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[{"orgOrder":0,"company":"Orphazyme","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Orphazyme Phase 2 Study of Arimoclomol In Gaucher Disease Demonstrates Marked Improvements in Key Clinical Markers","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Orphazyme"},{"orgOrder":0,"company":"Orphazyme","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"CytRx Corporation Highlights Orphazyme's Announcement of its Phase 2 Study Results with Arimoclomol in Gaucher Disease","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Orphazyme"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Receives Positive Feedback from FDA on Regulatory Path for Tesomet in Prader-Willi Syndrome (PWS)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Saniona"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona receives Pre-IND Feedback from FDA on Regulatory Path for Tesomet in Prader-Willi Syndrome (PWS) and Hypothalamic Obesity (HO)","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Small molecule","graph2":"Saniona"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Updates Tesomet Clinical Development Timelines Based on Manufacturing Feedback from U.S. FDA","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Saniona"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Initiates Phase 2b Clinical Trial of Tesomet for Prader-Willi Syndrome","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"December 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Saniona"},{"orgOrder":0,"company":"Saniona","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Saniona Provides Update on Ongoing Review of Tesofensine in Mexico","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2022","url1":"","url2":"","graph1":"Small molecule","graph2":"Saniona"},{"orgOrder":0,"company":"Ascendis Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Ascendis Pharma A\/S Receives Orphan Designation for TransCon\u2122 CNP for the Treatment of Achondroplasia in Europe","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Peptide","productStatus":"New Molecular Entity","date":"August 2020","url1":"","url2":"","graph1":"Peptide","graph2":"Ascendis Pharma"},{"orgOrder":0,"company":"Ascendis Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Once-Weekly TransCon\u2122 CNP Achieved Primary Efficacy Objective, with Superiority at 100 \u00b5g\/kg\/week, in Ascendis Pharma\u2019s Phase 2 ACcomplisH Trial of Children with Achondroplasia Aged 2 to 10 Years","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase II","country":"DENMARK","productType":"Peptide","productStatus":"New Molecular Entity","date":"November 2022","url1":"","url2":"","graph1":"Peptide","graph2":"Ascendis Pharma"}]

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Ascendis Pharma

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Once-Weekly TransCon™ CNP Achieved Primary Efficacy Objective, with Superiority at 100 µg/kg/week, in Ascendis Pharma’s Phase 2 ACcomplisH Trial of Children with Achon...

Details:

TransCon CNP is an investigational prodrug of CNP in development for the treatment of ACH in children. Designed to provide continuous CNP exposure, goal of TransCon CNP is to optimize efficacy with a safe and convenient once-weekly dose.

Lead Product(s): Natriuretic Peptide, C-Type

Therapeutic Area: Genetic Disease Product Name: TransCon CNP

Highest Development Status: Phase II Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable November 13, 2022

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Saniona

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Saniona Provides Update on Ongoing Review of Tesofensine in Mexico

Details:

Tesomet (Tesofensine) is a serotonin–noradrenaline–dopamine reuptake inhibitor from the phenyltropane family of drugs, which is being developed for the treatment of obesity.

Lead Product(s): Tesofensine,Metoprolol Tartrate

Therapeutic Area: Genetic Disease Product Name: Tesomet

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 20, 2022

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Saniona

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Saniona Initiates Phase 2b Clinical Trial of Tesomet for Prader-Willi Syndrome

Details:

Adult patients receiving Tesomet achieved a statistically significant reduction in hyperphagia, as well as a reduction in body weight. Adolescent patients demonstrated dose-dependent reductions in hyperphagia and body weight in open-label extensions of the study.

Lead Product(s): Tesofensine,Metoprolol Tartrate

Therapeutic Area: Genetic Disease Product Name: Tesomet

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable December 28, 2021

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Saniona

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Saniona Updates Tesomet Clinical Development Timelines Based on Manufacturing Feedback from U.S. FDA

Details:

The company requested FDA feedback, and the FDA agreed with the company’s proposal but requested additional information regarding Tesomet manufacturing.

Lead Product(s): Tesofensine,Metoprolol Tartrate

Therapeutic Area: Genetic Disease Product Name: Tesomet

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 21, 2021

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Saniona receives Pre-IND Feedback from FDA on Regulatory Path for Tesomet in Prader-Willi Syndrome (PWS) and Hypothalamic Obesity (HO)

Details:

FDA recommended that Saniona conduct a supportive Phase 2b study prior to initiating a Phase 3 study to confirm the safety and efficacy of the doses intended for commercialization.

Lead Product(s): Tesofensine,Metoprolol Tartrate

Therapeutic Area: Genetic Disease Product Name: Tesomet

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 09, 2020

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Ascendis Pharma

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Ascendis Pharma A/S Receives Orphan Designation for TransCon™ CNP for the Treatment of Achondroplasia in Europe

Details:

TransCon CNP is a investigational long-acting prodrug of CNP, designed to provide continuous exposure of CNP at safe, therapeutic levels via a single, weekly subcutaneous dose.

Lead Product(s): Natriuretic Peptide, C-Type

Therapeutic Area: Genetic Disease Product Name: TransCon CNP

Highest Development Status: Phase II Product Type: Peptide

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable August 12, 2020

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Orphazyme

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CytRx Corporation Highlights Orphazyme's Announcement of its Phase 2 Study Results with Arimoclomol in Gaucher Disease

Details:

Arimoclomol demonstrated a marked and clinically meaningful dose-dependent reduction in liver and spleen size. Data supports Orphazyme's intention to proceed with pivotal stage clinical development in Gaucher disease .

Lead Product(s): Arimoclomol

Therapeutic Area: Genetic Disease Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 29, 2020

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Orphazyme

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Orphazyme Phase 2 Study of Arimoclomol In Gaucher Disease Demonstrates Marked Improvements in Key Clinical Markers

Details:

The data show a dose-dependent effect of arimoclomol on certain disease-relevant clinical secondary endpoints, such as liver and spleen size.

Lead Product(s): Arimoclomol

Therapeutic Area: Genetic Disease Product Name: Undisclosed

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 24, 2020

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Saniona

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Saniona Receives Positive Feedback from FDA on Regulatory Path for Tesomet in Prader-Willi Syndrome (PWS)

Details:

The positive feedback regarding the proposed regulatory path for Tesomet confirmed that Tesomet may be advanced via the 505(b)2 pathway, and the agency indicated agreement with Saniona on the design, the proposed doses, and duration of the potential Phase 2b clinical trial in PWS.

Lead Product(s): Tesofensine,Metoprolol Tartrate

Therapeutic Area: Genetic Disease Product Name: Tesomet

Highest Development Status: Phase II Product Type: Small molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 09, 2020

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