Recent Updates
Recently added Catalysts

FE203799 GLP-2 analogue

Phase 1

Short Bowel Syndrome | Small molecule | Gastrointestinal |Ironwood Pharmaceuticals, Inc.|Last Updated: Oct 26, 2024

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

FE203799 GLP-2 analogue · 1 trial · 1 indication

Phase 1 1
NCT03415594Safety, Efficacy, PD of FE203799 in Short Bowel Syndrome on Parenteral SupportShort Bowel Syndrome
COMPLETED8 Analytics
PHASE1COMPLETED
Safety, Efficacy, PD of FE203799 in Short Bowel Syndrome on Parenteral Support
Short Bowel SyndromeUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of treatment-emergent adverse events
Day -28 to Day 29

Adverse events (AEs) as assessed by CTCAE v4.03

Secondary Endpoints

Assessment of intestinal failure and gut absorption
Day -3 - Day 28
Assessment of gut regeneration
Day 1 - Day 29
Plasma Trough concentration (Ctrough) of study drug
Day 1 - Day 29
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeSUPPORTIVE_CARE

Treatment Arms

ArmTypeDescription
FE203799 5 mgEXPERIMENTALFE203799 GLP-2 analogue, once weekly, subcutaneous administration
PlaceboPLACEBO_COMPARATORPlacebo FE203799 GLP-2 analogue, once weekly, subcutaneous administration
FE203799 10 mgOTHERFE203799 GLP-2 analogue, once weekly, subcutaneous administration

Interventions

NameTypeDescription
FE203799 GLP-2 analogueDRUGFE203799 5 mg subQ once weekly
FE203799 Placebo GLP-2 analogueDRUGPlacebo subQ once weekly
Unlock Study Design Details

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 small intestine 2. 18-80 years of age 3. Body Mass Index (BMI) between 16.0 and 32.0 4. Patients with a jejuno- or ileostomy and a faecal wet weight excretion of at least 1500 g/day, as recorded within the last 18 m...

Countries:Denmark
Unlock Eligibility Criteria

Competitive Landscape -Short Bowel Syndrome 8 trials

Frequently asked questions about FE203799 GLP-2 analogue

What is FE203799 GLP-2 analogue used for?

FE203799 GLP-2 analogue is an investigational small molecule being developed for Short Bowel Syndrome, a gastrointestinal condition. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.

What does FE203799 GLP-2 analogue target?

FE203799 GLP-2 analogue is a GLP-2 analogue, meaning it is designed to mimic the activity of glucagon-like peptide-2, a hormone involved in intestinal growth and function. This mechanism is being studied for its potential to help patients with Short Bowel Syndrome.

Who makes FE203799 GLP-2 analogue?

FE203799 GLP-2 analogue is being developed by Ironwood Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol IRWD.

What phase is FE203799 GLP-2 analogue in?

FE203799 GLP-2 analogue is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. Its Phase 1 trial has been completed.

What clinical trials is FE203799 GLP-2 analogue in?

FE203799 GLP-2 analogue has one completed Phase 1 trial, NCT03415594, titled 'Safety, Efficacy, PD of FE203799 in Short Bowel Syndrome on Parenteral Support.' This randomized, double-blind, placebo-controlled study enrolled 8 participants in Denmark.