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Showing 1–19 of 19 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: Tetrahydrouridine Clear all
Completed Phase 1 Interventional Accepts healthy volunteers

Effect of Food on the Pharmacokinetics of Decitabine/Tetrahydrouridine Combination Capsules in Healthy Adult Subjects

NCT04086238
View directory record Official record
Conditions
Healthy
Interventions
Decitabine
Drug
Lead sponsor
EpiDestiny, Inc.
Industry
Eligibility
18 Years to 50 Years
Enrollment
46 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated Jan 21, 2020 · Synced Sep 14, 2026, 12:34 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

A Study to Test How Either a Capsule or a Tablet With NDec (Decitabine and Tetrahydrouridine) Works in the Body of Healthy People

NCT06291285
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Decitabine-THU
Drug
Lead sponsor
Novo Nordisk A/S
Industry
Eligibility
18 Years to 64 Years
Enrollment
44 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024
U.S. locations
1
States / cities
Salt Lake City, Utah
Source: ClinicalTrials.gov public record
Updated Dec 28, 2025 · Synced Sep 14, 2026, 12:34 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Randomized, Single-dose, Crossover Study of 4 Decitabine and Tetrahydrouridine (EPI01) Formulations in Healthy Subjects

NCT03828084
View directory record Official record
Conditions
Healthy
Interventions
Decitabine
Drug
Lead sponsor
EpiDestiny, Inc.
Industry
Eligibility
18 Years to 50 Years · Male only
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2019
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated May 8, 2019 · Synced Sep 14, 2026, 12:34 PM EDT
Recruiting Phase 1 Interventional

A Study of Nicotinamide With Oral Tetrahydrouridine and Decitabine to Treat High Risk Sickle Cell Disease

NCT04055818
View directory record Official record
Conditions
Sickle Cell Disease
Interventions
Nicotinamide
Drug
Lead sponsor
EpiDestiny, Inc.
Industry
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2020 – 2027
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated May 24, 2025 · Synced Sep 14, 2026, 12:34 PM EDT
Completed Phase 1 Interventional

Cytochlor and Tetrahydrouridine as Radiosensitizers and Cisplatin Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat)

NCT00077051
View directory record Official record
Conditions
Head and Neck Cancer
Interventions
cisplatin, cytochlor, tetrahydrouridine, radiation therapy
Drug · Radiation
Lead sponsor
University of Miami
Other
Eligibility
21 Years to 120 Years
Enrollment
1 participant
Healthy volunteers
Healthy volunteers not accepted
Timeline
2004 – 2007
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Dec 14, 2016 · Synced Sep 14, 2026, 12:34 PM EDT
Completed Phase 1 Interventional

FdCyd and THU for Advanced Solid Tumors

NCT01534598
View directory record Official record
Conditions
Neoplasms
Interventions
FdCyd + THU
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years to 120 Years
Enrollment
59 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2025
U.S. locations
6
States / cities
Duarte, California • Los Angeles, California • Sacramento, California + 3 more
Source: ClinicalTrials.gov public record
Updated Feb 9, 2026 · Synced Sep 14, 2026, 12:34 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

To Study the Oral Bioavailability of a New Combination Formation of Decitabine and Tetrahydrouridine in Healthy Males

NCT05816356
View directory record Official record
Conditions
Healthy
Interventions
Decitabine, Tetrahydrouridine
Drug
Lead sponsor
EpiDestiny, Inc.
Industry
Eligibility
18 Years to 50 Years · Male only
Enrollment
10 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2023
U.S. locations
1
States / cities
San Antonio, Texas
Source: ClinicalTrials.gov public record
Updated May 21, 2025 · Synced Sep 14, 2026, 12:34 PM EDT
Terminated Phase 1Phase 2 Interventional Results available

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

NCT03233724
View directory record Official record
Conditions
Carcinoma, Non-Small-Cell Lung, Lung Cancer, Non-Small Cell Lung Cancer, Carcinoma, Esophageal, Malignant Pleural Mesotheliomas
Interventions
Decitabine (DAC), Tetrahydrouridine (THU), Pembrolizumab
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years to 99 Years
Enrollment
9 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2021
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated May 30, 2023 · Synced Sep 14, 2026, 12:34 PM EDT
Terminated Early Phase 1 Interventional Results available

