Pemphigus Vulgaris Clinical Trials 2025: Emerging Therapies, Key Players, and Treatment Landscape | DelveInsight

DelveInsight's "Pemphigus Vulgaris - Pipeline Insight, 2025" provides a comprehensive overview of the evolving treatment landscape for pemphigus vulgaris, a rare, chronic, and potentially life-threatening autoimmune blistering disorder. Despite corticosteroids and immunosuppressants being the standard of care, many patients continue to experience relapses, adverse effects, and incomplete disease control, highlighting the urgent need for more effective pemphigus vulgaris treatment options. Understanding bullous pemphigoid vs pemphigus vulgaris is crucial, as both disorders manifest with blistering yet differ in pathophysiology and therapeutic requirements, influencing patient management strategies.

The pemphigus vulgaris pipeline is rapidly expanding with innovative therapies, including B-cell targeted therapies such as rituximab, FcRn inhibitors like RYSTIGGO and VYVGART, complement inhibitors such as ULTOMIRIS and SOLIRIS, and next-generation immunomodulators designed to restore immune tolerance. Emerging small molecules and biologics targeting cytokines and signaling pathways involved in autoantibody production are also in development, offering prospects for more precise and durable disease control. This evolution further emphasizes the clinical distinctions between pemphigus vulgaris vs bullous pemphigoid, supporting accurate diagnosis and treatment selection.

Clinical trials in PV are focused on reducing relapse rates and minimizing long-term corticosteroid use, with candidates spanning monoclonal antibodies, FcRn inhibitors, and combination immunotherapies. As these therapies progress through late-stage development, the PV market is expected to transition from conventional immunosuppressive therapy toward targeted, immune-modulating approaches, improving patient outcomes, reducing treatment-related toxicity, and addressing the chronic, relapsing nature of this rare autoimmune disorder.

Interested in learning more about the current treatment landscape and the key drivers shaping the Pemphigus Vulgaris pipeline? Click here: https://www.delveinsight.com/sample-request/pemphigus-vulgaris-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Key Takeaways from the Pemphigus Vulgaris Pipeline Report
• DelveInsight's Pemphigus Vulgaris pipeline analysis depicts a strong space with 3+ active players working to develop 3+ pipeline drugs for Pemphigus Vulgaris treatment.
• The leading Pemphigus Vulgaris companies include Argenx, SinoMab Bioscience, Cabaletta Bio, Artiva Biotherapeutics, and others, who are evaluating their lead assets to improve the Pemphigus Vulgaris treatment landscape.
• Key Pemphigus Vulgaris pipeline therapies in various stages of development include Efgartigimod PH20, SN1011, DSG3-CAART, AlloNK, and others.
• In August 2025, Cabaletta Bio announced plans to present initial clinical data from the RESET-PV trial, evaluating rese-cel without preconditioning in patients with pemphigus vulgaris. The company also plans to initiate enrollment in myositis registrational cohorts in the second half of 2025.
• In October 2024, a study was published suggesting that ofatumumab is well-tolerated, effective, and convenient for patients with pemphigus vulgaris, showing favorable steroid-sparing effects. The subcutaneous administration feature of ofatumumab offers a potentially convenient option for patients.
• In September 2024, a systematic review and meta-analysis was published, evaluating the efficacy and safety of low-dose rituximab in the treatment of pemphigus. The analysis incorporated five comparative studies and nine single-arm studies, revealing no statistically significant differences between high-dose and low-dose rituximab groups in complete remission, relapse rates, and time to disease control.

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Pemphigus Vulgaris Overview
Pemphigus Vulgaris (PV) is a rare, chronic autoimmune disorder that causes painful blistering of the skin and mucous membranes, most commonly in the mouth, throat, nose, eyes, and genitals. The disease occurs when the immune system mistakenly produces antibodies against desmogleins-proteins that help bind skin cells together-leading to cell separation (acantholysis) and blister formation. PV typically affects adults between 40 and 60 years old and, without treatment, can be life-threatening due to complications like infection, fluid loss, and difficulty eating.

