Hidradenitis Suppurativa Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Hidradenitis Suppurativa Pipeline Insight 2025" report provides comprehensive insights about 24+ companies and 24+ pipeline drugs in Hidradenitis Suppurativa pipeline landscape. It covers the Hidradenitis Suppurativa 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.

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Key Takeaways from the Hidradenitis Suppurativa Pipeline Report

* In April 2025, Novartis Pharmaceuticals announced study is to establish the efficacy, safety, and tolerability of remibrutinib (LOU064) Dose A and Dose B compared to placebo in participants with moderate to severe hidradenitis suppurativa (HS).
* In April 2025, Avalo Therapeutics Inc . conducted a study is to evaluate the efficacy and safety of AVTX-009 compared with placebo in patients with moderate to severe Hidradenitis Suppurativa (HS). This is a randomized, double-blind, placebo-controlled, parallel-group, Phase 2 study. Patients will be randomized to one of two AVTX-009 dose regimens or matching placebo in a 1:1:1 ratio.
* In April 2025, UCB Biopharma SRL organized a study is to evaluate the safety of long-term therapy of bimekizumab in study participants with moderate to severe hidradenitis suppurativa (HS).
* DelveInsight's Hidradenitis Suppurativa pipeline report depicts a robust space with 24+ active players working to develop 24+ pipeline therapies for Hidradenitis Suppurativa treatment.
* The leading Hidradenitis Suppurativa Companies such as InflaRx, Novartis, UCB, ChemoCentryx, Eli Lilly and Company, Janssen Biotech, AbbVie, Pfizer, Amgen, Incyte Corporation, CSL Behring, Kymera Therapeutics, Lytix Biopharma, Aclaris Therapeutics, Boehringer Ingelheim, and Azora Therapeutics and others.
* Promising Hidradenitis Suppurativa Pipeline Therapies such as Remibrutinib Dose A, AVTX-009, Izokibep, Bimekizumab, Sonelokimab (M1095), Adalimumab and others.

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Hidradenitis Suppurativa Emerging Drugs Profile

* Vilobelimab: InflaRx

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, which is not the case for molecules blocking the cleavage of C5. Vilobelimab has been demonstrated to control the inflammatory response driven tissue and organ damage by specifically blocking C5a as a key "amplifier" of this response in pre-clinical studies. Vilobelimab is believed to be the first monoclonal anti-C5a antibody introduced into clinical development. Approximately 300 people have been treated with vilobelimab in clinical trials, and the antibody has been shown to be well tolerated. Vilobelimab is currently being developed for various indications, including Hidradenitis Suppurativa, ANCA-associated vasculitis, Pyoderma Gangraenosum, cancer and severe COVID19.

* Secukinumab: Novartis

Secukinumab is the first and only fully human biologic that directly inhibits interleukin-17A (IL-17A), an important cytokine involved in the inflammation of psoriatic arthritis (PsA), moderate to severe plaque psoriasis, ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA)12,13. Cosentyx is a proven medicine and has been studied clinically for more than 14 years. The medicine is backed by robust evidence, including 5 years of clinical data in adults supporting long-term safety and efficacy across moderate to severe plaque psoriasis, PsA and AS14-20. These data strengthen the position of Cosentyx as a treatment across AS, nr-axSpA, PsA and moderate to severe plaque psoriasis, supported by more than 500,000 patients treated worldwide since launch in 2015.

* Avacopan: ChemoCentryx

Avacopan, approved by the FDA as an adjunctive treatment of ANCA-associated vasculitis, is a first-in-class, orally-administered small molecule that employs a novel, highly targeted mode of action in complement-driven autoimmune and inflammatory diseases. While the precise mechanism in ANCA vasculitis has not been definitively established, Avacopan, by blocking the complement 5a receptor (C5aR) for the pro-inflammatory complement system fragment known as C5a on destructive inflammatory cells such as blood neutrophils, is presumed to arrest the ability of those cells to do damage in response to C5a activation, which is known to be the driver of ANCA vasculitis. Avacopan's selective inhibition of only the C5aR leaves the beneficial C5a pathway through the C5L2 receptor functioning normally. ChemoCentryx is also developing TAVNEOS for the treatment of patients with C3 glomerulopathy (C3G), hidradenitis suppurativa (HS) and Lupus Nephritis (LN).

