Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07519395 | A Study to Investigate Abdominal Symptoms With Camlipixant Compared With Placebo in Adults With Irritable Bowel Syndrome - Diarrhea (IBS-D) and Irritable Bowel Syndrome - Mixed (IBS-M) | PHASE2 | NOT YET_RECRUITING | 420 | — | — | Apr 6, 2026 | Jul 9, 2027 | Apr 9, 2026 | - | — |
Participants rate their pain intensity daily on a numeric rating scale from 0 (no pain) to 10 (worst possible pain). Weekly API scores are derived by averaging daily API scores. Higher score indicates worst outcome. A repeated measures statistical analysis is applied to weekly scores, and the result for the Weeks 7 to 12 interval is obtained by averaging adjusted mean estimates for Weeks 7, 8, 9, 10, 11 and 12.
| Arm | Type | Description |
|---|---|---|
| Placebo/Placebo or Camlipixant | PLACEBO_COMPARATOR | Participants will receive placebo in Part A and Placebo or Camlipixant in Part B. |
| Camlipixant dose level 1/Placebo or Camlipixant | EXPERIMENTAL | Participants will receive Camlipixant dose level 1 in Part A and Placebo or Camlipixant in Part B. |
| Camlipixant dose level 2/Placebo or Camlipixant | EXPERIMENTAL | Participants will receive Camlipixant dose level 2 in Part A and Placebo or Camlipixant in Part B. |
| Camlipixant dose level 3/Placebo or Camlipixant | EXPERIMENTAL | Participants will receive Camlipixant dose level 3 in Part A and Placebo or Camlipixant in Part B |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo to be administered |
| Camlipixant | DRUG | Camlipixant to be administered |
Inclusion Criteria: * Male or female aged 18 to 80 years inclusive, at the time of signing the Informed consent form (ICF). * Diagnosis of IBS-D or IBS-M according to the Rome IV criteria at screening * Moderate or severe irritable bowel syndrome (IBS) based on Irritable bowel syndrome Severity Sco...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Ardelyx, Inc. | ARDX | 4 | PHASE3 | Tenapanor |
| AbbVie, Inc. | ABBV | 2 | PHASE3 | Eluxadoline |
| 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 | NA | Undisclosed |