Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as 25mg Eluxadoline
Eluxadoline · 2 trials · 1 indication
Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
| Arm | Type | Description |
|---|---|---|
| Open Label 6-11 years of age: Eluxadoline 50mg | EXPERIMENTAL | Eluxadoline two 25mg tablets, oral administration, twice daily with food. Take at approximately the same time each day. |
| Open Label 12-17 years of age: Eluxadoline 100 mg | EXPERIMENTAL | Eluxadoline one 100mg tablet, oral administration, twice daily with food. May use 25mg tablets to administer 100mg dose. Take at approximately the same time each day. |
| Double Blind 6-11 years of age: Eluxadoline 25mg | EXPERIMENTAL | Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID |
| Double Blind 6-11 years of age: Eluxadoline 50mg | EXPERIMENTAL | Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID |
| Double Blind 12-17 years of age: Eluxadoline 25mg | EXPERIMENTAL | Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID |
| Double Blind 12-17 years of age: Eluxadoline 50mg | EXPERIMENTAL | Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID |
| Double Blind 12-17 years of age: Eluxadoline 100mg | EXPERIMENTAL | Blinding will be accomplished via administration of a constant number of oral tablets in each age group (6 to 11 years of age and 12 to 17 years of age) where all participants in an age group will receive the same total number of oral tablets at each administration. Phase 2 completers who choose to remain on double-blind eluxadoline and received placebo in the lead-in Phase 2 study 3030-202-002 will be assigned to double-blind eluxadoline 25 mg BID |
| Eluxadoline 25mg | EXPERIMENTAL | Eluxadoline 25mg, oral administration, twice daily |
| Eluxadoline 50mg | EXPERIMENTAL | Eluxadoline 50mg, oral administration, twice daily |
| Eluxadoline 100mg | EXPERIMENTAL | Eluxadoline 100mg, oral administration, twice daily |
| Placebo | EXPERIMENTAL | Dose-matched placebo, oral administration, twice daily |
| Name | Type | Description |
|---|---|---|
| 25mg Eluxadoline | DRUG | Oral Tablets |
| 100mg Eluxadoline | DRUG | Oral Tablets |
| Eluxadoline | DRUG | Oral tablets |
| Placebo | DRUG | Oral tablets |
Inclusion Criteria: Inclusion Criteria: * Male or female participants must be 6 to 17 years of age (inclusive) * Participants must have completed study intervention in their lead-in study Exclusion Criteria: * Participant has an unresolved AE or a clinically significant finding on a physical exa...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Eluxadoline |
| Ardelyx, Inc. | ARDX | 3 | PHASE3 | Tenapanor |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | - | Undisclosed |
| Johnson & Johnson | JNJ | 1 | - | Anti TNF therapy including infliximab, No Biologics |
| Cooper Companies, Inc. | COO | 1 | N/A | Undisclosed |
Eluxadoline is used for irritable bowel syndrome, specifically irritable bowel syndrome with diarrhea (IBS-D). It is being studied in pediatric patients aged 6 years and older. The drug is a small molecule being developed by AbbVie Inc. (ABBV) and is currently in Phase 3 clinical development.
Eluxadoline is a small molecule that acts on opioid receptors in the gastrointestinal tract. It is being developed to treat irritable bowel syndrome with diarrhea (IBS-D). The drug is designed to reduce pain and diarrhea associated with the condition by modulating gut motility and secretion.
Eluxadoline is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is currently in Phase 3 clinical trials for irritable bowel syndrome with diarrhea (IBS-D) in pediatric patients.
Eluxadoline is in Phase 3 clinical development for irritable bowel syndrome with diarrhea (IBS-D). It is an investigational drug and has not been approved by the FDA. The ongoing Phase 3 trial is evaluating oral eluxadoline in pediatric participants with IBS-D.
Eluxadoline is being studied in two clinical trials. NCT03339128 is a Phase 2 study exploring the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea in children, with 95 participants. NCT04880876 is a Phase 3 study evaluating oral eluxadoline in pediatric participants with IBS-D, with 124 participants.
Yes, Eluxadoline is also known as 25mg Eluxadoline. The drug is being developed by AbbVie Inc. (ABBV) for irritable bowel syndrome with diarrhea (IBS-D). It is currently in Phase 3 clinical trials for pediatric patients with this condition.