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[{"company":"Leo Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LEO Pharma Presents Phase 3 Data in Atopic Dermatitis and Plaque Psoriasis at the American Academy of Dermatology Virtual Meeting","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Leo Pharma"},{"company":"Leo Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LEO Pharma Announces European Medicines Agency Acceptance of Marketing Authorization Application for tralokinumab to Treat Atopic Dermatitis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"New Molecular Entity","date":"June 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Leo Pharma"},{"company":"Leo Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LEO Pharma Announces U.S. FDA Acceptance of Biologics License Application for Tralokinumab for Moderate-to-Severe Atopic Dermatitis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"New Molecular Entity","date":"July 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Leo Pharma"},{"company":"Leo Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LEO Pharma Announces British Journal of Dermatology Publication of Three Pivotal Ph 3 Trials of Tralokinumab","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Leo Pharma"},{"company":"Leo Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LEO Pharma to Highlight New Data in Medical Dermatology at EADV Virtual 2020","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Leo Pharma"},{"company":"Leo Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LEO Pharma Presents Data for Tralokinumab on Pooled Safety, S. Aureus Colonization Reduction and Impact on Vaccine Response Rates","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"New Molecular Entity","date":"October 2020","url1":"","url2":"","graph1":"Large molecule","graph2":"Leo Pharma"},{"company":"Leo Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LEO Pharma Receives Positive CHMP Opinion of Adtralza\u00ae (tralokinumab) for the Treatment of Adults With Moderate-to-Severe Atopic Dermatitis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Leo Pharma"},{"company":"Leo Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LEO Pharma Presents Long-Term Safety and Efficacy Data for Tralokinumab in Adults With Moderate-to-Severe Atopic Dermatitis at AAD VMX 2021","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"New Molecular Entity","date":"April 2021","url1":"","url2":"","graph1":"Large molecule","graph2":"Leo Pharma"},{"company":"Leo Pharma","sponsor":"Japan Tobacco Inc","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LEO Pharma Starts first Phase 3 Clinical Trial with Delgocitinib Cream in Adult Patients with Moderate-To-Severe Chronic Hand Eczema","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Small molecule","productStatus":"New Molecular Entity","date":"May 2021","url1":"","url2":"","graph1":"Small molecule","graph2":"Leo Pharma"},{"company":"Leo Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"LEO Pharma Receives Positive CHMP Opinion of Adtralza\u00ae (tralokinumab) for the Treatment of Adolescents With Moderate-to-Severe Atopic Dermatitis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Large molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Large molecule","graph2":"Leo Pharma"}]

Leo Pharma

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LEO Pharma Receives Positive CHMP Opinion of Adtralza® (tralokinumab) for the Treatment of Adolescents With Moderate-to-Severe Atopic Dermatitis

Details:

The CHMP opinion is based on data from the Phase 3 ECZTRA 6 trial, which evaluated the efficacy and safety of Adtralza (tralokinumab) (150 mg or 300 mg) monotherapy compared to placebo in adolescents with moderate-to-severe AD who were candidates for systemic therapy.

Lead Product(s): Tralokinumab

Therapeutic Area: Dermatology Product Name: Adtralza

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable September 16, 2022

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Leo Pharma

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LEO Pharma Starts first Phase 3 Clinical Trial with Delgocitinib Cream in Adult Patients with Moderate-To-Severe Chronic Hand Eczema

Details:

Delgocitinib inhibits activation of the JAK-STAT pathway, which plays a key role in the immune system in driving the pathophysiology of chronic inflammatory skin diseases.

Lead Product(s): Delgocitinib

Therapeutic Area: Dermatology Product Name: LP0133

Highest Development Status: Phase III Product Type: Small molecule

Partner/Sponsor/Collaborator: Japan Tobacco Inc

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable May 18, 2021

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Leo Pharma

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LEO Pharma Receives Positive CHMP Opinion of Adtralza® (tralokinumab) for the Treatment of Adults With Moderate-to-Severe Atopic Dermatitis

Details:

If authorized, Adtralza® (tralokinumab) will be the first approved biologic that specifically targets the IL-13 cytokine, a key driver of atopic dermatitis signs and symptoms.

