Lactulose
Generlac, Lactulose (lactulose) is a small molecule pharmaceutical. Lactulose was first approved as Cephulac on 1982-01-01. It is used to treat constipation and hepatic encephalopathy in the USA.
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Commercial
Trade Name
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Generlac, Lactulose (discontinued: Acilac, Cephulac, Cholac, Chronulac, Constilac, Constulose, Duphalac, Enulose, Evalose, Heptalac, Lactulose, Laxilose, Portalac)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| constulose | ANDA | 2022-06-01 |
| enulose | ANDA | 2023-03-15 |
| generlac | ANDA | 2024-07-16 |
| kristalose | ANDA | 2018-09-17 |
| lactulose | ANDA | 2024-10-29 |
| lactulose solution | ANDA | 2024-10-29 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| constipation | HP_0002019 | D003248 | K59.0 |
| hepatic encephalopathy | — | D006501 | K72.91 |
Agency Specific
FDA
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Clinical
Clinical Trials
186 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain diseases | D001927 | HP_0001298 | G93.40 | 4 | 8 | 7 | 14 | 19 | 50 |
| Hepatic encephalopathy | D006501 | — | K72.91 | 4 | 8 | 7 | 14 | 19 | 50 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 1 | 7 | 7 | 6 | 15 | 31 |
| Fibrosis | D005355 | — | — | 1 | 6 | 6 | 5 | 13 | 26 |
| Constipation | D003248 | HP_0002019 | K59.0 | 1 | 3 | 7 | 6 | 5 | 21 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | 1 | — | 2 | 9 | 12 |
| End stage liver disease | D058625 | EFO_1001311 | K72.1 | 2 | 1 | 1 | 1 | 6 | 10 |
| Syndrome | D013577 | — | — | 1 | 1 | — | 3 | 4 | 9 |
| Liver failure | D017093 | HP_0001399 | K72.9 | 2 | — | — | 1 | 5 | 8 |
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | 3 | 2 | 2 | 1 | 7 |
Show 24 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colonoscopy | D003113 | — | — | — | 1 | 1 | — | 3 | 5 |
| Abdominal pain | D015746 | HP_0002027 | R10.9 | — | — | 1 | — | 3 | 4 |
| Critical illness | D016638 | — | — | — | — | 2 | — | 1 | 3 |
| Ascites | D001201 | HP_0001541 | R18 | — | — | 1 | — | 1 | 2 |
| Gastrointestinal diseases | D005767 | — | — | — | 1 | 1 | — | 1 | 2 |
| Digestive system diseases | D004066 | HP_0011024 | K92.9 | — | 1 | 1 | — | 1 | 2 |
| Delirium | D003693 | — | R41.0 | — | — | 1 | — | — | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34.0 | — | — | 1 | — | — | 1 |
| Lung diseases | D008171 | HP_0002088 | J98.4 | — | — | 1 | — | — | 1 |
| Interstitial lung diseases | D017563 | HP_0006530 | J84.89 | — | — | 1 | — | — | 1 |
Show 11 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | MP_0001845 | — | — | 1 | — | — | 2 | 3 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | — | — | 2 | 3 |
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | — | 1 | — | — | 1 | 2 |
| Premature birth | D047928 | EFO_0003917 | O60 | 1 | 1 | — | — | — | 2 |
| Covid-19 | D000086382 | — | — | — | 2 | — | — | — | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | — | 1 | — | — | — | 1 |
| Aids dementia complex | D015526 | EFO_0002608 | — | — | 1 | — | — | — | 1 |
| Rosacea | D012393 | — | L71 | — | 1 | — | — | — | 1 |
Show 5 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 2 | — | — | — | 4 | 6 |
| Crohn disease | D003424 | EFO_0000384 | K50 | 1 | — | — | — | 1 | 2 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | 1 | — | — | — | — | 1 |
| Insulin resistance | D007333 | HP_0000855 | — | 1 | — | — | — | — | 1 |
| Opioid-related disorders | D009293 | EFO_0005611 | F11 | 1 | — | — | — | — | 1 |
| Gastric emptying | D005746 | — | — | 1 | — | — | — | — | 1 |
| Postural orthostatic tachycardia syndrome | D054972 | — | G90.A | 1 | — | — | — | — | 1 |
| Tachycardia | D013610 | HP_0001649 | R00.0 | 1 | — | — | — | — | 1 |
| Orthostatic intolerance | D054971 | — | — | 1 | — | — | — | — | 1 |
| Burns | D002056 | — | T30.0 | 1 | — | — | — | — | 1 |
Show 5 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Communicable diseases | D003141 | — | — | — | — | — | — | 2 | 2 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | — | — | 2 | 2 |
| Alcoholic liver cirrhosis | D008104 | EFO_1000802 | K70.3 | — | — | — | — | 1 | 1 |
| Graft vs host disease | D006086 | — | D89.81 | — | — | — | — | 1 | 1 |
| Colonic diseases | D003108 | — | — | — | — | — | — | 1 | 1 |
| Anemia | D000740 | HP_0001903 | D64.9 | — | — | — | — | 1 | 1 |
| Iron-deficiency anemia | D018798 | HP_0001891 | D50 | — | — | — | — | 1 | 1 |
| Deficiency diseases | D003677 | EFO_1001067 | E63 | — | — | — | — | 1 | 1 |
| Iron deficiencies | D000090463 | — | — | — | — | — | — | 1 | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | — | — | — | 1 | 1 |
Show 32 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Lactulose |
| INN | lactulose |
| Description | Lactulose is a synthetic galactosylfructose disaccharide used in the treatment of constipation and hepatic encephalopathy. It has a role as a laxative and a gastrointestinal drug. |
| Classification | Small molecule |
| Drug class | — |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O[C@@H]1O[C@H](CO)[C@H](O)[C@H](O)[C@H]1O |
Identifiers
| PDB | — |
| CAS-ID | 4618-18-2 |
| RxCUI | — |
| ChEMBL ID | CHEMBL296306 |
| ChEBI ID | 6359 |
| PubChem CID | 11333 |
| DrugBank | DB00581 |
| UNII ID | 9U7D5QH5AE (ChemIDplus, GSRS) |
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Lactulose
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Safety
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Adverse Events
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4,469 adverse events reported
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