Imaging Study for FdCyd and THU Cancer Treatment

NCT01479348
View directory record Official record
Conditions
Head and Neck Neoplasms, Lung Neoplasms, Urinary Bladder Neoplasms, Breast Neoplasms
Interventions
[F-18]-5-FLUORO-2'-DEOXYCYTIDINE, Tetrahydrouridine intravenous (IV), Tetrahydrouridine (oral), Positron emission tomography (PET)/Computed tomography (CT)
Drug · Diagnostic Test
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years to 99 Years
Enrollment
5 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011 – 2019
U.S. locations
1
States / cities
Bethesda, Maryland
Source: ClinicalTrials.gov public record
Updated Jun 1, 2020 · Synced Sep 14, 2026, 12:34 PM EDT
Recruiting Phase 1 Interventional

A Study of Oral Tetrahydrouridine-Decitabine in Relapsed or Refractory Myelodysplastic Syndromes (MDS)

NCT07006025
View directory record Official record
Conditions
MDS
Interventions
Decitabine
Drug
Lead sponsor
Treebough Therapies
Industry
Eligibility
18 Years and older
Enrollment
20 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2027
U.S. locations
1
States / cities
The Bronx, New York
Source: ClinicalTrials.gov public record
Updated Jan 14, 2026 · Synced Sep 14, 2026, 12:34 PM EDT
Completed Phase 1 Interventional

Cytochlor, Tetrahydrouridine, and External-Beam Radiation Therapy in Treating Patients With Cancer That Has Spread to the Brain

NCT00521183
View directory record Official record
Conditions
Brain and Central Nervous System Tumors
Interventions
Cytochlor, Tetrahydrouridine, Radiation Therapy
Drug · Radiation
Lead sponsor
Brian Lally
Other
Eligibility
21 Years and older
Enrollment
2 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2007 – 2014
U.S. locations
1
States / cities
Miami, Florida
Source: ClinicalTrials.gov public record
Updated Nov 24, 2014 · Synced Sep 14, 2026, 12:34 PM EDT
Completed Phase 2 Interventional

Research Study Investigating How Well NDec Works in People With Sickle Cell Disease

NCT05405114
View directory record Official record
Conditions
Sickle Cell Disease
Interventions
NDec - oral decitabine-tetrahydrouridine, HU - Hydroxyurea, Placebo
Drug
Lead sponsor
Novo Nordisk A/S
Industry
Eligibility
18 Years and older
Enrollment
96 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2022 – 2025
U.S. locations
53
States / cities
Mobile, Alabama • Los Angeles, California • Oakland, California + 37 more
Source: ClinicalTrials.gov public record
Updated Jul 21, 2026 · Synced Sep 14, 2026, 12:34 PM EDT
Completed Phase 1 Interventional

5-Fluoro-2'-Deoxcyctidine and Tetrahydrouridine to Treat Patients With Advanced Cancer

NCT00359606
View directory record Official record
Conditions
Neoplasms
Interventions
5-Fluoro-2-Deoxycytidine (FdCyd), Laboratory Biomarker Analysis, Pharmacological Study, Tetrahydrouridine (THU)
Drug · Other
Lead sponsor
City of Hope Medical Center
Other
Eligibility
18 Years and older
Enrollment
58 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
1999 – 2012
U.S. locations
4
States / cities
Duarte, California • Los Angeles, California • Sacramento, California + 1 more
Source: ClinicalTrials.gov public record
Updated May 5, 2015 · Synced Sep 14, 2026, 12:34 PM EDT
Completed Phase 1 Interventional

Study of Decitabine and Tetrahydrouridine (THU) in Patients With Sickle Cell Disease

