Product Description
Nanatinostat (VRx-3996) is an orally available histone deacetylase (HDAC) inhibitor being developed by Viracta. Nanatinostat is selective for specific isoforms of Class I HDACs, which is key to inducing viral genes that are epigenetically silenced in EBV-associated malignancies. Nana-val (nanatinostat and valganciclovir) is being investigated in multiple subtypes of relapsed/refractory EBV+ lymphoma and in advanced EBV+ solid tumors in three ongoing trials, one of which is a registration-enabling global, multicenter, open-label Phase 2 basket trial in relapsed/refractory EBV+ lymphoma (NAVAL-1). (Sourced from: https://viracta.investorroom.com/2021-11-29-Viracta-Therapeutics-Announces-Orphan-Drug-Designation-Granted-by-FDA-for-its-All-Oral-Combination-of-Nanatinostat-and-Valganciclovir-Nana-val-for-the-Treatment-of-Epstein-Barr-Virus-Positive-Diffuse-Large-B-cell-Lymphoma)
Mechanisms of Action: HDAC Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation:
Orphan Drug - Diffuse Large B-Cell Lymphoma|Lymphoma|Lymphoma, B-Cell
Orphan Drug - Lymphoma|T-Cell Lymphoma
Orphan Drug - Lymphoma|T-Cell Lymphoma|T-Cell Peripheral Lymphoma
Orphan Drug - Nasopharyngeal Cancer *
Approval Status: Not Approved
Approved Countries: None
Approved Indications: None
Known Adverse Events: None
Company: Viracta Therapeutics
Company Location:
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count: 1
Highest Development Phases
Phase 2: Relapsed/Refractory Lymphoma
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| NAVAL-1 | P2 |
Active, not recruiting |
Relapsed/Refractory Lymphoma |
2025-10-01 |