Sphingosine-1-phosphate Clinical Trials

Size	Price	Qty
1mg	USD 297

Clinical Trials

Multiple clinical trials, predominantly Phase 2 and Phase 3 alongside observational studies, evaluate sphingosine-1-phosphate across diverse therapeutic areas, sponsored primarily by academic research institutions and university hospitals. These investigations target neuroinflammatory, autoimmune, respiratory, and inflammatory conditions, including multiple sclerosis, rheumatoid arthritis, asthma, bacterial pneumonia, acne vulgaris, interstitial cystitis, and periodontal disease. Recruitment statuses across these studies range from completed and actively recruiting to terminated or not yet recruiting.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07335952	COMPLETED	Rheumatoid Arthritis	Peking University People's Hospital	2024-09-02	PHASE2
NCT06930430	COMPLETED	Sphingosine 1-phosphate; Interleukin 1-beta; Gingival Crevicular Fluid; Non-surgical Periodontal Therapy; Split-mouth Design	Ondokuz Mayıs University	2023-05-15
NCT04134351	UNKNOWN	Asthma	Guy's and St Thomas' NHS Foundation Trust	2020-02-04
NCT04007328	UNKNOWN	Pneumonia, Bacterial	Taipei Medical University WanFang Hospital	2019-06-15	PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2026-01-13)

Check the Sphingosine-1-phosphate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Sphingosine-1-phosphate acts as a potent endogenous agonist that binds to S1P1–5 receptors as well as GPR3, GPR6, and GPR12, triggering intracellular calcium mobilization and downstream signaling cascades. These biochemical pathways modulate key cellular processes, including cell proliferation, migration, and cytoskeletal organization, which directly influence inflammatory and immune responses involved in clinical conditions like multiple sclerosis, rheumatoid arthritis, and asthma.

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>).