Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Calcifediol
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : Vifor Fresenius Medical Care Renal Pharma
Deal Size : Not Applicable
Deal Type : Not Applicable
RAYALDEE® Launched in Germany by OPKO Health’s Licensee, VFMCRP
Details : RAYALDEE extended-release capsules are indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.
Brand Name : Rayaldee
Molecule Type : Small molecule
Upfront Cash : Not Applicable
February 03, 2022
Lead Product(s) : Calcifediol
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : Vifor Fresenius Medical Care Renal Pharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : RAYALDEE is an extended-release oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3. The REsCue trial randomized symptomatic COVID-19 outpatients in a 1:1 ratio to 4 weeks of treatment with RAYALDEE or placebo and a...
Brand Name : Rayaldee
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 30, 2021
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Rayaldee is an extended-release oral formulation of calcifediol, a prohormone of calcitriol, the active form of vitamin D3. The product is the first and only medicine approved by the US FDA for raising serum total 25D and lowering blood levels of intact ...
Brand Name : Rayaldee
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 30, 2021
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Calcifediol
Therapeutic Area : Endocrinology
Study Phase : Approved
Sponsor : CSL Vifor
Deal Size : Undisclosed
Deal Type : Termination
OPKO Health Reports Transfer of Licensed Rights to RAYALDEE® in Japan to Vifor
Details : OPKO Health announced a transfer of the licensed rights to RAYALDEE in Japan from Japan Tobacco to Vifor Fresenius Medical Care Renal Pharma (VFMCRP). EirGen and VFMCRP have agreed to transfer the rights to RAYALDEE® in Japan to VFMCRP.
Brand Name : Rayaldee
Molecule Type : Small molecule
Upfront Cash : Undisclosed
May 24, 2021
Lead Product(s) : Calcifediol
Therapeutic Area : Endocrinology
Highest Development Status : Approved
Sponsor : CSL Vifor
Deal Size : Undisclosed
Deal Type : Termination
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
OPKO Health Initiates Clinical Trial of RAYALDEE in COVID-19 Patients
Details : The randomized, double-blind placebo-controlled study will evaluate the safety and efficacy of RAYALDEE (calcifediol) extended-release capsules to treat symptomatic patients infected with SARS-CoV-2 (REsCue).
Brand Name : Rayaldee
Molecule Type : Small molecule
Upfront Cash : Not Applicable
September 15, 2020
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
FDA Authorizes OPKO Health Clinical Trial Evaluating RAYALDEE in COVID-19 Patients
Details : The REsCue trial will have 4 weeks of treatment with RAYALDEE or placebo and 2 weeks of follow-up. The objective is to raise and maintain serum total 25-hydroxyvitamin D (25D) within the range of 50-100 ng/mL in order to mitigate COVID-19 severity.
Brand Name : Undisclosed
Molecule Type : Small molecule
Upfront Cash : Not Applicable
June 01, 2020
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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