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Label indication VIBERZI is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D). VIBERZI is a mu-opioid receptor agonist, indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D). ( 1 ) FDA label
Also known as Viberzi
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...
Top 5 of 9 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AbbVie, Inc. | ABBV | 1 | PHASE3 | Eluxadoline |
| Ardelyx, Inc. | ARDX | 2 | PHASE3 | Tenapanor |
| Disc Medicine, Inc. | IRON | 1 | PHASE2 | DISC-0974 |
| Eli Lilly and Company | LLY | 2 | PHASE2 | LY3537031 |
| GSK plc Sponsored ADR | GSK | 1 | PHASE2 | Camlipixant |
Eluxadoline is used to treat irritable bowel syndrome, a gastrointestinal condition. It is being studied in patients with irritable bowel syndrome with diarrhea, including pediatric patients aged 6 years and older. Development is currently at Phase 3.
Eluxadoline targets OPRM1, the mu opioid receptor. It acts as an agonist at this receptor, meaning it activates it. OPRM1 is the molecular target of eluxadoline, and this receptor activity underlies its therapeutic approach in irritable bowel syndrome.
Eluxadoline is developed by AbbVie Inc., which trades under the ticker ABBV. AbbVie is the company behind the drug's clinical development program in irritable bowel syndrome.
Eluxadoline is in Phase 3 development. It is an investigational small molecule and is not described as approved. The Phase 3 program is evaluating oral eluxadoline in pediatric participants with irritable bowel syndrome with diarrhea.
Eluxadoline has been studied in two trials. NCT04880876 is a Phase 3 study of oral eluxadoline in pediatric participants with irritable bowel syndrome with diarrhea, currently enrolling by invitation with 124 participants. NCT03339128 was a completed Phase 2 study with 272 participants across the United States, Europe, and Canada.
Yes, 25mg eluxadoline refers to the same drug as eluxadoline. It is an alternative name used for the same small molecule being developed by AbbVie Inc. for irritable bowel syndrome.