Pyoderma Gangrenosum (PG) - Pipeline Insight, 2025

DelveInsight's, "Pyoderma Gangrenosum (PG) - Pipeline Insight, 2025" report provides comprehensive insights about 2+ companies and 2+ pipeline drugs in Pyoderma Gangrenosum (PG) pipeline landscape. It covers the pipeline drug profiles, including clinical and nonclinical stage products. It also covers the therapeutics assessment by product type, stage, route of administration, and molecule type. It further highlights the inactive pipeline products in this space.

Geography Covered:

• Global coverage

Pyoderma Gangrenosum (PG): Understanding

Pyoderma Gangrenosum (PG): Overview

Pyoderma Gangrenosum (PG) is an ulcerative, non-infectious inflammatory dermatosis classified as a neutrophilic dermatosis, which also includes conditions like Sweet's syndrome and Behcet's syndrome. Despite its name, PG is not caused by infection or gangrene and should not be confused with pyogenic granuloma. PG is often associated with systemic diseases and typically affects individuals around the median age of 59, with a higher incidence in females. The condition is rare, with an estimated incidence of 0.63 per 100,000 people, and there appears to be a genetic component, as PG tends to cluster in families and siblings. Diagnosis is primarily clinical, requiring the exclusion of other similar skin disorders.

The pathogenesis of PG is not fully understood, but it is believed to involve a combination of genetic mutations, neutrophil dysfunction, and immune dysregulation. Some PG lesions show clonal T-cell proliferation, and inflammasomes, which play a role in innate immune signaling, may contribute to neutrophil chemotaxis in these lesions. Mutations in Janus kinase 2, which is involved in cytokine production, have been linked to PG, and abnormal cytokine signaling, particularly by T cells and macrophages, is thought to drive the disease. Inflammatory mediators, such as IL-23, are elevated in PG lesions, where IL-23 activates neutrophils and promotes IL-17-mediated inflammation, further exacerbating the condition. Additionally, there is evidence suggesting that PG may result from an exaggerated immune response to an underlying systemic condition, such as inflammatory bowel disease or rheumatoid arthritis, contributing to its development and persistence.

Classical PG typically presents as an extremely painful, erythematous lesion that rapidly progresses to a blistered or necrotic ulcer, often with a ragged undermined edge and a violaceous or erythematous border. While the lower legs are most commonly affected, PG can occur at any body site and may be triggered by minor trauma, known as pathergy. Misdiagnosis as a simple non-healing ulcer is common, leading to debridement, which can worsen the condition due to the pathergic response. PG predominantly affects adults, with rare childhood cases reported. Although some families may have PG as part of inherited syndromes, most patients do not have a family history. The classic ulcerative form accounts for around 85% of cases, but PG can also present in bullous, vegetative, pustular, peristomal, or superficial granulomatous forms, with subtypes occasionally transitioning between each other. Diagnosing PG requires exclusion of other causes of cutaneous ulceration, as there are no definitive laboratory or histopathological criteria. PG can also involve extracutaneous sites, including the eyes, lungs, and spleen.

The treatment of PG involves managing both the underlying systemic disease, if present, and controlling the progression of the skin lesions. Systemic immunosuppressive therapy, including corticosteroids or cyclosporine, may be necessary for rapidly expanding lesions, though studies such as the STOP GAP trial found no significant difference in healing rates between the two drugs. For indolent or localized cases, topical therapies like steroids, tacrolimus, or intralesional injections may be sufficient. Wound care and pain management are crucial, with careful debridement to avoid triggering the pathergic response. Prophylactic use of immunosuppressants before surgery may help prevent recurrence in patients with a history of aggressive PG. Additionally, biologics such as anti-TNF-alpha agents (etanercept, adalimumab), IL-12/23 inhibitors (ustekinumab), and IL-1 beta (canakinumab) and IL-6 inhibitors (tocilizumab) have shown efficacy in treating PG, offering promising options for patients with refractory disease.

"Pyoderma Gangrenosum (PG) - Pipeline Insight, 2025" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Pyoderma Gangrenosum (PG) pipeline landscape is provided which includes the disease overview and Pyoderma Gangrenosum (PG) treatment guidelines. The assessment part of the report embraces, in depth Pyoderma Gangrenosum (PG) commercial assessment and clinical assessment of the pipeline products under development. In the report, detailed description of the drug is given which includes mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, Pyoderma Gangrenosum (PG) collaborations, licensing, mergers and acquisition, funding, designations and other product related details.

