Ponesimod (ACT-128800) Clinical Trials

Size	Price	Qty
5mg	USD 147
25mg	USD 497

Clinical Trials

Multiple clinical trials evaluate ponesimod across Phase 1, Phase 2, and Phase 3 stages for conditions including multiple sclerosis, ulcerative colitis, chronic graft-versus-host disease, and chronic plaque psoriasis, as well as safety and pharmacokinetics in healthy volunteers. Sponsored by academic and industry entities such as Actelion, Janssen Pharmaceutica, and Johns Hopkins University, these studies exhibit varied recruitment statuses including completed, recruiting, active not recruiting, and terminated. Across these trials, key evaluations focus on pharmacokinetic parameters, long-term safety, and therapeutic efficacy across diverse patient cohorts.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT07686081	RECRUITING	Ulcerative Colitis (UC)	Vanda Pharmaceuticals	2026-09	PHASE3
NCT07362017	RECRUITING	Moderate-to-severe Chronic Plaque Psoriasis	Vanda Pharmaceuticals	2026-02-17	PHASE3
NCT03500328	ACTIVE_NOT_RECRUITING	Multiple Sclerosis, Relapsing-Remitting	Johns Hopkins University	2018-05-02
NCT03232073	COMPLETED	Multiple Sclerosis	Actelion	2017-07-05	PHASE3
NCT01093326	COMPLETED	Multiple Sclerosis	Actelion	2010-05-12	PHASE2
NCT05552196	COMPLETED	Healthy	Janssen Pharmaceutica N.V., Belgium	2022-10-18	PHASE1
NCT05552196	Completed	Healthy	Janssen Pharmaceutica N.V. Belgium	2022-10-18	Phase 1
NCT02907177	TERMINATED	Multiple Sclerosis	Actelion	2017-03-30	PHASE3
NCT03882255	COMPLETED	Healthy	Janssen Pharmaceutica N.V., Belgium	2019-03-20	PHASE1
NCT02425644	COMPLETED	Multiple Sclerosis	Actelion	2015-06-04	PHASE3
NCT02461134	TERMINATED	Chronic Graft Versus Host Disease	Actelion	2016-09-29	PHASE2
NCT02068235	COMPLETED	Healthy	Actelion	2014-08	PHASE1
NCT02136888	COMPLETED	Healthy	Actelion	2011-08	PHASE1
NCT02029482	Completed	Safety and Tolerability	Actelion	2010-04	Phase 1
NCT02223832	Completed	Healthy	Actelion	2009-02	Phase 1

(data from https://clinicaltrials.gov, updated on 2026-08-18)

Check the Ponesimod (ACT-128800) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ponesimod is a potent, selective sphingosine-1-phosphate receptor 1 (S1P1) immunomodulator with an EC50 of 5.7 nM that induces target receptor internalization, thereby preventing lymphocyte egress from secondary lymphoid organs into the systemic circulation. By sequestering lymphocytes and reducing auto-aggressive cell infiltration into peripheral tissues, ponesimod alleviates inflammatory tissue destruction in autoimmune diseases such as multiple sclerosis, ulcerative colitis, and psoriasis.

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>).