Schnitzler syndrome - Pipeline Insight, 2025

DelveInsight’s, “Schnitzler syndrome - Pipeline Insight, 2025,” report provides comprehensive insights about 5+ companies and 5+ pipeline drugs in Schnitzler syndrome 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

Schnitzler syndrome Understanding

Schnitzler syndrome: Overview

Schnitzler syndrome is a rare disorder characterized by a chronic reddish rash that resembles hives (urticaria) and elevated levels of a specific protein in the blood (monoclonal IgM gammopathy). Symptoms associated with Schnitzler syndrome may include repeated bouts of fever, joint inflammation (arthritis), joint pain (arthralgia), bone pain, and other findings such as enlarged lymph nodes (lymphadenopathy). A monoclonal IgM gammopathy refers to the uncontrolled growth of a single clone (monoclonal) of plasma cells, which results in the abnormal accumulation of M-proteins (also known as immunoglobulin M or IgM) in the blood. However, the specific role these proteins play and the exact cause of Schnitzler syndrome is unknown. Schnitzler syndrome is difficult to classify and some researchers have suggested that it is an acquired autoinflammatory syndrome. Autoinflammatory syndromes are a group of disorders characterized by recurrent episodes of inflammation due to an abnormality of the innate immune system. They are not the same as autoimmune disorders, in which the adaptive immune system malfunctions and mistakenly attacks healthy tissue.

""Schnitzler syndrome - Pipeline Insight, 2025"" report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Schnitzler syndrome pipeline landscape is provided which includes the disease overview and Schnitzler syndrome treatment guidelines. The assessment part of the report embraces, in depth Schnitzler syndrome 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, Schnitzler syndrome 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 Schnitzler syndrome R&D. The therapies under development are focused on novel approaches to treat/improve Schnitzler syndrome.

Schnitzler syndrome Emerging Drugs Chapters

This segment of the Schnitzler syndrome report encloses its detailed analysis of various drugs in different stages of clinical development, including phase 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.

Schnitzler syndrome Emerging Drugs

• Dapansutrile: Olatec Therapeutics

Dapansutrile (lab code: OLT1177®) is an investigational small molecule, new chemical entity that specifically binds to and blocks NLRP3 (nucleotide-binding and oligomerization domain [NOD]-, leucine rich repeat-, pyrin domain-containing 3), the sensor molecule integral in the formation of the NLRP3 inflammasome. Inflammasomes are multiprotein complexes involved in intracellular surveillance of danger signals that trigger an intense inflammatory response, via generation of bioactive IL-1β and IL-18 through caspase-1 activation. Dapansutrile has been shown to prevent the formation of the NLRP3 inflammasome, which in turn inhibits the production of IL-1β and IL-18. NLRP3 is one of the most characterized inflammasome sensors due to its involvement in a wide range of disorders, including sterile inflammation, infections, and rare genetic autoimmune syndromes. Olatec Therapeutics is conducting a a Phase II pilot, open-label, single-center, repeat dose, proof-of-concept safety, pharmacodynamics and efficacy study of orally administered investigational drug (OLT1177® Capsules) in subjects with a rare disease called Schnitzler’s Syndrome.

• RPH-104: R-Pharm

RPH-104 is a biological product (a novel heterodimeric fusion protein that inhibits IL-1) that is being developed to treat a variety of diseases characterized by systemic inflammation, recurrent fevers, joint lesions and rashes, and to treat metabolic diseases, etc. The U.S. Food and Drug Administration (US FDA) has designated the drug RPH-104 as an orphan drug for the treatment of Schnitzler syndrome. Currently, the drug is in Phase II stage of Clinical trial evaluation for the treatment of Schnitzler’s Syndrome.

Further product details are provided in the report……..

Schnitzler syndrome: Therapeutic Assessment

This segment of the report provides insights about the different Schnitzler syndrome drugs segregated based on following parameters that define the scope of the report, such as:

• Major Players in Schnitzler syndrome

There are approx. 5+ key companies which are developing the therapies for Schnitzler syndrome. The companies which have their Schnitzler syndrome drug candidates in the most advanced stage, i.e. phase II include, Olatec Therapeutics.

• Phases

DelveInsight’s report covers around 5+ 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

Schnitzler syndrome 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.
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal Antibody
• Peptides
• Polymer
• Small molecule
• Gene therapy
• Product Type

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

Schnitzler syndrome: Pipeline Development Activities

The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Schnitzler syndrome 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 Schnitzler syndrome drugs.

Schnitzler syndrome Report Insights

• Schnitzler syndrome Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

Schnitzler syndrome 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 Schnitzler syndrome drugs?
• How many Schnitzler syndrome drugs are developed by each company?
• How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Schnitzler syndrome?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Schnitzler syndrome 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 Schnitzler syndrome and their status?
• What are the key designations that have been granted to the emerging drugs?

Key Players

• Olatec Therapeutics
• R-Pharm
• Novartis
• Roche

Key Products

• Dapansutrile
• RPH-104
• Canakinumab
• Tocilizumab