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Last update 27 Feb 2026

PCS-499

Last update 27 Feb 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

deuterated analog of 1-((S)-5-hydroxyhexyl)-3,7-dimethylxanthine (HDX), deuterated S-lisofylline, Deuterated Undisclosed Antiflammatory/Antioxidant/Antifibrotic Agent

+ [2]

Target

cGMP-PDE

Action

inhibitors

Mechanism

cGMP-PDE inhibitors(3',5'-cyclic phosphodiesterase inhibitors)

Therapeutic Areas

Endocrinology and Metabolic DiseaseSkin and Musculoskeletal DiseasesUrogenital Diseases+ [1]

Active Indication-

Inactive Indication

Chronic Kidney DiseasesDiabetes Mellitus, Type 2Necrobiosis Lipoidica+ [2]

Originator Organization

Concert Pharmaceuticals, Inc.

Active Organization-

Inactive Organization

Concert Pharmaceuticals, Inc.

Processa Pharmaceuticals, Inc.

License Organization

Processa Pharmaceuticals, Inc.

Concert Pharmaceuticals, Inc.

Drug Highest PhaseDiscontinuedPhase 2

First Approval Date-

Regulation-

Structure/Sequence

Molecular FormulaC13H20N4O3

InChIKeyNSMXQKNUPPXBRG-WHPHVCHMSA-N

CAS Registry1268605-91-9

Clinical Trials associated with PCS-499

NCT04800562

/ TerminatedPhase 2

A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of PCS499 in Treating Ulcerations in Patients Who Have Necrobiosis Lipoidica

This is a randomized, double blind, placebo controlled study that will evaluate the efficacy and safety of PCS499 as compared to placebo for the treatment of ulcerations of patients with necrobiosis lipoidica (NL) and will inform the design of future studies. Approximately 20 ulcerated NL patients who also meet other inclusion/exclusion criteria will be enrolled in the study. The primary objective of this study is to evaluate the efficacy of PCS499 as compared with placebo in ulcerated patients with Necrobiosis Lipoidica.

Start Date12 Apr 2021

Sponsor / Collaborator

Processa Pharmaceuticals, Inc.

NCT03698864

/ CompletedPhase 2

An Open-Label Study to Evaluate the Safety and Tolerability of PCS499 for the Treatment of Necrobiosis Lipoidica

This is an open-label study that will evaluate the safety of PCS499 for the treatment of necrobiosis lipoidica (NL) and will inform the design of future studies. Approximately 12 NL patients (6-9 patients without ulceration and 3-6 patients with ulceration) who also meet other inclusion/exclusion criteria will be enrolled in the study. The primary objective of this study is to evaluate the safety and tolerability profile of PCS499 in patients with Necrobiosis Lipoidica.

Start Date07 Nov 2018

Sponsor / Collaborator

Processa Pharmaceuticals, Inc.

NCT03836222

/ CompletedPhase 1

A Phase I, Single Centre, Open-Label, Non-Randomised Study to Evaluate the PK of Single and Optional Multiple Dosing Regimens of MR Formulations of PCS499 Compared to Trental® (Pentoxifylline) Administered to Healthy Subjects Under Fed Conditions

This was a Phase I, single centre, open-label, non-randomised study and was designed to be conducted in up to 2 parts. The purpose of Part 1 was to identify a MR formulation of PCS499 that would provide an optimal dosing regimen in patients. The purpose of Part 2 of the study was to generate repeat dose information for the selected MR formulation of PCS499 in order to provide additional PK information for future patient studies.

Start Date26 Feb 2018

Sponsor / Collaborator

Processa Pharmaceuticals, Inc.

[+1]

100 Clinical Results associated with PCS-499

100 Translational Medicine associated with PCS-499

100 Patents (Medical) associated with PCS-499

Literatures (Medical) associated with PCS-499

01 Jul 2016·Clinical pharmacology in drug developmentQ4 · MEDICINE

A First‐in‐Patient, Multicenter, Double‐Blind, 2‐Arm, Placebo‐Controlled, Randomized Safety and Tolerability Study of a Novel Oral Drug Candidate, CTP‐499, in Chronic Kidney Disease

Q4 · MEDICINE

Article

Author: Braman, Virginia ; Liu, Julie ; Cheng, Changfu ; Shipley, James ; Graham, Philip ; Neutel, Joel ; Dao, Michael ; Sabounjian, LuAnn ; Wu, Lijun

Abstract:

