Ponesimod

Generic Name: Ponesimod

Brand Names: Ponvory

Drug Type: Small Molecule

Chemical Formula: C_₂₃H_₂₅ClN_₂O_₄S

CAS Number: 854107-55-4

Unique Ingredient Identifier: 5G7AKV2MKP

Background: Ponesimod is a selective sphingosine 1-phosphate receptor 1 modulator indicated in the treatment of relapsing forms of multiple sclerosis in adults. Ponesimod was developed out of a need for a more selective modulator of sphingosine 1-phosphate receptor 1 than fingolimod. Fingolimod's activity at sphingosine 1-phosphate receptor 3 was suspected to be responsible for a portion of it's adverse effects, and so more selective modulators were developed.

Ponesimod was granted FDA approval on 18 March 2021.

Indication: Ponesimod is indicated to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Associated Conditions: Relapsing Multiple Sclerosis (RMS), Relapsing Remitting Multiple Sclerosis (RRMS), Active Secondary Progressive Multiple Sclerosis (SPMS)

Clinical Trials

A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate

Recruiting

Conditions: Multiple Sclerosis

Interventions: Biological: Alemtuzumab
Drug: Diroximel Fumarate
Drug: Fingolimod
Drug: Glatiramer acetate
Biological: Interferon beta
Biological: Natalizumab
Biological: Ocrelizumab
Biological: Ofatumumab
Drug: Ozanimod
Biological: Peginterferon beta-1a
Drug: Ponesimod
Drug: Siponimod

First Posted Date: 2023-01-18

Last Posted Date: 2025-01-30

Lead Sponsor: Biogen

Target Recruit Count: 1178

Registration Number: NCT05688436

Locations: 🇺🇸
OptumInsight, Eden Prairie, Minnesota, United States

A Study of Ponesimod in Healthy Adult Participants

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Ponesimod
Drug: Carbamazepine

First Posted Date: 2022-09-23

Last Posted Date: 2025-04-27

Lead Sponsor: Janssen Pharmaceutica N.V., Belgium

Target Recruit Count: 28

Registration Number: NCT05552196

Locations: 🇧🇪
Clinical Pharmacology Unit, Merksem, Belgium

A Study of Ponesimod in Healthy Adult Participants Receiving Propranolol at Steady State

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: Ponesimod dose range (2 - 20 mg)
Drug: Placebo Propranolol
Drug: Propranolol 80 mg

First Posted Date: 2019-03-20

Last Posted Date: 2025-04-27

Lead Sponsor: Janssen Pharmaceutica N.V., Belgium

Target Recruit Count: 52

Registration Number: NCT03882255

Locations: 🇧🇪
SGS Clinical Pharmacology Unit (located in ZNA Stuivenberg), Antwerpen, Belgium

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

Phase 3

Completed

Conditions: Multiple Sclerosis

Interventions: Drug: Ponesimod

First Posted Date: 2017-07-27

Last Posted Date: 2025-04-25

Lead Sponsor: Actelion

Target Recruit Count: 877

Registration Number: NCT03232073

Locations: 🇫🇷
Hopital Nord Laennec - CHU NANTES, Nantes Cedex 1, France
🇵🇱
NEURO MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna, Katowice, Poland
🇵🇱
Centrum Opieki Zdrowotnej Orkan Med, Ksawerow, Poland

and more 145 locations

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®)

Phase 3

Terminated

Conditions: Multiple Sclerosis

Interventions: Drug: Ponesimod
Other: Placebo

First Posted Date: 2016-09-20

Last Posted Date: 2021-05-18

Lead Sponsor: Actelion

Target Recruit Count: 136

Registration Number: NCT02907177

Locations: 🇺🇸
Associated Neurologists, Danbury, Connecticut, United States
🇺🇸
Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, Torrance, California, United States
🇺🇸
OhioHealth Research Institute, Columbus, Ohio, United States

and more 116 locations

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

Phase 2

Terminated

Conditions: Chronic Graft Versus Host Disease

Interventions: Drug: Ponesimod

First Posted Date: 2015-06-03

Last Posted Date: 2025-02-04

Lead Sponsor: Actelion

Target Recruit Count: 1

Registration Number: NCT02461134

Locations: 🇺🇸
Fred Hutchinson Cancer Res CTR, Seattle, Washington, United States
🇺🇸
Virginia Piper Cancer Institute, Scottsdale, Arizona, United States
🇺🇸
Moore Cancer Center - UCSD, La Jolla, California, United States

and more 7 locations