Management of pemphigus vulgaris usually involves immunosuppressive therapies aimed at reducing autoantibody production. Corticosteroids are commonly used as first-line treatment, often in combination with steroid-sparing agents like azathioprine, mycophenolate mofetil, or biologics such as rituximab. Advances in targeted therapies are being explored, including investigational agents like CAAR-T cells and FcRn or neonatal Fc receptor blockers, which aim to offer more durable disease control with fewer side effects. Early diagnosis and consistent management are crucial for improving quality of life and long-term outcomes.

Find out more about Pemphigus Vulgaris medication at https://www.delveinsight.com/sample-request/pemphigus-vulgaris-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Pemphigus Vulgaris Treatment Analysis: Drug Profile
CABA-201: Cabaletta Bio
CABA-201 is an investigational CD19-directed CAR-T cell therapy that incorporates a 4-1BB co-stimulatory domain and is fully human in design. It is intended for the treatment of autoimmune diseases where B cells play a central role in disease initiation and persistence. Administered as a one-time infusion, CABA-201 is engineered to transiently but completely eliminate all CD19-positive cells, potentially resetting the immune system and delivering robust clinical responses without the need for ongoing therapy. Cabaletta Bio is advancing CABA-201 within its RESETTM (REstoring SElf-Tolerance) clinical program, which includes multiple company-sponsored trials targeting a broad range of autoimmune conditions across therapeutic areas such as dermatology, neurology, and rheumatology. Currently, CABA-201 is in Phase I/II development for the treatment of Pemphigus Vulgaris.

AlloNK: Artiva Biotherapeutics
AlloNK is an allogeneic, off-the-shelf, cryopreserved natural killer (NK) cell therapy candidate designed to enhance antibody-dependent cellular cytotoxicity (ADCC), facilitating B-cell depletion when used in combination with monoclonal antibodies (mAbs) or NK cell engagers. As a non-genetically modified and non-targeted NK cell product, AlloNK can be flexibly paired with different agents to address a variety of disease targets. It is currently being studied in clinical trials for systemic lupus erythematosus (SLE), both with and without lupus nephritis, as well as in a basket investigator-initiated trial covering multiple autoimmune conditions. Additionally, AlloNK is being evaluated for non-Hodgkin lymphoma and in combination with Affimed's innate cell engager, acimtamig, for CD30-positive relapsed/refractory lymphomas. For Pemphigus Vulgaris, AlloNK is currently in Phase I clinical development.

Learn more about the novel and emerging Pemphigus Vulgaris pipeline therapies at https://www.delveinsight.com/sample-request/pemphigus-vulgaris-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Pemphigus Vulgaris Therapeutics Assessment
By Product Type
• Mono
• Combination
• Mono/Combination.

By Stage
• 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

By Route of Administration
• Oral
• Intravenous
• Subcutaneous
• Parenteral
• Topical

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

Scope of the Pemphigus Vulgaris Pipeline Report
• Coverage: Global
• Key Pemphigus Vulgaris Companies: Argenx, SinoMab Bioscience, Cabaletta Bio, Artiva Biotherapeutics, and others.
• Key Pemphigus Vulgaris Pipeline Therapies: Efgartigimod PH20, SN1011, DSG3-CAART, AlloNK, and others.

To dive deep into rich insights for drugs used for Pemphigus Vulgaris treatment, visit: https://www.delveinsight.com/sample-request/pemphigus-vulgaris-pipeline-insight?utm_source=openpr&utm_medium=pressrelease&utm_campaign=jpr

Table of Contents
1. Introduction
2. Executive Summary
3. Pemphigus Vulgaris Pipeline: Overview
4. Analytical Perspective In-depth Commercial Assessment
5. Pemphigus Vulgaris Pipeline Therapeutics
6. Pemphigus Vulgaris Pipeline: Late-Stage Products (Phase III)
7. Pemphigus Vulgaris Pipeline: Mid-Stage Products (Phase II)
8. Pemphigus Vulgaris Pipeline: Early Stage Products (Phase I)
9. Therapeutic Assessment
10. Inactive Products
11. Company-University Collaborations (Licensing/Partnering) Analysis
12. Key Companies
13. Key Products
14. Unmet Needs
15. Market Drivers and Barriers
16. Future Perspectives and Conclusion
17. Analyst Views
18. Appendix

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Jatin Vimal
jvimal@delveinsight.com
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Healthcare Consulting
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This release was published on openPR.