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{{Short description|Medication for the treatment of multiple sclerosis}}
{{Use dmy dates|date=December 2023}}
{{cs1 config |name-list-style=vanc |display-authors=6}}
{{Infobox drug
| image = Ponesimod.svg
| width = 190
| alt = 
| image2 = Ponesimod ball-and-stick model.png
| alt2 = 
| caption = 

<!-- Clinical data -->
| pronounce         = 
| tradename         = Ponvory
| Drugs.com         = {{drugs.com|cons|ponesimod}}
| MedlinePlus       = 
| DailyMedID        = Ponesimod
| pregnancy_AU      = D
| pregnancy_AU_comment = <ref name="Ponvory APMDS" /><ref>{{cite web | title=Updates to the Prescribing Medicines in Pregnancy database | website=Therapeutic Goods Administration (TGA) | date=21 December 2022 | url=https://www.tga.gov.au/resources/resource/guidance/updates-prescribing-medicines-pregnancy-database | access-date=2 January 2023}}</ref>
| pregnancy_category= 
| routes_of_administration = [[Oral administration|By mouth]]
| class             = 
| ATC_prefix        = L04
| ATC_suffix        = AE04
| ATC_supplemental  = 

<!-- Legal status -->
| legal_AU          = S4
| legal_AU_comment  = <ref name="Ponvory APMDS">{{cite web | title=Ponvory APMDS | website=Therapeutic Goods Administration (TGA) | date=24 March 2022 | url=https://www.tga.gov.au/resources/auspmd/ponvory | access-date=4 April 2022}}</ref>
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| legal_BR_comment  = 
| legal_CA                 = Rx-only
| legal_CA_comment         = <ref>{{cite web | title=Summary Basis of Decision (SBD) for Ponvory | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00546&lang=en | access-date=29 May 2022 | archive-date=30 May 2022 | archive-url=https://web.archive.org/web/20220530033736/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00546&lang=en | url-status=live }}</ref>
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| legal_UK_comment  = 
| legal_US          = Rx-only
| legal_US_comment  = <ref name="Ponvory FDA label">{{cite web | title=Ponvory- ponesimod tablet, film coated Ponvory- ponesimod kit | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5be69660-738c-4db7-b0d4-517aa873dc41 | access-date=31 March 2021 | archive-date=21 January 2022 | archive-url=https://web.archive.org/web/20220121025449/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5be69660-738c-4db7-b0d4-517aa873dc41 | url-status=live }}</ref>
| legal_EU          = Rx-only
| legal_EU_comment  = <ref name="Ponvory EPAR" /><ref>{{cite web | title=Ponvory Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1550.htm | access-date=3 March 2023}}</ref>
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<!-- Pharmacokinetic data -->
| bioavailability = 
| protein_bound = 
| metabolism = 2 main metabolites
| metabolites       = 
|  elimination_half-life = 31–34 hrs<ref name="Brossard" />
| duration_of_action = 
| excretion = Feces (57–80%, 26% unchanged), urine (10–18%)<ref name="Reyes" />

<!-- Identifiers -->
| CAS_number = 854107-55-4
| CAS_supplemental  = 
| PubChem = 11363176
| IUPHAR_ligand     = 
| DrugBank          = DB12016
| ChemSpiderID = 9538103
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| KEGG = D11215
| ChEBI             = 
| ChEMBL = 1096146
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| synonyms = ACT-128800

<!-- Chemical data -->
| IUPAC_name = (2''Z'',5''Z'')-5-{3-Chloro-4-[(2''R'')-2,3-dihydroxypropoxy]benzylidene}-3-(2-methylphenyl)-2-(propylimino)-1,3-thiazolidin-4-one
| C=23 | H=25 | Cl=1 | N=2 | O=4 | S=1
| SMILES = CCC/N=C\1/N(C(=O)/C(=C/C2=CC(=C(C=C2)OC[C@@H](CO)O)Cl)/S1)C3=CC=CC=C3C
| StdInChI=1S/C23H25ClN2O4S/c1-3-10-25-23-26(19-7-5-4-6-15(19)2)22(29)21(31-23)12-16-8-9-20(18(24)11-16)30-14-17(28)13-27/h4-9,11-12,17,27-28H,3,10,13-14H2,1-2H3/b21-12-,25-23-/t17-/m1/s1
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}}

'''Ponesimod''', sold under the brand name '''Ponvory''', is a [[medication]] for the treatment of [[multiple sclerosis]].<ref name="Ponvory FDA label" /><ref name="Janssen PR">{{cite press release | title=Janssen Announces U.S. FDA Approval of Ponvory (ponesimod), an Oral Treatment for Adults with Relapsing Multiple Sclerosis Proven Superior to Aubagio (teriflunomide) in Reducing Annual Relapses and Brain Lesions | publisher=Janssen | via=PR Newswire | date=19 March 2021 | url=https://www.prnewswire.com/news-releases/janssen-announces-us-fda-approval-of-ponvory-ponesimod-an-oral-treatment-for-adults-with-relapsing-multiple-sclerosis-proven-superior-to-aubagio-teriflunomide-in-reducing-annual-relapses-and-brain-lesions-301250985.html | access-date=19 March 2021 | archive-date=19 March 2021 | archive-url=https://web.archive.org/web/20210319122225/https://www.prnewswire.com/news-releases/janssen-announces-us-fda-approval-of-ponvory-ponesimod-an-oral-treatment-for-adults-with-relapsing-multiple-sclerosis-proven-superior-to-aubagio-teriflunomide-in-reducing-annual-relapses-and-brain-lesions-301250985.html | url-status=live }}</ref> It is a [[sphingosine-1-phosphate receptor modulator]].<ref name="Ponvory FDA label" />

The most common side effects include upper respiratory tract infection, hepatic transaminase elevation, and hypertension.<ref name="Ponvory FDA label" /><ref name="Ponvory EPAR" /><ref name="Janssen PR" />

Ponesimod was approved for medical use in the United States in March 2021,<ref name="Ponvory FDA label" /><ref name="Janssen PR" /> and in the European Union in June 2021.<ref>{{cite web|title=European Medicines Agency Approval of Ponesimod|date=24 March 2021 |url=https://www.ema.europa.eu/en/medicines/human/EPAR/ponvory|url-status=live|access-date=4 August 2021|archive-date=4 August 2021|archive-url=https://web.archive.org/web/20210804184458/https://www.ema.europa.eu/en/medicines/human/EPAR/ponvory}}</ref>

== Medical uses ==
Ponesimod is [[indicated]] for the treatment of relapsing forms of multiple sclerosis including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.<ref name="Ponvory FDA label" /><ref name="Ponvory EPAR" />

==Adverse effects==
Common adverse effects in studies were temporary [[bradycardia]] (slow heartbeat), usually at the beginning of the treatment, [[dyspnoea]] (breathing difficulties), and increased [[liver enzymes]] (without symptoms). No significant increase of infections was observed under ponesimod therapy.<ref name="Spreitzer" /> [[QT prolongation]] is detectable but was considered to be too low to be of clinical importance in a study.<ref name="Hoch" />

==Mechanism of action==
Like [[fingolimod]], which is already approved for the treatment of multiple sclerosis, ponesimod blocks the [[sphingosine-1-phosphate receptor]]. This mechanism prevents [[lymphocyte]]s (a type of white blood cells) from leaving [[lymph node]]s.<ref name="Spreitzer" /> Ponesimod is selective for subtype 1 of this receptor, [[S1PR1|S1P<sub>1</sub>]].<ref name="Actelion" />

== History ==
=== Clinical trials ===
In a 2009–2011 [[Phase II clinical trial]] including 464 multiple sclerosis patients, ponesimod treatment resulted in fewer new active brain [[lesions]] than [[placebo]], measured during the course of 24 weeks.<ref name="Spreitzer" /><ref name="Olsson" />