NCT01685515
View directory record Official record
Conditions
Sickle Cell Disease
Interventions
Oral Decitabine and Tetrahydrouridine, Placebo
Drug
Lead sponsor
Yogen Saunthararajah
Other
Eligibility
18 Years and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012 – 2018
U.S. locations
1
States / cities
Chicago, Illinois
Source: ClinicalTrials.gov public record
Updated Sep 10, 2018 · Synced Sep 14, 2026, 12:34 PM EDT
Completed Phase 2 Interventional Results available

Rational EpigenetiC Immunotherapy for SEcond Line Therapy in Patients With NSCLC: PRECISE Trial

NCT02664181
View directory record Official record
Conditions
Lung Cancer, Non-small Cell Lung Cancer
Interventions
Nivolumab, oral decitabine, Tetrahydrouridine
Drug
Lead sponsor
Case Comprehensive Cancer Center
Other
Eligibility
18 Years and older
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2024
U.S. locations
2
States / cities
Bethesda, Maryland • Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Sep 2, 2024 · Synced Sep 14, 2026, 12:34 PM EDT
Completed Early Phase 1 Interventional

p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Refractory/Relapsed Lymphoid Malignancies

NCT02846935
View directory record Official record
Conditions
T-cell Lymphoma, Aggressive B-cell Lymphoma, Non-Hodgkin's Lymphomas, Indolent B-cell Lymphoma
Interventions
Decitabine, Tetrahydrouridine
Drug
Lead sponsor
Yogen Saunthararajah
Other
Eligibility
18 Years and older
Enrollment
7 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2018
U.S. locations
1
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Jan 6, 2019 · Synced Sep 14, 2026, 12:34 PM EDT
Completed Early Phase 1 Interventional

p53/p16-Independent Epigenetic Therapy With Oral Decitabine/Tetrahydrouridine for Pancreatic Cancer

NCT02847000
View directory record Official record
Conditions
Metastatic Pancreatic Adenocarcinoma
Interventions
Tetrahydrouridine, Decitabine
Drug
Lead sponsor
Yogen Saunthararajah
Other
Eligibility
18 Years and older
Enrollment
13 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2017
U.S. locations
2
States / cities
Cleveland, Ohio
Source: ClinicalTrials.gov public record
Updated Jan 8, 2019 · Synced Sep 14, 2026, 12:34 PM EDT
Completed Phase 2 Interventional Results available

A Multi-Histology Phase II Study of 5-Fluoro-2'-Deoxycytidine With Tetrahydrouridine (FdCyd + THU)

NCT00978250
View directory record Official record
Conditions
Head and Neck Neoplasms, Lung Neoplasms, Urinary Bladder Neoplasms, Breast Neoplasms
Interventions
5-Fluoro-2'-Deoxycytidine (FdCyd) + Tetrahydrouridine (THU)
Drug
Lead sponsor
National Cancer Institute (NCI)
NIH
Eligibility
18 Years to 120 Years
Enrollment
95 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2019
U.S. locations
4
States / cities
Davis, California • Duarte, California • South Pasadena, California + 1 more
Source: ClinicalTrials.gov public record
Updated Dec 26, 2019 · Synced Sep 14, 2026, 12:34 PM EDT
Completed Phase 1 Interventional

5-Fluoro-2'-Deoxycytidine and Tetrahydrouridine in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndromes

NCT01041443
View directory record Official record
Conditions
Adult Acute Myeloid Leukemia, de Novo Myelodysplastic Syndromes, Previously Treated Myelodysplastic Syndromes, Recurrent Adult Acute Myeloid Leukemia, Secondary Acute Myeloid Leukemia, Secondary Myelodysplastic Syndromes, Untreated Adult Acute Myeloid Leukemia
Interventions
5-fluoro-2-deoxycytidine, tetrahydrouridine, laboratory biomarker analysis, reverse transcriptase-polymerase chain reaction, DNA methylation analysis
Drug · Other · Genetic
Lead sponsor
City of Hope Medical Center
Other
Eligibility
18 Years and older
Enrollment
25 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2009 – 2013
U.S. locations
1
States / cities
Duarte, California
Source: ClinicalTrials.gov public record
Updated Jun 7, 2015 · Synced Sep 14, 2026, 12:34 PM EDT