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Crofelemer Product

Phase 1

Short Bowel Syndrome | Small molecule | Gastrointestinal |Jaguar Health, Inc.|Last Updated: Feb 12, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment6
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06326645Open-Label Pilot Study With Crofelemer in Patients With Short Bowel SyndromeEARLY_PHASE1 RECRUITING 6Mar 3, 2025Feb 1, 2026Feb 12, 20261 United States
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Study Endpoints
Primary Endpoints
Ostomy output reduction
12 weeks

Change in ostomy output from baseline over the entire 12-week treatment period as average weekly ostomy output at week 12.

Secondary Endpoints
Change in average weekly Parenteral Support (PS) volume
16 weeks from treatment start
Change in SBS-QoL (Short bowel syndrome quality of life)
16 weeks from treatment start
Change in GSRS (Gastrointestinal Symptom Rating Scale)
16 weeks from treatment start
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Crofelemer GroupEXPERIMENTAL -
Interventions
NameTypeDescription
Crofelemer Oral ProductDRUGCrofelemer powder for solution (50g and 100g) or Crofelemer Powder for Oral Solution (100 mg/mL or 30 mg/mL vials for reconstitution and oral dosing)
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients must understand and provide written informed consent before they can participate in the study. They must understand the study procedures of the trial and be willing to complete the required assessments; 2. Male and female patients aged ≥ 18 years; 3. SBS patients wit...

Countries:United States
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Competitive Landscape -Short Bowel Syndrome 9 trials
Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06326645studyFirstPostDate: changed