Sphingosine Clinical Trials

Size	Price	Qty
25mg	USD 147
1g	USD 970

Clinical Trials

Multiple clinical trials are currently evaluating sphingosine and related pathways across a diverse spectrum of conditions, including glioblastoma, Type II Gaucher disease, diabetes mellitus, sphingolipidoses, coronavirus infections, multiple sclerosis, and acne vulgaris. Spanning Phase 1 through Phase 3 investigations alongside observational registries and biomarker assessments, these protocols are sponsored by academic institutions, university hospitals, and biopharmaceutical entities such as Duke University, the University of California San Francisco, and RedHill Biopharma. Participant recruitment status across these studies varies, encompassing active protocols reported as recruiting, completed, or not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT04657146	Recruiting	Glioblastoma	Duke University	2024-02-05	--
NCT06272149	Recruiting	Type II Gaucher Disease	Xinhua Hospital Shanghai Jiao Tong University School of Medicine\|Shanghai Vitalgen BioPharma Co. Ltd.	2023-03-01	Early Phase 1
NCT05524246	Recruiting	Hematopoietic Stem Cell Transplant (HSCT)\|Endothelial Injury	Children''s Hospital Medical Center Cincinnati	2023-01-27	Phase 1
NCT04467840	COMPLETED	COVID-19; Lung Infection	RedHill Biopharma Limited	2020-08-21	PHASE2; PHASE3
NCT04414618	COMPLETED	Coronavirus Infections	RedHill Biopharma Limited	2020-07-02	PHASE2
NCT03447964	Completed	Diabetes Mellitus Type 2\|Diabetes Mellitus Type 1	Groupe Hospitalier Pitie-Salpetriere	2017-04-04	--
NCT01488513	COMPLETED	Pancreatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific	RedHill Biopharma Limited	2011-08	PHASE1

(data from https://clinicaltrials.gov, updated on 2024-05-22)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a fundamental 18-carbon amino alcohol backbone of cell membrane sphingolipids, sphingosine is phosphorylated by sphingosine kinases to produce sphingosine-1-phosphate, thereby triggering downstream G protein-coupled receptor signaling that regulates cell proliferation, survival, and trafficking. Targeting this metabolic cascade alters intracellular ceramide-to-sphingosine-1-phosphate balance, offering therapeutic utility in clinical trial indications including sphingolipidoses, metabolic dysfunction, and inflammatory diseases.

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>).