Tetrahydrouridine

Overview

Tetrahydrouridine has been used in trials studying the treatment of Neoplasms, Lung Neoplasms, Breast Neoplasms, Sickle Cell Disease, and Head and Neck Cancer, among others.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
To Study the Oral Bioavailability of a New Combination Formation of Decitabine and Tetrahydrouridine in Healthy Males	2023/04/18	NCT05816356	Phase 1	Completed	EpiDestiny, Inc.
Oral Decitabine and Tetrahydrouridine as Epigenetic Priming for Pembrolizumab-Mediated Immune Checkpoint Blockade in Patients With Inoperable, or Unresectable Locally Advanced or Metastatic Non-Small Cell Lung Cancers and Esophageal Carcinomas	2017/07/31	NCT03233724	Phase 1	Terminated	National Cancer Institute (NCI)
p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Refractory/Relapsed Lymphoid Malignancies	2016/07/27	NCT02846935	Early Phase 1	Completed	Yogen Saunthararajah
p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Pancreatic Cancer	2016/07/27	NCT02847000	Early Phase 1	Completed	Yogen Saunthararajah
Adjuvant Oral Decitabine and Tetrahydrouridine With or Without Celecoxib in People Undergoing Pulmonary Metastasectomy	2016/07/21	NCT02839694	Phase 1	Withdrawn	National Cancer Institute (NCI)
Rational EpigenetiC Immunotherapy for SEcond Line Therapy in Patients With NSCLC: PRECISE Trial	2016/01/26	NCT02664181	Phase 2	Active, not recruiting	Case Comprehensive Cancer Center
Study of Decitabine and Tetrahydrouridine (THU) in Patients With Sickle Cell Disease	2012/09/14	NCT01685515	Phase 1	Completed	Yogen Saunthararajah
Imaging Study for FdCyd and THU Cancer Treatment	2011/11/24	NCT01479348	Early Phase 1	Terminated	National Cancer Institute (NCI)
5-Fluoro-2'-Deoxycytidine and Tetrahydrouridine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes	2009/12/31	NCT01041443	Phase 1	Completed	City of Hope Medical Center
Cytochlor, Tetrahydrouridine, and External-Beam Radiation Therapy in Treating Patients With Cancer That Has Spread to the Brain	2007/08/27	NCT00521183	Phase 1	Completed	Brian Lally

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

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