[{"orgOrder":0,"company":"Lipidor AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipidor Presents Updated Project Plan - Initiates Phase III study of AKP02 in-House","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"May 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Cadila Pharmaceuticals","sponsor":"Lipidor AB","pharmaFlowCategory":"D","amount":"Undisclosed","upfrontCash":"Undisclosed","newsHeadline":"Lipidor, Cadila to Conduct Ph III Study of Anti-Psoriasis Candidate","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase II","country":"INDIA","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase II"},{"orgOrder":0,"company":"MC2 Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MC2 Therapeutics Announces Submission of Marketing Authorization Application in EU for Wynzora \u00ae Cream","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"DENMARK","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"MC2 Therapeutics","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"MC2 Therapeutics Announces FDA Approval of Wynzora\u00ae Cream (calcipotriene and betamethasone dipropionate) for Adults with Plaque Psoriasis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Approved","country":"DENMARK","productType":"Small molecule","productStatus":"Approved","date":"July 2020","url1":"","url2":"","graph1":"Dermatology","graph2":"Approved"},{"orgOrder":0,"company":"Surface Oncology","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Surface Ophthalmics Previews Important Clinical Progress in 2021","therapeuticArea":"Ophthalmology","highestDevelopmentStatus":"Phase II","country":"U.S.A","productType":"Small molecule","productStatus":"New Molecular Entity","date":"January 2021","url1":"","url2":"","graph1":"Ophthalmology","graph2":"Phase II"},{"orgOrder":0,"company":"Lipidor AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipidor- Update on the Company's Phase III Clinical Trial of Drug Candidate AKP02 for Treatment of Psoriasis","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"April 2021","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Lipidor AB","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Lipidor Updates on Phase III Study of AKP02 In Treatment of Psoriasis - Half of Patients Now Recruited","therapeuticArea":"Dermatology","highestDevelopmentStatus":"Phase III","country":"SWEDEN","productType":"Small molecule","productStatus":"Approved","date":"May 2022","url1":"","url2":"","graph1":"Dermatology","graph2":"Phase III"},{"orgOrder":0,"company":"Acasti Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Acasti Pharma Announces Initiation of Pharmacokinetic Study for GTX-102, the Company\u2019s Drug Candidate for the Treatment of Ataxia Telangiectasia","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"September 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I"},{"orgOrder":0,"company":"Acasti Pharma","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Acasti Announces Preliminary Topline Results Met All Outcome Measures in the Pharmacokinetic Bridging Study for GTX-102, the Company\u2019s Drug Candidate for the Treatment of Ataxia Telangiectasia","therapeuticArea":"Genetic Disease","highestDevelopmentStatus":"Phase I","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"December 2022","url1":"","url2":"","graph1":"Genetic Disease","graph2":"Phase I"}]
Find Clinical Drug Pipeline Developments & Deals for Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11beta,16beta)-
GTX-102 (betamethasone) is a novel, proprietary, concentrated oral-mucosal metered spray of betamethasone intended to improve the neurological symptoms of Ataxia Telangiectasia (A-T).
GTX-102 is a novel, proprietary, concentrated oral-mucosal metered spray of betamethasone intended to improve the neurological symptoms of Ataxia Telangiectasia (AT) in a pediatric population for which there are currently no FDA-approved therapies.
Positive results from the Phase III study with Lipidor’s drug candidate AKP02, which is based on calcipotriol alone & in combination with betamethasone, show that AKVANO® technology works well for drugs for treatment of psoriasis.
SURF-201 (betamethasone 0.2% in Klarity®) is being studied for the treatment of pain and inflammation following ocular surgery. Results from the Phase II trial for SURF-201 are expected in the early part of 2021.
The FDA approval is based on the results of the US Phase 3 clinical trial1 against active comparator Taclonex® Topical Suspension (calcipotriene and betamethasone dipropionate.
The MAA is supported by two comprehensive Phase 3 trials1 including a trial conducted in EU evaluating the efficacy and safety of Wynzora® Cream compared to vehicle and active comparator Dovobet/Daivobet® Gel in patients with psoriasis vulgaris.
Lipidor AB has penned an agreement with Cadila Pharmaceuticals to conduct a Phase III study for Lipidor’s drug candidate AKP-02. AKP-02 is an antipsoriasis medicine that combines the active substances calcipotriol and betamethasone with Lipidor’s spray-based AKVANO technology.
Company has successfully completed Phase III study of calcipotriol spray (AKP01) against mild to moderate plaque psoriasis and is planning for a licensing project.