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standardized root extract of Withania somnifera
- Development stage
- Unknown
- Lead developer
- Tata Memorial Centre
- Modality
- Metabolically Activated Prodrugs → Prodrugs/Conditional Activator Small Molecules → Small Molecules, Classical Binding Small Molecules → Small Molecules
- Administration
- Oral
01
Overview
Standardized root extract of *Withania somnifera* (Ashwagandha), specifically enriched for Withaferin A (SWA), is a botanical drug candidate being developed by the Tata Memorial Centre. It is primarily investigated as a prophylaxis for acute Graft-versus-Host Disease (aGvHD) in adult patients with hematological malignancies undergoing allogeneic hematopoietic stem cell transplantation. The extract exhibits immunomodulatory and anti-inflammatory properties, potentially through the modulation of the JAK2/STAT3 signaling pathway and cytokine profiles. In clinical studies, it is administered orally alongside standard GvHD prophylaxis (e.g., calcineurin inhibitors and methotrexate) to reduce the incidence and severity of aGvHD. Previous Phase I studies have also evaluated its safety in patients with advanced osteosarcoma.
- Other names
- Standardized Withaferin AAshwagandha root extractWithania somnifera root extract
02
Targets
STAT3 (Signal Transducer and Activator of Transcription 3)JAK2 (Janus kinase 2)
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