TheraRadar
Data updated: Jun 17, 2026

LACTULOSE

Osmotic Activity
Hepatology Approved 1992-05-29

For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.

Source: FDA Label • BAJAJ
Jump to: Indications Approvals Trials Competitors Safety Patents
17
Indications
--
Phase 3 Trials
34
Years on Market

Details

Status
Prescription
First Approved
1992-05-29
Routes
ORAL, RECTAL, ORAL
Dosage Forms
SOLUTION, FOR SOLUTION

Companies

BAJAJ SCIEGEN PHARMS APOZEAL PHARMS PAI HOLDINGS CUMBERLAND PHARMS Hikma ROXANE PHARMOBEDIENT PACO Fresenius Kabi CHARTWELL RX TARO ANI PHARMS MORTON GROVE LANNETT CO INC Aurobindo Pharma SOLVAY VISTAPHARM LLC PHARM ASSOC
Active Ingredient: LACTULOSE

LACTULOSE Approval History

1993
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1999
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2025
2026
Original
New Indication
New Form
Label Update
73 FDA actions from 1992 to 2026
Apr 2026 SUPPL
Label · Labeling
Mar 2025 ORIGINAL
Update
Dec 2024 ORIGINAL
Update

What LACTULOSE Treats

17 FDA approvals

Originally approved for its first indication in 1992 . Covers 17 distinct patient populations.

  • Other (17)
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Clinical Trial Registry

21 trials
Trial Sponsor ID Phase Status Title
NCT07534995 CACMREZZ2025-A-10 Ph 3 not yet recruiting A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Trial
NCT07354100 (BLOOM) IRB25-1467 Ph 1, Ph 2 recruiting Lactulose to Improve Gut Health in Cancer Patients Receiving Immunotherapy
NCT05794555 HUM00225275 CER-2021C3-24907 Ph 3 completed LiveSMART Trial to Prevent Falls in Patients With Cirrhosis
NCT05754996 CL (3202) Ph 3 completed Efficacy and Safety of Nifuroxazide in the Treatment of Hepatic Encephalopathy in Egyptian Patients With Liver Cirrhosis
NCT07037394 ARGO-HEC 187-2023-/PHEC Ph 4 completed A Trial for Comparing Rifaximin, Probiotic and L-ornithine- L Aspartate With Lactulose in Overt Hepatic Encephalopathy.
NCT06538077 HERB PGI/HEP/567 Ph 4 recruiting BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE
NCT05700695 IEC/04/2022-2385 Ph 1 completed Intravenous BCAA for HE in ACLF (BCAA-HE-ACLF)
NCT06835361 Clotrimazole+Lactulose-II/III Ph 2, Ph 3 recruiting Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis
NCT06748638 DZQH-KYLL-24-35 Ph 4 enrolling by invitation Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy
NCT05061992 results posted HUM00204056 Ph 2, Ph 3 completed A Trial to Improve Quality of Life in People With Cirrhosis
NCT04238416 BCAA-ACLF IEC-08/2019-1336 Ph 1 completed Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF
NCT00748904 0801009635 Ph 4 withdrawn Rifaximin Versus Lactulose in Renal Failure
NCT03833999 MOLID 85-1807 Ph 4 completed Mode of Action of Ondansetron, a 5-HT Receptor 3 Antagonist, in Lactulose Induced Diarrhoea
NCT01842581 results posted RFHE4044 Ph 4 completed The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy
NCT02158182 DI/14/107/03/028 Ph 4 completed Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding
NCT02228616 CR102381 PRUCOP4005, PRU-C-13-CN-004-V02 Ph 4 completed Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation
NCT02086825 11-00665 Ph 3 withdrawn A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure
NCT00508482 results posted 2006BAI12B05-1 Ph 2 completed A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation
NCT00811434 MHE results posted 0808-19 Clarian Grant VFR-279 Ph 2 terminated Study of Lactulose in Children With Chronic Liver Disease
NCT01842113 Rifaximin and Nutrition Ph 4 terminated Quality of Life and Nutritional Improvements in Cirrhotic Patients
NCT01008293 MHE MHE-VSL3-YKJ_AIIMS_ver1 Ph 2, Ph 3 completed Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

LACTULOSE FDA Label Details

Indications & Usage

For the treatment of constipation. In patients with a history of chronic constipation, lactulose solution therapy increases the number of bowel movements per day and the number of days on which bowel movements occur.

Looking for the branded version?

GENERLAC

Full clinical data, patents, trials, and competitive landscape for lactulose.

See GENERLAC

Data Sources

FDA Approval: ANDA076645 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.