This “Systemic Lupus Erythematosus- Pipeline Insight, 2022” report provides comprehensive insights about 60+ companies and 60+ pipeline drugs in Systemic Lupus Erythematosus 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.
Systemic lupus erythematosus (SLE), is the most common type of lupus. SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. The seriousness of SLE can range from mild to life-threatening. SLE is most commonly seen in women in the reproductive age group (frequently starting at childbearing age), although lupus is increasingly recognized after the age of 40 years, particularly in the Europeans. Lupus occurs when the immune system attacks healthy tissue in the body (an autoimmune disease). It is likely that lupus results from a combination of genetics and the environment. It appears that people with an inherited predisposition for lupus may develop the disease when they come into contact with something in the environment that can trigger lupus. SLE is a chronic autoimmune disease that can affect almost any organ system; thus, its presentation and course are highly variable, ranging from indolent to fulminant. The times when symptoms get worse are called relapses, or flares. The times when symptoms are under control are called remissions. The general symptoms are not specific. Common symptoms include: Feeling very tired, joint pain or swelling (arthritis), fever, skin rash, mouth sores, hair loss and some people with lupus have problems with the heart, lungs, kidneys, blood cells, or nervous system. The diagnosis of systemic lupus erythematosus is based on clinical and laboratory criteria. SLE is difficult to diagnose in primary care because many of the symptoms (e.g., fatigue, rash, joint pain) are nonspecific and overlap with those of more common conditions. Furthermore, biomarkers are often negative or normal early in the course of the illness. The most common presenting symptoms are constitutional, such as fatigue, weight loss, and fever without a focal infection, occurring in up to 90% of patients. There is no complete cure for SLE currently, but there are many treatments available to help particular symptoms. The disease involves a wide range of clinical features that encompasses vascular, immune and fibrotic manifestations along-with the involvement of many organs. Treatments of Systemic Lupus Erythematosus include NSAIDs and antimalarial agents, which are the first-line therapies for mild SLE.
“Systemic Lupus Erythematosus- Pipeline Insight, 2022" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Systemic Lupus Erythematosus pipeline landscape is provided which includes the disease overview and Systemic Lupus Erythematosus treatment guidelines. The assessment part of the report embraces, in depth Systemic Lupus Erythematosus 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, Systemic Lupus Erythematosus collaborations, licensing, mergers and acquisition, funding, designations and other product related details.
This segment of the Systemic Lupus Erythematosus 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.
Obinutuzumab: Roche
Obinutuzumab (Gazyva/Gazyvaro) is an engineered monoclonal antibody designed to attach to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells. Gazyva/Gazyvaro is designed to attack and destroy targeted B-cells both directly and together with the body's immune system. Gazyva is marketed as Gazyvaro in the EU and Switzerland. The drug is currently in Phase III stage of development to treat Systemic lupus erythematosus.
Ianalumab: Novartis
Ianalumab (VAY736) is an anti-B-cell activating factor (BAFF) receptor fully human monoclonal antibody, engineered for direct ADCC-mediated B-cell depletion. The drug is currently in Phase II stage of clinical trial evaluation to treat SLE. Ianalumab is also being studied in other Novartis-led trials in chronic lymphocytic leukemia, rheumatoid arthritis and Idiopathic pulmonary fibrosis among other indications.
LABP-104: Landos Biopharma Inc.
LABP-104 is an oral, systemically distributed, small-molecule therapeutic candidate which activates LANCL2, a surface membrane-associated receptor that is responsible for modulating key cellular and molecular changes tied to autoimmune diseases. LABP-104 is currently in clinical development for systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). To date, treatment with LABP-104 has reduced the production of interferon alpha in human PBMCs from SLE patients and provided protection from clinical disease and tissue pathology in mouse models of lupus. Landos has initiated a Phase 1 trial of LABP-104 in healthy volunteers for the treatment of SLE and RA.
Ex-204: Exinda Therapeutics
Ex-204 (Bendamustine oral) is an antineoplastic" or "cytotoxic drug. As per the company pipeline the Bendamustine oral is in preclinical stage for Systemic Lupus Erythematosus.
This segment of the report provides insights about the different Systemic Lupus Erythematosus drugs segregated based on following parameters that define the scope of the report, such as:
There are approx. 60+ key companies which are developing the therapies for Systemic Lupus Erythematosus. The companies which have their Systemic Lupus Erythematosus drug candidates in the most advanced stage, i.e. phase III include, Roche.
The drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Systemic Lupus Erythematosus therapeutic drugs key players involved in developing key drugs.
The report covers the detailed information of collaborations, acquisition and merger, licensing along with a thorough therapeutic assessment of emerging Systemic Lupus Erythematosus drugs.
