Approval Probability
TA Base Rate
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Also known as deuterated pentoxifylline analog
PCS499 · 1 trial · 1 indication
Number of Participants with Adverse Events/Serious Adverse Events (by type, severity, and relatedness)
| Arm | Type | Description |
|---|---|---|
| PCS499 900mg twice a day | EXPERIMENTAL | deuterated pentoxifylline analog dosed twice a day at 900 mg |
| Name | Type | Description |
|---|---|---|
| PCS499 | DRUG | PCS499 900mg twice a day with food |
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 being developed for the treatment of necrobiosis lipoidica, a chronic inflammatory skin condition. It is an investigational small molecule from Processa Pharmaceuticals, Inc. that has been studied in a Phase 2 clinical trial. It is not approved for commercial use and remains in clinical development.
PCS499 is being developed by Processa Pharmaceuticals, Inc., a biopharmaceutical company that trades under the ticker symbol PCSA. The company is advancing the asset as a small molecule candidate in dermatology, specifically for necrobiosis lipoidica.
PCS499 is in Phase 2 clinical development. A Phase 2 study evaluating the safety and tolerability of PCS499 for necrobiosis lipoidica has been completed. The drug is investigational and has not been approved by the FDA for any indication.
PCS499 has been studied in one clinical trial, NCT03698864, titled A Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica. The Phase 2 trial enrolled 12 participants in the United States and has been completed. It was an uncontrolled study without randomization or blinding.
No, PCS499 is not FDA approved. It is an investigational small molecule in Phase 2 clinical development for necrobiosis lipoidica. The only completed trial, NCT03698864, evaluated safety and tolerability in 12 participants, and further clinical development would be required before any regulatory review.