In a 2010–2012 Phase II clinical trial including 326 patients with psoriasis, 46 or 48% of patients (depending on dosage) had a reduction of at least 75% [[Psoriasis Area and Severity Index]] (PASI) score compared to placebo in 16 weeks.<ref name="Spreitzer" /><ref name="Vaclavkova" /> The approval is already applied for in 2020.<ref>{{cite web|date=6 July 2020|title=Ozanimod bei schubförmiger MS zugelassen|url=https://www.amsel.de/multiple-sklerose-news/medizin/ozanimod-bei-schubfoermiger-ms-zugelassen/|access-date=3 October 2020|website=Multiple Sklerose News – AMSEL|language=de|archive-date=26 October 2020|archive-url=https://web.archive.org/web/20201026212638/https://www.amsel.de/multiple-sklerose-news/medizin/ozanimod-bei-schubfoermiger-ms-zugelassen/|url-status=live}}</ref>

In a 2015–2019 Phase III randomised, double-blind clinical trial of 1133 adult patients with [[relapsing]] multiple sclerosis, those under ponesimod treatment showed a 30% reduction in annual relapse rate and a significantly reduced number of new inflammatory lesions on brain [[Magnetic resonance imaging|MRI]] by 56% compared to those taking [[teriflunomide]].<ref>{{cite web|title=Europe Approves Ponvory Ponesimod for Multiple Sclerosis|url=https://www.europeanpharmaceuticalreview.com/news/155150/europe-approves-ponvory-ponesimod-for-multiple-sclerosis/|url-status=live|access-date=4 August 2021|archive-date=4 August 2021|archive-url=https://web.archive.org/web/20210804185342/https://www.europeanpharmaceuticalreview.com/news/155150/europe-approves-ponvory-ponesimod-for-multiple-sclerosis/}}</ref>

In October 2020, Janseen-Cilag International NV submitted an application for the modification of agreed pediatric investigation plan (PIP) to European Medicines Agency (including deferral and waiver criteria). This application was launched for the amendments of proposed changes against the European Medicines Agency’s decisions issued in November 2012 and April 2018. The approved procedure has already started in December 2022. To evaluate pharmacodynamics and pharmacokinetics efficacy of ponesimod in pediatric patients with relapsing-remitting multiple sclerosis (RRMS); a multicenter, randomized, double blind clinical study of duration of 108 weeks treatment for age group 10 to less than 18 years, is in progress. The clinical trial will end in November 2027.<ref>{{cite web |last=EMA |date=17 September 2018 |title=EMEA-000798-PIP01-09-M03 |url=https://www.ema.europa.eu/en/medicines/human/paediatric-investigation-plans/emea-000798-pip01-09-m03 |access-date=12 June 2023 |website=European Medicines Agency |language=en}}</ref><ref>{{cite journal | vauthors = Rose K, Müller T | title = Children with multiple sclerosis should not become therapeutic hostages | journal = Therapeutic Advances in Neurological Disorders | volume = 9 | issue = 5 | pages = 389–395 | date = September 2016 | pmid = 27582894 | pmc = 4994785 | doi = 10.1177/1756285616656592 }}</ref>

== Society and culture ==

=== Legal status ===
In March 2021, the [[Committee for Medicinal Products for Human Use]] (CHMP) of the [[European Medicines Agency]] (EMA) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ponvory, intended for the treatment of active relapsing forms of multiple sclerosis.<ref name="Ponvory: Pending EC decision" /> The applicant for this medicinal product is Janssen-Cilag International N.V.<ref name="Ponvory: Pending EC decision">{{cite web | title=Ponvory: Pending EC decision | website=[[European Medicines Agency]] (EMA) | date=25 March 2021 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/ponvory | access-date=27 March 2021 | archive-date=26 March 2021 | archive-url=https://web.archive.org/web/20210326190838/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/ponvory | url-status=live }}</ref> Ponesimod was approved for medical use in the European Union in May 2021.<ref name="Ponvory EPAR">{{cite web | title=Ponvory EPAR | website=[[European Medicines Agency]] (EMA) | date=24 March 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/ponvory | access-date=18 December 2021 | archive-date=19 March 2022 | archive-url=https://web.archive.org/web/20220319221017/https://www.ema.europa.eu/en/medicines/human/EPAR/ponvory | url-status=live }}</ref>

== References ==
{{reflist|refs=
<ref name="Reyes">{{cite journal | vauthors = Reyes M, Hoch M, Brossard P, Wagner-Redeker W, Miraval T, Dingemanse J | title = Mass balance, pharmacokinetics and metabolism of the selective S1P1 receptor modulator ponesimod in humans | journal = Xenobiotica; the Fate of Foreign Compounds in Biological Systems | volume = 45 | issue = 2 | pages = 139–149 | date = February 2015 | pmid = 25188442 | doi = 10.3109/00498254.2014.955832 | s2cid = 23905158 }}</ref>
<ref name="Brossard">{{cite journal | vauthors = Brossard P, Scherz M, Halabi A, Maatouk H, Krause A, Dingemanse J | title = Multiple-dose tolerability, pharmacokinetics, and pharmacodynamics of ponesimod, an S1P1 receptor modulator: favorable impact of dose up-titration | journal = Journal of Clinical Pharmacology | volume = 54 | issue = 2 | pages = 179–188 | date = February 2014 | pmid = 24408162 | doi = 10.1002/jcph.244 | s2cid = 38041837 | doi-access = free }}</ref>
<ref name="Spreitzer">{{cite journal | vauthors = Spreitzer H | date = 29 September 2014 | title = Neue Wirkstoffe – Ponesimod | journal = Österreichische Apothekerzeitung | issue = 20/2014 | pages = 42 | language = German }}</ref>
<ref name="Actelion">{{cite web|url=http://www1.actelion.com/sites/en/scientists/development-pipeline/phase-2/ponesimod.page|title=Ponesimod|publisher=Actelion|access-date=31 October 2014|url-status=dead|archive-url=https://web.archive.org/web/20111203112835/http://www1.actelion.com/sites/en/scientists/development-pipeline/phase-2/ponesimod.page|archive-date=3 December 2011}}</ref>
<ref name="Olsson">{{cite journal | vauthors = Olsson T, Boster A, Fernández Ó, Freedman MS, Pozzilli C, Bach D, Berkani O, Mueller MS, Sidorenko T, Radue EW, Melanson M | title = Oral ponesimod in relapsing-remitting multiple sclerosis: a randomised phase II trial | journal = Journal of Neurology, Neurosurgery, and Psychiatry | volume = 85 | issue = 11 | pages = 1198–1208 | date = November 2014 | pmid = 24659797 | pmc = 4215282 | doi = 10.1136/jnnp-2013-307282 }}</ref>
<ref name="Vaclavkova">{{cite journal | vauthors = Vaclavkova A, Chimenti S, Arenberger P, Holló P, Sator PG, Burcklen M, Stefani M, D'Ambrosio D | title = Oral ponesimod in patients with chronic plaque psoriasis: a randomised, double-blind, placebo-controlled phase 2 trial | journal = Lancet | volume = 384 | issue = 9959 | pages = 2036–2045 | date = December 2014 | pmid = 25127208 | doi = 10.1016/S0140-6736(14)60803-5 | s2cid = 20452934 }}</ref>
<ref name="Hoch">{{cite journal | vauthors = Hoch M, Darpo B, Brossard P, Zhou M, Stoltz R, Dingemanse J | title = Effect of ponesimod, a selective S1P1 receptor modulator, on the QT interval in healthy individuals | journal = Basic & Clinical Pharmacology & Toxicology | volume = 116 | issue = 5 | pages = 429–437 | date = May 2015 | pmid = 25287214 | doi = 10.1111/bcpt.12336 | doi-access =  | s2cid = 10426898 }}</ref>
}}

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[[Category:Immunosuppressants]]
[[Category:Multiple sclerosis]]
[[Category:Thiazolidines]]
[[Category:2-Tolyl compounds]]
[[Category:Propyl compounds]]
[[Category:S1P receptor modulators]]

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