Processa Pharmaceuticals, Inc. (PCSA)
Processa Pharmaceuticals, Inc. is a biopharmaceutical company in the clinical development stage, committed to identifying and progressing therapeutic agents for patients with critical unmet medical requirements throughout the United States. The company's leading investigational drug, PCS499, is an oral tablet presently undergoing Phase 2B clinical assessment. It aims to treat both ulcerative and non-ulcerative manifestations of necrobiosis lipoidica, a chronic and disfiguring dermatological condition. Processa's portfolio also features PCS12852, a unique selective 5-hydroxytryptamine 4 (5-HT4) receptor agonist. This compound is currently in Phase 2A clinical trials for its potential application in managing gastroparesis, chronic constipation, constipation-predominant irritable bowel syndrome, and functional dyspepsia. Furthermore, the firm is advancing PCS3117, a cytosine analog, which has reached Phase 2B clinical trials for its use in pancreatic cancer and non-small cell lung cancer. Another candidate, PCS6422, an oral, potent, selective, and irreversible inhibitor of dihydropyrimidine dehydrogenase, is progressing through Phase 1B clinical trials for metastatic colorectal and breast cancers. In addition, Processa is developing PCS11T, an analog derived from the drugs SN38 and irinotecan, intended for the treatment of diverse cancer types. The company was founded in 2011 and maintains its corporate headquarters in Hanover, Maryland.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Processa Pharmaceuticals, Inc.
Trials need funding. See this company's dilution risk and cash position.
- Phase 2Terminated
Open Label Extension Study of HT-100 in Patients With DMD
HT-100
Duchenne Muscular Dystrophy
NCT01978366Enrollment17StartOct 2013Primary CompletionApr 2016CompletionApr 2016 - Phase 2Completed
A Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica
PCS499
Necrobiosis Lipoidica
NCT03698864Enrollment12StartNov 2018Primary CompletionFeb 2020CompletionFeb 2020 - Phase 2Terminated
A Clinical Trial to Evaluate PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica
PCS499
Necrobiosis Lipoidica
NCT04800562Enrollment4StartApr 2021Primary CompletionFeb 2023CompletionApr 2023 - Phase 2Completed
Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis
PCS12852, Placebo
Gastroparesis
NCT05270460Enrollment25StartMar 2022Primary CompletionSep 2022CompletionOct 2022 - Phase 2Terminated
A Phase 2 Study of PCS6422 With Capecitabine in Patients With Advanced or Metastatic Breast Cancer
PCS6422 and capecitabine, Capecitabine
Breast Cancer, TNBC - Triple-Negative Breast Cancer +1
NCT06568692Enrollment20StartOct 2024Primary CompletionJul 2026CompletionJul 2026 - Phase 1/2Terminated
Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of HT-100 in Duchenne Muscular Dystrophy
HT-100
Duchenne Muscular Dystrophy
NCT01847573Enrollment17StartMay 2013Primary CompletionMar 2016CompletionMar 2016 - Phase 1/2Completed
Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies
RX-3117
Solid Tumor, Metastatic Bladder Cancer
NCT02030067Enrollment127StartDec 2013Primary CompletionJul 2019CompletionDec 2019 - Phase 1/2Completed
RX-3117 in Combination With Abraxane® in Subjects With Metastatic Pancreatic Cancer
RX-3117
Metastatic Pancreatic Cancer
NCT03189914Enrollment46StartOct 2017Primary CompletionOct 2019CompletionNov 2019 - Phase 1Completed
Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® Administered to Healthy Subjects
PCS499, Trental
Healthy
NCT03836222Enrollment18StartFeb 2018Primary CompletionJun 2018CompletionJun 2018 - Phase 1Completed
A Study of the Safety and PK of PCS6422 (Eniluracil) with Capecitabine in Patients with Advanced, Refractory GI Tract Tumors
PCS6422 and capecitabine
Advanced Cancer, Refractory Cancer +1
NCT04861987Enrollment23StartJun 2021Primary CompletionJun 2024CompletionSep 2024
| Drug / Therapy | Link | ||
|---|---|---|---|
| Phase 2 | Terminated | HT-100 | NCT01978366 |
| Phase 2 | Completed | PCS499 | NCT03698864 |
| Phase 2 | Terminated | PCS499 | NCT04800562 |
| Phase 2 | Completed | PCS12852, Placebo | NCT05270460 |
| Phase 2 | Terminated | PCS6422 and capecitabine, Capecitabine | NCT06568692 |
| Phase 1/2 | Terminated | HT-100 | NCT01847573 |
| Phase 1/2 | Completed | RX-3117 | NCT02030067 |
| Phase 1/2 | Completed | RX-3117 | NCT03189914 |
| Phase 1 | Completed | PCS499, Trental | NCT03836222 |
| Phase 1 | Completed | PCS6422 and capecitabine | NCT04861987 |