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Crofelemer Product

Phase 1

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

Target and mechanism

Molecular targetANO1, CFTR
Target classBlocker
ModalitySmall molecule

Also known as Crofelemer Oral Product

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment6

FDA Designations

No designations recorded

Clinical trial landscape

Crofelemer Product · 1 trial · 1 indication

Early Phase 1 1
NCT06326645Open-Label Pilot Study With Crofelemer in Patients With Short Bowel SyndromeShort Bowel Syndrome
RECRUITING6 Analytics
EARLY_PHASE1RECRUITING
Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome
Short Bowel SyndromeUnlock trial analytics

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 to 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 8 trials

Frequently asked questions about Crofelemer Product

What is Crofelemer Product used for?

Crofelemer Product is an investigational small molecule being developed for Short Bowel Syndrome, a gastrointestinal condition. It is currently in early Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in an open-label pilot trial in the United States.

Who makes Crofelemer Product?

Crofelemer Product is being developed by Jaguar Health, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol JAGX. The company is conducting an early Phase 1 clinical trial of the drug in patients with Short Bowel Syndrome.

What phase is Crofelemer Product in?

Crofelemer Product is in early Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing trial is an open-label pilot study with a planned enrollment of 6 participants, and it is currently recruiting patients in the United States.

What clinical trials is Crofelemer Product in?

Crofelemer Product is being studied in one active clinical trial, NCT06326645, titled 'Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome.' This early Phase 1 trial is recruiting 6 adult patients in the United States and is not randomized or blinded.

Is Crofelemer Product the same as Crofelemer Oral Product?

Yes, Crofelemer Product is also known as Crofelemer Oral Product. Both names refer to the same investigational drug being developed by Jaguar Health, Inc. for Short Bowel Syndrome. The drug is currently in early Phase 1 clinical trials.