Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
FE203799 GLP-2 analogue · 1 trial · 1 indication
Adverse events (AEs) as assessed by CTCAE v4.03
| Arm | Type | Description |
|---|---|---|
| FE203799 5 mg | EXPERIMENTAL | FE203799 GLP-2 analogue, once weekly, subcutaneous administration |
| Placebo | PLACEBO_COMPARATOR | Placebo FE203799 GLP-2 analogue, once weekly, subcutaneous administration |
| FE203799 10 mg | OTHER | FE203799 GLP-2 analogue, once weekly, subcutaneous administration |
| Name | Type | Description |
|---|---|---|
| FE203799 GLP-2 analogue | DRUG | FE203799 5 mg subQ once weekly |
| FE203799 Placebo GLP-2 analogue | DRUG | Placebo subQ once weekly |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 3 | PHASE3 | Teduglutide |
| Ironwood Pharmaceuticals, Inc. Class A | IRWD | 2 | PHASE3 | Apraglutide |
| Jaguar Health, Inc. | JAGX | 1 | PHASE2 | Crofelemer |
FE203799 GLP-2 analogue is being developed for Short Bowel Syndrome, a gastrointestinal condition in which patients cannot absorb enough nutrients from food and often require parenteral support. It is an investigational therapy and has not been approved for any indication.
FE203799 GLP-2 analogue is being developed by Ironwood Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker IRWD. The company is the sponsor of the clinical program evaluating the compound in Short Bowel Syndrome.
FE203799 GLP-2 analogue is in Phase 1 clinical development. It is an investigational drug and is not FDA approved. The program has completed one Phase 1 trial in Short Bowel Syndrome, and no trials are currently listed as active.
One Phase 1 trial has evaluated FE203799 GLP-2 analogue: NCT03415594, titled Safety, Efficacy, PD of FE203799 in Short Bowel Syndrome on Parenteral Support. The trial was completed, enrolled 8 participants, was randomized, double blind, and placebo controlled, and was conducted in Denmark in adults aged 18 years and older.
FE203799 is a GLP-2 analogue. As a GLP-2 analogue, it is designed to act on GLP-2 receptor signaling, the pathway associated with intestinal growth and nutrient absorption. In the completed Phase 1 trial, the compound was evaluated for safety, efficacy, and pharmacodynamics in Short Bowel Syndrome patients receiving parenteral support.