Guadecitabine sodium Clinical Trials

Size	Price	Qty
5mg	USD 870
25mg	USD 2,190

Clinical Trials

Guadecitabine sodium is evaluated across multiple Phase I through III clinical trials investigating hematologic malignancies such as acute myeloid leukemia, alongside solid tumors including metastatic colorectal adenocarcinoma, small cell and non-small cell lung cancers, urothelial carcinoma, castration-resistant prostate cancer, and melanoma. Supported by pharmaceutical, academic, and government sponsors, these studies encompass active, recruiting, completed, and withdrawn protocols.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03220477	ACTIVE_NOT_RECRUITING	Lung Cancer	Memorial Sloan Kettering Cancer Center	2017-08-04	PHASE1
NCT02935361	ACTIVE_NOT_RECRUITING	Chronic Myelomonocytic Leukemia; Myelodysplastic Syndrome; Recurrent Acute Myeloid Leukemia With Myelodysplasia-Related Changes	University of Southern California	2016-11-02	PHASE1; PHASE2
NCT02998567	ACTIVE_NOT_RECRUITING	Non Small Cell Lung Cancer	Royal Marsden NHS Foundation Trust	2017-01-26	PHASE1
NCT02684162	COMPLETED	Acute Myeloid Leukemia; Chronic Myelomonocytic Leukemia; Myelodysplastic Syndrome; Recurrent Acute Myeloid Leukemia; Recurrent Myelodysplastic Syndrome	M.D. Anderson Cancer Center	2016-06-22	PHASE2
NCT02131597	COMPLETED	High Risk Myelodysplastic Syndrome	M.D. Anderson Cancer Center	2014-11-10	PHASE2
NCT04340843	ACTIVE_NOT_RECRUITING	Locally Advanced Unresectable Primary Central Chondrosarcoma; Metastatic Primary Central Chondrosarcoma; Unresectable Primary Central Chondrosarcoma	National Cancer Institute (NCI)	2020-09-08	PHASE2
NCT04250246	UNKNOWN	Melanoma; Non Small Cell Lung Cancer	Italian Network for Tumor Biotherapy Foundation	2020-03	PHASE2
NCT03308396	ACTIVE_NOT_RECRUITING	Advanced Kidney Cancer; Kidney Cancer; Clear Cell Renal Cell Carcinoma	Ajjai Alva, MD	2017-12-19	PHASE1; PHASE2
NCT03576963	WITHDRAWN	Colorectal Adenocarcinoma; CpG Island Methylator Phenotype; Metastatic Microsatellite Stable Colorectal Carcinoma; Refractory Colorectal Carcinoma; Stage IV Colorectal Cancer AJCC v8; Stage IVA Colorectal Cancer AJCC v8; Stage IVB Colorectal Cancer AJCC v8; Stage IVC Colorectal Cancer AJCC v8	University of Southern California	2020-01-30	PHASE1; PHASE2
NCT03603964	TERMINATED	Acute Myeloid Leukemia; Myeloid Dysplastic Syndrome	Astex Pharmaceuticals, Inc.	2018-07-18	PHASE2
NCT03257761	ACTIVE_NOT_RECRUITING	Extrahepatic Bile Duct Adenocarcinoma, Biliary Type; Gallbladder Adenocarcinoma, Biliary Type; Metastatic Pancreatic Adenocarcinoma; Recurrent Cholangiocarcinoma; Recurrent Gallbladder Carcinoma; Recurrent Hepatocellular Carcinoma; Recurrent Intrahepatic Cholangiocarcinoma; Recurrent Pancreatic Carcinoma; Stage III Gallbladder Cancer AJCC V7; Stage III Hepatocellular Carcinoma AJCC v7; Stage III Intrahepatic Cholangiocarcinoma AJCC v7; Stage III Pancreatic Cancer AJCC v6 and v7; Stage IIIA Gallbladder Cancer AJCC v7; Stage IIIA Hepatocellular Carcinoma AJCC v7; Stage IIIB Gallbladder Cancer AJCC v7; Stage IIIB Hepatocellular Carcinoma AJCC v7; Stage IIIC Hepatocellular Carcinoma AJCC v7; Stage IV Gallbladder Cancer AJCC v7; Stage IV Hepatocellular Carcinoma AJCC v7; Stage IV Pancreatic Cancer AJCC v6 and v7; Stage IVA Gallbladder Cancer AJCC v7; Stage IVA Hepatocellular Carcinoma AJCC v7; Stage IVA Intrahepatic Cholangiocarcinoma AJCC v7; Stage IVB Gallbladder Cancer AJCC v7; Stage IVB Hepatocellular Carcinoma AJCC v7; Stage IVB Intrahepatic Cholangiocarcinoma AJCC v7; Unresectable Gallbladder Carcinoma; Unresectable Pancreatic Carcinoma	University of Southern California	2018-02-07	PHASE1
NCT03913455	COMPLETED	Small Cell Lung Cancer; Extensive-stage Small Cell Lung Cancer	Shadia Jalal, MD	2019-06-06	PHASE2
NCT03075826	COMPLETED	Myeloproliferative Neoplasms	Weill Medical College of Cornell University	2016-03-15	PHASE2
NCT02096055	COMPLETED	Untreated Adult Acute Myeloid Leukemia	M.D. Anderson Cancer Center	2014-04-04	PHASE2