The prevalence of chronic kidney disease (CKD) related to type 2 diabetes is increasing worldwide. In addition to standard of care, treatment with anti‐inflammatory and antifibrotic agents such as CTP‐499, a novel oral, multisubtype selective inhibitor of phosphodiesterases, may be important in CKD treatment. A phase 1b randomized, double‐blind, placebo‐controlled clinical trial of CTP‐499 in CKD patients (25 active, 8 placebo) with an estimated glomerular filtration rate of 30–59 mL/min/1.73 m2 was conducted to assess safety and tolerability. Secondary outcomes included pharmacokinetics and exploratory effects on inflammatory and hematology markers. Patients received 600 mg CTP‐499 or matching placebo tablets orally once daily for 2 weeks, then twice daily for 2 additional weeks. CTP‐499 was well tolerated with no serious or severe adverse events, or adverse events leading to discontinuation. CTP‐499 was rapidly absorbed and produced acceptable interpatient variability. Of the 5 metabolites (M1–M5), M5 was the most abundant in plasma and urine. Exposure to CTP‐499 and metabolites was higher in CKD patients than previously reported in healthy volunteers. No statistically significant differences were detected between the CTP‐499‐ and placebo‐treated groups for any of the biomarkers tested. This study provides data supporting further evaluation of CTP‐499 in CKD patients.

01 Jul 2014·Journal of chromatography. B, Analytical technologies in the biomedical and life sciencesQ3 · MEDICINE

Quantitative analyses of CTP-499 and five major metabolites by core-structure analysis

Q3 · MEDICINE

Article

Author: Braman, Virginia ; Wu, Lijun ; Graham, Phillip ; Tang, Xiaonan ; Lin, Zhongping John ; Liu, Julie F ; Zhao, Harry ; Ke, Jing ; Erol, Halil ; Cheng, Changfu ; Lin, Chih Hsien ; Bridson, Gary

CTP-499 is a novel oral multi-subtype selective inhibitor of PDEs that is currently in clinical testing, in combination with angiotensin modulators, as a potentially first-in-class treatment for diabetic kidney disease. The compound was discovered and developed by using Concert's proprietary DCE Platform(®) in which deuterium was incorporated at select positions of 1-((S)-5-hydroxyhexyl)-3,7-dimethylxanthine (HDX). CTP-499 metabolizes to five major metabolites: C-21256, D-M2, D-M3, D-M4 and M5, of which all contains deuterium except M5. During in vivo metabolism, however, H/D exchange takes place. As a result, each analyte, except M5, has multiple molecular masses. To accurately quantify the analytes, we developed an LC-MS/MS method focusing on the core structures of the molecules, termed "core-structure analyses". The core-structure analyses method was then validated under GLP guidance in dog, rat and rabbit plasma, with a sample volume of 50 μL. Results demonstrated that this approach accurately quantifies each of the six analytes despite partial exchange of deuterium with hydrogen atoms in the in vivo samples. The validation parameters included accuracy, precision, sensitivity, stability, dilution integrity, hemolysis, matrix effect, selectivity, and recovery. Acceptable intra-run and inter-run assay precision (%CV ≤ 5.5%) and accuracy (90.1-106.7%) were achieved over a linear range of 10-5,000 ng/mL of each analyte. Various stability tests, including bench-top, freeze/thaw, stock solution, and long-term storage, were also performed. All stability results met acceptance criteria. The robustness of the methods was demonstrated by the incurred sample reproducibility (ISR) tests. After validation, the method was successfully used in support of multiple toxicological studies of CTP-499.

