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LB1148

Phase 2

Ileus | Small molecule | Gastrointestinal |Genelux Corporation|Last Updated: Sep 27, 2021

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment131

FDA Designations

No designations recorded

Clinical trial landscape

LB1148 · 1 trial · 1 indication

Phase 2 1
NCT05056935Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative IleusIleus
COMPLETED131 Analytics
PHASE2COMPLETED
Study to Evaluate LB1148 for Return of Gastrointestinal Function, Decrease Post-Operative Ileus
IleusUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to reach GI-2
within 14 days after surgery

• GI-2 is defined as the toleration of solid food and first bowel movement. * Ability to tolerate a solid oral diet is defined as the time from the end of surgery (the time of last skin staple or suture is placed by surgeon) to the time a patient finishes first solid meal that requires chewing and no significant nausea or vomiting for 4 hours after solid meal). * First bowel movement is defined as the time from the end of surgery to the first passage of stool.

Secondary Endpoints

Time to reach GI-3
within 14 days after surgery
Nausea Verbal Rating Scoring Scale
within 14 days after surgery
Number of days in the hospital
within 14 days after surgery
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
LB1148EXPERIMENTALactive
PlaceboPLACEBO_COMPARATORplacebo

Interventions

NameTypeDescription
LB1148DRUGA total of 700 mL of LB1148 will be administered orally as a split dose before surgery.
PlaceboDRUGA total of 700 mL of placebo will be administered orally as a split dose before surgery.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: 1. Scheduled to undergo an elective (non-emergent) bowel resection with or without a planned stoma via laparotomy or minimally invasive technique. This includes any subject in which a resection of the small intestine, colon, or rectum is performed for any elected indication. 2. ...

Countries:China
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Frequently asked questions about LB1148

What is LB1148 used for?

LB1148 is an investigational small molecule being developed for ileus, a gastrointestinal condition. It is designed to help return gastrointestinal function and decrease post-operative ileus. The drug is currently in clinical development and has completed a Phase 2 trial.

What does LB1148 target?

The specific molecular target of LB1148 has not been disclosed. It is a small molecule being studied for its effects on gastrointestinal function, particularly in the context of post-operative ileus. The mechanism of action is not publicly detailed.

Who makes LB1148?

LB1148 is being developed by Genelux Corporation, a biopharmaceutical company traded on the stock exchange under the ticker symbol GNLX. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with ileus.

What phase is LB1148 in?

LB1148 is in Phase 2 of clinical development. A Phase 2 trial has been completed, which studied the drug for the return of gastrointestinal function and decrease of post-operative ileus. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is LB1148 in?

LB1148 has one completed clinical trial registered as NCT05056935. This Phase 2 study evaluated the drug for return of gastrointestinal function and decrease of post-operative ileus. The trial enrolled 131 participants in China and was randomized, double-blind, and placebo-controlled.

Is LB1148 the same as any other drug?

No alternative names for LB1148 have been reported. The drug is known only by its development code LB1148 and is being studied by Genelux Corporation for the treatment of ileus.