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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.
Lead Product(s): Calcifediol
Therapeutic Area: Endocrinology Product Name: Rayaldee
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Vifor Fresenius Medical Care Renal Pharma
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 03, 2022
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 2-week follow-up.
Lead Product(s): Calcifediol
Therapeutic Area: Infections and Infectious Diseases Product Name: Rayaldee
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2021
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 iPTH.
Lead Product(s): Calcifediol
Therapeutic Area: Infections and Infectious Diseases Product Name: Rayaldee
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 30, 2021
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.
Lead Product(s): Calcifediol
Therapeutic Area: Endocrinology Product Name: Rayaldee
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: CSL Vifor
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Termination May 24, 2021
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).
Lead Product(s): Calcifediol
Therapeutic Area: Infections and Infectious Diseases Product Name: Rayaldee
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2020
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.
Lead Product(s): Calcifediol
Therapeutic Area: Infections and Infectious Diseases Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 01, 2020
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