01 Jun 2013·Nature medicineQ1 · MEDICINE

Heavy drugs draw heavy interest from pharma backers

Q1 · MEDICINE

Author: Katsnelson, Alla

The idea of using deuterium to improve the properties of drugs is not entirely new.More than 50 years ago, in one of the earliest descriptions of the isotope′s effects on a drug′s pharmacodynamic properties, chemists from the Canada′s University of Ottawa, in collaboration with US scientists at what is now Bristol-Myers Squibb, reported that adding deuterium isotopes to a mol. that modulated the sympathetic nervous system limited its metabolism in cats (Science, 133, 102-104, 1961).A handful of companies pursued the strategy in the following decades, including the New Jersey drug giant Merck, which tried to use the process to reduce the toxicity of an antibiotic, but nothing ever panned out.So why the resurgence of interest now? "I asked myself that question a lot in the early period," says Pratik Shah, executive chairman of Auspex′s board of directors and a partner in the venture capital firm Thomas, McNerney & Partners. "What am I missing? Why hasn′t someone already done this?" One reason is that chem. techniques have improved significantly, notes Sheila DeWitt, chief executive of DeuteRx, which was spun out of Deuteria after its acquisition late last year. "Anal. methods have caught up to what is needed," she says.Between the various companies working in this space, a handful of deuterium-containing agents have gone into human trials.Auspex′s SD-809, a deuterated version of a drug called tetrabenzine, which is used for treating abnormal movement disorders, is the most advanced: in June, the company launched a 100-person, phase 3 study testing the SD-809 in people with Huntington′s disease.Meanwhile, Concert′s lead candidate-CTP-499, a first-in-class agent that aims to treat diabetic kidney disease by inhibiting multiple isoforms of the phosphodiesterase enzyme-is now undergoing phase 2 testing.Company scientists published pos. phase 1 safety data in Feb. (Clin. Pharmacol. Drug Dev.2, 53-56, 2013).CTP-499′s phase 2 trial is expected to wrap up late this year.Despite the clin. momentum, Vaz cautions that designing deuterium-containing drugs is far from straightforward. "Just sticking deuterium on a mol. won′t do it for you," he says.Vaz′s team at Pfizer has begun systematically looking at how to determine whether using deuterium will benefit a compound "The question is finding the right system that will translate to an in vivo effect," he says.Plus, even if the science can be worked out, success for deuterated drugs will ultimately require navigating a dizzying patent landscape that, in recent years, has undergone "a land-grab for deuterium-containing chem. entities," notes Shah.Dozens of patent applications for deuterated compounds have been approved, but since most are for improvements to already-existing agents, questions are increasingly being raised about whether the use of deuterium is novel and non-obvious.So far, companies have been able to argue that the isotope′s effects are not predictable.But as the space gets crowded, that could change. "Someday," predicts Vaz, "it′s probably going to go to court."

News (Medical) associated with PCS-499

05 Nov 2025

·www.globenewswire.com

Processa Pharmaceuticals Announces Poster Presentation of Adaptive Phase 2/3 PCS499 Study in FSGS at ASN Kidney Week 2025

VERO BEACH, Fla., Nov. 05, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage biopharmaceutical company developing Next Generation Cancer (NGC) therapies and innovative treatments for rare diseases, today announced that its abstract, “Adaptive Phase 2/3 Study for PCS499 (499) in Patients with Focal Segmental Glomerulosclerosis (FSGS)”, has been accepted for presentation at the American Society of Nephrology (ASN) Kidney Week 2025, taking place November 5–9, 2025, in Houston, Texas. The poster will be presented as part of the session “Glomerular Clinical Trials: From Data to Impact” on Friday, November 7, 2025, from 10:00 a.m. to 12:00 p.m. Central Time. The poster board number is FR-PO0829. PCS499 is an analog of a metabolite of pentoxifylline (PTX). PTX has been shown to decrease proteinuria in clinical studies with CKD patients but the dose limiting side effects limits its use. PCS499 has demonstrated a favorable safety profile over PTX allowing for a higher dose and potentially greater therapeutic benefit in rare kidney diseases such as FSGS, a serious condition with limited treatment options. The adaptive Phase 2/3 design that Processa will be discussing with FDA later this year and presenting at ASN aims to optimize dosing and accelerate the path toward regulatory approval. “We are honored to present our PCS499 program at ASN Kidney Week, the premier forum for advancing kidney disease research and patient care,” said David Young, Pharm.D., Ph.D., President of Research and Development at Processa Pharmaceuticals. “This adaptive Phase 2/3 study represents a critical step in addressing the urgent need for safer, more effective therapies for patients with FSGS. We believe PCS499 has the potential to significantly improve patient outcomes in this underserved population.” About FSGS Focal Segmental Glomerulosclerosis is a rare, progressive kidney disease characterized by scarring in the kidney’s filtering units, often leading to end-stage renal disease. There are currently no FDA-approved therapies specifically indicated for FSGS, underscoring the urgent need for new treatment options. About Processa Pharmaceuticals, Inc. Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. In addition to its core oncology programs, Processa is actively pursuing strategic partnerships for non-oncology assets to unlock additional value For more information, visit our website at www.processapharma.com. Forward-Looking Statements This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements. Company Contact: Patrick Lin(925) 683-3218plin@processapharma.com Investor Relations: Dave GentryRedChip Companies, Inc.1-407-644-4256PCSA@redchip.com

