Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LX1031 High Dose · 1 trial · 1 indication
The primary efficacy endpoint was the proportion of subjects experiencing relief of IBS pain and discomfort at Week 4 as measured by the response to the question,"In the past 7 days have you had adequate relief of your irritable bowel syndrome pain and discomfort?"
| Arm | Type | Description |
|---|---|---|
| High dose | EXPERIMENTAL | A high dose of LX1031; daily oral intake for 28 days |
| Low Dose | EXPERIMENTAL | A low dose of LX1031; daily oral intake for 28 days |
| Placebo | PLACEBO_COMPARATOR | Matching placebo dosing with daily oral intake |
| Name | Type | Description |
|---|---|---|
| LX1031 High Dose | DRUG | A high dose of LX1031; daily oral intake for 28 days |
| LX1031 Low Dose | DRUG | A low dose of LX1031; daily oral intake for 28 days. |
| Placebo | DRUG | Matching placebo dosing with daily oral intake |
Inclusion Criteria: * Males and females aged 18-70 years old * Documented diagnosis of IBS (IBS-diarrhea or IBS-mixed) based upon Rome III criteria * Abdominal pain/discomfort at least 2 days per week during the screening and run-in periods * Normal structural evaluation of the colon within 5 years...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Eluxadoline |
| Ardelyx, Inc. | ARDX | 3 | PHASE3 | Tenapanor |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | - | Undisclosed |
| Johnson & Johnson | JNJ | 1 | - | Anti TNF therapy including infliximab, No Biologics |
| Cooper Companies, Inc. | COO | 1 | N/A | Undisclosed |
LX1031 High Dose is an investigational small molecule being studied for the treatment of Irritable Bowel Syndrome (IBS). It is being developed by Lexicon Pharmaceuticals, Inc. (ticker: LXRX) and is currently in Phase 2 clinical development.
The specific molecular target of LX1031 High Dose is not disclosed in the available information. The drug is being studied for its potential effects in Irritable Bowel Syndrome, but its mechanism of action has not been specified.
LX1031 High Dose is being developed by Lexicon Pharmaceuticals, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol LXRX. The company is conducting clinical research on this drug for Irritable Bowel Syndrome.
LX1031 High Dose is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial for this drug has been completed.
LX1031 High Dose has been studied in one clinical trial with the identifier NCT00813098, titled 'Study of LX1031 in Subjects With Non-Constipating Irritable Bowel Syndrome'. This Phase 2 trial was completed and enrolled 155 participants in the United States.
LX1031 High Dose is a specific dosage form of the drug LX1031. The clinical trial NCT00813098 evaluated LX1031 in subjects with non-constipating Irritable Bowel Syndrome, and the high dose refers to one of the dose levels tested in that study.