Lactulose

Summary

Lactulose (CHEMBL296306) is an approved small-molecule gastrointestinal drug (ATC A06AD11); indicated across 6 conditions including constipation disorder and brain disorder.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Small molecule
• ATC class: A06AD11 (+1 more)
• Indications: 6 conditions
• Clinical trials: 92
• Chemistry: 342.3 Da · C12H22O11

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL296306
Name	Lactulose
Type	Small molecule
Max phase	4
FDA approved	yes
PubChem CID	11333
ChEBI	CHEBI:6359
ATC	A06AD11, A06AD61
Molecular formula	C12H22O11
Molecular weight	342.3
InChIKey	JCQLYHFGKNRPGE-FCVZTGTOSA-N

SMILES: C([C@@H]1[C@@H]([C@@H]([C@H]([C@@H](O1)O[C@@H]2[C@H](O[C@@]([C@H]2O)(CO)O)CO)O)O)O)O

IUPAC name: (2S,3R,4S,5R,6R)-2-[(2R,3S,4S,5R)-4,5-dihydroxy-2,5-bis(hydroxymethyl)oxolan-3-yl]oxy-6-(hydroxymethyl)oxane-3,4,5-triol

ChEBI definition: A synthetic galactosylfructose disaccharide used in the treatment of constipation and hepatic encephalopathy.

Pharmacological roles (ChEBI): laxative, gastrointestinal drug.

Also known as: Acilac, Bifiteral, Cephulac, Cholac, Chronulac, Constilac, Constulose, Duphalac, Duphalac dry, E966, Enulose, Evalose

Parent form; salt/anhydrous children: CHEMBL1237068

Patent coverage: 8,892 distinct patent families (29,042 SureChEMBL compound mentions), from 1 matched compound structure(s). Mentions count patents naming the compound (not distinct inventions), so promiscuous / reference molecules inflate the mention figure — families are the dedup metric.

Targets

Targets

Broader ChEMBL bioactivity targets: 1 (assay-derived). Sample: Menin/Histone-lysine N-methyltransferase MLL.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

6 indications (2 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).

Indication	Trial phase	MONDO	EFO
constipation disorder	4	MONDO:0002203	HP:0002019
brain disorder	3	MONDO:0005560	HP:0001298
atopic eczema	2	MONDO:0004980	EFO:0000274
cirrhosis of liver	2	MONDO:0005155	EFO:0001422

2 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 92.

Phase distribution

Phase	Trials
Not specified	37
PHASE4	24
PHASE2	11
PHASE3	8
PHASE2/PHASE3	5
PHASE1	4
EARLY_PHASE1	2
PHASE1/PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT04073290	PHASE4	RECRUITING	Prevention of Post-TIPS Hepatic Encephalopathy by Administration of Rifaximin and Lactulose
NCT06538077	PHASE4	RECRUITING	BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE
NCT06748638	PHASE4	ENROLLING_BY_INVITATION	Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy
NCT00160264	PHASE4	COMPLETED	Study to Investigate if Adding Lactulose to Vitamin D and Calcium Has an Effect on the Preservation of Bone in Postmenopausal Women
NCT00160290	PHASE4	TERMINATED	Trial to Evaluate Effect of Lactulose on Hard Stools in Patients With Hemorrhoids or Anal Fissures
NCT00375375	PHASE4	COMPLETED	Effect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life
NCT00712543	PHASE4	COMPLETED	A Preference Study Comparing Kristalose® and Liquid Lactulose
NCT00740142	PHASE4	COMPLETED	Efficacy of Combined Oral L-ornithine-L-aspartate and Lactulose in Patients With Hepatic Encephalopathy
NCT00748904	PHASE4	WITHDRAWN	Rifaximin Versus Lactulose in Renal Failure
NCT01175538	PHASE4	UNKNOWN	Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis
NCT01178372	PHASE4	UNKNOWN	Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis
NCT01842113	PHASE4	TERMINATED	Quality of Life and Nutritional Improvements in Cirrhotic Patients
NCT01842581	PHASE4	COMPLETED	The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy
NCT02158182	PHASE4	COMPLETED	Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding
NCT02228616	PHASE4	COMPLETED	Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation
NCT03100513	PHASE4	UNKNOWN	PEG (Polyethylene Glycol)Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy
NCT03177434	PHASE4	UNKNOWN	Efficacy of Dicopeg Junior in Comparison With Lactulose for the Treatment of Functional Constipation in Children Aged 6 Months to 6 Years.
NCT03833999	PHASE4	COMPLETED	Mode of Action of Ondansetron, a 5-HT Receptor 3 Antagonist, in Lactulose Induced Diarrhoea
NCT03987893	PHASE4	UNKNOWN	PEG3350 in ACLF With Hepatic Encephalopathy
NCT04436601	PHASE4	UNKNOWN	Polyethylene Glycol Versus Lactulose on Hepatic Encephalopathy in Patients With Cirrhosis;(PEGHE Trial)
NCT05134584	PHASE4	UNKNOWN	Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders
NCT05788627	PHASE4	UNKNOWN	Effectiveness of Oral Lactulose Versus Lactulose Enema in Hepatic Encephalopathy
NCT05920213	PHASE4	UNKNOWN	Efficacy of L-Ornithine L-Aspartate and Polyethylene Glycol in Cirrhotic Patients With Overt Hepatic Encephalopathy
NCT07037394	PHASE4	COMPLETED	A Trial for Comparing Rifaximin, Probiotic and L-ornithine- L Aspartate With Lactulose in Overt Hepatic Encephalopathy.
NCT06835361	PHASE2/PHASE3	RECRUITING	Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis
NCT07534995	PHASE3	NOT_YET_RECRUITING	A Prospective, Multicenter, Randomized, Parallel-controlled, Superiority Trial
NCT00364689	PHASE3	TERMINATED	RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial
NCT00553423	PHASE3	UNKNOWN	Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage
NCT00745147	PHASE3	COMPLETED	Comparison of TCM and Laxatives for Adults With Chronic Constipation
NCT01008293	PHASE2/PHASE3	COMPLETED	Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life
NCT02086825	PHASE3	WITHDRAWN	A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure
NCT02464124	PHASE2/PHASE3	UNKNOWN	Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy
NCT03957668	PHASE3	UNKNOWN	Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation
NCT05061992	PHASE2/PHASE3	COMPLETED	A Trial to Improve Quality of Life in People With Cirrhosis
NCT05341180	PHASE2/PHASE3	COMPLETED	Efficacy of Polyethylene Glycol vs Lactulose With Isabgol in Acute Fissure-in-Ano: PEGASIS Trial
NCT05754996	PHASE3	COMPLETED	Efficacy and Safety of Nifuroxazide in the Treatment of Hepatic Encephalopathy in Egyptian Patients With Liver Cirrhosis
NCT05794555	PHASE3	COMPLETED	LiveSMART Trial to Prevent Falls in Patients With Cirrhosis
NCT07354100	PHASE1/PHASE2	NOT_YET_RECRUITING	Lactulose to Improve Gut Health in Cancer Patients Receiving Immunotherapy
NCT00001337	PHASE2	COMPLETED	Dose-Adjusted EPOCH Chemotherapy and Rituximab (CD20+) in Previously Untreated Aggressive Non-Hodgkin’s Lymphoma
NCT00004796	PHASE2	COMPLETED	Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No CPIC/DPWG dosing guideline or drug-level clinical/variant annotations in PharmGKB for this molecule.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).