Synopsis
Synopsis
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EU WC
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KDMF
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NDC API
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VMF
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USP
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JP
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South Africa
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1. 5-(3-chloro-4-(2,3-dihydroxy-propoxy)benzylidene)-2-propylimino-3-o-tolyl-thiazolidin-4-one
2. Act 128800
3. Act-128800
4. Act128800
5. Ponvory
1. 854107-55-4
2. Act-128800
3. Ponvory
4. 5g7akv2mkp
5. Chembl1096146
6. Act128800
7. (2z,5z)-5-(3-chloro-4-((2r)-2,3-dihydroxypropoxy)phenylmethylidene)-3-(2-methylphenyl)-2-(propylimino)-1,3-thiazolidin-4-one
8. (5z)-5-[[3-chloro-4-[(2r)-2,3-dihydroxypropoxy]phenyl]methylidene]-3-(2-methylphenyl)-2-propylimino-1,3-thiazolidin-4-one
9. (z)-5-((z)-3-chloro-4-((r)-2,3-dihydroxypropoxy)benzylidene)-2-(propylimino)-3-(o-tolyl)thiazolidin-4-one
10. Unii-5g7akv2mkp
11. Ponesimod [inn]
12. (2z,5z)-5-(3-chloro-4-((r)-2,3-dihydroxypropoxy)benzylidene)-2-(propylimino)-3-(o-tolyl)thiazolidin-4-one
13. 4-thiazolidinone, 5-[[3-chloro-4-[(2r)-2,3-dihydroxypropoxy]phenyl]methylene]-3-(2-methylphenyl)-2-(propylimino)-, (2z,5z)-
14. Ponesimod [usan:inn]
15. 4-thiazolidinone, 5-((3-chloro-4-((2r)-2,3-dihydroxypropoxy)phenyl)methylene)-3-(2-methylphenyl)-2-(propylimino)-, (2z,5z)-
16. Act 128800
17. Ponesimod (usan/inn)
18. Ponesimod [usan]
19. Ponesimod [who-dd]
20. Ponesimod,act-128800
21. Gtpl9320
22. Ponesimod (act-128800)
23. Ponesimod [orange Book]
24. Schembl15477934
25. Schembl15477937
26. Dtxsid50234631
27. Amy23424
28. Enb-0040
29. Ex-a1417
30. Bdbm50316768
31. Mfcd18207776
32. S8241
33. Zinc34509627
34. At27979
35. Ccg-269345
36. Compound 8bo [pmid:20446681]
37. Db12016
38. Ac-30921
39. As-35140
40. Bp175283
41. Hy-10569
42. D11215
43. (2z,5z)-5-(3-chloro-4-((2r)-2,3-dihydroxypropoxy)benzylidene)-3-(2-methylphenyl)-2-(propylimino)-1,3-thiazolidin-4-one
44. (z,z)-5-[3-chloro-4-((2s)-2,3-dihydroxy-propoxy)-benzylidene]-2-propylimino-3-otolyl-thiazolidin-4-one
45. 4-thiazolidinone,5-[[3-chloro-4-[(2r)-2,3-dihydroxypropoxy]phenyl]methylene]-3-(2-methylphenyl)-2-(propylimino)-,(2z,5z)-
46. 5-(3-chloro-4-(((2r)-2,3-dihydroxypropyl)oxy)benz-(z)-ylidene)-2-((z)-propylimino)-3-(o-tolyl)thiazolidin-4-one
47. 5-(3-chloro-4-(2,3-dihydroxy-propoxy)benzylidene)-2-propylimino-3-o-tolyl-thiazolidin-4-one
Molecular Weight | 461.0 g/mol |
---|---|
Molecular Formula | C23H25ClN2O4S |
XLogP3 | 4.6 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 6 |
Rotatable Bond Count | 8 |
Exact Mass | 460.1223562 g/mol |
Monoisotopic Mass | 460.1223562 g/mol |
Topological Polar Surface Area | 108 Ų |
Heavy Atom Count | 31 |
Formal Charge | 0 |
Complexity | 674 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 1 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 1 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Ponesimod is indicated to treat adults with relapsing forms of multiple sclerosis, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.
Ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.
Ponesimod is a sphingosine 1-phosphate receptor 1 modulator indicated to treat adults with relapsing forms of multiple sclerosis. It has a long duration of action as it is given once daily. Patients should be counselled about the risk of infections, bradyarrhythmia, atrioventricular conduction delays, decreased respiratory function, liver injury, increased blood pressure, cutaneous malignancies, fetal harm, and macular edema.
Sphingosine 1 Phosphate Receptor Modulators
Agents that affect the function of G-protein coupled SPHINGOSINE 1-PHOSPHATE RECEPTORS. Their binding to the receptors blocks lymphocyte migration and are often used as IMMUNOSUPPRESSANTS. (See all compounds classified as Sphingosine 1 Phosphate Receptor Modulators.)
L04AA
L - Antineoplastic and immunomodulating agents
L04 - Immunosuppressants
L04A - Immunosuppressants
L04AA - Selective immunosuppressants
L04AA50 - Ponesimod
Absorption
A 10mg oral dose of ponesimod is 84% bioavailable. Ponesimod reaches a Cmax of 109 ng/mL, with a Tmax of 4.0 hours, and an AUC of 3872 h\*ng/mL.
Route of Elimination
57.3-79.6% of a radiolabelled oral dose is recovered in the feces, with 16-26% as the unmetabolized parent compound and 22% as the M12 metabolite. 10.3-18.4% of an oral dose is eliminated in the urine. 0.6-1.9% of a radiolabelled dose was recovered as expired CO2.
Volume of Distribution
The volume of distribution of ponesimod at steady state is 160 L.
Clearance
The clearance of ponesimod is 3.8 L/h.
Ponesimod can be sulfated to the M5 metabolite, oxidized to an undefined M27 metabolite, reduced to the M6 metabolite, dealkylated to the M32 metabolite, or oxidized and hydrolyzed to the M13 metabolite. Ponesimod can also be oxidized by CYP2J2, CYP3A4, CYP3A5, CYP4F3A, and CYP4F12 to the M12 metabolite. The undefined M27 metabolite can be glucuronidated by UGT1A1 and UGT 2B7 to the M38, M39, and M40 metabolites. The M12 metabolite is either dealkylated to the M32 metabolite or oxidized and hydrolyzed to M13. M13 is dealkylated to M32, which is reduced and oxidized to M48.
Ponesimod has an elimination half life of 33 hours.
The sphingosine 1-phosphate receptor 1 (S1P1R) is expressed on the surface of lymphocytes and detects sphingosine 1-phosphate (S1P) at nanomolar concentrations. S1P is a metabolite of the cell membrane component, sphingomyelin. As sphingomyelin degrades, lymphocytes respond to agonism of S1P1R by concentration gradients of S1P. Lymphocytes leave the lymphoid organs in response to higher concentrations of S1P in blood and lymph. Ponesimod modulates this response by stimulating and internalizing S1P1R on lymphocytes, effectively blinding them to concentration gradients of S1P, reducing the number of lymphocytes in blood. Ponesimod is roughly 650 times more selective for S1P1R than S1P.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
About the Company : Established in 2004, Metrochem API is one of the fastest-growing APIs, pellets & intermediates manufacturers. It has 6 dedicated manufacturing facilities for its 3 core product gro...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
About the Company : Saptagir Laboratories Private incorporated in 2016, is a manufacturer and supplier of Active Pharmaceutical Ingredients (APIs) and Intermediates for a wide range of therapeutic cat...
About the Company : Sichuan Taienkang Pharmaceutical Co., Ltd., established in 2020, is a subsidiary of Guangdong Taienkang Pharmaceutical Co., Ltd. The company specializes in the R&D, production, and...
Details:
Ponvory(ponesimod), an oral S1P1R modulator, whch has been approved for active forms of relapsing multiple sclerosis in adults.
