Ponesimod

Overview

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

Title	Posted	Study ID	Phase	Status	Sponsor
A Study to Assess Pregnancy Outcomes in Women Exposed to Diroximel Fumarate	2023/01/18	NCT05688436	N/A	Recruiting	Biogen
A Study of Ponesimod in Healthy Adult Participants	2022/09/23	NCT05552196	Phase 1	Completed	Janssen Pharmaceutica N.V., Belgium
A Study of Ponesimod in Healthy Adult Participants Receiving Propranolol at Steady State	2019/03/20	NCT03882255	Phase 1	Completed	Janssen Pharmaceutica N.V., 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	2017/07/27	NCT03232073	Phase 3	Completed	Actelion
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®)	2016/09/20	NCT02907177	Phase 3	Terminated	Actelion
Clinical Study to Investigate the Biological Activity, Safety, Tolerability, and Pharmacokinetics of Ponesimod in Subjects With Symptomatic Chronic GVHD	2015/06/03	NCT02461134	Phase 2	Terminated	Actelion
Oral Ponesimod Versus Teriflunomide In Relapsing MUltiple Sclerosis	2015/04/24	NCT02425644	Phase 3	Completed	Actelion
Study to Evaluate the Pharmacokinetics, Tolerability, and Safety of ACT-128800 in Japanese and Caucasian Healthy Male and Female Subjects	2014/08/22	NCT02223832	Phase 1	Completed	Actelion
Study of the Electrocardiographic Effects of Ponesimod in Healthy Male and Female Subjects	2014/05/13	NCT02136888	Phase 1	Completed	Actelion
Mass Balance, Pharmacokinetics, and Metabolism of 14C-labeled ACT-128800 Administered to Healthy Male Subjects	2014/04/30	NCT02126956	Phase 1	Completed	Actelion

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
PONVORY	Janssen Pharmaceuticals, Inc	50458-720	ORAL	20 mg in 1 1	8/16/2023

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Ponvory	Laboratoires Juvisé Pharmaceuticals,149 Boulevard Bataille de Stalingrad,69100 Villeurbanne,FRANCE	Authorised	5/19/2021

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
PONVORY ponesimod 2 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7 mg, 8 mg, 9 mg, 10 mg film-coated tablet (Treatment initiation pack) blister composite pack	370320	Janssen-Cilag Pty Ltd	Medicine	A	3/11/2022
PONVORY ponesimod 20 mg film-coated tablet blister pack	370319	Janssen-Cilag Pty Ltd	Medicine	A	3/11/2022

AI-Powered Research

Premium Access