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FE203799

Phase 1

SBS - Short Bowel Syndrome | Small molecule | Other |Ironwood Pharmaceuticals, Inc.|Last Updated: Oct 24, 2024

Development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jan 2018

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

FE203799 · 1 trial · 1 indication

Phase 1 1
NCT03408132Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal InsufficiencySBS - Short Bowel Syndrome
COMPLETED8 Analytics
PHASE1COMPLETED
Metabolic Balance Study of FE203799 in Patients With SBS With Intestinal Insufficiency
SBS - Short Bowel Syndrome
NCT034081328
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Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events
Day -28 to Day 26 plus 6 weeks

Adverse events as assessed by CTCAE v4.03

Secondary Endpoints

Assessment of intestinal insufficiency and gut absorption
Day -28 to day 26
Assessment of gut regeneration
Baseline (Day -7) to end of treatment period (Day 26) plus 6 weeks
Maximum observed plasma concentration (Cmax)
Day 1 to end of treatment period (Day 26)
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeSUPPORTIVE_CARE

Treatment Arms

ArmTypeDescription
FE203799 5 mgEXPERIMENTALFE203799 5 mg subcutaneous injection

Interventions

NameTypeDescription
FE203799DRUGFE203799 5 mg subcutaneous once weekly
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Males and females with SBS secondary to surgical resection of the small intestine, with or without an intact colon. 2. 18-80 years of age 3. Average faecal wet weight excretion of ≥1500 g/day during the baseline balance study 4. Average urine production \<2000 mL/day during t...

Countries:Denmark
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Competitive Landscape -Short Bowel Syndrome 8 trials (matched to "SBS - Short Bowel Syndrome")

CompanyTickerTrialsLead PhaseDrugs
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK4PHASE3Teduglutide
Jaguar Health, Inc.JAGX1PHASE2Crofelemer
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