This section highlights FDA-related milestones and regulatory updates for drugs developed by Heatwurx (PCSA).
Over the past two years, Heatwurx has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
NGC-Cap, PCS6422, PCS499, and NGC-Iri. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
NGC-Cap FDA Regulatory Timeline and Events
NGC-Cap is a drug developed by Heatwurx for the following indication: In patients with advanced or metastatic breast cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NGC-Cap
- Announced Date:
- January 5, 2026
- Indication:
- In patients with advanced or metastatic breast cancer
Announcement
Processa Pharmaceuticals, reported that it completed the enrollment and dosing of the 20 patients required for the planned formal interim analysis in its ongoing Phase 2 clinical study evaluating NGC-Cap, Processa's proprietary combination treatment of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer.
AI Summary
Processa Pharmaceuticals said it completed enrollment and dosing of the 20 patients required for the planned formal interim analysis of its Phase 2 study of NGC‑Cap, the company’s combination of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer. The randomized study compares NGC‑Cap to standard capecitabine monotherapy. Patients had at least one prior cancer treatment, with a median of two to three prior regimens. NGC‑Cap uses a single dose of PCS6422 given one day before capecitabine, followed by capecitabine at 150 mg twice daily on a seven days on/seven days off schedule; the control arm uses standard capecitabine dosing.
The formal interim analysis, expected in Q1 2026, will compare safety and early efficacy between arms. Key objectives are to determine whether NGC‑Cap shows meaningful safety or efficacy benefits, decide if a different NGC‑Cap dose should be added as a third arm, and assess whether the study’s overall sample size should be adjusted to guide future development.
Read Announcement- Drug:
- NGC-Cap
- Announced Date:
- October 2, 2024
- Indication:
- In patients with advanced or metastatic breast cancer
Announcement
Processa Pharmaceuticals, announced that the first patient has been dosed in a Phase 2 clinical trial evaluating NGC-Cap for the treatment of advanced or metastatic breast cancer.
AI Summary
Processa Pharmaceuticals announced that the first patient has been dosed in its Phase 2 clinical trial for advanced or metastatic breast cancer. This adaptive-designed, randomized study is comparing two doses of NGC-Cap against standard capecitabine monotherapy. The trial aims to assess the safety and efficacy of NGC-Cap while determining the optimal dosage regimen. NGC-Cap combines capecitabine, a commonly used chemotherapy drug, with PCS6422, which is designed to improve treatment tolerance and effectiveness. The study builds on promising results from earlier trials and is expected to guide further development. Processa plans to include 60 to 90 patients at multiple global centers, with interim results anticipated to be released in mid-2025.
Read Announcement- Drug:
- NGC-Cap
- Announced Date:
- July 30, 2024
- Target Action Date:
- Q3 2024
- Estimated Target Date Range:
- July 1, 2024 - September 30, 2024
- Indication:
- In patients with advanced or metastatic breast cancer
Announcement
Processa expects to enroll the first patient into this trial in the third quarter of 2024.
AI Summary
Processa Pharmaceuticals announced that its open-label Phase 2 trial will soon begin evaluating Next Generation Capecitabine (NGC-Cap) for advanced or metastatic breast cancer. The trial is designed as a global, multicenter study, comparing two different doses of NGC-Cap against the FDA-approved monotherapy capecitabine in about 60 to 90 patients. In this study, NGC-Cap is administered with PCS6422, an irreversible DPD enzyme inhibitor, aiming to provide higher levels of the active drug 5-FU to cancer cells while potentially reducing harmful side effects.
A key milestone for Processa is that they expect to enroll the first patient in the third quarter of 2024, with initial trial data anticipated by mid-2025. The trial will help determine the optimal dosage and evaluate the safety and efficacy of this next-generation combination treatment in the fight against breast cancer.
