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)
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>).
- Suramin sodium salt Solubility in DMSO
- Suramin sodium salt Stock Solution
- Suramin sodium salt Storage
- Suramin sodium salt Stability
- Suramin sodium salt Molecular Weight
- Suramin sodium salt SMILES
- Suramin sodium salt CAS Number
- Suramin sodium salt Chemical Structure (2D and 3D)
- Suramin sodium salt SDS|MSDS