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-...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE4 | Tradipitant |
| United Therapeutics Corporation | UTHR | 1 | PHASE4 | Undisclosed |
PCS12852 is an investigational small molecule being developed for the treatment of gastroparesis, a condition characterized by delayed gastric emptying. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
PCS12852 is being developed by Processa Pharmaceuticals, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol PCSA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with gastroparesis.
PCS12852 is in Phase 2 clinical development. A Phase 2 clinical trial has been completed to evaluate the drug's safety, pharmacokinetics, and efficacy on gastric emptying rate in patients with moderate to severe gastroparesis.
PCS12852 has been studied in one completed Phase 2 clinical trial, registered as NCT05270460. This trial evaluated the safety, pharmacokinetics, and efficacy of PCS12852 on gastric emptying rate in patients with moderate to severe gastroparesis. The study enrolled 25 participants in the United States.
PCS12852 is not FDA approved. It is an investigational drug currently in clinical development for gastroparesis. The completed Phase 2 trial represents an early stage of evaluation, and further studies would be needed to establish its safety and efficacy.
The PCS12852 clinical trial, NCT05270460, was a randomized, double-blind, placebo-controlled Phase 2 study. It enrolled 25 adult patients with moderate to severe gastroparesis in the United States to assess the drug's effects on gastric emptying rate.