Overview
Lactulose is a synthetic disaccharide derivative of lactose that is most commonly used as a laxative agent despite also being formally indicated to serve as an adjunct therapy in treating portal-systemic encephalopathy (PSE). Despite being first synthesized in 1929, investigations regarding its possible use as a laxative for the treatment of chronic constipation did not occur until the 1960s and its first clinical use for treating PSE was not until 1966. Nevertheless, although lactulose received formal FDA approval in 1977 and has since become a readily available generic and brand-name non-prescription medication listed on the World Health Organization's List of Essential Medicines as one of the most effective and safe medicines employed in a health system, data regarding its optimal place in therapy is often ambiguous. Especially considering the use of lactulose as a laxative is typically only considered after lifestyle and dietary modifications fail and the fact that lactulose therapy cannot be ethically withheld from patients diagnosed with PSE in a placebo study, the substance may just be one of many options available for treating constipation and its efficacy in managing PSE may never be formally confirmed or refuted via clinical investigation.
Indication
Lactulose is indicated for use as a laxative in the treatment of chronic constipation in adults and geriatric patients. Additionally, lactulose is also employed as an adjunct to protein restriction and supportive therapy for the prevention and treatment of portal-systemic encephalopathy (PSE), including both the hepatic pre-coma and coma variations. In particular, lactulose solution has been effective at managing PSE resulting from surgical portacaval shunts or from chronic hepatic diseases like cirrhosis. Moreover, there have also been studies demonstrating the capacity for lactulose to minimize the formation of gallstones and even some investigations regarding the experimental use of the agent in developing novel anticancer agents owing to its ability to bind galactin carbohydrates involved in various tumor progressions .
Associated Conditions
- Constipation
- Hepatic Encephalopathy (HE)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/07/24 | Not Applicable | Not yet recruiting | General Hospital of Shenyang Military Region | ||
2025/07/15 | Not Applicable | Recruiting | |||
2025/06/25 | Phase 4 | Completed | Qurratul Ain Jamil | ||
2025/06/04 | Not Applicable | Not yet recruiting | |||
2025/02/19 | Phase 2 | Recruiting | |||
2025/02/04 | Not Applicable | Not yet recruiting | |||
2024/12/27 | Phase 4 | ENROLLING_BY_INVITATION | Haifeng Lan | ||
2024/12/17 | Not Applicable | ENROLLING_BY_INVITATION | NIN Institute | ||
2024/08/05 | Phase 4 | Recruiting | Post Graduate Institute of Medical Education and Research, Chandigarh | ||
2024/07/03 | Not Applicable | Recruiting | General Hospital of Shenyang Military Region |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Lannett Company, Inc. | 0527-5125 | ORAL | 10 g in 15 mL | 1/30/2020 | |
| Lannett Company, Inc. | 0527-5120 | ORAL | 10 g in 15 mL | 7/27/2022 | |
| Morton Grove Pharmaceuticals, Inc. | 60432-037 | ORAL | 10 g in 15 mL | 11/4/2019 | |
| Aidarex Pharmaceuticals LLC | 53217-009 | ORAL | 10 g in 15 mL | 10/2/2013 | |
| Morton Grove Pharmaceuticals, Inc. | 60432-038 | ORAL, RECTAL | 10 g in 15 mL | 1/8/2019 | |
| Pharmaceutical Associates, Inc. | 0121-0873 | ORAL | 10 g in 15 mL | 12/21/2022 | |
| Xttrium Laboratories, Inc. | 0116-4005 | ORAL | 10 g in 15 mL | 3/21/2023 | |
| Bio-Pharm, Inc. | 59741-249 | ORAL | 10 g in 15 mL | 6/15/2018 | |
| VistaPharm, Inc. | 66689-039 | ORAL | 10 g in 15 mL | 11/19/2020 | |
| Chartwell RX, LLC | 62135-002 | ORAL | 10 g in 15 mL | 4/5/2024 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| DUPHALAC SYRUP | SIN02818P | SYRUP | 67 g/100 ml | 5/18/1989 | |
| LACTUS SYRUP 66% w/v | SIN10132P | SYRUP | 66% w/v | 10/2/1998 | |
| LACTUL SOLUTION 670MG/ML | SIN14720P | SOLUTION | 670mg/ml | 1/12/2015 | |
| DHACTULOSE SYRUP | SIN11494P | SYRUP | 3.35 g/5 ml | 4/25/2001 |
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| MARTULOSE SOLUTION 3.35G/5ML | N/A | N/A | N/A | 11/28/2002 |
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| BLOOMS THE CHEMIST LACTULOSE 667 mg/mL oral liquid bottle | 366773 | Medicine | A | 5/21/2021 | |
| APOHEALTH LACTULOSE 667 mg/mL oral liquid bottle | 337591 | Medicine | A | 6/9/2020 | |
| DULOSE lactulose 667 mg/mL oral liquid bottle | 220095 | Medicine | A | 2/13/2014 | |
| DUPHALAC Lactulose 667mg/mL oral liquid bottle | 13295 | Medicine | A | 8/28/1991 | |
| CHEMISTS' OWN CONSTIPATION RELIEF SYRUP lactulose 667 mg/mL oral liquid bottle | 220096 | Medicine | A | 2/13/2014 | |
| ACTILAX lactulose 660 mg/mL oral liquid bottle | 43582 | Medicine | A | 3/24/1993 |
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| GEN-LAC - LIQ 667MG/ML | genpharm ulc | 02143542 | Liquid - Oral | 667 MG / ML | 12/31/1990 |
| M-LACTULOSE | mantra pharma inc | 02447797 | Solution - Oral | 667 MG / ML | N/A |
| DUPHALAC | solvay pharma inc | 02231527 | Powder - Oral | 95 G / 100 G | 11/27/1997 |
| RATIO-LACTULOSE | ratiopharm inc division of teva canada limited | 02183641 | Solution - Oral | 667 MG / ML | 7/30/1996 |
| JAMP-LACTULOSE | orbus pharma inc | 02280078 | Syrup - Oral | 667 MG / ML | 11/7/2006 |
| LACTULOSE SOLUTION USP - LIQ 667MG/ML | bdh inc. | 02148056 | Liquid - Oral | 667 MG / ML | 12/31/1995 |
| WOODWARD'S LAXATIVE SYRUP | pharmacare ltd., south africa | 02241028 | Syrup - Oral | 3.3 G / 5 ML | N/A |
| PHL-LACTULOSE SOLN 667MG/ML | pharmel inc | 02266415 | Solution - Oral | 667 MG / ML | N/A |
| RATIO-LACTULOSE | ratiopharm inc division of teva canada limited | 00690686 | Solution - Oral | 667 MG / ML | 12/31/1987 |
| LACTULOSE | 9113657 canada inc | 02447916 | Solution - Oral | 667 MG / ML | N/A |
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| DUPHALAC 10 G SOLUCION ORAL EN SOBRE | Cooper Consumer Health B.V. | 60189 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LACTULOSA LAINCO 10 g SOLUCION ORAL EN SOBRES EFG | Lainco S.A. | 69299 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| LACTULOSA LEVEL 667,5 mg/ml SOLUCION ORAL | Laboratorios Ern S.A. | 59469 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Not Commercialized |
| LACTULOSA LAINCO 3,33 g/5 ml SOLUCION ORAL EFG | Lainco S.A. | 69300 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
| DUPHALAC 667 MG/ML SOLUCION ORAL | Cooper Consumer Health B.V. | 46197 | SOLUCIÓN ORAL | Medicamento Sujeto A Prescripción Médica | Commercialized |
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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