Urticaria - Pipeline Insight, 2024

This “Urticaria- Pipeline Insight, 2024” report provides comprehensive insights about 20+ companies and 25+ pipeline drugs in Urticaria 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

Urticaria: Understanding

Urticaria: Overview

Urticaria, commonly known as hives, is a skin condition characterized by the sudden appearance of raised, itchy welts (wheals) on the skin. These welts can vary in size, from small spots to large patches, and can appear anywhere on the body. Urticaria is a common condition, affecting up to 20% of people at some point in their lives. The condition can be acute, lasting less than six weeks, or chronic, lasting longer than six weeks. While acute urticaria is often triggered by allergic reactions, chronic urticaria can be more challenging to diagnose and treat due to its persistent nature. The primary symptom of urticaria is the appearance of welts or wheals on the skin. These welts are typically red, pink, or flesh-colored and are often surrounded by a red halo. They can vary in shape and size and may change locations, disappearing from one area and appearing in another over the course of minutes to hours. The welts are usually itchy and can cause a burning or stinging sensation. In some cases, urticaria can also cause angioedema, which is swelling beneath the skin, often around the eyes, lips, and genitals. Severe cases can lead to difficulty breathing or swallowing, necessitating immediate medical attention.

Urticaria occurs when certain cells in the skin, called mast cells, release histamine and other chemicals into the bloodstream. This process can be triggered by a variety of factors. Common triggers include allergic reactions to foods, medications, insect stings, or contact with certain plants or animals. Non-allergic triggers can include infections, stress, exercise, heat, cold, pressure on the skin, and sun exposure. In chronic urticaria, the exact cause often remains unknown, although autoimmune mechanisms are suspected in many cases. The release of histamine causes the blood vessels to leak fluid into the surrounding tissues, leading to the characteristic swelling and itching.

The diagnosis of urticaria is primarily clinical, based on the appearance of the skin lesions and the patient’s history. In acute cases, identifying and eliminating the trigger often resolves the condition. For chronic urticaria, a detailed patient history and physical examination are essential. Additional tests may include blood tests, allergy tests, or skin biopsies to rule out other conditions and identify potential underlying causes. In some cases, a challenge test, where potential triggers are introduced under controlled conditions, may be conducted.

Treatment of urticaria aims to relieve symptoms and, when possible, address the underlying cause. Antihistamines are the first line of treatment and can be very effective in reducing itching and swelling. For more severe cases, oral corticosteroids may be prescribed for short-term use. Chronic urticaria that does not respond to antihistamines may be treated with medications that target the immune system, such as omalizumab, a monoclonal antibody. Avoiding known triggers is crucial in managing the condition. In cases where an allergen is identified, desensitization therapy may be beneficial. Lifestyle modifications, such as stress management and avoiding temperature extremes, can also help manage symptoms.

"Urticaria- Pipeline Insight, 2024" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Urticaria pipeline landscape is provided which includes the disease overview and Urticaria treatment guidelines. The assessment part of the report embraces, in depth Urticaria 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, Urticaria 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 Urticaria R&D. The therapies under development are focused on novel approaches to treat/improve Urticaria.

Urticaria Emerging Drugs Chapters

This segment of the Urticaria 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.

Urticaria Emerging Drugs

Dupilumab: Regeneron Pharmaceuticals

Dupilumab (Dupixent), which was invented using Regeneron's proprietary VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways and is not an immunosuppressant. Dupilumab is been developed in collaboration with Sanofi. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase III trials, establishing that IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases. These diseases include approved indications for Dupixent, such as atopic dermatitis, asthma, chronic rhinosinusitis with nasal polyposis (CRSwNP), prurigo nodularis and EoE. Dupixent has received regulatory approvals in one or more countries around the world for use in certain patients with atopic dermatitis, asthma, CRSwNP, EoE or prurigo nodularis in different age populations. Dupixent is currently approved for one or more of these indications in more than 60 countries, including in Europe, the U.S. and Japan. More than 750,000 patients are being treated with Dupixent globally. Currently, the drug is in Phase III stage of its development for the treatment of Urticaria.

TAS5315: Taiho Pharmaceutical Co., Ltd

TAS5315 is a novel oral investigational drug candidate being developed by Taiho Pharmaceutical Co., Ltd. The drug candidate is a BTK inhibitor that is been developed for various indications like rheumatoid arthritis, detrusor underactivity with overactive bladder and chronic spontaneous urticarial. Currently, the drug is in Phase II stage of its development for the treatment of Urticaria.

AK006: Allakos Inc.

AK006 is a humanized IgG1 monoclonal antibody which activates the inhibitory receptor Siglec-6. AK006 is directed to an extracellular epitope of the Siglec-6 receptor that was identified for its ability to generate strong inhibitory signals to mast cells. Furthermore, AK006 was engineered to have higher cell surface residence time which may increase mast cell inhibition. In addition to inhibition, in preclinical studies AK006 reduces mast cell numbers via antibody-dependent cellular phagocytosis (ADCP) in the presence of activated macrophages. In vitro and in vivo studies have demonstrated AK006 inhibits multiple modes of mast cell activation including IgE, IL-33, KIT, C5a, and MRGPRX2, resulting in the broad suppression of inflammation. In preclinical studies, AK006 displays significantly stronger mast cell inhibition than AK002. Currently, the drug is in Phase I stage of its development for the treatment of Urticaria.

Urticaria: Therapeutic Assessment

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

Major Players in Urticaria

• There are approx. 20+ key companies which are developing the therapies for Urticaria. The companies which have their Urticaria drug candidates in the most advanced stage, i.e. phase III include, Regeneron Pharmaceuticals

Phases

This report covers around 25+ 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

Urticaria 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.

Urticaria: Pipeline Development Activities

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

Urticaria Report Insights

• Urticaria Pipeline Analysis
• Therapeutic Assessment
• Unmet Needs
• Impact of Drugs

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

Key Players

• Regeneron Pharmaceuticals
• Taiho Pharmaceutical Co., Ltd
• Allakos Inc
• Yuhan Corporation
• United BioPharma
• Hangzhou Highlightll Pharmaceutical Co., Ltd
• Kiniksa Pharmaceuticals, Ltd.
• Celldex Therapeutics
• Longbio Pharma
• Celltrion
• Enanta Pharmaceuticals

Key Products

• Dupilumab
• TAS5315
• AK006
• YH35324
• UB-221
• TLL-018
• KPL-716
• AK002
• CDX-0159
• LP-003
• CT-P39

Research programme: Chronic urticaria therapeutics

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