Lead Product(s): Ponesimod,Inapplicable
Therapeutic Area: Neurology Brand Name: Ponvory
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 30, 2024
Lead Product(s) : Ponesimod,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Vanda Announces Completion of Transfer of FDA Marketing Authorization for PONVORY®
Details : Ponvory(ponesimod), an oral S1P1R modulator, whch has been approved for active forms of relapsing multiple sclerosis in adults.
Product Name : Ponvory
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 30, 2024
Details:
Juvise Pharmaceuticals will leverage its expertise to commercialize Ponvory (ponesimod), a first-line treatment option for active forms of relapsing multiple sclerosis outside of North America.
Lead Product(s): Ponesimod,Inapplicable
Therapeutic Area: Neurology Brand Name: Ponvory
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Juvise Pharmaceuticals
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Acquisition March 26, 2024
Lead Product(s) : Ponesimod,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Juvise Pharmaceuticals
Deal Size : Undisclosed
Deal Type : Acquisition
Juvisé Pharmaceuticals Acquires Ponvory® Ex-US/Canada and Opens Capital To Bpifrance
Details : Juvise Pharmaceuticals will leverage its expertise to commercialize Ponvory (ponesimod), a first-line treatment option for active forms of relapsing multiple sclerosis outside of North America.
Product Name : Ponvory
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
March 26, 2024
Details:
Through the acquisition, Vanda expands its commercial portfolio by including Ponvory (ponesimod), a daily oral selective sphingosine-1-phosphate receptor 1 (S1P1R) modulator, indicated to treat adults with relapsing forms of multiple sclerosis.
Lead Product(s): Ponesimod,Inapplicable
Therapeutic Area: Neurology Brand Name: Ponvory
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Vanda Pharmaceuticals
Deal Size: $100.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition July 12, 2023
Lead Product(s) : Ponesimod,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Vanda Pharmaceuticals
Deal Size : $100.0 million
Deal Type : Acquisition
Vanda Pharmaceuticals Acquires U.S. and Canadian Rights to PONVORY® (ponesimod), a Selective S1P1...
Details : Through the acquisition, Vanda expands its commercial portfolio by including Ponvory (ponesimod), a daily oral selective sphingosine-1-phosphate receptor 1 (S1P1R) modulator, indicated to treat adults with relapsing forms of multiple sclerosis.
Product Name : Ponvory
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
July 12, 2023
Details:
Undisclosed
Lead Product(s): Ponesimod,Carbamazepine
Therapeutic Area: Undisclosed Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 23, 2022
Lead Product(s) : Ponesimod,Carbamazepine
Therapeutic Area : Undisclosed
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
A Study of Ponesimod in Healthy Adult Participants
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 23, 2022
Details:
The trial was designed to evaluate the efficacy and safety of once daily oral ponesimod 20mg vs. once per day teriflunomide 14mg, an approved first-line oral treatment, in adult patients with RMS. In total, 1,133 adult patients were randomised at 162 sites in 28 countries.
Lead Product(s): Ponesimod,Inapplicable
Therapeutic Area: Neurology Brand Name: Ponvory
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable October 13, 2021
Lead Product(s) : Ponesimod,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
New Subgroup Analysis of the Phase 3 OPTIMUM Study Demonstrates the Benefits of PONVORYTM▼ (Pone...
Details : The trial was designed to evaluate the efficacy and safety of once daily oral ponesimod 20mg vs. once per day teriflunomide 14mg, an approved first-line oral treatment, in adult patients with RMS. In total, 1,133 adult patients were randomised at 162 sit...
Product Name : Ponvory
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
October 13, 2021
Details:
PONVORY™, a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, approved to treat adults with relapsing forms of MS in both the United States and European Union earlier this year.
Lead Product(s): Ponesimod,Inapplicable
Therapeutic Area: Neurology Brand Name: Ponvory
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 29, 2021
Lead Product(s) : Ponesimod,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : PONVORY™, a once-daily oral selective sphingosine-1-phosphate receptor 1 (S1P1) modulator, approved to treat adults with relapsing forms of MS in both the United States and European Union earlier this year.
