LOTRONEX (alosetron hydrochloride)
Lotronex helps women with severe, chronic diarrhea-predominant irritable bowel syndrome (IBS) who have not found relief through conventional therapies. It is used when symptoms like intense abdominal pain, frequent urgency, or fecal incontinence are severe enough to cause disability or restrict daily activities. Because of the risk of serious gastrointestinal side effects, it is prescribed only for patients whose symptoms have lasted at least six months and where other physical abnormalities have been ruled out.
How LOTRONEX Works
This drug works by blocking 5-HT3 receptors located on the nerves of the gastrointestinal tract. By inhibiting these receptors, it modulates the enteric nervous system to reduce visceral pain and slow down colonic transit. This helps manage the hypersensitivity and overactive motor responses that lead to the abnormal pain and bowel patterns seen in IBS.
Details
- Status
- Prescription
- First Approved
- 2000-02-09
- Routes
- ORAL
- Dosage Forms
- TABLET
LOTRONEX Approval History
What LOTRONEX Treats
2 indicationsLOTRONEX is approved for 2 conditions since its original approval in 2000. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Irritable Bowel Syndrome
- Diarrhea
LOTRONEX Boxed Warning
SERIOUS GASTROINTESTINAL ADVERSE REACTIONS Infrequent but serious gastrointestinal adverse reactions have been reported with the use of LOTRONEX. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization, and rarely, blood transfusion, surgery, and death. LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have not responded adequately to conventional therapy [see Indications and Usage...
WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS Infrequent but serious gastrointestinal adverse reactions have been reported with the use of LOTRONEX. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization, and rarely, blood transfusion, surgery, and death. LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have not responded adequately to conventional therapy [see Indications and Usage ( 1 )] . LOTRONEX should be discontinued immediately in patients who develop constipation or symptoms of ischemic colitis. Patients should immediately report constipation or symptoms of ischemic colitis to their prescriber. LOTRONEX should not be resumed in patients who develop ischemic colitis. Patients who have constipation should immediately contact their prescriber if the constipation does not resolve after LOTRONEX is discontinued. Patients with resolved constipation should resume LOTRONEX only on the advice of their treating prescriber [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.1 ), ( 5.2 )]. WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS See full prescribing information for complete boxed warning. Infrequent but serious gastrointestinal adverse reactions have been reported with the use of LOTRONEX. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization and, rarely, blood transfusion, surgery, and death. LOTRONEX is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have not responded adequately to conventional therapy. ( 1 ) Discontinue LOTRONEX immediately in patients who develop constipation or symptoms of ischemic colitis. Do not resume LOTRONEX in patients who develop ischemic colitis. ( 2.1 , 5.1 , 5.2 )
LOTRONEX Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
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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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.
LOTRONEX FDA Label Details
Indications & Usage
FDA Label (PDF)LOTRONEX is indicated for the treatment of Irritable Bowel Syndrome; Diarrhea.
WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS Infrequent but serious gastrointestinal adverse reactions have been reported with the use of LOTRONEX. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization, and rarely, blood transfusi...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.