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Geography Covered
- Global coverage
Systemic Lupus Erythematosus: Understanding
Systemic Lupus Erythematosus: Overview
Systemic lupus erythematosus (SLE), is the most common type of lupus. SLE is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. The seriousness of SLE can range from mild to life-threatening. SLE is most commonly seen in women in the reproductive age group (frequently starting at childbearing age), although lupus is increasingly recognized after the age of 40 years, particularly in the Europeans. Lupus occurs when the immune system attacks healthy tissue in the body (an autoimmune disease). It is likely that lupus results from a combination of genetics and the environment. It appears that people with an inherited predisposition for lupus may develop the disease when they come into contact with something in the environment that can trigger lupus. SLE is a chronic autoimmune disease that can affect almost any organ system; thus, its presentation and course are highly variable, ranging from indolent to fulminant. The times when symptoms get worse are called relapses, or flares. The times when symptoms are under control are called remissions. The general symptoms are not specific. Common symptoms include: Feeling very tired, joint pain or swelling (arthritis), fever, skin rash, mouth sores, hair loss and some people with lupus have problems with the heart, lungs, kidneys, blood cells, or nervous system. The diagnosis of systemic lupus erythematosus is based on clinical and laboratory criteria. SLE is difficult to diagnose in primary care because many of the symptoms (e.g., fatigue, rash, joint pain) are nonspecific and overlap with those of more common conditions. Furthermore, biomarkers are often negative or normal early in the course of the illness. The most common presenting symptoms are constitutional, such as fatigue, weight loss, and fever without a focal infection, occurring in up to 90% of patients. There is no complete cure for SLE currently, but there are many treatments available to help particular symptoms. The disease involves a wide range of clinical features that encompasses vascular, immune and fibrotic manifestations along-with the involvement of many organs. Treatments of Systemic Lupus Erythematosus include NSAIDs and antimalarial agents, which are the first-line therapies for mild SLE.
“Systemic Lupus Erythematosus- Pipeline Insight, 2022" report outlays comprehensive insights of present scenario and growth prospects across the indication. A detailed picture of the Systemic Lupus Erythematosus pipeline landscape is provided which includes the disease overview and Systemic Lupus Erythematosus treatment guidelines. The assessment part of the report embraces, in depth Systemic Lupus Erythematosus 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, Systemic Lupus Erythematosus 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 Systemic Lupus Erythematosus R&D. The therapies under development are focused on novel approaches to treat/improve Systemic Lupus Erythematosus.
Systemic Lupus Erythematosus Emerging Drugs Chapters
This segment of the Systemic Lupus Erythematosus 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.
Systemic Lupus Erythematosus Emerging Drugs
Obinutuzumab: Roche
Obinutuzumab (Gazyva/Gazyvaro) is an engineered monoclonal antibody designed to attach to CD20, a protein expressed on certain B cells, but not on stem cells or plasma cells. Gazyva/Gazyvaro is designed to attack and destroy targeted B-cells both directly and together with the body's immune system. Gazyva is marketed as Gazyvaro in the EU and Switzerland. The drug is currently in Phase III stage of development to treat Systemic lupus erythematosus.
Ianalumab: Novartis
Ianalumab (VAY736) is an anti-B-cell activating factor (BAFF) receptor fully human monoclonal antibody, engineered for direct ADCC-mediated B-cell depletion. The drug is currently in Phase II stage of clinical trial evaluation to treat SLE. Ianalumab is also being studied in other Novartis-led trials in chronic lymphocytic leukemia, rheumatoid arthritis and Idiopathic pulmonary fibrosis among other indications.
LABP-104: Landos Biopharma Inc.
LABP-104 is an oral, systemically distributed, small-molecule therapeutic candidate which activates LANCL2, a surface membrane-associated receptor that is responsible for modulating key cellular and molecular changes tied to autoimmune diseases. LABP-104 is currently in clinical development for systemic lupus erythematosus (SLE) and rheumatoid arthritis (RA). To date, treatment with LABP-104 has reduced the production of interferon alpha in human PBMCs from SLE patients and provided protection from clinical disease and tissue pathology in mouse models of lupus. Landos has initiated a Phase 1 trial of LABP-104 in healthy volunteers for the treatment of SLE and RA.
Ex-204: Exinda Therapeutics
Ex-204 (Bendamustine oral) is an antineoplastic" or "cytotoxic drug. As per the company pipeline the Bendamustine oral is in preclinical stage for Systemic Lupus Erythematosus.
Systemic Lupus Erythematosus: Therapeutic Assessment
This segment of the report provides insights about the different Systemic Lupus Erythematosus drugs segregated based on following parameters that define the scope of the report, such as:
Major Players in Systemic Lupus Erythematosus
There are approx. 60+ key companies which are developing the therapies for Systemic Lupus Erythematosus. The companies which have their Systemic Lupus Erythematosus drug candidates in the most advanced stage, i.e. phase III include, Roche.
Phases
This report covers around 60+ 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
Systemic 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
- Intra-articular
- Intraocular
- Intrathecal
- Intravenous
- Ophthalmic
- Oral
- Parenteral
- Subcutaneous
- Topical
- Transdermal
- Molecule Type
Products have been categorized under various Molecule types such as
- Oligonucleotide
- Peptide
- Small molecule
- Product Type
The drugs have been categorized under various product types like Mono, Combination and Mono/Combination.
