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Inapplicable"},{"orgOrder":0,"company":"PANTHERx Rare Pharmacy","sponsor":"Inapplicable","pharmaFlowCategory":"DU","therapeuticArea":"Rare Diseases and Disorders","country":"U.S.A","productType":"Other Small Molecule","year":"2023","type":"Inapplicable","leadProduct":"Leniolisib Phosphate","moa":"PI3K-delta","graph1":"Rare Diseases and Disorders","graph2":"Approved FDF","graph3":"PANTHERx Rare Pharmacy","amount2":0,"highestDevelopmentShortName":"","therapeuticAreaShortName":"Rare Diseases","amount2New":0,"dosageForm":"Oral Capsule","sponsorNew":"PANTHERx Rare Pharmacy \/ Inapplicable","highestDevelopmentStatusID":"15","companyTruncated":"PANTHERx Rare Pharmacy \/ Inapplicable"}]

    Find Clinical Drug Pipeline Developments & Deals for Leniolisib Phosphate

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    Pharming

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    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Immunology

    Study Phase : Phase II/ Phase III

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Pharming Group Begins Phase II Leniolisib Trial for CVID Treatment

    Details : Joenja (leniolisib) is an oral small molecule PI3K delta inhibitor, which is currently being evaluated for the treatment of common variable immunodeficiency (CVID) with immune dysregulation.

    Product Name : Joenja

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    March 20, 2025

    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Immunology

    Highest Development Status : Phase II/ Phase III

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Pharming

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    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Rare Diseases and Disorders

    Study Phase : Phase III

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Pharming Announces Positive Topline Data in Pediatric Clinical Trial of Leniolisib

    Details : Joenja (leniolisib) is an oral small molecule PI3K delta inhibitor, which is currently being evaluated for the treatment of activated phosphoinositide 3-kinase delta syndrome.

    Product Name : Joenja

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    December 11, 2024

    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Rare Diseases and Disorders

    Highest Development Status : Phase III

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Genetic Disease

    Study Phase : Phase II

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Pharming Begins Phase II Trial of Leniolisib in Primary Immunodeficiencies

    Details : Joenja (leniolisib) is an oral small molecule PI3K delta inhibitor, which is currently being evaluated for the treatment of primary immunodeficiency disorders.

    Product Name : Joenja

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    October 10, 2024

    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase II

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Rare Diseases and Disorders

    Study Phase : Phase III

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Pharming Announces Completion of Enrollment in Pediatric Clinical Trial of Leniolisib

    Details : Joenja (leniolisib) is an oral PI3K delta inhibitor, the first targeted treatment for activated PI3K delta syndrome in patients aged 12 and older, now being developed for children aged 4 to 11.

    Product Name : Joenja

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    August 04, 2024

    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Rare Diseases and Disorders

    Highest Development Status : Phase III

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Genetic Disease

    Study Phase : Phase II

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Pharming Group Announces Development Plans for Leniolisib for Additional Primary Immunodeficiencies (PIDs)

    Details : Joenja (leniolisib) is an oral small molecule PI3Kẟ inhibitor approved in US as the first and only targeted treatment of activated phosphoinositide 3-kinase delta (PI3Kδ) syndrome (APDS) in adult and pediatric patients 12 years of age and older.

    Product Name : Joenja

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    December 13, 2023

    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Genetic Disease

    Highest Development Status : Phase II

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Pharming

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    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Rare Diseases and Disorders

    Study Phase : Phase III

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Pharming Announces First Patient Dosed in Pediatric Clinical Trial for Children Aged 1 to 6 Years for Leniolis...

    Details : Leniolisib is an oral small molecule phosphoinositide 3-kinase delta inhibitor approved in the US as the first and only targeted treatment of activated phosphoinositide 3-kinase delta syndrome in adult and pediatric patients 12 years of age and older.

    Product Name : Joenja

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    November 21, 2023

    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Rare Diseases and Disorders

    Highest Development Status : Phase III

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Rare Diseases and Disorders

    Study Phase : Phase III

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Pharming Group Provides Updates on EMA Regulatory Review of Leniolisib MAA and Plans to File For UK Regulatory...

    Details : Joenja (leniolisib) is an oral, selective PI3K-delta inhibitor which inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells in patients with ...

    Product Name : Joenja

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    October 11, 2023

    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Rare Diseases and Disorders

    Highest Development Status : Phase III

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Rare Diseases and Disorders

    Study Phase : Phase III

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Pharming Announces First Patient Enrolled in Phase III Clinical Trial of Leniolisib for the Treatment of APDS ...

    Details : Joenja (leniolisib) is an oral, selective PI3K-delta inhibitor which inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells in patients with ...

    Product Name : Joenja

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    September 08, 2023

    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Rare Diseases and Disorders

    Highest Development Status : Phase III

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    PANTHERx Rare Pharmacy

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    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Rare Diseases and Disorders

    Study Phase : Approved FDF

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    PANTHERx® Rare Launches Drug for APDS

    Details : Joenja (leniolisib) is an oral, selective PI3K-delta inhibitor which inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells in patients with ...

    Product Name : Joenja

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    March 28, 2023

    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Rare Diseases and Disorders

    Highest Development Status : Approved FDF

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Rare Diseases and Disorders

    Study Phase : Approved FDF

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Pharming Announces US FDA Approval of Joenja® (leniolisib) as The First and Only Treatment Indicated for APDS

    Details : Joenja (leniolisib) is an oral, selective PI3K-delta inhibitor which inhibits the signalling pathways that lead to increased production of PIP3, hyperactivity of the downstream mTOR/AKT pathway, and to the dysregulation of B and T cells in patients with ...

    Product Name : Joenja

    Product Type : Other Small Molecule

    Upfront Cash : Inapplicable

    March 24, 2023

    Lead Product(s) : Leniolisib Phosphate

    Therapeutic Area : Rare Diseases and Disorders

    Highest Development Status : Approved FDF

    Sponsor : Inapplicable

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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