Product Name : Ponvory
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 29, 2021
Details:
Within the OPTIMUM study, overall, the number of treatment-emergent adverse events reported was similar between the ponesimod and teriflunomide treated groups, and the majority were mild/moderate and did not warrant treatment discontinuation.
Lead Product(s): Ponesimod,Inapplicable
Therapeutic Area: Neurology Brand Name: Ponvory
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 24, 2021
Lead Product(s) : Ponesimod,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EC Approves PONVORYTM for the Treatment of Adults with Relapsing Forms of Multiple Sclerosis
Details : Within the OPTIMUM study, overall, the number of treatment-emergent adverse events reported was similar between the ponesimod and teriflunomide treated groups, and the majority were mild/moderate and did not warrant treatment discontinuation.
Product Name : Ponvory
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 24, 2021
Details:
Positive opinion is based on the pivotal Phase 3 OPTIMUM study evaluating the efficacy and safety of ponesimod vs. teriflunomide, an active comparator and oral standard of care treatment in adult patients with relapsing multiple sclerosis.
Lead Product(s): Ponesimod,Inapplicable
Therapeutic Area: Neurology Brand Name: Ponvory
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 26, 2021
Lead Product(s) : Ponesimod,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Positive opinion is based on the pivotal Phase 3 OPTIMUM study evaluating the efficacy and safety of ponesimod vs. teriflunomide, an active comparator and oral standard of care treatment in adult patients with relapsing multiple sclerosis.
Product Name : Ponvory
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 26, 2021
Details:
Head-to-head pivotal clinical trial results showed PONVORY™ treatment led to nearly a third fewer annual relapses than teriflunomide. PONVORY™ is the first and only FDA-approved oral disease modifying therapy studied against an established oral comparator.
Lead Product(s): Ponesimod,Inapplicable
Therapeutic Area: Neurology Brand Name: Ponvory
Study Phase: Approved FDFProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 19, 2021
Lead Product(s) : Ponesimod,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Head-to-head pivotal clinical trial results showed PONVORY™ treatment led to nearly a third fewer annual relapses than teriflunomide. PONVORY™ is the first and only FDA-approved oral disease modifying therapy studied against an established oral compa...
Product Name : Ponvory
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 19, 2021
Details:
Head-to-head OPTIMUM Phase 3 study showed superior efficacy of ponesimod 20 mg on the primary endpoint as well as most secondary endpoints, compared to Aubagio® (teriflunomide).
Lead Product(s): Ponesimod,Inapplicable
Therapeutic Area: Neurology Brand Name: Ponvory
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 18, 2020
Details : Head-to-head OPTIMUM Phase 3 study showed superior efficacy of ponesimod 20 mg on the primary endpoint as well as most secondary endpoints, compared to Aubagio® (teriflunomide).
Product Name : Ponvory
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
March 18, 2020
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PharmaCompass offers a list of Ponesimod API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Ponesimod manufacturer or Ponesimod supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ponesimod manufacturer or Ponesimod supplier.
PharmaCompass also assists you with knowing the Ponesimod API Price utilized in the formulation of products. Ponesimod API Price is not always fixed or binding as the Ponesimod Price is obtained through a variety of data sources. The Ponesimod Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ponesimod manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ponesimod, including repackagers and relabelers. The FDA regulates Ponesimod manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ponesimod API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Ponesimod manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ponesimod supplier is an individual or a company that provides Ponesimod active pharmaceutical ingredient (API) or Ponesimod finished formulations upon request. The Ponesimod suppliers may include Ponesimod API manufacturers, exporters, distributors and traders.
click here to find a list of Ponesimod suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
Ponesimod Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Ponesimod GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Ponesimod GMP manufacturer or Ponesimod GMP API supplier for your needs.
A Ponesimod CoA (Certificate of Analysis) is a formal document that attests to Ponesimod's compliance with Ponesimod specifications and serves as a tool for batch-level quality control.
Ponesimod CoA mostly includes findings from lab analyses of a specific batch. For each Ponesimod CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Ponesimod may be tested according to a variety of international standards, such as European Pharmacopoeia (Ponesimod EP), Ponesimod JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ponesimod USP).