Drugs / Exosome
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | DMD-related muscular dystrophy | — | “IND filed to investigate CDC-exosomes in patients with DMD (April 2020)” capricor.com ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07192666 | Sep 2025 → Sep 2026 overdue | Sjogren syndrome | Guangdong ProCapZoom Biosciences Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05813379 | Feb 2022 → Jul 2023 | — | Isfahan University of Medical Sciences | Unknown | No outcome recorded |
| Phase 1/2 | NCT03384433 | Apr 2019 → Jun 2021 | cerebrovascular disorder | Isfahan University of Medical Sciences | Unknown | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07319533 | Jan 2026 → Jan 2027 expected | vasculogenic impotence | Labbafinejad Medical Center | Not yet recruiting | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT06391307 | May → Nov 2024 | pilonidal sinus | Mustafa Azizoğlu | Unknown | No outcome recorded |
| — | NCT06466850 | Jan 2024 → Dec 2026 expected | osteoarthritis, knee | Isfahan University of Medical Sciences | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2026-05-13 | BioRestorative Therapies | Results BioRestorative Therapies Presents New Preclinical Data at ISCT 2026 Highlighting Source-Specific Exosome Functionality and Commercial Applications in BioCosmeceuticals biorestorative.com ↗ |
| 2025-11-24 | Capricor Inc. | Results Capricor Therapeutics Presents New Data Demonstrating a Scalable Framework for Loading Therapeutic Oligonucleotides into Exosomes at AAEV 2025 capricor.com ↗
Engineered exosomes derived from 293F cells were successfully loaded with therapeutic siRNA and PMO cargo using optimized electroporation conditions. |
| 2024-12-17 | Aposcience AG | Results Paper on content analysis of APOSEC recently published aposcience.at ↗
Subsequently, in vitro assays showed that the exosome and protein fractions of irradiated and non-irradiated PBMC secretome were the major biological components that enhanced cell mobility; conversely, secreted lipids and microparticles had no effects. |
| 2024-11-12 | Capricor Inc. | Results Capricor Therapeutics to Present Exosome Platform Updates at 2024 American Association of Extracellular Vesicles Annual Meeting capricor.com ↗
The findings highlight a potential exosome-based approach for the treatment of Duchenne muscular dystrophy (DMD) by delivering phosphorodiamidate morpholino oligomers (PMOs). |
| 2024-02-15 | Merakris Therapeutics | Results A New Frontier in Healing Chronic Wounds: A Breakthrough Injectable Therapy merakris.com ↗
The model demonstrates closure initiation in exosome-containing models, with limited closure in exosome-depleted amniotic fluid models. |
| 2023-05-16 | Kimera Labs Inc. | Regulatory Kimera® Labs Receives FDA Phase I/IIa IND Clearance For Its MSC Exosomes Human Study kimeralabs.com ↗
Kimera® Labs Inc., the first and leading worldwide MSC exosome research lab and producer, is pleased to announce the FDA IND (Investigational New Drug) approval of its exosomes in a Phase I/IIa clinical trial. |
| 2022-06-23 | Coya Therapeutics | Results Coya Therapeutics Announces Peer-Reviewed Publication of its First- in-Class Regulatory T cell derived Exosomes and Their Therapeutic Potential in Neurodegeneration and Inflammation-Related Diseases coyatherapeutics.com ↗
Characterization of Treg-derived exosomes show Treg cells-conserved functional moieties and demonstrate potent immunomodulatory function on pro-inflammatory myeloid cells and T cell proliferation, while also showing anti-inflammatory function in multiple in vivo pre-clinical disease models |
| 2022-05-04 | Brainstorm-Cell Therapeutics | Results BrainStorm Announces Presentation of NurOwn® Exosome Preclinical Data at ISCT 2022 San Francisco Meeting brainstorm-cell.com ↗
NurOwn-derived exosomes showed more potent anti-inflammatory effects in vitro compared to naïve mesenchymal stem cell-derived exosomes |
| 2021-08-04 | Capricor Inc. | Results Capricor Announces Joint Publication with the US Army Institute of Surgical Research for Cardiosphere-Derived Exosomes as a Potential Therapeutic for Shock capricor.com ↗
announced today the publication, of a manuscript, which shows that cardiosphere-derived exosomes (CDC-EVs) can attenuate kidney damage and promote new blood vessel formation in a preclinical model of acute trauma, both of which are important factors in post-shock recovery. |