Read Announcement- Drug:
- NGC-Cap
- Announced Date:
- July 30, 2024
- Target Action Date:
- H1 2025
- Estimated Target Date Range:
- January 1, 2025 - June 30, 2025
- Indication:
- In patients with advanced or metastatic breast cancer
Announcement
Processa Pharmaceuticals announced that Initial data expected mid-2025
AI Summary
Processa Pharmaceuticals recently announced that it will begin enrolling patients for an open-label Phase 2 trial targeting advanced or metastatic breast cancer. The trial, which will be conducted across multiple centers, aims to compare two different doses of its novel product candidate NGC-Cap with the current FDA-approved capecitabine treatment. This study is designed to assess both the safety and effectiveness of NGC-Cap and to help determine the best dosage regimens under FDA guidelines.
A key highlight of the announcement is that initial data from this trial are expected to be available by mid-2025. This timeline offers important information about how the new therapy may perform in comparison to existing treatments, providing insight into a potential advancement in cancer care with improved tolerability and efficacy for patients facing advanced breast cancer.
Read Announcement- Drug:
- NGC-Cap
- Announced Date:
- July 30, 2024
- Indication:
- In patients with advanced or metastatic breast cancer
Announcement
Processa Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for Next Generation Capecitabine (NGC-Cap), its lead product candidate.
AI Summary
Processa Pharmaceuticals announced that the FDA has cleared its Investigational New Drug (IND) application for Next Generation Capecitabine (NGC-Cap), the company’s lead product candidate. This milestone clearance now permits Processa to begin a Phase 2 clinical trial in patients with advanced or metastatic breast cancer. The trial, set to start enrollment this quarter, will evaluate two dosing regimens of NGC-Cap compared to the standard FDA‐approved capecitabine therapy. According to David Young, President of Research and Development, early data from the trial are expected around mid-2025. The company hopes that NGC-Cap will offer a more effective treatment option by delivering significantly higher exposure of the active drug to cancer cells while maintaining a safety profile similar to or better than current capecitabine treatments. This development marks an important step forward in Processa’s effort to enhance chemotherapy treatment for cancer patients.
Read Announcement
PCS6422 FDA Regulatory Timeline and Events
PCS6422 is a drug developed by Heatwurx for the following indication: Advanced, Refractory Gastrointestinal Tract Tumors.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PCS6422
- Announced Date:
- December 17, 2025
- Indication:
- Advanced, Refractory Gastrointestinal Tract Tumors
Announcement
Processa Pharmaceuticals, today provided a clinical update on its ongoing Phase 2 study of NGC-Cap, the combination treatment of PCS6422 and capecitabine, in patients with advanced or metastatic breast cancer.
AI Summary
Processa Pharmaceuticals reported preliminary Phase 2 results for NGC-Cap, the combination of PCS6422 and capecitabine, in advanced or metastatic breast cancer. Data from the first 16 of 19 patients show NGC-Cap substantially increases exposure to the active, cancer-killing capecitabine metabolites while greatly reducing a toxic catabolite (FBAL) — up to tenfold less than standard capecitabine. Nineteen patients have been randomized (NGC-Cap 150 mg twice daily versus mono-capecitabine 1,000 mg/m² twice daily) and the full dataset was not yet complete for this early readout.
More patients on NGC-Cap experienced side effects tied to the active metabolites and had a higher number of such events, but the severity was similar between arms. Hand-foot syndrome rates were comparable, with only mild (Grade 1) symptoms in the NGC-Cap group versus up to Grade 2 with monotherapy. Processa expects a formal interim analysis of the first 20 patients in early 2026 and plans to finish enrollment by Q1 2026.
Read Announcement- Drug:
- PCS6422
- Announced Date:
- May 30, 2025
- Indication:
- Advanced, Refractory Gastrointestinal Tract Tumors
Announcement
Processa Pharmaceuticals, announced the acceptance of three abstracts for the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 to June 3, 2025, at McCormick Place in Chicago, Illinois.
AI Summary
Processa Pharmaceuticals announced that three of its research abstracts have been accepted for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The event will be held from May 30 to June 3, 2025, at McCormick Place in Chicago, Illinois. The abstracts highlight key advances in the company’s oncology pipeline, with a focus on next generation cancer therapies. Included are studies on both preclinical and clinical developments, such as a Phase 2 adaptive trial that combines eniluracil with capecitabine in patients with advanced or metastatic breast cancer. One abstract outlines the safety and efficacy results from an early Phase 1b study, while another details a new approach to improve a tumor-targeting pro-drug of SN-38. These presentations underscore Processa’s commitment to improving cancer treatment options by enhancing drug safety and effectiveness.
