GENERLAC (lactulose)
GENERLAC is indicated for the treatment of Hepatic Encephalopathy.
Details
- Status
- Prescription
- First Approved
- 1996-10-31
- Routes
- ORAL, RECTAL
- Dosage Forms
- SOLUTION
GENERLAC Approval History
What GENERLAC Treats
1 indicationsGENERLAC is approved for 1 conditions since its original approval in 1996. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hepatic Encephalopathy
GENERLAC Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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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 | not yet 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 |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
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.
GENERLAC FDA Label Details
Indications & Usage
GENERLAC is indicated for the treatment of Hepatic Encephalopathy.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.