[{"orgOrder":0,"company":"Ipsen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ipsen\u2019s palovarotene clinical program in fibrodysplasia ossificans progressiva reaches prespecified interim analysis futility criteria","therapeuticArea":"Musculoskeletal","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2020","url1":"","url2":"","graph1":"Musculoskeletal","graph2":"Phase III"},{"orgOrder":0,"company":"Ipsen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ipsen Demonstrates Continued Commitment to Rare Diseases with Eight Abstracts Accepted at ENDO 2020","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Ipsen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ipsen to Present Results from Move, the First Global Phase III Trial in Fibrodysplasia Ossificans Progressiva (fop), at Asbmr 2020","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Ipsen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ipsen To Present New Insights at ASBMR For Potential Treatment of Ultra-Rare Disease Fibrodysplasia Ossificans Progressiva, Including Global Phase III MOVE Trial Results","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"September 2020","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Ipsen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"FDA Accepts Ipsen\u2019s Nda for Ultra-Rare Genetic Disorder Drug","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase III","country":"FRANCE","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2021","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase III"},{"orgOrder":0,"company":"Ipsen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Health Canada Approves Ipsen\u2019s Sohonos (palovarotene capsules) as the First Approved Treatment for Fibrodysplasia Ossificans Progressiva","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"January 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Ipsen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ipsen Announces U.S. FDA Priority Review for Palovarotene New Drug Application in Patients with Fibrodysplasia Ossificans Progressiva Following Resubmission","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"June 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Ipsen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ipsen Receives Complete Response Letter for Palovarotene, an Investigational Treatment for Fibrodysplasia Ossificans Progressiva","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Ipsen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ipsen Receives New FDA PDUFA Date for Investigational Palovarotene for The Treatment of People With FOP","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Approved","country":"FRANCE","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Approved"},{"orgOrder":0,"company":"Ipsen","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not 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Find Clinical Drug Pipeline Developments & Deals for Palovarotene
Sohonos (palovarotene) is a selective agonist of RARγ, a receptor expressed in chondrogenic cells and chondrocytes that acts as a transcriptional repressor, which is investigated for the treatment of fibrodysplasia ossificans progressiva.
Sohonos (palovarotene) is a selective agonist of RARγ, a receptor expressed in chondrogenic cells and chondrocytes that acts as a transcriptional repressor. Palovarotene is the first medicine to be submitted for regulatory approval for fibrodysplasia ossificans progressiva.
Sohonos (palovarotene) is a selective agonist of RARγ, a receptor expressed in chondrogenic cells and chondrocytes that acts as a transcriptional repressor. It decreases BMP signaling and subsequently inhibits the SMAD1/5/8 signaling pathway.
Palovarotene is authorized for use in appropriate patients in Canada and United Arab Emirates where it is marketed as SohonosTM (palovarotene capsules).4 Investigational palovarotene is under review with a number of regulatory authorities.
Sohonos (palovarotene) is an oral investigational, selective retinoic-acid receptor gamma (RARγ) agonist being developed as a potential treatment for people living with the debilitating ultra-rare genetic disorder fibrodysplasia ossificans progressiva (FOP).
Sohonos (palovarotene), an oral selective retinoic-acid receptor gamma (RARγ) agonist approved by Health Canada indicated to reduce the formation of heterotopic ossification in adults and children with fibrodysplasia ossificans progressiva.
Analysis of the primary endpoint data demonstrated a 62% reduction in mean annualised new HO volume in participants treated with palovarotene versus untreated participants from a natural-history study.
Post hoc analyses showed substantial reduction (62%) in mean annualized new heterotopic ossification volume in patients with FOP who were treated with oral investigational therapy palovarotene.
The data include a first-of-its kind study highlighting one-year data on the natural progression of FOP and the impact of heterotopic ossification (HO) on patients’ physical functioning over time.
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