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Chronulac

(Lactulose)

ApprovedSmall molecule

SSolvay Pharmaceuticals

Lactulose is used to treat constipation by drawing water into the intestines to soften stool and promote bowel movements. It's also used to treat a serious liver condition called hepatic encephalopathy by reducing ammonia levels in the blood.[2] Chronulac is currently approved and in use across 16 indications[4].[1]

Chronulac is one of 352 small molecule programs targeting Encephalopathy. It is currently in Approved.

16

Indications

68

Total Trials

10

Active Trials

351

Competitors

3

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

EncephalopathyUnknown status

Cirrhosis of LiverApproved

Atopic EczemaApproved

Premature BirthApproved

EndometriosisActive, not recruiting

Chronic Kidney DiseaseActive, not recruiting

Nosocomial InfectionActive, not recruiting

Constipation DisorderActive, not recruiting

Chronic Liver FailureActive, not recruiting

Diabetes MellitusActive, not recruiting

EncephalopathyApproved

Unknown status

Cirrhosis of LiverApproved

Approved

Atopic EczemaApproved

Approved

Premature BirthApproved

Approved

EndometriosisPreclinical

Active, not recruiting

Chronic Kidney DiseasePreclinical

Active, not recruiting

Nosocomial InfectionPreclinical

Active, not recruiting

Constipation DisorderApproved

Active, not recruiting

Chronic Liver FailurePreclinical

Active, not recruiting

Diabetes MellitusPreclinical

Active, not recruiting

Showing 10 of 15 indications

Competition

Competitive Landscape

172 competitors in Chronic Kidney Disease

#DrugCompanyPhaseTrials

Chronulac

SSolvay Pharmaceuticals

Effcamgcit

UUniversity of Texas Southwestern Medical Center

Uloric

Sovaldi

Glucotrol

Vemlidy

Lorelco

Activase

Flomax

PROCRIT

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

Encephalopathy

NCT06483737

Q3 2027

Post-ApprovalRecruiting

Cirrhosis

NCT06538077

Q4 2027

N/ANot yet recruiting

Encephalopathy

NCT07273734

Q2 2029

Phase 1/2Not yet recruiting

Immunotherapy

NCT07354100

Clinical

Trials by Indication[1]

Encephalopathy27 trials

Efficacy Study of Polyethylene Glycol 3350-electrolyte Solution (GoLYTELY®) Versus Lactulose in Patients With Hepatic Encephalopathy.

Completed·UUniversity of Texas Southwestern Medical Center·N/A·NCT01283152·50 enrolled

Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhosis

Unknown status·GGovind Ballabh Pant Hospital·Phase 4·NCT01178372

The Effects of Nitazoxanide in Hepatic Encephalopathy

Unknown status·—·Phase 2·NCT02334163·36 enrolled

Show 24 more trials

Efficacy of L-Ornithine L-Aspartate and Polyethylene Glycol in Cirrhotic Patients With Overt Hepatic Encephalopathy

Unknown status·JJinnah Postgraduate Medical Centre·Phase 4·NCT05920213·360 enrolled

To Assess Efficacy of Nutritional Therapy in Secondary Prophylaxis of Hepatic Encephalopathy Versus Lactulose in Patients With Liver Cirrhosis.

Withdrawn·IInstitute of Liver and Biliary Sciences, India·N/A·NCT03161106

A Trial for Comparing Rifaximin, Probiotic and L-ornithine- L Aspartate With Lactulose in Overt Hepatic Encephalopathy.