01 Jul 2025

·www.globenewswire.com

Processa Pharmaceuticals Provides Portfolio and Business Update

Signed binding term sheet granting Intact Therapeutics an exclusive option to license PCS12852Continue enrolling patients in Phase 2 study of PCS6422Strengthened balance sheet with $7M capital infusion VERO BEACH, Fla., July 01, 2025 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a clinical-stage pharmaceutical company developing next-generation cancer therapies, provides updates on its product pipeline, upcoming milestones and business activities. “We are taking deliberate steps to focus our resources on programs with the highest potential for clinical success and commercial impact,” said Dr. David Young, President Research and Development at Processa. “Our approach continues to center on developing safer, more effective treatments for cancer while creating value through strategic business development and disciplined pipeline management.” “Our NGC-Cap Phase 2 clinical trial in metastatic breast cancer is actively enrolling patients. We continue to anticipate sharing initial data in the second half of 2025,” said George Ng, Chief Executive Officer of Processa Pharmaceuticals. “The streamlining of our development pipeline, signing of strategic partnerships, and optimizing our capital allocation, enable us to make the necessary investments in our science in order to enhance shareholder value.” Key Portfolio Updates: PCS6422 (NGC-Cap): PCS6422, Processa’s lead oncology asset in combination with capecitabine (NGC-Cap), is actively enrolling patients in a Phase 2 study for metastatic breast cancer. The program remains a top priority, with the remaining patients needed for the pre-planned interim analysis expected to be enrolled in the second half of 2025. The trial builds on compelling safety and efficacy signals observed in earlier studies, including improved tolerability and increased exposure to active cancer-killing metabolites.PCS499: Based on preliminary positive results in kidney disease and the FDA allowing surrogate endpoints to now be used in rare kidney diseases, Processa is currently designing a new adaptive pivotal PCS499 Phase III study to discuss with the FDA later this year. In addition, Processa is establishing a dedicated subsidiary to hold PCS499. The move is intended to enhance strategic flexibility in targeting capital raising and potential partnership exploration after meeting with the FDA. PCS12852: As previously announced, Processa has signed a binding term sheet with Intact Therapeutics, Inc. granting an exclusive option to license PCS12852 for gastroparesis and related gastrointestinal motility disorders. Under the terms, Processa is eligible for up to $454 million in milestone payments, a 12% royalty on future sales, and a 3.5% equity stake in Intact. The partnership represents a strategic monetization of non-core assets while maintaining upside potential.PCS11T: PCS11T is Processa’s preclinical oncology asset based on the active metabolite of irinotecan. The company continues to define and explore preclinical and clinical development strategies as well as opportunities to support future development.PCS3117: After determining that the time and cost required to advance PCS3117 to a meaningful milestone would be too high, Processa has terminated the license agreement for PCS3117 and returning the rights to the original licensor. Commitment to Shareholder Value These portfolio changes align with Processa’s strategic intent to focus on oncology assets with strong differentiation, scientific rationale, commercial opportunity and clear regulatory pathways. The company believes this will optimize our human and capital resources, expedite the unlocking of hidden asset value through partnerships, and position the organization to deliver long-term shareholder returns. Investor Webinar Processa CEO George Ng will participate in a live investor webinar on Wednesday, July 9, 2025, at 4:15 p.m. ET to discuss the company’s strategic pipeline realignment and value-creating milestones. To register for the free webinar, please visit: https://www.redchip.com/webinar/PCSA/85765532754 Questions can be pre-submitted to PCSA@redchip.com or online during the live event. About Processa Pharmaceuticals, Inc. Processa is a clinical-stage pharmaceutical company focused on developing the Next Generation Cancer (NGC) drugs with improved safety and efficacy. Processa’s NGC drugs are modifications of existing FDA-approved oncology therapies resulting in an alteration of the metabolism and/or distribution of these drugs while maintaining the existing mechanisms of killing the cancer cells. By combining its novel oncology pipeline with proven cancer-killing active molecules and its Regulatory Science Approach, Processa’s strategy is to develop more effective therapy options with improved tolerability for cancer patients through an efficient regulatory path. In addition to its core oncology programs, Processa is actively pursuing strategic partnerships for non-oncology assets to unlock additional value For more information, visit our website at www.processapharma.com. Forward-Looking Statements This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements. Company Contact:Patrick Lin(925) 683-3218plin@processapharma.com Investor Relations:Dave GentryRedChip Companies, Inc.1-407-644-4256PCSA@redchip.com

License out/inPhase 2Phase 3

04 Jan 2023

·www.biospace.com

Processa Pharmaceuticals To Present an Update on Its Future Therapeutic Focus and Strategy at the Biotech Showcase on January 11, 2023.

