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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05270460 | Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis | PHASE2 | COMPLETED | 25 | — | — | Mar 9, 2022 | Oct 6, 2022 | Jul 21, 2023 | 9 | United States |
Change from baseline in gastric emptying rate was determined by the AUC by Gastric Emptying Breath Test (GEBT) at Day 28 after administration of PCS12852 or placebo.
Time for 50% gastric emptying (t50) metric assessed by the GEBT
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
PK parameters were estimated from concentration-time data using noncompartmental methods, as data permitted.
| Arm | Type | Description |
|---|---|---|
| PCS12852 0.1mg | EXPERIMENTAL | PCS12852 0.1mg tablet |
| PCS12852 0.5mg | EXPERIMENTAL | PCS12852 0.5mg tablet |
| Placebo | PLACEBO_COMPARATOR | Similar in appearance to active study drug |
| Name | Type | Description |
|---|---|---|
| PCS12852 | DRUG | PCS12852 oral tablet administered once daily |
| Placebo | DRUG | Placebo comparator oral tablet administered once daily |
Inclusion Criteria: * Has documented diagnosis of moderate to severe DG or IG according to the ANMS GCSI-DD score during the Screening period (score of \>2 on average of the screening days). * Moderate to severe delay in gastric emptying rate as measured by the GEBT at Screening defined as GE half-...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE4 | Tradipitant |
| United Therapeutics Corporation | UTHR | 1 | PHASE4 | Undisclosed |