Numerous clinical trials evaluate cytidine-derived therapeutic strategies across conditions including hematologic malignancies (such as acute myeloid leukemia, myelodysplastic syndromes, and chronic lymphocytic leukemia), solid tumors like breast and colorectal cancers, and healthy volunteer cohorts. Spanning Early Phase 1 through Phase 4, these studies encompass various recruitment statuses—including recruiting, active not recruiting, completed, and terminated—and are supported by academic, government, and pharmaceutical sponsors.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT05355051 | RECRUITING | Hodgkin's Lymphoma |
M.D. Anderson Cancer Center |
2022-10-05 | PHASE2 |
| NCT03875287 | ACTIVE_NOT_RECRUITING | Solid Tumor |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
2019-04-17 | PHASE1 |
| NCT06536959 | RECRUITING | Relapsed Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia; Myelodysplastic Syndromes; Minimal Residual Disease |
Beijing 302 Hospital |
2024-07-18 | PHASE2 |
| NCT06886425 | RECRUITING | Myelodysplastic Syndromes (MDS); Leukemia Acute Myeloid - AML |
Assistance Publique Hopitaux De Marseille |
2021-06-14 | |
| NCT06291285 | Not yet recruiting | Healthy Volunteers |
Novo Nordisk A/S |
2024-02-27 | Phase 1 |
| NCT05262465 | UNKNOWN | Adult Acute Myeloid Leukemia |
guomei |
2020-07-01 | |
| NCT01892371 | COMPLETED | FLT3 Gene Mutation Negative; FLT3 Internal Tandem Duplication Positive; Recurrent Acute Myeloid Leukemia; Recurrent Chronic Myelomonocytic Leukemia; Recurrent Myelodysplastic Syndrome; Refractory Acute Myeloid Leukemia; Refractory Chronic Myelomonocytic Leukemia; Refractory Myelodysplastic Syndrome |
M.D. Anderson Cancer Center |
2013-11-12 | PHASE1; PHASE2 |
| NCT04722952 | UNKNOWN | Immunotherapy; Refractory Leukemia; Relapsed Adult AML; Acute Myeloid Leukemia |
The First Affiliated Hospital of Soochow University |
2021-05-01 | PHASE3 |
| NCT01333046 | COMPLETED | Hodgkin Lymphoma; Non-Hodgkin Lymphoma; Hodgkin Disease |
Baylor College of Medicine |
2012-01 | PHASE1 |
| NCT01839240 | COMPLETED | Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia |
University of Chicago |
2012-06-06 | PHASE1 |
| NCT02940483 | COMPLETED | Brain Tumor Recurrent |
The University of Texas Health Science Center, Houston |
2017-02-01 | EARLY_PHASE1 |
| NCT03337516 | Unknown status | Acute Myeloid Leukemia |
Assistance Publique Hopitaux De Marseille |
2017-06-21 | Not Applicable |
| NCT03955991 | Active not recruiting | Stress |
University of Miami|Florida Department of Health |
2016-07-21 | Phase 4 |
| NCT03465202 | Unknown status | Breast Cancer|Colorectal Cancer |
Newcastle-upon-Tyne Hospitals NHS Trust|University of Newcastle Upon-Tyne |
2016-05 | Phase 4 |
| NCT00413478 | TERMINATED | Chronic Lymphocytic Leukemia; Leukemia |
M.D. Anderson Cancer Center |
2006-09 | PHASE2 |
| NCT00996515 | COMPLETED | Advanced Solid Tumor Malignancies |
New Mexico Cancer Research Alliance |
2008-06 | PHASE1 |
| NCT00997243 | TERMINATED | Leukemia; Myelodysplastic Syndromes |
Alison Walker |
2009-11 | PHASE2 |
| NCT00739388 | COMPLETED | Leukemia |
Swiss Cancer Institute |
2008-07 | PHASE2 |
| NCT00089089 | TERMINATED | Hematopoietic/Lymphoid Cancer; Unspecified Adult Solid Tumor, Protocol Specific |
National Cancer Institute (NCI) |
2004-09 | PHASE1 |
| NCT00075010 | COMPLETED | Leukemia; Myelodysplastic Syndromes |
M.D. Anderson Cancer Center |
2004-01-23 | PHASE1; PHASE2 |
| NCT00061620 | COMPLETED | Hematologic Malignancies |
M.D. Anderson Cancer Center |
2001-09-06 | PHASE1 |
| NCT00043381 | COMPLETED | Myelodysplastic Syndrome |
Astex Pharmaceuticals, Inc. |
2001-04 | PHASE3 |
| NCT00002818 | COMPLETED | Drug/Agent Toxicity by Tissue/Organ; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm |
Virginia Commonwealth University |
1995-02 | PHASE1 |
| NCT00001040 | COMPLETED | HIV Infections |
Hoffmann-La Roche |
PHASE2 | |
| NCT00042016 | COMPLETED | Chronic Myelogenous Leukemia |
Astex Pharmaceuticals, Inc. |
2002-07 | PHASE2 |
| NCT00000969 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
||
| NCT00001022 | COMPLETED | HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE3 | |
| NCT00002265 | COMPLETED | HIV Infections |
Hoffmann-La Roche |
PHASE2 |
(data from https://clinicaltrials.gov, updated on 2026-05-18)
Check the
Cytidine
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.