Completed·QQurratul Ain Jamil·Phase 4·NCT07037394·252 enrolled

Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy

Unknown status·SSherief Abd-Elsalam·Phase 2/3·NCT02464124·120 enrolled

Intravenous Branched Chain Amino Acids for Hepatic Encephalopathy in ACLF

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 1·NCT04238416·70 enrolled

Polyethylene Glycol Versus Lactulose on Hepatic Encephalopathy in Patients With Cirrhosis;(PEGHE Trial)

Unknown status·—·Phase 4·NCT04436601·102 enrolled

Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life

Completed·CCD Pharma India Pvt. Ltd.·Phase 2/3·NCT01008293·120 enrolled

The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy

Completed·BBausch Health Americas, Inc.·Phase 4·NCT01842581·222 enrolled

Safety and Efficacy of AST-120 Compared to Lactulose in Patients With Hepatic Encephalopathy

Completed·OOcera Therapeutics·Phase 2·NCT00558038·40 enrolled

Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT01218568·120 enrolled

RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial

Terminated·UUniversity of Miami·Phase 3·NCT00364689·13 enrolled

Secondary Prophylaxis of Hepatic Encephalopathy in Cirrhotic Patients

Unknown status·MMadonna Magdy Fahmy·Phase 1·NCT05279586·316 enrolled

PEG3350 in ACLF With Hepatic Encephalopathy

Unknown status·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 4·NCT03987893·60 enrolled

UDCA to Prevent Post-TIPS Hepatic Encephalopathy

Not yet recruiting·WWest China Hospital·N/A·NCT07273734·270 enrolled

Human Albumin Infusion in Liver Cirrhosis and Overt Hepatic Encephalopathy (HACHE)

Recruiting·GGeneral Hospital of Shenyang Military Region·N/A·NCT06483737·174 enrolled

Lactulose, L-ornithine L-aspartate, or Rifaximin Versus Placebo for Preventing Hepatic Encephalopathy in Variceal Bleeding

Completed·HHospital General de Mexico·Phase 4·NCT02158182·88 enrolled

Efficacy and Safety of Nifuroxazide in the Treatment of Hepatic Encephalopathy in Egyptian Patients With Liver Cirrhosis

Completed·—·Phase 3·NCT05754996·80 enrolled

Effect of Lactulose on Minimal Hepatic Encephalopathy and Health-Related Quality of Life

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 4·NCT00375375·80 enrolled

Effectiveness of Oral Lactulose Versus Lactulose Enema in Hepatic Encephalopathy

Unknown status·—·Phase 4·NCT05788627·100 enrolled

Efficacy and Safety of E.Coli Nissle 1917 in Patients With Mild (Stage 1-2) or Minimal Hepatic Encephalopathy

Completed·—·N/A·NCT04787276·42 enrolled

High Volume Plasmapheresis for Refractory Hepatic Encephalopathy in Liver Intensive Care Unit.

Withdrawn·IInstitute of Liver and Biliary Sciences, India·N/A·NCT03115697

PEG (Polyethylene Glycol)Versus Lactulose For Treatment Of Overt Hepatic Encephalopathy

Unknown status·SSherief Abd-Elsalam·Phase 4·NCT03100513·100 enrolled

Hepatic Encephalopathy: Lactulose or Polyethylene Glycol (H.E.L.P.)

Withdrawn·NNew York Presbyterian Brooklyn Methodist Hospital·N/A·NCT01923376

Primary Prophylaxis of Hepatic Encephalopathy in Patients With Cirrhosis

Unknown status·GGovind Ballabh Pant Hospital·Phase 4·NCT01175538

Constipation7 trials

Movicol in Childhood Constipation (ProMotion Study)

Completed·NNorgine·Phase 2·NCT00403858·60 enrolled

Efficacy of Dicopeg Junior in Comparison With Lactulose for the Treatment of Functional Constipation in Children Aged 6 Months to 6 Years.

Unknown status·CChildren's Memorial Health Institute, Poland·Phase 4·NCT03177434·102 enrolled

Effect of Agave Inulin on Constipation and Quality of Life in Peritoneal Dialysis Patients.

