Exosomes Clinical Trials and Studies: EMA, PDMA, FDA Approvals, Mechanism of Action, ROA, NDA, IND, and Companies

DelveInsight's, "Exosomes Pipeline Insight 2025" report provides comprehensive insights about 70+ companies and 75+ pipeline drugs in Exosomes 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.

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Key Takeaways from the Exosomes Pipeline Report

* In February 2025, Aegle Therapeutics announced a trial is a prospective, open label, randomized, multi-center study, with intra-subject paired- wound control, intended to assess the safety and preliminary efficacy of administering EVs derived from allogeneic MSCs to 10-50 cm2 wounds in RDEB subjects with wounds persisting for at least four weeks.
* DelveInsight's Exosomes pipeline report depicts a robust space with 70+ active players working to develop 75+ pipeline therapies for Exosomes treatment.
* The leading Exosomes Companies such as Capricor Therapeutics, Regeneus, Aegle Therapeutics, Innovex Therapeutics, Coya Therapeutics, EV Therapeutics, StemXO Therapeutics, Brexogen, ILIAS Biologics, Organicell Regenerative Medicine, Codiak BioSciences, Direct Biologics , and others.
* Promsiing Exosomes therapies such as Anlotinib, AGLE 102, TISSEEL , and others.

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Exosomes Emerging Drugs Profile

* CAP-1002: Capricor

Capricor's (CAP-1002) is based on cardiosphere-derived cells, or CDCs, a cardiac-derived cell therapy that was first identified in the academic laboratory of Capricor's scientific founder, Dr. Eduardo Marban. CDCs have been the subject of over 100 peer-reviewed scientific publications and have been administered to over 200 human subjects across several clinical trials. CAP-1002 contains cardiosphere-derived cells, a type of heart cell progenitor, or precursor cell, that secretes tiny vesicles called exosomes. These exosomes then modulate the activity of the immune system and stimulate cellular regeneration. It is being investigated for its potential to modify the immune system's activity to encourage cellular regeneration. The cells function by releasing exosomes that are taken up largely by macrophages and T-cells and begin a cycle of repair. Currently, the drug is in Phase III stage of its development for the treatment of Duchenne Muscular Dystrophy.

* Progenza: Regeneus

Progenza is an off-the-shelf allogeneic stem cell product with the first targeted treatment being for knee osteoarthritis. The product is produced from mesenchymal stem cells (MSCs) from adipose (fat) tissue from a healthy donor who has been extensively screened. Progenza includes secretions from donor MSCs that improves viability and functionality of the cells after freezing. Adipose tissue is readily available from donors in large quantities and has significantly higher MSCs per gram of tissue than other tissue sources such as bone marrow or cord tissue. Adipose derived MSCs also have the added advantage of showing greater capacity for expansion than MSCs from other tissue types. The MSCs are expanded through the company's proprietary and scalable manufacturing process. The company has demonstrated the capacity to produce millions of therapeutic doses of Progenza from a single donor. When Progenza cells are injected into the damaged joint or tissue, the MSCs have the potential to reduce pain and inflammation and slow the progression of disease. Currently, the drug is in Phase II stage of Clinical trial evaluation for the treatment of Osteoarthritis.

* AGLE 102: Aegle Therapeutics

AGLE-102 contains COL7 protein as well as COL7A1 mRNA, which in preclinical models stimulates recessive DEB cells (cannot make any COL7) to produce COL7. AGLE-102 has the potential to induce functional regeneration and organization of complex tissue structures in DEB and EB patients that can potentially accelerate and enhance healing, reduce scarring, and improve overall cosmesis. In addition, AGLE-102 is non-immunogenic and carries the immunomodulating and anti-inflammatory properties of MSCs. Aegle's Phase I/II clinical trial involving AGLE-102 in individuals living with Recessive Dystrophic Epidermolysis Bullosa (RDEB) is now open for enrollment. Currently, the drug is in Phase I/II stage of its development for the treatment of Dystrophic Epidermolysis Bullosa.

The Exosomes Pipeline Report Provides Insights into

* The report provides detailed insights about companies that are developing therapies for the treatment of Exosomes with aggregate therapies developed by each company for the same.
* It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Exosomes Treatment.
* Exosomes Companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects.
* Exosomes Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type.
* Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Exosomes market

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Exosomes Companies

Capricor Therapeutics, Regeneus, Aegle Therapeutics, Innovex Therapeutics, Coya Therapeutics, EV Therapeutics, StemXO Therapeutics, Brexogen, ILIAS Biologics, Organicell Regenerative Medicine, Codiak BioSciences, Direct Biologics, and others.

Exosomes pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration

* Oral
* Intravenous
* Subcutaneous
* Parenteral
* Topical

Exosomes Products have been categorized under various Molecule types such as

* Recombinant fusion proteins
* Small molecule
* Monoclonal antibody
* Peptide
* Polymer
* Gene therapy

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Scope of the Exosomes Pipeline Report

* Coverage- Global
* Exosomes Companies- Capricor Therapeutics, Regeneus, Aegle Therapeutics, Innovex Therapeutics, Coya Therapeutics, EV Therapeutics, StemXO Therapeutics, Brexogen, ILIAS Biologics, Organicell Regenerative Medicine, Codiak BioSciences, Direct Biologics , and others.
* Exosomes therapies- Anlotinib, AGLE 102, TISSEEL, and others.
* Exosomes Therapeutic Assessment by Product Type: Mono, Combination, Mono/Combination
* Exosomes Therapeutic Assessment by Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III

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Table of Content

* Introduction
* Executive Summary
* Exosomes : Overview
* Pipeline Therapeutics
* Therapeutic Assessment
* Exosomes - DelveInsight's Analytical Perspective
* Late Stage Products (Phase III)
* CAP-1002: Capricor Therapeutics
* Drug profiles in the detailed report.....
* Mid Stage Products (Phase II)
* Progenza: Regeneus
* Drug profiles in the detailed report.....
* Early Stage Products (Phase I/II)
* AGLE 102: Aegle Therapeutics
* Drug profiles in the detailed report.....
* Preclinical and Discovery Stage Products
* Drug Name: Company Name
* Drug profiles in the detailed report.....
* Inactive Products
* Exosomes Key Companies
* Exosomes Key Products
* Exosomes - Unmet Needs
* Exosomes - Market Drivers and Barriers
* Exosomes - Future Perspectives and Conclusion
* Exosomes Analyst Views
* Exosomes Key Companies
* Appendix

About Us

DelveInsight is a leading healthcare-focused market research and consulting firm that provides clients with high-quality market intelligence and analysis to support informed business decisions. With a team of experienced industry experts and a deep understanding of the life sciences and healthcare sectors, we offer customized research solutions and insights to clients across the globe. Connect with us to get high-quality, accurate, and real-time intelligence to stay ahead of the growth curve.

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