Report Highlights:

• The companies and academics are working to assess challenges and seek opportunities that could influence Pyoderma Gangrenosum (PG) R&D. The therapies under development are focused on novel approaches to treat/improve Pyoderma Gangrenosum (PG).

Pyoderma Gangrenosum (PG) Emerging Drugs Chapters

This segment of the Pyoderma Gangrenosum (PG) report encloses its detailed analysis of various drugs in different stages of clinical development, including Phase III, II, I, Preclinical and Discovery. It also helps to understand clinical trial details, expressive pharmacological action, agreements and collaborations, and the latest news and press releases.

Pyoderma Gangrenosum (PG) Emerging Drugs

• Vilobelimab: InflaRx GmbH

Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody, which highly and effectively blocks the biological activity of C5a and demonstrates high selectivity towards its target in human blood. Thus, vilobelimab leaves the formation of the membrane attack complex (C5b-9) intact as an important defense mechanism of the innate immune system, which is not the case for molecules blocking C5. In preclinical studies, vilobelimab has been shown to control the inflammatory response-driven tissue and organ damage by specifically blocking C5a as a key "amplifier" of this response. Vilobelimab has also been granted Orphan Drug Designation for the treatment of PG by both the U.S. Food and Drug Administration (FDA) in the United States and the European Medicines Agency in Europe, as well as Fast Track Designation by the FDA. Currently, the drug is in Phase III stage of its development for the treatment of Pyoderma Gangrenosum (PG).

• Guselkumab: Janssen Scientific Affairs, LLC

Guselkumab is a fully human monoclonal antibody developed by Janssen Scientific Affairs, LLC, targeting the p19 subunit of interleukin-23 (IL-23). This innovative therapeutic agent selectively inhibits IL-23-mediated inflammatory pathways, potentially offering a novel approach to managing complex inflammatory conditions like Pyoderma Gangrenosum. By blocking the IL-23 cytokine before it can activate Th17 helper T-cells, guselkumab disrupts the inflammatory cascade that contributes to tissue damage and aberrant immune responses. The drug's high-specificity mechanism of action allows for precise modulation of inflammatory processes, presenting a promising therapeutic strategy for addressing the underlying immunological dysregulation associated with pyoderma gangrenosum. Currently, the drug is in Phase II stage of its clinical trial for the treatment of Pyoderma Gangrenosum (PG).

Pyoderma Gangrenosum (PG): Therapeutic Assessment

This segment of the report provides insights about the different Pyoderma Gangrenosum (PG) drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Pyoderma Gangrenosum (PG)
• There are approx. 2+ key companies which are developing the therapies for Pyoderma Gangrenosum (PG). The companies which have their Pyoderma Gangrenosum (PG) drug candidates in the most advanced stage, i.e. Phase III include, InflaRx GmbH.
• Phases

DelveInsight's report covers around 2+ products under different phases of clinical development like

• Late stage products (Phase III)
• Mid-stage products (Phase II)
• Early-stage product (Phase I) along with the details of
• Pre-clinical and Discovery stage candidates
• Discontinued & Inactive candidates
• Route of Administration

Pyoderma Gangrenosum (PG) pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical
• Molecule Type

Products have been categorized under various Molecule types such as

• Recombinant fusion proteins
• Small molecule
• Monoclonal antibody
• Peptide
• Polymer
• Gene therapy
• Product Type

Drugs have been categorized under various product types like Mono, Combination and Mono/Combination.

Pyoderma Gangrenosum (PG): Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, II, I, preclinical and discovery stage. It also analyses Pyoderma Gangrenosum (PG) therapeutic drugs key players involved in developing key drugs.

Pipeline Development Activities

The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Pyoderma Gangrenosum (PG) drugs.

Pyoderma Gangrenosum (PG) Report Insights

• Pyoderma Gangrenosum (PG) Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Pyoderma Gangrenosum (PG) Report Assessment

• Pipeline Product Profiles
• Therapeutic Assessment
• Pipeline Assessment
• Inactive drugs assessment
• Unmet Needs

Key Questions:

Current Treatment Scenario and Emerging Therapies:

• How many companies are developing Pyoderma Gangrenosum (PG) drugs?
• How many Pyoderma Gangrenosum (PG) drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Pyoderma Gangrenosum (PG)?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Pyoderma Gangrenosum (PG) therapeutics?
• What are the recent trends, drug types and novel technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Pyoderma Gangrenosum (PG) and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• InflaRx GmbH
• Janssen Scientific Affairs, LLC
• Boehringer Ingelheim

Key Products

• Vilobelimab
• Guselkumab
• Spesolimab