NCT03206047	COMPLETED	Platinum-Resistant Fallopian Tube Carcinoma; Platinum-Resistant Ovarian Carcinoma; Platinum-Resistant Primary Peritoneal Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma	National Cancer Institute (NCI)	2017-11-08	PHASE1; PHASE2
NCT03454984	UNKNOWN	Myelodysplastic Syndromes; Acute Myeloid Leukemia	Groupe Francophone des Myelodysplasies	2018-11	PHASE2
NCT03179943	ACTIVE_NOT_RECRUITING	Urothelial Carcinoma	Fox Chase Cancer Center	2017-11-27	PHASE2
NCT01966289	COMPLETED	Metastatic Colorectal Cancer	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	2014-04-14	PHASE1
NCT02901899	COMPLETED	Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma	Northwestern University	2016-11-11	PHASE2
NCT02907359	COMPLETED	Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic	Astex Pharmaceuticals, Inc.	2017-01-13	PHASE3
NCT03165721	TERMINATED	Paraganglioma; Gastrointestinal Stromal Tumors; Carcinoma, Renal Cell; Renal Neoplasms; Pheochromocytoma	National Cancer Institute (NCI)	2017-08-16	PHASE2
NCT02920008	COMPLETED	Acute Myeloid Leukemia	Astex Pharmaceuticals, Inc.	2017-03-16	PHASE3
NCT03576963	Withdrawn	Colorectal Adenocarcinoma\|CpG Island Methylator Phenotype\|Metastatic Microsatellite Stable Colorectal Carcinoma\|Refractory Colorectal Carcinoma\|Stage IV Colorectal Cancer AJCC v8\|Stage IVA Colorectal Cancer AJCC v8\|Stage IVB Colorectal Cancer AJCC v8\|Stage IVC Colorectal Cancer AJCC v8	University of Southern California\|National Cancer Institute (NCI)\|Bristol-Myers Squibb\|Astex Pharmaceuticals Inc.	2020-01-30	Phase 1\|Phase 2
NCT02892318	COMPLETED	Acute Myeloid Leukemia	Hoffmann-La Roche	2016-10-31	PHASE1
NCT01896856	COMPLETED	Previously Treated Metastatic Colorectal Cancer	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	2013-10-23	PHASE1; PHASE2
NCT03085849	COMPLETED	Extensive-stage Small Cell Lung Cancer	Catherine Shu	2017-12-15	PHASE1
NCT02429466	COMPLETED	Germ Cell Tumor; Testis Cancer; Testicular Cancer	Nasser Hanna	2015-04-27	PHASE1
NCT02348489	COMPLETED	Leukemia, Myeloid, Acute	Astex Pharmaceuticals, Inc.	2015-03-19	PHASE3
NCT03085849	Completed	Extensive-stage Small Cell Lung Cancer	Catherine Shu\|Columbia University	2017-12-15	Phase 1
NCT03179943	Active not recruiting	Urothelial Carcinoma	Fox Chase Cancer Center\|Stand Up To Cancer\|Van Andel Research Institute	2017-11-27	Phase 2
NCT02293993	COMPLETED	Acute Myeloid Leukemia	Otsuka Pharmaceutical Co., Ltd.	2015-01-07	PHASE1
NCT02998567	Recruiting	Castration-Resistant Prostatic Cancer\|Non Small Cell Lung Cancer	Royal Marsden NHS Foundation Trust\|Astex Pharmaceuticals Inc.\|Merck Sharp & Dohme LLC\|Institute of Cancer Research United Kingdom	2017-01-26	Phase 1
NCT02892318	Completed	Acute Myeloid Leukemia	Hoffmann-La Roche	2016-10-31	Phase 1
NCT02608437	UNKNOWN	Metastatic Melanoma	Italian Network for Tumor Biotherapy Foundation	2015-10	PHASE1
NCT01696032	COMPLETED	Ovarian Cancer	Astex Pharmaceuticals, Inc.	2012-09	PHASE2
NCT01261312	COMPLETED	MDS; CMML; AML	Astex Pharmaceuticals, Inc.	2011-01-04	PHASE1; PHASE2
NCT02197676	COMPLETED	MDS	Groupe Francophone des Myelodysplasies	2014-08-04	PHASE2
NCT01752933	COMPLETED	Hepatocellular Carcinoma	Astex Pharmaceuticals, Inc.	2012-12	PHASE2

(data from https://clinicaltrials.gov, updated on 2026-08-05)

Check the Guadecitabine sodium product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Guadecitabine sodium acts as a next-generation hypomethylating agent that incorporates into genomic DNA and inhibits DNA methyltransferases, thereby reversing aberrant hypermethylation and restoring the expression of epigenetically silenced tumor suppressor genes. This demethylating activity restores normal cellular differentiation pathways and induces apoptosis in malignant cells, providing a clear biological basis for its clinical evaluation in acute myeloid leukemia and various solid tumors.

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>).