Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PCS499 · 2 trials · 2 indications
Evaluation of Adverse Events/Serious Adverse Events (by type, severity, and relatedness)
Serial blood sampling at specified time points for determination of plasma concentration-time profiles
Serial blood sampling at specified time points for determination of plasma concentration-time profiles
| Arm | Type | Description |
|---|---|---|
| PCS499 900mg twice a day | EXPERIMENTAL | - |
| PCS499 MR Tablet Prototype 2 | EXPERIMENTAL | 600 mg single dose |
| Trental MR tablet 400mg | ACTIVE_COMPARATOR | single dose |
| PCS499 MR Tablet Prototype 4 | EXPERIMENTAL | 600mg single dose |
| PCS499 MR Tablet Prototype 1 | EXPERIMENTAL | 600mg single dose |
| Trental MR Tablet | ACTIVE_COMPARATOR | 400 mg multiple dose |
| PCS499 MR Tablet 900mg | EXPERIMENTAL | multiple dose |
| PCS499 MR Tablet 600mg | EXPERIMENTAL | multiple dose |
| Name | Type | Description |
|---|---|---|
| PCS499 | DRUG | PCS499 900mg twice a day with food |
| Trental | DRUG | comparator tablet |
Inclusion Criteria: 1. Male or female patients age 18 to 80 years of age, inclusive, at Screening. 2. Biopsy-confirmed diagnosis of NL. Biopsies of continually active lesions performed outside of this clinical study will need to be reviewed and the diagnosis confirmed by the study pathologist. For ...
PCS499 is an investigational small molecule being studied for the treatment of Necrobiosis Lipoidica, a rare skin condition. It has also been evaluated in healthy subjects for pharmacokinetic studies. The drug is currently in clinical development and is not yet approved by regulatory authorities.
PCS499 is being developed by Processa Pharmaceuticals, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol PCSA. The company is conducting clinical trials to evaluate the safety, tolerability, and pharmacokinetics of this investigational drug.
PCS499 has completed Phase 1 and Phase 2 clinical trials. A Phase 1 study in healthy subjects and a Phase 2 study in patients with Necrobiosis Lipoidica have both been completed. The drug remains investigational and is not yet approved for any indication.
PCS499 has been studied in two completed clinical trials. NCT03698864 evaluated safety and tolerability in 12 patients with Necrobiosis Lipoidica in the United States. NCT03836222 evaluated pharmacokinetics of modified-release formulations in 18 healthy subjects in the United Kingdom.
PCS499 is not the same as Trental, but it is being compared to it. In a clinical trial, PCS499 modified-release formulations were studied against Trental (pentoxifylline) in healthy subjects. PCS499 is a separate investigational drug being developed by Processa Pharmaceuticals.