Lead Product(s): Tralokinumab

Therapeutic Area: Dermatology Product Name: Adtralza

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 23, 2021

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Leo Pharma

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LEO Pharma Presents Long-Term Safety and Efficacy Data for Tralokinumab in Adults With Moderate-to-Severe Atopic Dermatitis at AAD VMX 2021

Details:

Interim analysis at 56 weeks from ECZTEND, an open-label extension trial, demonstrates sustainable and durable efficacy of tralokinumab in adult patients. The overall safety profile of tralokinumab was consistent with that observed in the parent trials.

Lead Product(s): Tralokinumab

Therapeutic Area: Dermatology Product Name: Adtralza

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable April 23, 2021

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Leo Pharma

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LEO Pharma Presents Data for Tralokinumab on Pooled Safety, S. Aureus Colonization Reduction and Impact on Vaccine Response Rates

Details:

Results from a pooled safety analysis of three Phase 3 trials Phase 2 and Phase 2b trials demonstrate overall frequency of AEs with tralokinumab was comparable to placebo in the initial 16-week period in adults with moderate-to-severe atopic dermatitis.

Lead Product(s): Tralokinumab

Therapeutic Area: Dermatology Product Name: LP0162

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 29, 2020

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LEO Pharma to Highlight New Data in Medical Dermatology at EADV Virtual 2020

Details:

Data demonstrating efficacy of Tralokinumab, a human monoclonal antibody which targets the cytokine interleukin 13, and is designed for the treatment of asthma and other inflammatory diseases, will be presented at the EADV Virtual 2020.

Lead Product(s): Tralokinumab

Therapeutic Area: Dermatology Product Name: LP0162

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 27, 2020

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LEO Pharma Announces British Journal of Dermatology Publication of Three Pivotal Ph 3 Trials of Tralokinumab

Details:

Results show maintained response with tralokinumab in ECZTRA 1, 2 and ECZTRA 3 over 52 weeks and 32 weeks, respectively. In ECZTRA 3, there was reduction in use of TCS in adult patients receiving tralokinumab plus TCS compared to placebo plus TCS

Lead Product(s): Tralokinumab,Mometasone Furoate

Therapeutic Area: Dermatology Product Name: LP0162

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable October 16, 2020

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LEO Pharma Announces U.S. FDA Acceptance of Biologics License Application for Tralokinumab for Moderate-to-Severe Atopic Dermatitis

Details:

Submission includes data from pivotal ECZTRA 1, 2 and ECZTRA 3 Phase 3 studies evaluating safety and efficacy of tralokinumab.

Lead Product(s): Tralokinumab

Therapeutic Area: Dermatology Product Name: LP0162

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable July 09, 2020

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LEO Pharma Announces European Medicines Agency Acceptance of Marketing Authorization Application for tralokinumab to Treat Atopic Dermatitis

Details:

The MAA is based on data from the pivotal ECZTRA 1, 2 and 3 Phase 3 studies evaluating the efficacy and safety of tralokinumab.

Lead Product(s): Tralokinumab

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 11, 2020

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LEO Pharma Presents Phase 3 Data in Atopic Dermatitis and Plaque Psoriasis at the American Academy of Dermatology Virtual Meeting

Details:

Data include pivotal efficacy and safety clinical trials of tralokinumab monotherapy and tralokinumab with concomitant topical corticosteroid use in adult patients with moderate-to-severe atopic dermatitis.

Lead Product(s): Tralokinumab

Therapeutic Area: Dermatology Product Name: Undisclosed

Highest Development Status: Phase III Product Type: Large molecule

Partner/Sponsor/Collaborator: Not Applicable

Deal Size: Not Applicable Upfront Cash: Not Applicable

Deal Type: Not Applicable June 02, 2020

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