Siponimod (BAF312) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 397

Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate the therapeutic profile, safety, and efficacy of Siponimod (BAF312) in neurodegenerative and autoimmune conditions, including secondary progressive multiple sclerosis, relapsing-remitting multiple sclerosis, active dermatomyositis, and mild cognitive impairment associated with Alzheimer's disease. Sponsored by pharmaceutical entities such as Novartis Pharmaceuticals and Biogen alongside academic institutions like Johns Hopkins University, these studies encompass recruitment statuses ranging from active and recruiting to completed and terminated.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT00162474	RECRUITING	Healthy	Hadassah Medical Organization	2003-09
NCT06639282	RECRUITING	Alzheimer Disease; Mild Alzheimer Disease; MCI With Increased Risk for Alzheimer Disease; Cognitive Impairment, Mild	St. Joseph's Hospital and Medical Center, Phoenix	2025-08-26	PHASE2
NCT03500328	ACTIVE_NOT_RECRUITING	Multiple Sclerosis, Relapsing-Remitting	Johns Hopkins University	2018-05-02
NCT04926818	ACTIVE_NOT_RECRUITING	Multiple Sclerosis (MS)	Novartis Pharmaceuticals	2021-10-05	PHASE3
NCT04925557	TERMINATED	Secondary-progressive Multiple Sclerosis	State University of New York at Buffalo	2021-11-13	PHASE2; PHASE3
NCT03623243	COMPLETED	Multiple Sclerosis; Relapsing Multiple Sclerosis; Advancing Multiple Sclerosis	Novartis Pharmaceuticals	2019-02-14	PHASE3
NCT05376579	Active not recruiting	Active Secondary Progressive Multiple Sclerosis	Novartis Pharmaceuticals\|Novartis	2022-06-17	--
NCT04895202	Terminated	Secondary Progressive Multiple Sclerosis With Inflammatory Disease Activity	Novartis Pharmaceuticals\|Novartis	2021-11-19	--
NCT04792567	COMPLETED	Secondary Progressive Multiple Sclerosis	Novartis Pharmaceuticals	2021-04-19	PHASE4
NCT05826028	Completed	Secondary Progressive Multiple Sclerosis	Novartis Pharmaceuticals\|Novartis	2020-07-09	--
NCT03338998	COMPLETED	Hemorrhagic Stroke; Intracerebral Hemorrhage (ICH)	Novartis Pharmaceuticals	2017-12-24	PHASE2
NCT01185821	COMPLETED	Relapsing Remitting Multiple Sclerosis	Novartis Pharmaceuticals	2010-08-30	PHASE2
NCT01801917	TERMINATED	Polymyositis	Novartis Pharmaceuticals	2013-04-24	PHASE2
NCT01665144	COMPLETED	Secondary Progressive Multiple Sclerosis	Novartis Pharmaceuticals	2012-12-20	PHASE3
NCT02029274	TERMINATED	Active Dermatomyositis	Novartis Pharmaceuticals	2013-08-25	PHASE2
NCT01904214	COMPLETED	Renal Impairment	Novartis Pharmaceuticals	2013-07	PHASE1
NCT01565902	COMPLETED	Hepatic Impairment	Novartis Pharmaceuticals	2012-10	PHASE1
NCT02029274	Terminated	Active Dermatomyositis	Novartis Pharmaceuticals\|Novartis	2013-08-25	Phase 2
NCT01148810	TERMINATED	Polymyositis; Dermatomyositis	Novartis Pharmaceuticals	2010-06-15	PHASE2
NCT00879658	COMPLETED	Relapsing-remitting Multiple Sclerosis	Novartis Pharmaceuticals	2009-03-30	PHASE2
NCT00422175	COMPLETED	Healthy	Novartis	2006-10	PHASE1

(data from https://clinicaltrials.gov, updated on 2026-04-21)

Check the Siponimod (BAF312) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Siponimod (BAF312) is a potent, selective agonist of sphingosine-1-phosphate receptors S1P1 and S1P5 that triggers receptor internalization, thereby blocking the egress of functional lymphocytes from secondary lymphoid organs into circulation. By preventing auto-reactive immune cell infiltration into the central nervous system, this target-binding mechanism suppresses local neuroinflammation and tissue damage in patients with secondary progressive multiple sclerosis.

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>).