Ponvory

(Ponesimod)

Phase 3Small molecule

VVanda Pharmaceuticals

Ponvory is one of 6 small molecule programs targeting Ulcerative Colitis (UC). 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

Ulcerative Colitis (UC)Recruiting

Moderate-to-Severe Chronic Plaque PsoriasisRecruiting

Ulcerative Colitis (UC)Phase 3

Recruiting

Moderate-to-Severe Chronic Plaque PsoriasisPhase 3

Recruiting

Competition

Competitive Landscape

9 competitors in Ulcerative Colitis (UC)

#DrugCompanyPhaseTrials

Rinvoq

AbbVie

Approved

2 2

Omvoh

Eli Lilly

Approved

1 3

Vancocin

HHikma Pharmaceuticals LLC

Phase 2

2 4

Ponvory

VVanda Pharmaceuticals

Phase 3

1 5

Alinia

RRomark Laboratories L.C.

Preclinical

1 6

Alpha-0261

AAlphaMol Science Ltd. (Shanghai)

Phase 1

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

Timeline

Expected Milestones

Q4 2028

Phase 3Recruiting

Moderate-to-Severe Chronic Plaque Psoriasis

NCT07362017

Q3 2029

Phase 3Recruiting

Ulcerative Colitis (UC)

NCT07686081

Q1 2031

Active, not recruiting

Multiple Sclerosis

NCT05688436

Clinical

Trials by Indication[1]

Multiple Sclerosis4 trials

Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis

Completed· Johnson & Johnson logo

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

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

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

Show 1 more trial

Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Active, not recruiting· Biogen logo

Biogen··NCT05688436·1,178 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

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

3 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

Moderate-to-severe Chronic Plaque Psoriasis1 trial

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

Recruiting·VVanda Pharmaceuticals·Phase 3·NCT07362017·300 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

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

1 more patents

12728116Dec 24, 2044

Ponvory

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2028

Q3 2029

Q1 2031

Trials by Indication[1]

Multiple Sclerosis4 trials

Adult1 trial

Chronic GVHD1 trial

Female1 trial

Relapsing-Remitting Multiple Sclerosis1 trial

Oral1 trial

Moderate-to-severe Chronic Plaque Psoriasis1 trial

Ulcerative Colitis (UC)1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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