Read Announcement - Drug:
- PCS6422
- Announced Date:
- June 11, 2024
- Indication:
- Advanced, Refractory Gastrointestinal Tract Tumors
Announcement
Processa Pharmaceuticals, announced positive efficacy results from the preliminary evaluation of its recently completed Phase 1b clinical trial which defined the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose Range (RP2DR) for Next Generation Capecitabine (NGC-Cap) administered to patients with Stage III or IV gastrointestinal tract (GI) cancer.
AI Summary
Processa Pharmaceuticals has announced promising preliminary efficacy results from its Phase 1b clinical trial of Next Generation Capecitabine (NGC-Cap) for patients with Stage III or IV gastrointestinal (GI) cancer. The study successfully defined the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose Range (RP2DR) for NGC-Cap. Early outcomes showed that 66.7% of evaluable patients experienced progression-free survival lasting between 5 to 11 months. Notably, in the highest dose group, all patients demonstrated progression-free survival, including cases with partial responses and stable disease. Researchers believe that by increasing the exposure of 5-Fluorouracil to cancer cells while lowering toxic catabolite levels, NGC-Cap offers a better or similar side-effect profile compared to traditional capecitabine monotherapy. These results encourage further development of this treatment to improve chemotherapy options for advanced GI cancer patients.
Read Announcement
PCS499 FDA Regulatory Events
PCS499 is a drug developed by Heatwurx for the following indication: Ulcerations in Patients Who Have Necrobiosis Lipoidica.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- PCS499
- Announced Date:
- November 5, 2025
- Indication:
- Ulcerations in Patients Who Have Necrobiosis Lipoidica
Announcement
Processa Pharmaceuticals, Inc 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..
AI Summary
Processa Pharmaceuticals 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 Kidney Week 2025 in Houston, Texas, November 5–9. The poster will appear in the “Glomerular Clinical Trials: From Data to Impact” session on Friday, November 7, from 10:00 a.m. to 12:00 p.m. CT, at board number FR-PO0829.
PCS499 is an analog of a pentoxifylline metabolite with a better safety profile, allowing higher dosing and potentially greater benefit for patients with FSGS, a rare kidney disease marked by scarring and few treatment options. The adaptive Phase 2/3 design aims to optimize dosing and accelerate regulatory approval through flexible enrollment and interim data analyses.
David Young, Pharm.D., Ph.D., President of Research and Development at Processa, said the study represents a critical step toward safer, more effective FSGS therapies and could significantly improve outcomes for this underserved patient population.
Read Announcement
NGC-Iri FDA Regulatory Events
NGC-Iri is a drug developed by Heatwurx for the following indication: For cancer treatments.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- NGC-Iri
- Announced Date:
- August 19, 2024
- Indication:
- For cancer treatments
Announcement
Processa Pharmaceuticals announces positive data from preclinical studies that support the potential for NGC-Iri to have improved efficacy and a better side effect profile compared with the commonly used FDA-approved cancer treatments irinotecan and Onivyde® (the liposomal formulation of irinotecan). Next Generation irinotecan (NGC-Iri) is a pro
AI Summary
Processa Pharmaceuticals has announced promising preclinical data for its new drug, NGC-Iri, a prodrug of SN-38. In studies using a human melanoma xenograft mouse model, NGC-Iri delivered significantly more of the cancer-killing SN-38 to tumors compared to irinotecan and Onivyde®. For example, the tumor-to-muscle ratio was around 200 with NGC-Iri, versus less than 15 for the other treatments. This indicates that NGC-Iri concentrates SN-38 in the tumor while limiting its exposure in healthy tissue, potentially leading to fewer side effects.
Researchers believe that this improved distribution could make NGC-Iri a more effective and better-tolerated treatment option. The company plans to define the regulatory path, including identifying the target patient population, as they move forward with the development of this promising next-generation cancer therapy.
Read Announcement