* Imsidolimab: AnaptysBio

Imsidolimab, previously known as ANB019, is an antibody that inhibits the function of the interleukin-36-receptor, or IL-36R, which AnaptysBio plans to initially develop as a potential first-in-class therapy for patients suffering from generalized pustular psoriasis, or GPP, EGFR-mediated skin toxicity, ichthyosis, hidradenitis suppurativa and acne.

* Spesolimab: Boehringer Ingelheim

Spesolimab is a novel, humanized, selective antibody that blocks the activation of the interleukin-36 receptor (IL-36R), a signaling pathway within the immune system shown to be involved in the pathogeneses of several autoimmune diseases, including GPP. Spesolimab is also under investigation for the prevention of GPP flares and for the treatment of other neutrophilic skin diseases, such as palmoplantar pustulosis (PPP) and hidradenitis suppurativa (HS).

Hidradenitis Suppurativa Market Drivers

* Advancements in Research and Development
* Rise in awareness about the disease

Hidradenitis Suppurativa Market Barriers

* Stigma and Patient Reluctance
* Complexity of the disease

The Hidradenitis Suppurativa Pipeline Report Provides Insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Hidradenitis Suppurativa with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Hidradenitis Suppurativa Treatment.
* Hidradenitis Suppurativa Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Hidradenitis Suppurativa Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Hidradenitis Suppurativa market

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Hidradenitis Suppurativa Companies

InflaRx, Novartis, UCB, ChemoCentryx, Eli Lilly and Company, Janssen Biotech, AbbVie, Pfizer, Amgen, Incyte Corporation, CSL Behring, Kymera Therapeutics, Lytix Biopharma, Aclaris Therapeutics, Boehringer Ingelheim, and Azora Therapeutics and others.

Hidradenitis Suppurativa 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
* Parenteral
* Intravenous
* Subcutaneous
* Topical

Hidradenitis Suppurativa Products have been categorized under various Molecule types such as

* Monoclonal Antibody
* Peptides
* Polymer
* Small molecule
* Gene therapy

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Scope of the Hidradenitis Suppurativa Pipeline Report

* Coverage- Global
* Hidradenitis Suppurativa Companies- InflaRx, Novartis, UCB, ChemoCentryx, Eli Lilly and Company, Janssen Biotech, AbbVie, Pfizer, Amgen, Incyte Corporation, CSL Behring, Kymera Therapeutics, Lytix Biopharma, Aclaris Therapeutics, Boehringer Ingelheim, Azora Therapeutics and others.
* Hidradenitis Suppurativa Pipeline Therapies- Remibrutinib Dose A, AVTX-009, Izokibep, Bimekizumab, Sonelokimab (M1095), Adalimumab and others.
* Hidradenitis Suppurativa Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Hidradenitis Suppurativa Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

* Introduction
* Executive Summary
* Hidradenitis Suppurativa: Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Hidradenitis Suppurativa - DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* Vilobelimab: InflaRx
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* Spesolimab: Boehringer Ingelheim
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I/II)
* Drug name: Company name
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I)
* AT193: Azora Therapeutics
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug name: Company name
* Drug profiles in the detailed report.....
* Inactive Products
* Hidradenitis Suppurativa Key Companies
* Hidradenitis Suppurativa Key Products
* Hidradenitis Suppurativa - Unmet Needs
* Hidradenitis Suppurativa - Market Drivers and Barriers
* Hidradenitis Suppurativa - Future Perspectives and Conclusion
* Hidradenitis Suppurativa Analyst Views
* Hidradenitis Suppurativa Key Companies
* Appendix

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

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