Clinical Trials

Suramin sodium salt has been evaluated across multiple clinical trials spanning Phase I through Phase III for autism spectrum disorder and several oncological indications, including non-small cell lung, prostate, bladder, and breast cancers. Sponsored by organizations such as the National Cancer Institute, Cancer Research UK, the Eastern Cooperative Oncology Group, and Paxmedica, these studies assessed suramin as a monotherapy or in combination with docetaxel. Although recruitment records indicate that these trials are predominantly completed or terminated, they collectively illustrate significant clinical interest across diverse disease contexts.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT06866275 RECRUITING
Autism Spectrum Disorder (ASD)
Children's Hospital of Orange County
2025-04-09 PHASE2
NCT04496596 UNKNOWN
Acute Kidney Injury
Rediscovery Life Sciences
2020-11-13 PHASE2
NCT06058962 COMPLETED
Autism Spectrum Disorder
Paxmedica
2019-06-01 PHASE2
NCT03804749 UNKNOWN
Hand, Foot and Mouth Disease
First Affiliated Hospital of Zhejiang University
2018-12-19 PHASE1
NCT02508259 COMPLETED
Autism Spectrum Disorders
University of California, San Diego
2015-05 PHASE1; PHASE2
NCT01671332 COMPLETED
Carcinoma, Non Small Cell Lung
University of Wisconsin, Madison
2012-06 PHASE2
NCT01038752 TERMINATED
Non-small Cell Lung Cancer
Optimum Therapeutics, LLC
2010-08 PHASE2
NCT00054028 COMPLETED
Recurrent Breast Cancer; Stage IIIB Breast Cancer; Stage IV Breast Cancer
National Cancer Institute (NCI)
2002-12 PHASE1; PHASE2
NCT00066768 COMPLETED
Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
National Cancer Institute (NCI)
2003-07 PHASE1
NCT00006929 COMPLETED
Recurrent Non-small Cell Lung Cancer; Stage IIIB Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
National Cancer Institute (NCI)
2000-09 PHASE2
NCT00083109 COMPLETED
Recurrent Renal Cell Carcinoma; Stage IV Renal Cell Cancer
National Cancer Institute (NCI)
2004-03 PHASE1; PHASE2
NCT00002921 TERMINATED
Adrenocortical Carcinoma
SWOG Cancer Research Network
1997-03 PHASE2
NCT00004073 COMPLETED
Brain and Central Nervous System Tumors
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1999-12 PHASE2
NCT00003038 COMPLETED
Adrenocortical Carcinoma; Breast Cancer; Colorectal Cancer; Prostate Cancer; Unspecified Adult Solid Tumor, Protocol Specific
Mayo Clinic
1997-10 PHASE1
NCT00002723 COMPLETED
Prostate Cancer
National Cancer Institute (NCI)
1996-01 PHASE3
NCT00002881 COMPLETED
Prostate Cancer
Eastern Cooperative Oncology Group
1996-10 PHASE3
NCT00006476 COMPLETED
Bladder Cancer
Cancer Research UK
2000-10 PHASE1
NCT00001381 COMPLETED
Bladder Neoplasms; Carcinoma, Transitional Cell
National Cancer Institute (NCI)
1994-03 PHASE1
NCT00002652 COMPLETED
Multiple Myeloma and Plasma Cell Neoplasm
University of Arkansas
1995-05 PHASE2
NCT00001266 COMPLETED
Prostatic Neoplasm
National Cancer Institute (NCI)
1990-10 PHASE2
NCT00002639 COMPLETED
Brain and Central Nervous System Tumors
Emory University
1995-07 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-30)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Suramin sodium salt acts as a reversible, competitive inhibitor of protein-tyrosine phosphatases, sirtuins, and topoisomerase II, thereby disrupting intracellular phosphorylation cascades, epigenetic modifications, and DNA replication processes required for cellular proliferation. This multi-target biochemical inhibition suppresses cell survival signaling and arrests cell cycle progression, providing the biological basis for its evaluation in clinical trials targeting advanced malignancies such as prostate, bladder, and non-small cell lung cancers.

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.