| 2021-05-18 | Capricor Inc. | Results Capricor To Present Preclinical Data for Exosome-mRNA Vaccine for SARS-CoV-2 at the International Society for Extracellular Vesicles (ISEV) Annual Meeting capricor.com ↗
These data demonstrated that our exosome-based, multivalent mRNA vaccine elicited long-lasting cellular and humoral responses to both the N and S proteins. |
| 2021-03-09 | Capricor Inc. | Results Capricor Therapeutics Announces New Advances in Exosome-Mediated mRNA Delivery Platform capricor.com ↗
The data demonstrated functional RNA expression in vivo further showing the power of our exosome platform to potentially expand into areas beyond SARS-CoV-2. |
| 2021-01-19 | Capricor Inc. | Results Capricor Therapeutics Announces Publication Demonstrating Methods for Enhanced Potency of Cardiosphere-Derived Exosomes capricor.com ↗
Activation of canonical Wnt signaling correlated with increased enrichment of therapeutically relevant miRs including miR-22 and miR-146a both implicated in cell potency |
| 2020-11-09 | Capricor Inc. | Results Capricor Therapeutics Announces Positive Preclinical Data for Multivalent Exosome-mRNA Vaccine For COVID-19 capricor.com ↗
Capricor Therapeutics, Inc. (NASDAQ: CAPR), a clinical-stage biotechnology company focused on the discovery, development and commercialization of first-in-class cell- and exosome-based therapeutics for the treatment and prevention of a variety of diseases and disorders, in collaboration with researchers at Johns Hopkins University, announced today that positive data from a preclinical study for a multivalent exosome-based mRNA vaccine for COVID-19 has been posted on the bioRxiv preprint server and will be submitted for publication. |
| 2018-11-08 | Capricor Inc. | Results Capricor Therapeutics to Present Corporate Overview and Poster at Action Duchenne International Conference capricor.com ↗
Research Found Exosomes Increased Exercise Capabilities and Muscle Activity in a Mouse Model of Duchenne Muscular Dystrophy |
| 2018-10-03 | Capricor Inc. | Results Capricor Therapeutics to Present at 2018 Cell & Gene Meeting on the Mesa capricor.com ↗
In addition, during the three-day conference in La Jolla, CA, Capricor will provide a poster presentation on a pre-clinical study which found that extracellular vesicles, or exosomes, were the active component of CAP-1002. |
| 2018-08-21 | Capricor Inc. | Results Capricor Therapeutics Presents Results of Studies of CAP-2003 at Gordon Research Conference on Extracellular Vesicles capricor.com ↗
The studies further demonstrate that exosomes may be the active pharmaceutical ingredient (API) in CAP-1002, our cell therapy product, because these extracellular vesicles serve as cellular-messengers, altering function and physiology to balance inflammation so that cellular repair can be facilitated. |
| 2018-06-28 | Capricor Inc. | Results Capricor Therapeutics to Present at PPMD Annual Conference capricor.com ↗
Capricor will also provide a poster presentation that will report pre-clinical data demonstrating the immunomodulatory capability of the company’s exosome product, CAP-2003, and the ability of this product to improve exercise capabilities in mdx mice after systemic administration. |
| 2018-05-03 | Capricor Inc. | Results Capricor to Present on Exosomes at the Plenary Session of the International Society for Cellular Therapy in Montreal capricor.com ↗
The data support our assertions that CDC exosomes are different from MSC exosomes – that CDC exosomes are packed with specific RNAs and proteins, which drive their potency in treating inflammation and fibrosis. |
All press releases naming this drug 18 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 6 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | exosome | “The Exosome will be injected into each standardized injection point in a superficial manner.” NCT05813379 ↗ |
| Known as | MSC-Derived Exosome | “The goal of this clinical trial is to Investigate the Effect of Injection of MSC-Derived Exosome on Patients with Erectile Dysfunction” NCT07319533 ↗ |
| Modality | Other / unclassified | “Administration of cell-free exosomes derived from mesenchymal stem cell (MSCs) can be sufficient to exert therapeutic effects of intact MSCs after brain injury” NCT03384433 ↗ |
| Route | Other | “via Stereotaxis/Intraparanchymal” NCT03384433 ↗ |