Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PCS12852 · 1 trial · 1 indication
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-...
Top 1 of 2 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE4 | Tradipitant |
PCS12852 is an investigational small molecule developed by Processa Pharmaceuticals, Inc. for the treatment of gastroparesis, a gastrointestinal condition in which the stomach empties too slowly. It is a Phase 2 clinical-stage candidate and has not been approved by the FDA.
PCS12852 is being developed for gastroparesis, specifically for patients with moderate to severe forms of the condition. Its clinical program has focused on measuring its effect on gastric emptying rate, the speed at which the stomach empties its contents.
PCS12852 targets the 5-HT4 receptor, a serotonin receptor found in the gastrointestinal tract. Activation of this receptor is associated with increased gastrointestinal motility, which is the rationale for studying the drug in gastroparesis, where stomach emptying is slowed.
PCS12852 is being developed by Processa Pharmaceuticals, Inc., which trades under the ticker PCSA. The company is the sponsor of the drug's clinical program in gastroparesis.
PCS12852 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. Its completed Phase 2 trial evaluated the drug in patients with moderate to severe gastroparesis.
PCS12852 has been studied in the Phase 2 trial NCT05270460, titled Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis. The trial was completed, enrolled 25 participants, was randomized, double-blind, and placebo-controlled, and was conducted in the United States.