DelveInsight’s ‘Scleroderma Pipeline Insights’ report lays down a holistic coverage of the available therapies, Scleroderma pipeline therapies in different developmental phases of clinical trials, key companies active in the Scleroderma pipeline domain, driving factors and restraints in the commercial launch of the Scleroderma pipeline therapies, and future trends.
Some of the key highlights from the Scleroderma Pipeline report:
- DelveInsight’s analysis depicts a robust Scleroderma Pipeline with 50+ active players in the domain working on 50+ pipeline therapies.
- Key Scleroderma pipeline therapies such as Lenabasum, EHP 101, FT011, Belumosudil, Guselkumab, ECCS 50, KHK4827, SAR156597, Treprostinil, HZN-825, GS-248, Brentuximab Vedotin, C21, ARG201, Belumosudil, CAM2043, Tofacitinib, Sarilumab, FCX 013, VIB7734, AVID200 and others are under evaluation in different phases of clinical trials for the treatment of Scleroderma.
- Corbus Pharmaceuticals, Emerald Health Pharmaceuticals, Gesynta Pharma, Formation Biologics, Fibrocell Science, CSL Behring, ChemomAb, Luminary Therapeutics, Certa Therapeutics, Kadmon Corporation, Janssen Pharmaceutical, Horizon Therapeutics, Acceleron Pharma, Tvardi Therapeutics, BriaCell Therapeutics, Blade Therapeutics, Biosplice Therapeutics, AnaMar, Immunemed, Viela Bio among several others are key prominent pharma companies working in the domain.
- In January 2021, Timber Pharmaceuticals received Orphan Drug Designation from U.S. FDA for TMB-003 for the Treatment of Systemic Sclerosis.
- CiVi 030 is an intravenous formulation of iloprost, 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). CiVi 030 received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of Systemic Sclerosis (SSc).
- In April 2020, Horizon Therapeutics announced that it had acquired Curzion Pharmaceuticals and its development-stage oral selective lysophosphatidic acid 1 receptor (LPAR1) antagonist, CZN001 (renamed HZN-825), for the treatment of Systemic Sclerosis.
- FCX-013 is being developed as a disease-modifying, autologous cell-based gene therapy that utilizes lentiviral vectors to deliver functional matrix metalloproteinase 1 genes (MMP-1) to patients with moderate to severe localized Scleroderma.
- The U. S. Food and Drug Administration has granted Orphan Drug designation to FCX-013 for the treatment of localized Scleroderma. In addition, FCX-013 has been granted Rare Pediatric Disease designation and Fast Track designation for the treatment of moderate to severe localized Scleroderma.
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The Scleroderma Pipeline report comprises detailed information on ongoing clinical trials, deals, mergers & acquisitions taking place in the domain, recent approvals and failures in space, and growth prospects across the Scleroderma domain.
Scleroderma Overview
Scleroderma is a group of rare diseases that leads to the hardening and tightening of the skin and connective tissues. There are 2 major types of Scleroderma: Localized Scleroderma that affects the skin and Systemic Scleroderma that affects blood circulation and internal organs as well as the skin. The condition appears to affect women more as compared to men. At present, there exists no cure for the disease; however, there are symptomatic treatment approaches available.