HANOVER, MD, Jan. 04, 2023 (GLOBE NEWSWIRE) -- Processa Pharmaceuticals (Heatwurx Acquired Promet) Inc. (Nasdaq: PCSA), Dr. David Young, Processa Pharmaceuticals, CEO will present an update on Processa’s future therapeutic focus and strategy at the upcoming Biotech Showcase on January 11, 2023, at 10 am. This presentation will also be accessible at Processa management is available for one-on-one meetings with potential investors and partners in San Francisco throughout the J.P. Morgan 41st Annual HealthCare Conference week. Meetings can be requested through the Biotech Showcase partnering platform or by contacting Processa directly at mfloyd@processapharmaceuticals.com Details of Processa’s presentation at the Biotech Showcase are as follows: Date: Wednesday, January 11, 2023 Time: 10:00 AM Track: Yosemite A (Ballroom Level) About Processa Pharmaceuticals, Inc. The mission of Processa is to develop products with existing clinical evidence of efficacy for patients with unmet or underserved medical conditions who need treatment options that improve survival and/or quality of life. The Company uses its Regulatory Science Approach criteria when selecting and developing drugs to achieve high-value milestones effectively and efficiently. Current clinical pipeline programs include: Next Generation Capecitabine PCS6422 (metastatic colorectal cancer, breast cancer), PCS3117 (pancreatic and other cancers), PCS11T (small cell lung and other cancers), PCS12852 (gastroparesis, functional constipation), and PCS499 (ulcerative necrobiosis lipoidica). Members of the Processa development team have been involved with more than 30 approvals for indications in almost every division of the FDA (including drug products targeted to orphan disease conditions) and more than 100 FDA meetings throughout their careers. For more information, visit our website at . Forward-Looking Statements This release contains forward-looking statements. The statements in this press release that are not purely historical are forward-looking statements which involve risks and uncertainties. Actual future performance outcomes and results may differ materially from those expressed in forward-looking statements. Please refer to the documents filed by Processa Pharmaceuticals with the SEC, specifically the most recent reports on Forms 10-K and 10-Q, which identify important risk factors which could cause actual results to differ from those contained in the forward-looking statements. For More Information: Michael Floyd (301) 651-4256 mfloyd@processapharma.com Patrick Lin (925) 683-3218 plin@processapharma.com

Acquisition

100 Deals associated with PCS-499

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Ulcer	Phase 2	United States	Processa Pharmaceuticals, Inc.	12 Apr 2021
Necrobiosis Lipoidica	Phase 2	United States	Processa Pharmaceuticals, Inc.	07 Nov 2018
Chronic Kidney Diseases	Phase 2	United States	Concert Pharmaceuticals, Inc.	01 Jan 2012
Diabetes Mellitus, Type 2	Phase 2	United States	Concert Pharmaceuticals, Inc.	01 Jan 2012
Type 2 diabetes mellitus with established diabetic nephropathy	Phase 2	United States	Concert Pharmaceuticals, Inc.	01 Jan 2012

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03698864 (CTgov)	Phase 2	Necrobiosis Lipoidica	12	PCS499	gyllxfzosa = mebhngnelb fcajaioupy (msdevwxgyp, zdetzudvkv - iqdymstode) View more	-	03 Oct 2022
NCT03698864 (Corporate Publications) Manual	Phase 2	Necrobiosis Lipoidica	12	PCS-499	potcumdnvr(ndexzmoqhr) = uzzfochhsc rjoffybbeq (figoawwxme ) View more	Positive	17 Mar 2020
NCT01460199 (Pubmed \| Clin Pharmacol Drug Dev) Manual	Phase 1	Chronic Kidney Diseases	33	CTP-499	jflmnnstcc(vdfjrtcfnl) = no serious or severe adverse events ifuevbwhhn (egeqjecqqx ) View more	Positive	01 Jul 2016
NCT01460199 (Pubmed \| Clin Pharmacol Drug Dev) Manual	Phase 1	Chronic Kidney Diseases	33	Placebo		Positive	01 Jul 2016
Phase 2 clinical study (ASN2014)	Phase 2	Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases IL-18 \| clusterin \| MCP-1 ... View more	-	CTP-499	vepiwhywin(evnjxxmxty) = wtdsnlswnc gscsnknrou (pywxgelsud ) View more	Positive	11 Nov 2014
Phase 2 Trial of CTP-499 (ASN2013)	Phase 2	Diabetic Nephropathies HbA1c \| UACR \| eGFR	182	CTP-499 600 mg BID	nfdjteeznb(tcpnrjqssr) = gtmzzfmpqx qsovrwgqjs (uaahgvvrqa ) View more	-	05 Nov 2013
ASN2012	Phase 2	Chronic Kidney Diseases	-	CTP-499	czfnqehdao(vhnprolsti) = iwqassawol mkpbiibele (ekfcxyedfl )	Positive	30 Oct 2012

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