MYTESI (crofelemer)
Mytesi is an antidiarrheal that helps adult patients living with HIV or AIDS who experience non-infectious diarrhea while taking anti-retroviral therapy. It is used to provide relief from the symptoms of this condition. This medication is specifically prescribed for those whose diarrhea is not caused by an infection but is associated with their ongoing HIV treatment regimen.
How MYTESI Works
This drug works by blocking specific chloride ion channels, known as CFTR and CaCC, located in the lining of the intestines. By inhibiting these channels, it prevents the excessive secretion of chloride and the high volume of water loss that occurs during diarrhea. This process helps normalize the flow of water and electrolytes through the gastrointestinal tract.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2012-12-31
- Patent Cliff
- 2031
- Routes
- ORAL
- Dosage Forms
- TABLET, DELAYED RELEASE
MYTESI Approval History
What MYTESI Treats
2 indicationsMYTESI is approved for 2 conditions since its original approval in 2012. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Diarrhea
- HIV/AIDS
MYTESI 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.
Drugs Similar to MYTESI
3 of 10FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
5 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04486326 results posted | 2020P-000464 | Ph 4 | terminated | Crofelemer for Functional Diarrhea |
| NCT03898856 results posted | HSC-MS-18-0990 | Ph 4 | completed | Yield of Diagnostic Tests and Effects of Crofelemer for Chronic Idiopathic Diarrhea In Non-HIV Patients |
| NCT03094052 results posted | 167514 NCI-2017-01443 | Ph 2 | completed | Incidence and Severity of Diarrhea in Patients With HER2 Positive Breast Cancer Treated With Trastuzumab and Neratinib |
| NCT02910219 HALT-D results posted | MHRI GU 2015-0547 | Ph 2 | completed | Diarrhea Prevention and Prophylaxis With Crofelemer in HER2 Positive Breast Cancer Patients |
| NCT01374490 results posted | CFHD3092 | Ph 3 | completed | Safety and Tolerability of Crofelemer for HIV-Associated Diarrhea |
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.
MYTESI FDA Label Details
Indications & Usage
FDA Label (PDF)MYTESI is indicated for the treatment of Diarrhea; HIV/AIDS.
Pro Intelligence Preview
Deep insights for MYTESI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • 2 active patents
Trial Analysis
- • 5 total trials
- • Stage: Declining
Competitive Landscape
- • 10 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment