Scleroderma - Pipeline Insight, 2021

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DelveInsight’s, “Scleroderma - Pipeline Insight, 2021,” report provides comprehensive insights about 50+ companies and 50+ pipeline drugs in Scleroderma 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

Scleroderma Understanding

Scleroderma: Overview

Scleroderma, also known as Systemic Sclerosis, progressive systemic sclerosis or the CREST syndrome, is a chronic skin disorder that affects the skin, connective tissues and other internal organs. The disorder takes place sin humans, when the immune system causes the body to make the protein collagen, an important component of the skin, in huge amounts. The most recognizable feature that is observed in Scleroderma patients, is the process of progressive fibrosis that is a resultant of excessive deposition of the extracellular matrix components in several tissues and organs. Other characteristics of scleroderma comprise of vascular damage, inflammation and the presence of specific autoantibodies. Systemic sclerosis has been found to cause damage to the skin, including the internal organs of the body as lungs, heart, kidneys, musculoskeletal system and the gastrointestinal tract. Amongst all these, skin sclerosis has been observed to be the major symptom of systemic sclerosis. It can also be calculated using the Rodnan skin score (mRss) and using a detectable marker of the disease activity.

'Scleroderma - Pipeline Insight, 2021' report by DelveInsight outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Scleroderma pipeline landscape is provided which includes the disease overview and Scleroderma treatment guidelines. The assessment part of the report embraces, in depth Scleroderma 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, Scleroderma 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 Scleroderma R&D. The therapies under development are focused on novel approaches to treat/improve Scleroderma.

Scleroderma Emerging Drugs Chapters

This segment of the Scleroderma 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.

Scleroderma Emerging Drugs

• Iloprost: Eicos Sciences

Iloprost is a stable analogue of PGI2 and a potent prostacyclin (IP) receptor agonist. By mimicking PGI2, it is a vasodilator and inhibitor of platelet activation and fibrosis. Iloprost stimulates generation of cAMP by binding to the IP receptor, thereby affecting phospholipase activity and cytosolic calcium levels in platelets, fibroblasts, and endothelial cells. It is a potent vasodilator and platelet inhibitor with anti-inflammatory and anti-fibrotic effects being developed for the treatment of digital ischemic episodes in people with Systemic Sclerosis (SSc). The drug is currently in phase 3 of development stage for the treatment of scleroderma.

• EHP-101: Emerald Health Pharmaceuticals

EHP-101 is an oral formulation of VCE-004.8, a synthetic aminoquinone derivative of CBD with dual peroxisome proliferator-activated receptor gamma (PPAR?) and cannabinoid receptor type 2 (CB2) agonist activity. Both receptors are therapeutic targets for SSc. EHP-101 also modulates the hypoxia inducible factor (HIF) pathway, expanding the rationale for its development as a novel SSc drug. It is currently in phase II stage of development and is being developed by Emerald Health Pharmaceuticals.

• HZN-825: Horizon Pharmaceuticals

HZN 825 (formerly known as SAR 100842 and CZN 001) is an orally available, lysophosphatidic acid receptor 1 antagonist. In Phase I clinical studies conducted by Sanofi, HZN-825 was safe and well tolerated. The drug is currently in Phase II clinical studies for the treatment of Diffuse Cutaneous Systemic Sclerosis.

• Guselkumab: Janssen Biotech

Guselkumab (Tremfya) is a human immunoglobulin G1 ? (IgG1?) monoclonal antibody. Guselkumab selectively binds to the p19 subunit of IL-23 in dendritic cells and keratinocytes and blocks its interaction with the IL-23 receptor, which further prevents the release of other pro-inflammatory cytokines and chemokines via stimulation of immune cells, such as T helper 17 (Th17) cells. It is the first in its class to be approved in adults with moderate to severe plaque psoriasis. The drug is currently in Phase II clinical studies for the treatment of Systemic scleroderma among other clinical evaluations.

Further product details are provided in the repor

Scleroderma: Therapeutic Assessment

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

• Major Players in Scleroderma

There are approx. 50+ key companies which are developing the therapies for Scleroderma. The companies which have their Scleroderma drug candidates in the most advanced stage, i.e. phase III include, Eicos Sciences.

• Phases

DelveInsight’s report covers around 50+ 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

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

• Interdermal
• Intramuscular
• Intravenous
• Subcutaneous
• Topical.
• Molecule Type

Products have been categorized under various Molecule types such as

• Monoclonal Antibody
• Recombinant Proteins
• Skin disorder therapy
• Small molecule
• Gene therapy
• Stem cell therapy
• Product Type

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

Scleroderma: Pipeline Development Activities

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

Scleroderma Report Insights

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

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

Key Players

• Eicos Sciences
• Emerald Health Pharmaceuticals
• Horizon Pharmaceuticals
• Janssen Biotech
• Beijing Continent Pharmaceutical
• Kyowa Kirin
• Cytori therapeutics
• Corbus Pharmaceuticals
• Zenyaku Kogyo
• Sanofi
• Bayer
• ASKA Pharmaceutical
• United Therapeutics
• Cumberland Pharmaceuticals
• Gesynta Pharma
• Certa Therapeutics
• Vicore Pharma
• Seagen
• CSL Behring
• arGentis Pharmaceuticals
• Mitsubishi Tanabe Pharma
• Kadmon Pharmaceuticals
• GlaxoSmithKline
• Bristol-Myers Squibb
• Camurus
• Regeneron Pharmaceuticals
• Castle Creek Biosciences
• Talaris Therapeutics
• Viela Bio
• Formation Biologics
• Chemomab therapeutics
• AnaMar
• Atlantic Healthcare

Key Products

• Iloprost
• EHP-101
• HZN-825
• Guselkumab
• Pirfenidone
• KHK4827
• ECCS 50
• Lenabasum (JBT-101)
• Rituximab
• SAR156597
• Riociguat
• Rifaximin
• Treprostinil
• Ifetroban
• GS-248
• FT011
• Crisaborole
• C21
• Brentuximab Vedotin
• IgPro20
• ARG201
• Dersimelagon (MT-7117)
• Belumosudil
• Belimumab
• Abatacept
• CAM2043
• Tofacitinib
• Sarilumab
• Rilonacept
• FCX 013
• FCR001
• VIB7734
• AVID200
• CM-101
• AM 1476
• Renzapride

LIST OF TABLES

Table 1 Total Products for Scleroderma
Table 2 Late Stage Products
Table 3 Mid Stage Products
Table 4 Early Stage Products
Table 5 Pre-clinical & Discovery Stage Products
Table 6 Assessment by Product Type
Table 7 Assessment by Stage and Product Type
Table 8 Assessment by Route of Administration
Table 9 Assessment by Stage and Route of Administration
Table 10 Assessment by Molecule Type
Table 11 Assessment by Stage and Molecule Type
Table 12 Inactive Products

LIST OF FIGURES

Figure 1 Total Products for Scleroderma
Figure 2 Late Stage Products
Figure 3 Mid Stage Products
Figure 4 Early Stage Products
Figure 5 Preclinical and Discovery Stage Products
Figure 6 Assessment by Product Type
Figure 7 Assessment by Stage and Product Type
Figure 8 Assessment by Route of Administration
Figure 9 Assessment by Stage and Route of Administration
Figure 10 Assessment by Molecule Type
Figure 11 Assessment by Stage and Molecule Type
Figure 12 Inactive Products