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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Trade Name
FDA
EMA
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 | 2024-12-18 |
| generlac | ANDA | 2024-07-16 |
| kristalose | ANDA | 2018-09-17 |
| lactulose | ANDA | 2025-09-26 |
| lactulose solution | ANDA | 2025-02-02 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| constipation | — | D003248 | K59.0 |
| hepatic encephalopathy | — | D006501 | K72.91 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
No data
Clinical
Clinical Trials
207 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatic encephalopathy | D006501 | — | K72.91 | 4 | 8 | 7 | 16 | 18 | 51 |
| Brain diseases | D001927 | — | G93.40 | 1 | 8 | 4 | 10 | 14 | 35 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | 1 | 6 | 5 | 7 | 16 | 31 |
| Constipation | D003248 | — | K59.0 | 1 | 3 | 7 | 6 | 9 | 25 |
| Fibrosis | D005355 | — | — | 1 | 5 | 4 | 5 | 13 | 24 |
| Irritable bowel syndrome | D043183 | EFO_0000555 | K58 | — | 1 | — | 2 | 10 | 13 |
| Acute-on-chronic liver failure | D065290 | — | — | 2 | 1 | 1 | 1 | 6 | 11 |
| End stage liver disease | D058625 | EFO_1001311 | K72.1 | — | 2 | 2 | 1 | 5 | 9 |
| Liver failure | D017093 | — | K72.9 | — | 1 | 1 | 2 | 4 | 8 |
| Hepatic insufficiency | D048550 | — | — | — | 1 | 1 | 3 | 3 | 8 |
Show 23 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 | EFO_0003766 | R10.9 | — | — | 1 | — | 3 | 4 |
| Critical illness | D016638 | — | — | — | — | 2 | — | 1 | 3 |
| Ascites | D001201 | — | R18 | — | — | 1 | — | 1 | 2 |
| Digestive system diseases | D004066 | EFO_0000405 | K92.9 | — | 1 | 1 | — | 1 | 2 |
| Candidiasis | D002177 | — | B37 | — | 1 | 2 | — | — | 2 |
| Vulvovaginal candidiasis | D002181 | EFO_0007543 | B37.3 | — | 1 | 2 | — | — | 2 |
| Delirium | D003693 | — | R41.0 | — | — | 1 | — | — | 1 |
| Systemic scleroderma | D012595 | EFO_0000717 | M34 | — | — | 1 | — | — | 1 |
| Interstitial lung diseases | D017563 | EFO_0004244 | J84.9 | — | — | 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 |
| Sepsis | D018805 | EFO_0001420 | A41.9 | — | 1 | — | — | 1 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | 1 | — | — | 1 | 2 |
| Covid-19 | D000086382 | — | U07.1 | — | 2 | — | — | — | 2 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | 1 | — | — | — | 1 |
| Multiple myeloma | D009101 | — | C90.0 | — | 1 | — | — | — | 1 |
| Plasma cell neoplasms | D054219 | — | — | — | 1 | — | — | — | 1 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | — | 1 | — | — | — | 1 |
| Lymphoma | D008223 | — | C85.9 | — | 1 | — | — | — | 1 |
| Large b-cell lymphoma diffuse | D016403 | — | C83.3 | — | 1 | — | — | — | 1 |
Show 9 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 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | 1 | — | — | — | 1 | 2 |
| Crohn disease | D003424 | EFO_0000384 | K50 | 1 | — | — | — | 1 | 2 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | 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 |
| Orthostatic intolerance | D054971 | — | — | 1 | — | — | — | — | 1 |
| Burns | D002056 | — | T30.0 | 1 | — | — | — | — | 1 |
| Premature birth | D047928 | EFO_0003917 | O60 | 1 | — | — | — | — | 1 |
Show 6 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Communicable diseases | D003141 | — | — | — | — | — | — | 2 | 2 |
| Blind loop syndrome | D001765 | EFO_0007175 | K90.2 | — | — | — | — | 2 | 2 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | — | — | 2 | 2 |
| Graft vs host disease | D006086 | — | D89.81 | — | — | — | — | 1 | 1 |
| Colonic diseases | D003108 | — | — | — | — | — | — | 1 | 1 |
| Iron-deficiency anemia | D018798 | — | D50 | — | — | — | — | 1 | 1 |
| Iron deficiencies | D000090463 | — | E61.1 | — | — | — | — | 1 | 1 |
| Metabolic diseases | D008659 | EFO_0000589 | E88.9 | — | — | — | — | 1 | 1 |
| Growth disorders | D006130 | — | — | — | — | — | — | 1 | 1 |
| Gastrointestinal motility | D005769 | — | — | — | — | — | — | 1 | 1 |
Show 40 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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) |
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
â‚£
Kristalose – Cumberland Pharmaceuticals
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
Lactulose
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 13,791 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
5,056 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use