Vasceptor (topical curcumin gel) / Vascarta - LARVOL DELTA

Healing potential of curcumin gel in experimental wounds infected with resistant Pseudomonas aeruginosa: a comparative study with silver sulfadiazine. (PubMed, Naunyn Schmiedebergs Arch Pharmacol) - "This study compared the therapeutic efficacy of a topical curcumin gel with 1% SSD cream in MDR P. aeruginosa-infected excision wounds in rabbits. Epithelial thickness in the curcumin group (40.20 µm) was statistically similar to SSD (39.74 µm) and superior to controls. Overall, curcumin gel demonstrated potent antibacterial activity, superior early wound healing kinetics, effective immunomodulation, and complete tissue restoration, highlighting its preclinical potential as a biocompatible and efficacious alternative to SSD for MDR-infected wounds, warranting further clinical validation."

Journal • Immunology • Inflammation

Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease (clinicaltrials.gov) - P1 | N=25 | Recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Enrolling by invitation ➔ Recruiting

Enrollment status • Anemia • Genetic Disorders • Hematological Disorders • Sickle Cell Disease

Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease (clinicaltrials.gov) - P1 | N=25 | Enrolling by invitation | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Anemia • Genetic Disorders • Hematological Disorders • Sickle Cell Disease

Escalating Doses of VAS-101 in Subjects With Stable Sickle Cell Disease (clinicaltrials.gov) - P1 | N=25 | Not yet recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

New P1 trial • Anemia • Genetic Disorders • Hematological Disorders • Sickle Cell Disease

The effect of a topical curcumin formulation (VAS-101) on knee pain in adults with knee osteoarthritis: a randomised, double-blind, placebo-controlled study. (PubMed, Front Pain Res (Lausanne)) - "Conservative dosing of a topically applied curcumin-containing gel (VAS-101), administered every two days for 28 days, is associated with moderate reductions in knee pain in adults with knee osteoarthritis. Further investigations utilising larger sample sizes, longer treatment durations, and alternative treatment regimens will be important to identify how these factors affect treatment adherence, tolerance, and efficacy."

Journal • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

A novel transdermal curcumin gel shows potential in improving cardiac bioenergetic functions in Berkeley sickle cell mice. (PubMed, Blood Vessel Thromb Hemost) - "Here, we investigated the bioenergetic impairment in cardiac mitochondria as well as the putative benefits of a transdermal (TD) curcumin (VAS-101) treatment in a Berkeley SCD (BERK-SS) mouse model...Moreover, TD curcumin treatment caused improvements in various oxidative stress parameters in heart tissues of BERK-SS mice. Together, our results suggest that novel TD curcumin may affect oxygen homeostasis at cellular and subcellular levels by improving mitochondrial respiration in the heart muscle of BERK-SS mice."

Journal • Preclinical • Genetic Disorders • Hematological Disorders • Sickle Cell Disease

Efficacy of Topical Coenzyme Q10 and Curcumin for Oral Leukoplakia Treatment (clinicaltrials.gov) - P=N/A | N=34 | Recruiting | Sponsor: Alexandria University

New trial

The effect of a topical curcumin formulation (VAS101) on knee pain in adults with knee osteoarthritis (ANZCTR) - P=N/A | N=60 | Completed | Sponsor: Clinical Research Australia | Recruiting ➔ Completed

Trial completion • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Mechanisms of acute pain involve spinal IL17-TNF-α/IL-6–p38 MAPK activation in sickle cell disease (ASH 2025) - "We nextexamined if the novel transdermal curcumin (TDC; Vasceptor, Vascarta Inc.), which reduced inflammationand oxidative stress in sickle mice in the periphery (Goel et al., PNAS nexus 2025), has the potential toinhibit spinal inflammation, oxidative stress, and p38 phosphorylation...Since p38 is activated by cytokines and is also involved in the transcriptional regulation ofcytokines, leading to oxidative stress, we next examined if TDC or inhibition of p38 with neflamapimod(Nef) would prevent hypoxia-induced oxidative stress in a sickle microenvironment in the peripheral andCNS...We conclude that IL-17 orchestrates acute pain bypromoting IL-17-TNF-α/IL-6–p38 cascade in the CNS and periphery, leading to oxidative stress andmitochondrial dysfunction in sensory neurons. TDC interrupts this SCD pathophysiological cascade,suggestive of a preventive effect on acute pain episodes in SCD."

Genetic Disorders • Hematological Disorders • Metabolic Disorders • Musculoskeletal Diseases • Pain • Sickle Cell Disease • IL17A • IL6 • TNFA

Mechanism-Based Targeting of Sickle Cell Pathobiology and Pain with Novel Transdermal Curcumin (ASH 2023) - "TDC gel (VasceptorTM, Vascarta Inc.), containing 0.1 M of curcuminoids (derived from Curcugen, Dolcas-Biotech, LLC), or vehicle were applied (0.1 mL) topically by gentle rubbing to the abdomen on alternating days for 3 weeks followed by analysis of blood, organ pathology and skin secretome...TDC significantly ameliorates hyperalgesia (chronic pain), inflammation, hemolysis, oxidative stress, and organ damage and improves mitochondrial function and hematological parameters of SCD pathobiology, indicative of disease modifying and anti-nociceptive effects. The results suggest if started early in life, the use of an easy-to-deploy novel TDC formulation, with increased bioavailability and non-toxic properties that directly target sickle cell pathobiology, may prevent chronic pain in SCD."

Genetic Disorders • Hematological Disorders • Inflammation • Neuralgia • Pain • Sickle Cell Disease • CCL2 • CSF2 • IFNG

Mechanism-Based Treatable Targets for Organ Damage and Pain in Sickle Cell Disease (ASH 2024) - "TDC gel (Vasceptor®, Vascarta Inc.), containing 0.1 M of curcuminoids, or vehicle, were applied (0.1 mL) topically by gentle rubbing to the abdomen on alternating days for 3 wks followed by analysis of organs...The ease of topical application, affordability and a high safety profile suggest that TDC may be a novel treatment option for SCD patients, including children, globally. This presentation reflects the views of the authors and should not be construed to represent FDA's views or policies."

Genetic Disorders • Hematological Disorders • Inflammation • Neuralgia • Pain • Sickle Cell Disease • DLG4 • TNFA

Vascarta Inc: Transdermal Curcumin (VAS-101 Drug Candidate) Interrupts the Neuroinflammatory Pathophysiological Cascade Associated with Acute Sickle Cell Crisis (PRNewswire) - "New findings demonstrating a reversal in acute vaso-occlusive pain in sickle cell disease by a novel transdermal curcumin gel formulation to be presented at the 67th Annual American Society of Hematology meeting in Orlando....Anti-IL-17A antibodies administered intrathecally prior to inciting hypoxia/reoxygenation (H/R) significantly reduced mechanical, thermal, and musculoskeletal hyperalgesia compared to vehicle treated sickle mice....Mice treated with daily VAS-101 for two weeks showed lowered mechanical and cold sensitivity post H/R versus vehicle treated mice. They also exhibited significantly increased grip strength."

Preclinical • Sickle Cell Disease

Vascarta Receives FDA Orphan Drug Designation for Vasceptor in the Treatment of Sickle Cell Disease (PRNewswire) - "Vascarta Inc...announced today that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead drug candidate, Vasceptor (VAS-101), for the treatment of Sickle Cell Disease (SCD)."

Orphan drug • Sickle Cell Disease

Vascarta commences Proof of Concept Phase 1 clinical study of VAS-101 in sickle cell disease in the United States (PRNewswire) - "A first in human proof of concept phase I clinical study of VAS-101 (Vasceptor; topical curcumin gel) in sickle cell disease (SCD) is underway....Ten (10) patients with sickle cell disease will be treated with VAS-101 twice per week over 4 weeks for a total of 8 treatments; their blood will be drawn weekly. Five (5) patients will be treated topically on their forearm and five (5) patients will be treated sublingually (under the tongue), the duration of treatment is 29 days."

Trial status • Sickle Cell Disease

The effect of a topical curcumin formulation (VAS101) on knee pain in adults with knee osteoarthritis (ANZCTR) - P=N/A | N=60 | Recruiting | Sponsor: Clinical Research Australia | Initiation date: Feb 2025

Trial initiation date • Immunology • Musculoskeletal Pain • Osteoarthritis • Pain • Rheumatology

Vascarta commences a Phase I clinical study of VAS101 in osteoarthritis (PRNewswire) - "A 60-patient, randomized, double-blind, placebo-controlled phase I clinical study of VAS101 (topical curcumin gel) in osteoarthritis (OA) is underway. The study is being conducted at Clinical Research Australia, in Perth, Australia, under the direction of Dr. Adrian Lopresti, the Principal Investigator...To date, a total of 19 patients have initiated treatment to receive either VAS101 or placebo once every two days for 28 days. Pending positive results, a Phase II study in OA is anticipated to start in 2026....The primary study objective is to assess the safety and tolerability of VAS101 on knee pain in adult patients with chronic knee osteoarthritis. Secondary study objectives include evaluating the effect of VAS101 on symptom resolution, quality of life, and daily function; changes in the use of analgesics; and the presence of type II collagen cleavage products (CTX-II)."

New P2 trial • Trial status • Osteoarthritis