Ponvory

(Ponesimod)

Phase 3Small molecule

Ponvory is one of 94 small molecule programs targeting Relapsing-Remitting Multiple Sclerosis. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Relapsing-Remitting Multiple SclerosisActive, not recruiting

PsoriasisActive, not recruiting

Multiple SclerosisActive, not recruiting

Ulcerative Colitis (UC)Not yet recruiting

Relapsing-Remitting Multiple SclerosisPhase 2

Active, not recruiting

PsoriasisPhase 3

Active, not recruiting

Multiple SclerosisPhase 3

Active, not recruiting

Ulcerative Colitis (UC)Phase 3

Not yet recruiting

Competition

Competitive Landscape

605 competitors in Psoriasis

#DrugCompanyPhaseTrials

Ponvory

VVanda Pharmaceuticals

Phase 3

1 2

Cosentyx

Novartis

Preclinical

53 3

Stelara

Johnson & Johnson

Preclinical

37 4

Taltz

Eli Lilly

Preclinical

20 5

Bimzelx

UCB

Preclinical

17 6

Humira

CCelltrion

Preclinical

42 7

Ilumya

Sun Pharmaceutical Industries, Inc.

Preclinical

15 8

Raptiva

Roche

Preclinical

10 9

Remicade

OOrganon and Co

Preclinical

20 10

Siliq

BBausch Health Americas, Inc.

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2028

Phase 3Not yet recruiting

Psoriasis

NCT07362017

Q3 2029

Phase 3Not yet recruiting

Ulcerative Colitis (UC)

NCT07686081

Q1 2031

Recruiting

Pregnancy

NCT05688436

Clinical

Trials by Indication[1]

Multiple Sclerosis3 trials

Long-term Extension to Study AC-058B301 to Investigate Safety, Tolerability and Disease Control of Ponesimod 20 mg in Patients With Relapsing Multiple Sclerosis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03232073·877 enrolled

Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02425644·1,133 enrolled

Clinical Study to Compare the Efficacy and Safety of Ponesimod to Placebo in Subjects With Active Relapsing Multiple Sclerosis Who Are Treated With Dimethyl Fumarate (Tecfidera®)

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02907177·136 enrolled

Adult1 trial

A Study of Ponesimod in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05552196·28 enrolled

Chronic GVHD1 trial

Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Chronic GVHD

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02461134·1 enrolled

Psoriasis1 trial

Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis

Not yet recruiting·VVanda Pharmaceuticals·Phase 3·NCT07362017·300 enrolled

Pregnancy1 trial

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 Babies

Recruiting· Biogen logo

Biogen··NCT05688436·1,178 enrolled

4 more indications

Oral1 trial

Study to Investigate the Absolute Bioavailability of a Single Oral Dose of Ponesimod in Healthy Male Subjects

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02068235·17 enrolled

Female1 trial

Study of the Electrocardiographic Effects of Ponesimod in Healthy Male and Female Subjects

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT02136888·116 enrolled

Relapsing-Remitting Multiple Sclerosis1 trial

Clinical Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Ponesimod in Patients With Relapsing-remitting Multiple Sclerosis

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT01093326·353 enrolled

Ulcerative Colitis (UC)1 trial

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ponesimod in Patients With Moderately to Severely Active Ulcerative Colitis

Not yet recruiting·VVanda Pharmaceuticals·Phase 3·NCT07686081·150 enrolled

Regulatory

FDA Approval Timeline[4]

Mar 18, 2021

PONVORY

NDA NDA213498

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Ponesimod. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Ponesimod compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Ponesimod. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA213498). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Ponvory. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Vanda Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: VVanda Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Nov 16, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE43728Nov 16, 2029

9062014May 6, 2032

12336980Dec 10, 2035

10220023Dec 10, 2035

11951097Oct 10, 2042

Ponvory

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Q3 2029

Q1 2031

Trials by Indication[1]

Multiple Sclerosis3 trials

Adult1 trial

Chronic GVHD1 trial

Psoriasis1 trial

Pregnancy1 trial

Oral1 trial

Female1 trial

Relapsing-Remitting Multiple Sclerosis1 trial

Ulcerative Colitis (UC)1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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