Enrolling by invitation·NNIN Institute·N/A·NCT06738550·45 enrolled

Show 4 more trials

Pilot Study of the Effect of Lactulose on Post Caesarean Section Constipation

Unknown status·NNHS Fife·N/A·NCT01295138·30 enrolled

A Clinical Standardization Study of the Preferred Acupuncture Treatment Protocol to Treat Functional Constipation

Completed·GGuang'anmen Hospital of China Academy of Chinese Medical Sciences·Phase 2·NCT00508482·475 enrolled

Anal Dilatation for Infants and Children With Constipation

Unknown status·TTongji Hospital·N/A·NCT02255747·100 enrolled

Movicol in Childhood Constipation (ProMotion Study)

Completed·NNorgine·Phase 2·NCT00404040·60 enrolled

Cirrhosis4 trials

Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004796·16 enrolled

BCAA vs. Rifaximin in Patients With Cirrhosis for Secondary Prophylaxis of HE

Recruiting·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 4·NCT06538077·336 enrolled

Effect of Single vs Repeated Cycles of a Combination of Granulocyte Colony Stimulating Factor and Darbepoetin vs Standard Medical Treatment on Immunometabolic Profile in Patient With Early Decompensated Cirrhosis.

Not yet recruiting·IInstitute of Liver and Biliary Sciences, India·N/A·NCT07002827·60 enrolled

Show 1 more trial

A Trial to Improve Quality of Life in People With Cirrhosis

Completed·UUniversity of Michigan·Phase 2/3·NCT05061992·56 enrolled

Bowel Preparation3 trials

Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation

Unknown status·FFirst People's Hospital of Hangzhou·N/A·NCT04794049·800 enrolled

Effect of Lactulose and/or Polyethylene Glycol Solution for Bowel Preparation for Colonscopy Procedures

Completed·SSichuan University·Phase 3·NCT05076799·200 enrolled

Comparison of Oral Lactulose Versus Polyethylene Glycol for Bowel Preparation in Low-risk Patients

Completed·ZZhang Xiaofeng,MD·N/A·NCT05648318·255 enrolled

Lactulose2 trials

A Preference Study Comparing Kristalose® and Liquid Lactulose

Completed·CCumberland Pharmaceuticals·Phase 4·NCT00712543·50 enrolled

Assesment of Lactulose vs Lactobacillus Acidophilus Effect in CKD Patients

Unknown status·—··NCT05934552·150 enrolled

22 more indications

Renal Failure2 trials

A Randomized Comparison of Rifaximin Versus Lactulose in Hospitalized Cirrhotic Patients With Renal Failure

Withdrawn·NNYU Langone Health·Phase 3·NCT02086825

Rifaximin Versus Lactulose in Renal Failure

Withdrawn·WWeill Medical College of Cornell University·Phase 4·NCT00748904

Chronic constipation2 trials

Efficacy and Safety of PEG 3350 for Treatment of Chronic Constipation

Unknown status·FFakultas Kedokteran Universitas Indonesia·Phase 3·NCT03957668·184 enrolled

Efficacy and Safety of Prucalopride in Combination With Polyethylene Glycol or Lactulose in Women With Chronic Constipation

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT02228616·280 enrolled

Bowel Preparation for Colonoscopy2 trials

Lactulose vs. Polyethylene Glycol as Bowel Preparation for Colonoscopy in Adults

Completed·HHospital de Clínicas Dr. Manuel Quintela·N/A·NCT05726344·150 enrolled

Clinical Study on the Application of Lactulose Combined with Linaclotide in Bowel Preparation for Colonoscopy

Enrolling by invitation·HHaifeng Lan·Phase 4·NCT06748638·444 enrolled

Chronic Liver Failure1 trial

Effect of Goal Directed Ammonia Lowering Therapy in Acute on Chronic Liver Failure Patients With Hepatic Encephalopathy.

Completed·IInstitute of Liver and Biliary Sciences, India·N/A·NCT02321371·73 enrolled

Gut Microbiota1 trial

Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients

Recruiting·PPeking Union Medical College Hospital·N/A·NCT07065942·60 enrolled

Premature Infants1 trial

Lactulose Supplementation in Premature Infants

Completed·—·Phase 2·NCT00616876·28 enrolled

Liver Disease1 trial

Study of Lactulose in Children With Chronic Liver Disease

Terminated·IIndiana University·Phase 2·NCT00811434·16 enrolled

Functional Gastrointestinal Disorders1 trial

Efficacy of Linaclotide in Patients With Overlapping Functional Gastrointestinal Disorders

Unknown status·RRenJi Hospital·Phase 4·NCT05134584·78 enrolled

Intravenous1 trial

Intravenous BCAA for HE in ACLF (BCAA-HE-ACLF)

Completed·PPost Graduate Institute of Medical Education and Research, Chandigarh·Phase 1·NCT05700695·114 enrolled

Withdrawal1 trial

A Study of Controlled Lactulose Withdrawal

Completed·HHunter Holmes Mcguire Veteran Affairs Medical Center·N/A·NCT00914056·7 enrolled

Quality of Life1 trial

Quality of Life and Nutritional Improvements in Cirrhotic Patients

Terminated·TTampa General Hospital·Phase 4·NCT01842113·4 enrolled

Immunotherapy1 trial

Lactulose to Improve Gut Health in Cancer Patients Receiving Immunotherapy

Not yet recruiting·UUniversity of Chicago·Phase 1/2·NCT07354100·55 enrolled

Driving1 trial

Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies.

Completed·UUniversity Hospital, Caen·N/A·NCT01231828·55 enrolled

Gastrointestinal hemorrhage1 trial

Lactulose for the Prevention of Hepatic Encephalopathy in Cirrhotic Patients With Upper Gastrointestinal Hemorrhage

Unknown status·—·Phase 3·NCT00553423·128 enrolled

Ondansetron1 trial

Mode of Action of Ondansetron, a 5-HT Receptor 3 Antagonist, in Lactulose Induced Diarrhoea

Completed·UUniversity of Nottingham·Phase 4·NCT03833999·16 enrolled

Nosocomial Infection1 trial

Lactulose for the Prevention of Nosocomial Infections in Children

Unknown status·—·N/A·NCT00273949·100 enrolled

Inflammatory Mediators1 trial

S. Endotoxin, Inflammatory Mediators and MRS Before and After Treatment in MHE

Completed·GGovind Ballabh Pant Hospital·N/A·NCT01446523·60 enrolled

Outcome1 trial

Goal Directed Ammonia Lowering Therapy in Hyperammonemic ACLF Patients With no Overt HE to Reduce Major Adverse Liver Related Outcomes (GOAL Trial)

Not yet recruiting·IInstitute of Liver and Biliary Sciences, India·N/A·NCT06808009·90 enrolled

Anal fissure1 trial

Trial to Evaluate Effect of Lactulose on Hard Stools in Patients With Hemorrhoids or Anal Fissures

Terminated·SSolvay Pharmaceuticals·Phase 4·NCT00160290·97 enrolled

Vaginitis1 trial

Efficacy and Safety of Clotrimazole+Lactulose Vaginal Suppositories Vs. Clotrimazole Monotherapy in Adult Women with Candidal Vaginitis/Vulvovaginitis

Recruiting·AAVVA Pharmaceuticals Ltd.·Phase 2/3·NCT06835361·264 enrolled

Cirrhosis, Liver1 trial

LiveSMART: A Sequential, Multiple Assignment Randomized Trial to Prevent Falls in Patients With Cirrhosis

Completed·UUniversity of Michigan·Phase 3·NCT05794555·233 enrolled

Type II Diabetes Mellitus1 trial

Efficacy and Safety of Oral Lactulose Combined With Polyethylene Glycol Electrolytes Powder (PEG-ELS) for Bowel Preparation in Type II Diabetes Mellitus Patients: A Randomized Controlled Trial

Completed·GGeneral Hospital of Shenyang Military Region·Preclinical·NCT07084350·300 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

CHRONULAC

NDA NDA017884

Jan 1, 1982

CEPHULAC

NDA NDA017657

Jan 1, 1982

LACTULOSE

NDA NDA017906

Sources

References

[1]
ClinicalTrials.gov — 68 trial records for Lactulose. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Chronulac drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Lactulose compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Lactulose. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA017884). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Solvay Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: SSolvay Pharmaceuticals

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