Summit, New Jersey, August 20, 2026
Vascarta Inc. has announced the initiation of a Phase I clinical study of VAS-101 (Vasceptor®), a topical curcumin-based drug candidate being evaluated in people with sickle cell disease (SCD). The study is being conducted at the National Institutes of Health (NIH) Clinical Center and is designed to evaluate the safety and tolerability of escalating doses of VAS-101 in individuals with stable SCD. The program represents another step in the development of a potentially non-opioid approach for addressing pain, inflammation and other disease-related complications associated with sickle cell disease.
NIH Study Evaluates Safety and Tolerability
The Phase I study, titled A Phase 1 Study to Evaluate the Safety and Tolerability of Escalating Doses of VAS-101 in Subjects with Stable Sickle Cell Disease, is being led by Dr. Swee Lay Thein, Chief of the Sickle Cell Branch and Laboratory of Sickle Cell Genetics and Pathophysiology at the National Heart, Lung, and Blood Institute. Participants will receive progressively increasing doses of VAS-101 over the treatment period, allowing researchers to assess safety, tolerability and selected laboratory biomarkers. The study uses 0.2 mL of VAS-101 twice weekly for two weeks, followed by 0.4 mL twice weekly for two weeks and then 0.6 mL twice weekly for two weeks. Participants will subsequently undergo follow-up monitoring, with the complete study expected to span approximately 14 weeks from screening through follow-up.
Transdermal Curcumin Approach Targets SCD Challenges
VAS-101 is an 8.5% curcuminoid transdermal gel developed using Vascarta’s Curcugen® formulation and Vasporta™ transdermal delivery technology. The approach is designed to improve the bioavailability of curcuminoids while allowing the treatment to be applied topically. According to Vascarta, the investigational therapy is being developed to address biological processes associated with red blood cell instability, neuro-inflammation and vascular inflammation in sickle cell disease. The company is investigating whether this delivery approach can potentially provide therapeutic effects while reducing reliance on conventional pain medications. VAS-101 has previously been evaluated in a Phase I study using sublingual administration, with the company reporting safety and tolerability findings as well as changes in patient-reported and red blood cell-related biomarkers. The current NIH study is intended to further investigate the transdermal formulation and establish dose-related safety information in people with stable SCD.
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Sickle Cell Disease Creates Significant Treatment Needs
Sickle cell disease is a genetic blood disorder caused by a mutation affecting the beta-globin gene, resulting in the production of abnormal hemoglobin and the formation of sickled red blood cells. These cells can contribute to anemia, inflammation, vascular complications, organ damage and episodes of severe pain. Pain crises are among the most prominent complications of SCD, and managing recurrent pain can require multiple medications, including analgesics that may carry significant limitations. Vascarta is developing VAS-101 as a potential non-opioid therapeutic approach that could address some of the inflammatory and cellular mechanisms associated with SCD. However, the current Phase I study is primarily designed to establish safety and tolerability, and the potential clinical effectiveness of VAS-101 remains investigational. The company says biomarkers associated with efficacy will also be assessed at specific study timepoints at the NIH Clinical Center.The development program is being supported by Vascarta’s broader focus on transdermal pharmaceutical delivery technologies for inflammatory and pain-related conditions. The company is initially concentrating its development efforts on sickle cell disease and osteoarthritis. VAS-101 was invented by Dr. Joel Friedman and is exclusively licensed to Vascarta from the Albert Einstein College of Medicine.
Source: Vascarta press relese
