Cutaneous Lupus Erythematosus Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

Cutaneous Lupus Erythematosus Clinical Trials and Studies 2025: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight’s, “Cutaneous Lupus Erythematosus Pipeline Insight 2025” report provides comprehensive insights about 10+ companies and 12+ pipeline drugs in Cutaneous Lupus Erythematosus pipeline landscape. It covers the Cutaneous Lupus Erythematosus Pipeline drug profiles, including clinical and nonclinical stage products. It also covers the Cutaneous Lupus Erythematosus Pipeline 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 Cutaneous Lupus Erythematosus Pipeline Report

  • In April 2025, AstraZeneca announced a study are to evaluate the efficacy of anifrolumab compared with placebo in reducing skin disease in participants with active chronic and/or subacute CLE who are refractory and/or intolerant to antimalarial therapy. The secondary objectives of the study are to evaluate additional efficacy parameters of anifrolumab, safety, tolerability, quality of life, pharmacokinetics, pharmacodynamics, and immunogenicity.
  • In April 2025, Biogen conducted a study is to learn about the effect litifilimab has on lowering the activity of the skin disease. Researchers will measure symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator’s Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI).
  • In April 2025, Pfizer organized a study is to learn about the effects, safety and how PF-06823859 is processed in adults with cutaneous lupus erythematosus (CLE) or systemic lupus erythematosus (SLE) showing some skin symptoms.
  • DelveInsight’s Cutaneous Lupus Erythematosus pipeline report depicts a robust space with 10+ active players working to develop 12+ pipeline therapies for Cutaneous Lupus Erythematosus treatment.
  • The leading Cutaneous Lupus Erythematosus Companies such as Hoth Therapeutics, Zylo Therapeutics, Sanofi, Gilead Sciences, Bristol-Myers Squibb, Merck KGaA, Kyowa Kirin Co., Ltd., Priothera Ltd., Centessa Pharmaceuticals, and Horizon Therapeutics and others.
  • Promising Cutaneous Lupus Erythematosus Pipeline Therapies such as Litifilimab, Daxdilimab, SOTYKTU (deucravacitinib), Edecesertib, DS-7011a, Enpatoran, and others.

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Cutaneous Lupus Erythematosus Emerging Drugs Profile

  • BIIB059: Biogen

Litifilimab (known as BIIB059), discovered and developed in-house by Biogen scientists, is a humanized IgG1 monoclonal antibody (mAb) targeting blood dendritic cell antigen 2 (BDCA2) and is being investigated for the potential treatment of systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). Currently it is being evaluated in Phase II clinical trial in Participants with Active Subacute Cutaneous Lupus Erythematosus (SCLE) and/or Chronic Cutaneous Lupus Erythematosus (CCLE) with or without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy.

  • SAR443122: Sanofi

SAR443122 is a peripherally-restricted small molecule inhibitor of RIPK1 being evaluated in patients with cutaneous lupus erythematosus (CLE). Denali and Sanofi entered into a broad collaboration in October 2018 for the global development and commercialization of RIPK1 inhibitors. This includes peripherally restricted molecules such as SAR443122 (DNL758) and CNS-penetrant molecules such as DNL788 (SAR443820). A Phase II clinical study is assessing the efficacy and safety of the RIPK1-inhibitor SAR443122 in patients with moderate to severe subacute or discoid/chronic cutaneous lupus erythematosus.

The Cutaneous Lupus Erythematosus Pipeline Report Provides Insights into

  • The report provides detailed insights about companies that are developing therapies for the treatment of Cutaneous Lupus Erythematosus 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 Cutaneous Lupus Erythematosus Treatment.
  • Cutaneous Lupus Erythematosus Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
  • Cutaneous Lupus Erythematosus 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 Cutaneous Lupus Erythematosus market

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Cutaneous Lupus Erythematosus Companies

Hoth Therapeutics, Zylo Therapeutics, Sanofi, Gilead Sciences, Bristol-Myers Squibb, Merck KGaA, Kyowa Kirin Co., Ltd., Priothera Ltd., Centessa Pharmaceuticals, and Horizon Therapeutics and others.

Cutaneous Lupus Erythematosus pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs such as

  • Infusion
  • Intradermal
  • Intramuscular
  • Intranasal
  • Intravenous
  • Oral
  • Parenteral
  • Subcutaneous
  • Topical.

Cutaneous Lupus Erythematosus Products have been categorized under various Molecule types such as

  • Gene therapies
  • Small molecule
  • Vaccines
  • Polymers
  • Peptides
  • Monoclonal antibodies

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Scope of the Cutaneous Lupus Erythematosus Pipeline Report

  • Coverage- Global
  • Cutaneous Lupus Erythematosus Companies- Hoth Therapeutics, Zylo Therapeutics, Sanofi, Gilead Sciences, Bristol-Myers Squibb, Merck KGaA, Kyowa Kirin Co., Ltd., Priothera Ltd., Centessa Pharmaceuticals, and Horizon Therapeutics and others.
  • Cutaneous Lupus Erythematosus Pipeline Therapies- Litifilimab, Daxdilimab, SOTYKTU (deucravacitinib), Edecesertib, DS-7011a, Enpatoran, and others.
  • Cutaneous Lupus Erythematosus Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
  • Cutaneous Lupus Erythematosus Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

  1. Introduction
  2. Executive Summary
  3. Cutaneous Lupus Erythematosus: Overview
  4. Pipeline Therapeutics
  5. Therapeutic Assessment
  6. Cutaneous Lupus Erythematosus – DelveInsight’s Analytical Perspective
  7. In-depth Commercial Assessment
  8. Cutaneous Lupus Erythematosus Collaboration Deals
  9. Late Stage Products (Phase III)
  10. Drug Name: Company Name
  11. Mid Stage Products (Phase II)
  12. SAR443122: Sanofi
  13. Drug profiles in the detailed report…..
  14. Early Stage Products (Phase I)
  15. VIB7734: Horizon Therapeutics
  16. Drug profiles in the detailed report…..
  17. Pre-clinical and Discovery Stage Products
  18. HT-005 Z-Pods: Hoth Therapeutics/Zylo Therapeutics
  19. Inactive Products
  20. Cutaneous Lupus Erythematosus Key Companies
  21. Cutaneous Lupus Erythematosus Key Products
  22. Cutaneous Lupus Erythematosus- Unmet Needs
  23. Cutaneous Lupus Erythematosus- Market Drivers and Barriers
  24. Cutaneous Lupus Erythematosus- Future Perspectives and Conclusion
  25. Cutaneous Lupus Erythematosus Analyst Views
  26. Cutaneous Lupus Erythematosus Key Companies
  27. Appendix

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