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LX1033

Phase 2

Irritable Bowel Syndrome | Small molecule | Gastrointestinal |Lexicon Pharmaceuticals, Inc.|Last Updated: Mar 23, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment373

FDA Designations

No designations recorded

Clinical trial landscape

LX1033 · 1 trial · 1 indication

Phase 2 1
NCT01494233A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel SyndromeIrritable Bowel Syndrome
COMPLETED373 Analytics
PHASE2COMPLETED
A Multi-Center Trial to Determine the Safety and Efficacy of LX1033 in Subjects With Diarrhea-Predominant Irritable Bowel Syndrome
Irritable Bowel Syndrome
NCT01494233373
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Study Endpoints

Primary Endpoints

Change from baseline in stool consistency
4 weeks

Secondary Endpoints

Change from baseline in plasma 5-HIAA levels
4 weeks
Change from baseline in worst abdominal pain in past 24 hours
4 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Low doseEXPERIMENTAL500 mg LX1033 two times daily
Mid doseEXPERIMENTAL500 mg LX1033 three times daily
High doseEXPERIMENTAL1000 mg LX1033 two times daily
PlaceboPLACEBO_COMPARATORMatching placebo dosing

Interventions

NameTypeDescription
250 mg LX1033 tabletsDRUG250 mg LX1033 tablets administered orally
Placebo tabletDRUGMatching placebo tablet administered orally
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites81

Inclusion Criteria: * Male and female subjects, aged 18 to 70 years, with diarrhea-predominant IBS (IBS-D) with symptom onset at least 6 months prior to diagnosis * Two or more days per week with at least one stool with a consistency of Type 6 or 7 (Bristol Stool Form Scale) * Weekly average of wor...

Countries:United States
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Competitive Landscape -Irritable Bowel Syndrome 12 trials

CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV2PHASE3Eluxadoline
Ardelyx, Inc.ARDX3PHASE3Tenapanor
Disc Medicine, Inc.IRON1PHASE2DISC-0974
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK2 - Undisclosed
Johnson & JohnsonJNJ1 - Anti TNF therapy including infliximab, No Biologics
Cooper Companies, Inc.COO1N/AUndisclosed
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Frequently asked questions about LX1033

What is LX1033 used for?

LX1033 is an investigational small molecule being developed for the treatment of irritable bowel syndrome (IBS). It was studied in patients with diarrhea-predominant irritable bowel syndrome, a subtype of the condition characterized by frequent loose stools. The drug is not approved and remains in clinical development.

What does LX1033 target?

LX1033 is a small molecule that works by inhibiting the enzyme tryptophan hydroxylase, which is involved in the production of serotonin in the gut. By reducing serotonin synthesis, LX1033 aims to alleviate symptoms of diarrhea-predominant irritable bowel syndrome. This mechanism was evaluated in a Phase 2 clinical trial.

Who makes LX1033?

LX1033 is being developed by Lexicon Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol LXRX. The company conducted a Phase 2 clinical trial to evaluate the drug's safety and efficacy in patients with diarrhea-predominant irritable bowel syndrome.

What phase is LX1033 in?

LX1033 is in Phase 2 clinical development. A Phase 2 trial, which has been completed, evaluated the drug in 373 patients with diarrhea-predominant irritable bowel syndrome. The drug is investigational and has not been approved by regulatory authorities for any use.

What clinical trials is LX1033 in?

LX1033 has been studied in one completed Phase 2 clinical trial, identified as NCT01494233. This randomized, double-blind, placebo-controlled trial enrolled 373 participants in the United States to assess the safety and efficacy of LX1033 in subjects with diarrhea-predominant irritable bowel syndrome.

Is LX1033 the same as any other drug?

LX1033 is the primary name for this investigational compound developed by Lexicon Pharmaceuticals. No alternative names have been reported for this drug in clinical trial records. It is a distinct small molecule being studied specifically for irritable bowel syndrome.