Ponesimod

Treats relapsing forms of multiple sclerosis (MS). Sold as Ponvory. Every FDA application for this active ingredient.

As of Nov 14, 2026, FDA lists 1 application for Ponesimod (sold as Ponvory), first approved Mar 18, 2021, with 0 new uses approved and 0 published complete response letters.

First approved: Mar 18, 2021
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $7.0M
First approved in the EU: May 19, 2021

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Ponvory	Part D	$7.0M	+10%	87

Approvals in the EU (EMA)

First approved in the EU 2 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Ponvory, new substanceLaboratoires Juvisé Pharmaceuticals · May 19, 2021

Clinical Trials

4 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative ColitisUlcerative Colitis (UC) · Vanda Pharmaceuticals	Phase 3	Recruiting	Jul 7, 2026
Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque PsoriasisModerate-to-severe Chronic Plaque Psoriasis · Vanda Pharmaceuticals	Phase 3	Recruiting	Jan 23, 2026
A Study to Learn More About The Safety of Diroximel Fumarate (VUMERITY®) in Participants Who Took it During Pregnancy And About the Health of Their BabiesMultiple Sclerosis · Biogen	—	Active, not recruiting	Jan 18, 2023
Determining the Effectiveness of earLy Intensive Versus Escalation Approaches for RRMSMultiple Sclerosis, Relapsing-Remitting · The Cleveland Clinic	Phase 4	Active, not recruiting	May 24, 2018

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Mar 18, 2021	PonvoryNDA 213498 · New molecular entity	Vanda Pharms Inc	4	Marketed

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA