylene glycol 3350 electrolytes, Suclear, Trilyte)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
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
Polyethylene glycol 3350
+
Potassium chloride
+
Sodium bicarbonate
+
Sodium chloride
+
Sodium sulfate anhydrous
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| GOLYTELY | Braintree Laboratories | N-019011 RX | 1984-07-13 | 1 products, RLD, RS |
Show 5 discontinued
Ascorbic acid
+
Polyethylene glycol 3350
+
Potassium chloride
+
Sodium ascorbate
+
Sodium chloride
+
Sodium sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PLENVU | Salix Pharmaceuticals | N-209381 RX | 2018-05-04 | 1 products, RLD, RS |
| MOVIPREP | Salix Pharmaceuticals | N-021881 RX | 2006-08-02 | 1 products, RLD, RS |
Polyethylene glycol 3350
+
Potassium chloride
+
Sodium bicarbonate
+
Sodium chloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| NULYTELY | Braintree Laboratories | N-019797 RX | 1991-04-22 | 1 products, RLD, RS |
| NULYTELY-FLAVORED | Braintree Laboratories | N-019797 RX | 1994-11-18 | 1 products, RLD, RS |
Magnesium sulfate
+
Polyethylene glycol 3350
+
Potassium chloride
+
Sodium chloride
+
Sodium sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SUFLAVE | Braintree Laboratories | N-215344 RX | 2023-06-15 | 1 products, RLD, RS |
Polyethylene glycol 3350
+
Potassium chloride
+
Sodium bicarbonate
+
Sodium chloride
+
Sodium sulfate
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
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| basic care clearlax | ANDA | 2023-01-24 |
| berkley and jensen clearlax | ANDA | 2023-05-12 |
| care one clearlax | ANDA | 2023-02-27 |
| careone clearlax | ANDA | 2024-05-19 |
| clear lax | ANDA | 2024-12-02 |
| clearlax | ANDA | 2025-06-11 |
| comfortlax | ANDA | 2025-03-12 |
| dg health clearlax | ANDA | 2023-05-04 |
| discount drug mart | ANDA | 2025-03-24 |
| easylax | ANDA | 2024-12-03 |
Show 55 more
Indications
FDA
EMA
Show 9 more
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
MAGNESIUM SULFATE / POLYETHYLENE GLYCOL 3350 / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM SULFATE, SUFLAVE, BRAINTREE LABS | |||
| 2026-06-15 | NP | ||
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
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Clinical
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Constipation | D003248 | — | K59.0 | 2 | 8 | 8 | 29 | 9 | 55 |
| Colonoscopy | D003113 | — | — | — | 2 | 13 | 13 | 12 | 40 |
| Colonic neoplasms | D003110 | — | C18 | 1 | 1 | 4 | 1 | 1 | 7 |
| Colorectal neoplasms | D015179 | — | — | 1 | 1 | 1 | 2 | 1 | 6 |
| Crohn disease | D003424 | EFO_0000384 | K50 | 2 | 4 | — | 1 | — | 5 |
| Colonic polyps | D003111 | — | K63.5 | — | — | — | 2 | 2 | 4 |
| Gastrointestinal diseases | D005767 | — | — | — | 2 | — | 1 | 1 | 4 |
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | — | 2 | — | 1 | 1 | 4 |
| Brain diseases | D001927 | — | G93.40 | — | — | — | 1 | 2 | 3 |
| Hepatic encephalopathy | D006501 | — | K72.91 | — | — | — | 1 | 2 | 3 |
Show 34 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | 3 | — | — | 4 |
| Infections | D007239 | EFO_0000544 | — | — | 2 | 2 | — | — | 3 |
| Acquired immunodeficiency syndrome | D000163 | EFO_0000765 | B20 | — | 1 | 2 | — | — | 3 |
| Communicable diseases | D003141 | — | — | — | 1 | 1 | — | — | 2 |
| Immunologic deficiency syndromes | D007153 | — | D84.9 | — | 1 | 1 | — | — | 2 |
| Critical illness | D016638 | — | — | — | — | 1 | — | 1 | 2 |
| Post-traumatic stress disorders | D013313 | EFO_0001358 | F43.1 | — | 1 | 1 | — | — | 1 |
| Clostridioides difficile | D016360 | NCBITaxon_1496 | — | — | 1 | 1 | — | — | 1 |
| Endoscopy | D004724 | — | — | — | — | 1 | — | — | 1 |
| Hiv-1 | D015497 | — | — | — | — | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Intestinal diseases | D007410 | — | K63.9 | — | 2 | — | — | 2 | 4 |
| Syndrome | D013577 | — | — | 1 | 1 | — | — | 1 | 2 |
| Diarrhea | D003967 | — | R19.7 | — | 2 | — | — | — | 2 |
| Autistic disorder | D001321 | EFO_0003758 | F84.0 | — | 2 | — | — | — | 2 |
| Autism spectrum disorder | D000067877 | — | F84.0 | — | 2 | — | — | — | 2 |
| Pervasive child development disorders | D002659 | EFO_0003756 | F84 | — | 2 | — | — | — | 2 |
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | 1 | 1 | — | — | — | 1 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | 1 | — | — | — | 1 |
| Lacerations | D022125 | — | — | 1 | 1 | — | — | — | 1 |
| Peripheral nerve injuries | D059348 | — | — | 1 | 1 | — | — | — | 1 |
Show 8 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pancreatic ductal carcinoma | D021441 | — | — | 1 | — | — | — | — | 1 |
| Adenocarcinoma | D000230 | — | — | 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 | — | — | — | — | 3 | 3 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | — | — | — | — | 1 | 1 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | — | — | — | — | 1 | 1 |
| Pregnancy rate | D018873 | — | — | — | — | — | — | 1 | 1 |
| Hemorrhoids | D006484 | EFO_0009552 | K64 | — | — | — | — | 1 | 1 |
| Fecal incontinence | D005242 | — | R15 | — | — | — | — | 1 | 1 |
| Digestive system endoscopy | D016145 | — | — | — | — | — | — | 1 | 1 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | — | — | — | 1 | 1 |
| Pseudomembranous enterocolitis | D004761 | EFO_1001314 | A04.7 | — | — | — | — | 1 | 1 |
| Hyponatremia | D007010 | — | E87.1 | — | — | — | — | 1 | 1 |
Show 7 more
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 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. It is also used to clear the bowels (known as "bowel prep") before a colonoscopy, when the onset of the laxative effect is more rapid, typically within an hour.
|
| 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) |
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Safety
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63,443 adverse events reported
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