Midas Nintedanib Esylate Midas Nintedanib Esylate

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[{"orgOrder":0,"company":"Boehringer Ingelheim GmbH","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Boehringer Ingelheim Receives Positive CHMP Opinion For A Third Nintedanib Indication In Pulmonary Fibrosis","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Boehringer Ingelheim GmbH","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"European Commission Approves Third Nintedanib Indication in Pulmonary Fibrosis","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Boehringer Ingelheim GmbH","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Analyses of Ofev\u00ae Data in Patients with Chronic Fibrosing ILDs Available During American Thoracic Society Congress","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Boehringer Ingelheim GmbH","sponsor":"Icahn School of Medicine","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Icahn School of Medicine at Mount Sinai and Boehringer Ingelheim Collaborate to Study Nintedanib for Fibrosing ILD after COVID-19 infection","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"November 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Glenmark Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Glenmark Introduces NINDANIB for the Treatment of Pulmonary Fibrosis in India","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Cipla","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Cipla Launches Nintib to Treat Idiopathic Pulmonary Fibrosis, in Continuation of its Fight Against Rare Lung Diseases","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Approved","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"October 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Approved"},{"orgOrder":0,"company":"CohBar","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CohBar Antifibrotic Peptide in Combination with Nintedanib Shows Enhanced Effects in an Idiopathic Pulmonary Fibrosis Model","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Preclinical","country":"U.S.A","productType":"Peptide","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Preclinical"},{"orgOrder":0,"company":"Boehringer Ingelheim GmbH","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"OFEV Receives Positive Recommendation from CADTH and INESSS for the Treatment of Progressive Fibrosing Interstitial Lung Diseases (PF-ILD)","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"March 2021","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Boehringer Ingelheim GmbH","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Study Analysis Available During ATS 2021 Supports Long-Term Treatment with Ofev in Systemic Sclerosis-Associated Interstitial Lung Disease","therapeuticArea":"Immunology","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Immunology","graph2":"Approved"},{"orgOrder":0,"company":"Blade Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Blade Therapeutics Presents Data from Phase 1 and Preclinical Studies of Cudetaxestat at the American Thoracic Society 2022 International Conference","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Boehringer Ingelheim GmbH","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"New Data From Boehringer Ingelheim Support the Potential Use of Nintedanib in Children and Adolescents With Fibrosing Interstitial Lung Disease","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase III","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase III"},{"orgOrder":0,"company":"Avalyn Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Avalyn Pharma Reports Results of Phase 1 Study of AP02 in Healthy Volunteers and Participants with Idiopathic Pulmonary Fibrosis","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Phase I","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Phase I"},{"orgOrder":0,"company":"Boehringer Ingelheim GmbH","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"U.S. FDA Accepts Supplemental New Drug Application for OFEV\u00ae (nintedanib) for Children and Adolescents Aged 6-17 Years Old with Fibrosing Interstitial Lung Disease","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"Approved","country":"GERMANY","productType":"Small molecule","productStatus":"Approved","date":"July 2023","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"Approved"},{"orgOrder":0,"company":"Mannkind","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MannKind to Proceed With Phase 1 Nintedanib Dpi (Mnkd-201) Study for Pulmonary Fibrotic Diseases","therapeuticArea":"Pulmonary\/Respiratory Diseases","highestDevelopmentStatus":"IND Enabling","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2024","url1":"","url2":"","graph1":"Pulmonary\/Respiratory Diseases","graph2":"IND Enabling"}]

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            The inhaled therapeutic candidate MNKD-201 (nintedanib) is being evaluated in early-stage clinical trial studies for treating patients suffering from pulmonary fibrotic diseases.

            Lead Product(s): Nintedanib Esylate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: MNKD-201

            Highest Development Status: IND Enabling Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable April 30, 2024

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            OFEV (nintedanib) is an investigational drug in development for fibrosing interstitial lung disease. It inhibits profibrotic mediators including platelet-derived growth factor, TGF-β as well as VEGF, reducing fibroblast activity.

            Lead Product(s): Nintedanib Esylate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ofev

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable July 25, 2023

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            AP02 (nintedanib) is an investigational drug in development for pulmonary fibrosis. It inhibits profibrotic mediators including platelet-derived growth factor, fibroblast growth factor and transforming growth factor (TGF)-β as well as VEGF, reducing fibroblast activity.

            Lead Product(s): Nintedanib Esylate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: AP02

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 30, 2023

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            The InPedILD results showed that the weight-based dosing regimen of Ofev (nintedanib) in children and adolescents with fibrosing ILD resulted in comparable exposure to that observed in adult patients with fibrosing ILD.

            Lead Product(s): Nintedanib Esylate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ofev

            Highest Development Status: Phase III Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable September 05, 2022

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            No significant drug-drug interaction (DDI) seen with BLD-0409 (cudetaxestat) in combination with either pirfenidone or nintedanib, two approved therapies for idiopathic pulmonary fibrosis (IPF).

            Lead Product(s): Cudetaxestat,Nintedanib Esylate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: BLD-0409

            Highest Development Status: Phase I Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 16, 2022

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            In an analysis of SENSCIS-ON, the safety profile of Ofev in participants who continued therapy for an additional 52 weeks was consistent with that observed during the SENSCIS trial.

            Lead Product(s): Nintedanib Esylate

            Therapeutic Area: Immunology Product Name: Ofev

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable May 14, 2021

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            OFEV® is the first treatment available in Canada for chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype (also known as PF-ILD), which affects patients across more than 200 rare lung disorders.

            Lead Product(s): Nintedanib Esylate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: OFEV

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable March 04, 2021

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            New study will assess the potential impact of nintedanib in patients developing pulmonary fibrosis following acute lung injury from COVID-19 infection. Research collaboration will lead to insights about pulmonary fibrosis in the growing COVID-19 patient population.

            Lead Product(s): Nintedanib Esylate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Ofev

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Icahn School of Medicine

            Deal Size: Undisclosed Upfront Cash: Undisclosed

            Deal Type: Collaboration November 19, 2020

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            Preclinical data shows that combination of a CB5138 Analog with nintedanib, the leading standard of care for treatment of Idiopathic Pulmonary Fibrosis (IPF), produced enhanced effects compared to nintedanib alone in mice.

            Lead Product(s): CB5138 Analog peptides,Nintedanib Esylate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Undisclosed

            Highest Development Status: Preclinical Product Type: Peptide

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 26, 2020

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            Available as 100 mg and 150 mg capsules, it will be marketed under the brand name Nintib.

            Lead Product(s): Nintedanib Esylate

            Therapeutic Area: Pulmonary/Respiratory Diseases Product Name: Nintib

            Highest Development Status: Approved Product Type: Small molecule

            Partner/Sponsor/Collaborator: Not Applicable

            Deal Size: Not Applicable Upfront Cash: Not Applicable

            Deal Type: Not Applicable October 20, 2020

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