Novel Transdermal Curcumin (VAS-101) Improves Cardiac Mitochondrial Function in Sickle Cell Disease Mouse Model, New FDA Led Study Shows

SUMMIT, N.J., Dec. 3, 2025 /PRNewswire/ -- Vascarta Inc., is pleased to share results from a new study led by researchers at the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research (CBER), with scientists at the University of California, Irvine and Albert Einstein College of Medicine. The research demonstrates that Vascarta's proprietary transdermal curcumin formulation (VAS-101) reduces oxidative stress and improves cardiac mitochondrial bioenergetics in a humanized mouse model of sickle cell disease (SCD).

Sickle cell disease is associated with chronic oxidative stress, hemolysis, inflammation, and progressive multi‑organ injury, including significant cardiopulmonary complications. Mitochondrial dysfunction is increasingly recognized as a key driver of these pathologies.

In this study, investigators evaluated cardiac muscle mitochondria from Berkeley sickle mice (BERK‑SS), a well‑established SCD model expressing >99% human hemoglobin S. The researchers found that BERK‑SS mice exhibit impaired mitochondrial respiration, reduced activity of electron transport chain (ETC) complexes - particularly complex I and complex V - and elevated oxidative stress markers in cardiac tissue.

Published Manuscript here.

Key findings from the study include:

• Cardiac mitochondrial dysfunction in SCD: BERK‑SS mice demonstrated reduced oxygen consumption, impaired ETC activity, and disruptions across mitochondrial proteomic pathways, including oxidative phosphorylation, lipid metabolism, calcium regulation, and mitophagy.
  
  
• Elevated oxidative stress: Sickle mice showed significant increases in lipid peroxidation (4‑HNE), protein carbonylation, antioxidant enzymes, and mitochondrial HO‑1 hallmarks of hemoglobin‑ and heme‑driven oxidative injury.
  
  
• Treatment with VAS‑101 for 21 days reduced oxidative stress markers and partially restored mitochondrial bioenergetics. Notably, complex I enzymatic activity and abundance of multiple complex I subunits improved following treatment in this validated SCD model.
  
  
• Proteomic normalization: VAS‑101 reversed or mitigated abnormalities in mitochondrial proteins involved in β‑oxidation, glycolysis, membrane dynamics, calcium handling, and mitophagy, indicating broad mitochondrial protective effects in this validated SCD model.

Dr. Joel Friedman, inventor of VAS-101 and CSO of Vascarta Inc., stated: "These findings highlight mitochondrial dysfunction as a critical component of cardiac pathology in sickle cell disease and demonstrate that transdermal curcumin may help restore mitochondrial homeostasis by reducing oxidative stress and supporting electron transport chain activity, VAS‑101 may represent a promising therapeutic approach for addressing cardiopulmonary complications in SCD."

These findings build on earlier work showing that VAS‑101 reduces hemolysis, oxidative injury, inflammatory cytokines, mast cell activation and pain behaviors in this same SCD mouse model while achieving improved bioavailability and enhanced efficacy through transdermal delivery. This research adds to growing evidence that multi‑target antioxidant strategies such as transdermal curcumin can address key drivers of disease progression in sickle cell patients.

About Vascarta

Vascarta Inc. is a healthspan‑focused, clinical‑stage pharmaceutical company working to improve lives by developing first‑in‑class, safe, and effective treatments to reduce chronic pain and inflammation. Vascarta's proprietary drug delivery platform supports a growing pipeline of therapies targeting inflammatory diseases and cancer. The lead candidate, Vasceptor^® (VAS‑101), is a topically applied transdermal formulation that utilizes curcumin as its active pharmaceutical ingredient. The transdermal route significantly enhances curcumin's pleiotropic properties, including potent anti‑inflammatory activity, targeted nitric oxide release, analgesia, red blood cell stabilization, and multiple neuroprotective mechanisms. By bypassing the gastrointestinal tract and liver and delivering curcumin directly into systemic circulation, VAS‑101 appears to achieve therapeutic efficacy previously unattainable through oral formulations.

The company is advancing VAS‑101 following a positive Phase I clinical trial in osteoarthritis. It is also being clinically studied in sickle cell disease by the NIH and pre-clinically as a method to prevent and reduce neuro-inflammation resulting from cancer treatments.

Vascarta is actively pursuing Series A financing and strategic partnerships to advance the pipeline for commercialization. For more about Vascarta, please visit www.vascarta.com or follow the company on LinkedIn.

Contacts for further information:

Dr. Richard Prince, Chairman, CEO & President – [email protected]

Mr. David Hymson, Communications – [email protected]

SOURCE Vascarta Inc