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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. logo

Processa Pharmaceuticals, Inc.

NASDAQ:PCSAHealthcare
+0.00%$1.89
Mkt Cap$5.28M
Float2.33M
O/S2.79M
Vol
$ Vol
RVOL
Inst Own9.1%
Earnings
Dilution
Phase Distribution
10 lead-sponsored trials·0 active·6 completed
Phase 12
Phase 1/23
Phase 25
Status Overview
Completed6
Stopped4

Trials need funding. See this company's dilution risk and cash position.

Clinical Trials
Status
Phase
  • Phase 2
    Terminated

    Open Label Extension Study of HT-100 in Patients With DMD

    HT-100

    Duchenne Muscular Dystrophy

    Enrollment
    17
    Start
    Oct 2013
    Primary Completion
    Apr 2016
    Completion
    Apr 2016
    NCT01978366
  • Phase 2
    Completed

    A Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica

    PCS499

    Necrobiosis Lipoidica

    Enrollment
    12
    Start
    Nov 2018
    Primary Completion
    Feb 2020
    Completion
    Feb 2020
    NCT03698864
  • Phase 2
    Terminated

    A Clinical Trial to Evaluate PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica

    PCS499

    Necrobiosis Lipoidica

    Enrollment
    4
    Start
    Apr 2021
    Primary Completion
    Feb 2023
    Completion
    Apr 2023
    NCT04800562
  • Phase 2
    Completed

    Safety, PK and Efficacy of PCS12852 on Gastric Emptying Rate in Patients With Moderate to Severe Gastroparesis

    PCS12852, Placebo

    Gastroparesis

    Enrollment
    25
    Start
    Mar 2022
    Primary Completion
    Sep 2022
    Completion
    Oct 2022
    NCT05270460
  • Phase 2
    Terminated

    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

    Enrollment
    20
    Start
    Oct 2024
    Primary Completion
    Jul 2026
    Completion
    Jul 2026
    NCT06568692
  • Phase 1/2
    Terminated

    Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of HT-100 in Duchenne Muscular Dystrophy

    HT-100

    Duchenne Muscular Dystrophy

    Enrollment
    17
    Start
    May 2013
    Primary Completion
    Mar 2016
    Completion
    Mar 2016
    NCT01847573
  • Phase 1/2
    Completed

    Dose-Finding and Safety Study for Oral Single-Agent to Treat Advanced Malignancies

    RX-3117

    Solid Tumor, Metastatic Bladder Cancer

    Enrollment
    127
    Start
    Dec 2013
    Primary Completion
    Jul 2019
    Completion
    Dec 2019
    NCT02030067
  • Phase 1/2
    Completed

    RX-3117 in Combination With Abraxane® in Subjects With Metastatic Pancreatic Cancer

    RX-3117

    Metastatic Pancreatic Cancer

    Enrollment
    46
    Start
    Oct 2017
    Primary Completion
    Oct 2019
    Completion
    Nov 2019
    NCT03189914
  • Phase 1
    Completed

    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

    Enrollment
    18
    Start
    Feb 2018
    Primary Completion
    Jun 2018
    Completion
    Jun 2018
    NCT03836222
  • Phase 1
    Completed

    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

    Enrollment
    23
    Start
    Jun 2021
    Primary Completion
    Jun 2024
    Completion
    Sep 2024
    NCT04861987