[{"orgOrder":0,"company":"Glenmark Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Glenmark Pharmaceuticals Receives ANDA Approval for Fingolimod Capsules, 0.5 mg","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"June 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Zydus Lifesciences","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Zydus Cadila Receives US FDA Approval to Market Fingolimod Capsules & Verapamil HCl Injection","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"VYNE Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"VYNE Therapeutics Enrolls First Patient in Clinical Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"October 2021","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Announces U.S. Court of Appeals for the Federal Circuit (CAFC) Upholds Validity of GILENYA\u00ae (Fingolimod) Dosage Regimen Patent","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"VYNE Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"VYNE Therapeutics Announces Positive Phase 1b Efficacy Data for FMX114 from Phase 1b\/2a Trial for the Treatment of Mild-to-Moderate Atopic Dermatitis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"VYNE Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"VYNE Therapeutics Completes Enrollment in Phase 2a Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Plans to Petition the U.S. Court of Appeals for the Federal Circuit for Further Review to Uphold Validity of the Gilenya\u00ae (fingolimod) Dosing Regimen Patent","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"VYNE Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"VYNE Therapeutics Announces Results from its Phase 2a Trial of FMX114 for the Treatment of Mild-to-Moderate Atopic Dermatitis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase I\/ Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase I\/ Phase II"},{"orgOrder":0,"company":"Novartis Pharmaceuticals Corporation","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Novartis Plans To Petition The U.S. Supreme Court To Uphold Validity Of The Gilenya\u00ae (Fingolimod) Dosing Regimen Patent","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"SWITZERLAND","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Glenmark Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Glenmark Pharmaceuticals launches Fingolimod Capsules, 0.5 mg in the US","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"October 2022","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Cycle Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Multiple Sclerosis Patients in US Left Without Essential Patient Support Program Will Now Receive Equivalent Backing From Cycle Pharmaceuticals Following FDA\u2019s Approval of TASCENSO ODT\u00ae (fingolimod)","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"},{"orgOrder":0,"company":"Cycle Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Drug, Tascenso ODT\u00ae (fingolimod), Launched to Meet the Needs of Multiple Sclerosis Patients in the US Left Without Essential Patient Support","therapeuticArea":"Neurology","highestDevelopmentStatus":"Approved","country":"UNITED KINGDOM","productType":"Small molecule","productStatus":"Approved","date":"February 2023","url1":"","url2":"","graph1":"Neurology","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals for Fingolimod Hydrochloride
Tascenso (fingolimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
Tascenso (fingolimod) is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of MS, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
Fingolimod, an orally available immunomodulatory drug, is a sphingosine 1-phosphate receptor modulator used to treat patients with the relapsing-remitting form of multiple sclerosis (MS).
GILENYA (fingolimod) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults and children 10 years of age and older.
Mean reduction in ADSI score from baseline was -4.05 (-60.62% mean reduction) for FMX114 (tofacitinib) treated lesions compared to -3.48 (-51.32% mean reduction) for vehicle treated lesions at week 4 (p=0.228, OC, ITT).
Gilenya® (fingolimod), an oral, once-daily at 0.5mg and 0.25mg versus once-daily subcutaneous injections of glatiramer acetate 20mg in reducing disease activity over 12 months in patients with relapsing remitting multiple sclerosis (RRMS).
FMX114 (tofacitinib), is VYNE’s proprietary investigational combination gel formulation of tofacitinib and fingolimod, which has been designed to address both the source and cause of inflammation in AD.
FMX114, an investigational combination gel formulation of tofacitinib and fingolimod, demonstrated a statistically significant reduction in both absolute and percent change in ADSI score compared to vehicle at week 2.
HEC Pharma filed the ANDA to get generic version of Novartis' Gilenya® (fingolimod), in response to that Novartis filed litigation against ANDA filers for US Patent No. 9,187,405 and extend the validity of Gilenya till 2027.
FMX114 is VYNE’s proprietary investigational combination gel formulation of tofacitinib and fingolimod for the treatment of mild-to-moderate atopic dermatitis (AD).
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