ALOSETRON HYDROCHLORIDE
Alosetron hydrochloride treats women with severe, chronic diarrhea-predominant irritable bowel syndrome (IBS) that has lasted at least six months. It helps patients who have not seen improvement with conventional therapies and experience significant symptoms like intense abdominal pain, frequent urgency, or disability. This medication is specifically used when other causes of gastrointestinal issues have been ruled out and the potential benefits are deemed to outweigh the risks of serious side effects.
How ALOSETRON HYDROCHLORIDE Works
This drug works by blocking 5-HT3 receptors located on the nerves within the gastrointestinal tract. By inhibiting these receptors, it modulates the enteric nervous system to reduce the gut's hypersensitivity and overactive motor responses. This process helps manage the abnormal pain sensations and rapid colonic transit associated with the condition.
Details
- Status
- Prescription
- First Approved
- 2015-05-04
- Routes
- ORAL
- Dosage Forms
- TABLET
ALOSETRON HYDROCHLORIDE Approval History
What ALOSETRON HYDROCHLORIDE Treats
2 indicationsALOSETRON HYDROCHLORIDE is approved for 2 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Irritable Bowel Syndrome
- Diarrhea
ALOSETRON HYDROCHLORIDE Boxed Warning
SERIOUS GASTROINTESTINAL ADVERSE REACTIONS Infrequent but serious gastrointestinal adverse reactions have been reported with the use of alosetron hydrochloride. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization and rarely, blood transfusion, surgery and death. Alosetron hydrochloride is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have not responded adequately to conventional therap...
WARNING: SERIOUS GASTROINTESTINAL ADVERSE REACTIONS Infrequent but serious gastrointestinal adverse reactions have been reported with the use of alosetron hydrochloride. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization and rarely, blood transfusion, surgery and death. Alosetron hydrochloride 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) ] . Alosetron hydrochloride 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. Alosetron hydrochloride 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 alosetron hydrochloride is discontinued. Patients with resolved constipation should resume alosetron hydrochloride 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 alosetron hydrochloride. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization and, rarely, blood transfusion, surgery and death. Alosetron hydrochloride is indicated only for women with severe diarrhea-predominant irritable bowel syndrome (IBS) who have not responded adequately to conventional therapy. (1) Discontinue alosetron hydrochloride immediately in patients who develop constipation or symptoms of ischemic colitis. Do not resume alosetron hydrochloride in patients who develop ischemic coliti
ALOSETRON HYDROCHLORIDE 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
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Key Completed Trials
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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.
ALOSETRON HYDROCHLORIDE FDA Label Details
Indications & Usage
FDA Label (PDF)ALOSETRON HYDROCHLORIDE 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 alosetron hydrochloride. These events, including ischemic colitis and serious complications of constipation, have resulted in hospitalization and rarely, b...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.