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Scleroderma Pipeline Drugs
Drug |
Company |
Phase |
MoA |
RoA |
Lenabasum |
Corbus Pharmaceuticals |
III |
Cannabinoid receptor CB2 agonists |
Oral |
Iloprost |
Eicos Sciences |
III |
Epoprostenol agonists |
Intravenous |
KHK4827 |
Kyowa Kirin |
III |
Interleukin 17 receptor antagonists |
Subcutaneous |
ECCS-50 |
Cytori therapeutics |
III |
Cell replacements |
Subcutaneous |
EHP 101 |
Emerald Health Pharmaceuticals |
II |
Cannabinoid receptor CB2 agonists; Endothelial PAS domain-containing protein 1 inhibitors; Hypoxia-inducible factor 1 inhibitors; Peroxisome proliferator-activated receptor-gamma agonists |
Oral |
FT011 |
Certa Therapeutics |
II |
Platelet-derived growth factor inhibitors |
Oral |
Belumosudil |
Kadmon Corporation |
II |
Rho-associated kinase inhibitors |
Oral |
Guselkumab |
Janssen Pharmaceutical |
II |
Interleukin-23 subunit p19 inhibitors |
Intravenous, Subcutaneous |
FCX 013 |
Castle Creek Biosciences |
I/II |
Gene transference; Matrix metalloproteinase 1 replacements |
Intradermal |
VIB7734 |
Viela Bio |
I |
Dendritic cell inhibitors |
NA |
CM-101 |
Chemomab Therapeutics |
I |
Chemokine CCL24 inhibitors |
Intravenous |
AM1476 |
AnaMar |
I |
Serotonin 2B receptor antagonists |
Oral |
LMY-920 |
Luminary Therapeutics |
Preclinical |
Immunologic cytotoxicity; T lymphocyte replacements |
Parenteral |
CAN-10 |
Cantargia |
Preclinical |
Interleukin 1 inhibitors; Interleukin-33 inhibitors |
NA |
hzVSF v13 |
ImmuneMed |
Discovery |
Immunomodulators; Virus replication inhibitors |
NA |
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Scleroderma Therapeutics Assessment
The Scleroderma Pipeline report proffers an integral view of the Scleroderma emerging novel therapies segmented by Stage, Product Type, Route of Administration, Molecule Type, Target, and Mechanism of Action.
By Product Type
- Mono
- Combination
By Stage
- Discovery
- Pre-clinical
- Phase I
- Phase II
- Phase III
By Molecule Type
- Monoclonal Antibody
- Peptides
- Polymer
- Small molecule
- Gene therapy
By Route of Administration
- Oral
- Parenteral
- Subcutaneous
- Intravenous
- Intradermal
- Topical
By Mechanism of Action
- Collagen inhibitors; Cytokine inhibitors
- Dendritic cell inhibitors
- Serotonin 2B receptor antagonists
- Chemokine CCL24 inhibitors
- Platelet-derived growth factor inhibitors
- Gene transference; Matrix metalloproteinase 1 replacement
- Cell replacements
- Interleukin 1 inhibitors; Interleukin-33 inhibitors
By Targets
- Proteins
- Replication pathways
Scope of the Scleroderma Drug Pipeline Report
Coverage: Global
Key Players: Corbus Pharmaceuticals, Emerald Health Pharmaceuticals, Gesynta Pharma, Formation Biologics, Fibrocell Science, CSL Behring, ChemomAb, Luminary Therapeutics, Certa Therapeutics, Kadmon Corporation, Janssen Pharmaceutical, Horizon Therapeutics, Acceleron Pharma, Tvardi Therapeutics, BriaCell Therapeutics, Blade Therapeutics, Biosplice Therapeutics, AnaMar, Immunemed, Viela Bio among others.
Key Scleroderma Pipeline Therapies: Lenabasum, EHP 101, FT011, Belumosudil, Guselkumab, ECCS 50, KHK4827, SAR156597, Treprostinil, HZN-825, GS-248, Brentuximab Vedotin, C21, ARG201, Belumosudil, CAM2043, Tofacitinib, Sarilumab, FCX 013, VIB7734, AVID200 and several others.
Table of Contents
1 |
Report Introduction |
2 |
Executive Summary |
3 |
Scleroderma Disease Overview |
4 |
Scleroderma Pipeline Therapeutics Comparative Analysis |
5 |
Scleroderma Therapeutic Assessment |
6 |
In-depth Commercial Assessment |
7 |
Scleroderma – DelveInsight’s Analytical Perspective |
8 |
In-depth Commercial Scleroderma Assessment |
9 |
Scleroderma Collaboration Deals |
10 |
Late Stage Scleroderma Products (Phase III) |
10.1 |
Lenabasum: Corbus Pharmaceuticals |
11 |
Mid-Stage Scleroderma Products (Phase II) |
11.1 |
EHP 101: Emerald Health Pharmaceuticals |
12 |
Early Stage Scleroderma Products (Phase I) |
12.1 |
VIB7734: Viela Bio |
13 |
Pre-clinical and Discovery Stage Scleroderma Products |
13.1 |
LMY-920: Luminary Therapeutics |
14 |
Inactive Scleroderma Pipeline Products |
15 |
Key Scleroderma Products |
16 |
Unmet Needs |
17 |
Scleroderma Market Drivers and Barriers |
18 |
Future Perspectives and Conclusion |
19 |
Analyst Views |
20 |
Key Scleroderma Companies |
21 |
Appendix |
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