Systemic Lupus Erythematosus: Pipeline Development Activities
The report provides insights into different therapeutic candidates in phase II, I, preclinical and discovery stage. It also analyses Systemic Lupus Erythematosus 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 Systemic Lupus Erythematosus drugs.
Systemic Lupus Erythematosus Report Insights
- Systemic Lupus Erythematosus Pipeline Analysis
- Therapeutic Assessment
- Unmet Needs
- Impact of Drugs
Systemic Lupus Erythematosus Report Assessment
- Pipeline Product Profiles
- Therapeutic Assessment
- Pipeline Assessment
- Inactive drugs assessment
- Unmet Needs
Key Questions Answered
Current Treatment Scenario and Emerging Therapies:
- How many companies are developing Systemic Lupus Erythematosus drugs?
- How many Systemic Lupus Erythematosus drugs are developed by each company?
- How many emerging drugs are in mid-stage, and late-stage of development for the treatment of Systemic Lupus Erythematosus?
- What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, licensing activities related to the Systemic Lupus Erythematosus 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 Systemic Lupus Erythematosus and their status?
- What are the key designations that have been granted to the emerging drugs?
Key Players
- Roche
- ImmuPharma
- UCB
- Idorsia Pharmaceuticals
- Biogen
- Novartis
- Zenas Biopharma
- Horizon Therapeutics
- Provention Bio
- Janssen Research & Development
- AbbVie
- Medsenic
- Sanofi
- Amgen
- Pfizer
- Merck KGaA
- Resolve Therapeutics
- ILTOO
- Eli Lilly and Company
- Corbus Pharmaceuticals
- Corestem
- Bristol-Myers Squibb
- Alpine Immune Sciences
- Kezar Life Sciences
- Neovacs
- Kangpu Biopharmaceuticals
- InnoCare
- Eisai
- Boston Pharmaceuticals
Key Products
- Cenerimod
- BIIB059
- Ianalumab
- Obexelimab (XmAb5871)
- Daxdilimab (VIB7734)
- PRV-3279
- Nipocalimab
- ABBV 599
- NKTR-358 (LY3471851)
- Arscimed
- SAR441344
- Rozibafusp alfa
- Efavaleukin alfa
- PF-06700841
- Enpatoran
- RSLV-132
- Aldesleukin
- LY 3361237
- Lenabasum
- CS20AT04
- Daratumumab
- Iberdomide
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Table of Contents
IntroductionExecutive Summary
Systemic Lupus Erythematosus: Overview
- Causes
- Mechanism of Action
- Signs and Symptoms
- Diagnosis
- Disease Management
Pipeline Therapeutics
- Comparative Analysis
Therapeutic Assessment
- Assessment by Product Type
- Assessment by Stage and Product Type
- Assessment by Route of Administration
- Assessment by Stage and Route of Administration
- Assessment by Molecule Type
- Assessment by Stage and Molecule Type
Systemic Lupus Erythematosus- Analytical Perspective
Late Stage Products (Phase III)
- Comparative Analysis
- Product Description
- Research and Development
- Product Development Activities
Mid Stage Products (Phase II)
- Comparative Analysis
- Product Description
- Research and Development
- Product Development Activities
Early Stage Products (Phase I)
- Comparative Analysis
- Product Description
- Research and Development
- Product Development Activities
Preclinical and Discovery Stage Products
- Comparative Analysis
- Product Description
- Research and Development
- Product Development Activities
Inactive Products
- Comparative Analysis
Systemic Lupus Erythematosus Key Companies
Systemic Lupus Erythematosus Key Products
Systemic Lupus Erythematosus - Unmet Needs
Systemic Lupus Erythematosus - Market Drivers and Barriers
Systemic Lupus Erythematosus - Future Perspectives and Conclusion
Systemic Lupus Erythematosus Analyst Views
Systemic Lupus Erythematosus Key Companies
AppendixList of Tables
Table 1 Total Products for Systemic Lupus Erythematosus
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 ProductsList of Figures
Figure 1 Total Products for Systemic Lupus Erythematosus
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
Companies Mentioned
A selection of companies mentioned in this report includes:
- Roche
- ImmuPharma
- UCB
- Idorsia Pharmaceuticals
- Biogen
- Novartis
- Zenas Biopharma
- Horizon Therapeutics
- Provention Bio
- Janssen Research & Development
- AbbVie
- Medsenic
- Sanofi
- Amgen
- Pfizer
- Merck KGaA
- Resolve Therapeutics
- ILTOO
- Eli Lilly and Company
- Corbus Pharmaceuticals
- Corestem
- Bristol-Myers Squibb
- Alpine Immune Sciences
- Kezar Life Sciences
- Neovacs
- Kangpu Biopharmaceuticals
- InnoCare
- Eisai
- Boston Pharmaceuticals
