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 FDF
Sponsor : VFMCRP
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Rayaldee
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
March 02, 2022
Lead Product(s) : Calcifediol
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : VFMCRP
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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 ...
Product Name : Rayaldee
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
August 30, 2021
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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...
Product Name : Rayaldee
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
August 30, 2021
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Calcifediol
Therapeutic Area : Endocrinology
Study Phase : Approved FDF
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.
Product Name : Rayaldee
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Undisclosed
May 24, 2021
Lead Product(s) : Calcifediol
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Sponsor : CSL Vifor
Deal Size : Undisclosed
Deal Type : Termination
Lead Product(s) : Calcifediol
Therapeutic Area : Nutrition and Weight Loss
Study Phase : Phase II/ Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Efficacy and Safety of Calcifediol vs Placebo in Subjects With Vitamin D Deficiency
Details : Undisclosed
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
February 03, 2021
Lead Product(s) : Calcifediol
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase II/ Phase III
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19
Details : Undisclosed
Product Name : Rayaldee
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
September 16, 2020
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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).
Product Name : Rayaldee
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
September 15, 2020
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II
Sponsor : Junta de Andalucía | Dynamic Solutions | Faes Farma
Deal Size : Inapplicable
Deal Type : Inapplicable
Prevention and Treatment With Calcifediol of COVID-19 Induced Acute Respiratory Syndrome
Details : Undisclosed
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
April 29, 2020
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Sponsor : Junta de Andalucía | Dynamic Solutions | Faes Farma
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
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.
Product Name : Rayaldee
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
January 06, 2020
Lead Product(s) : Calcifediol
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Calcifediol
Therapeutic Area : Nephrology
Study Phase : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
Details : Undisclosed
Product Name : Undisclosed
Product Type : Vitamins/Minerals/Inorganic Salts
Upfront Cash : Inapplicable
July 26, 2018
Lead Product(s) : Calcifediol
Therapeutic Area : Nephrology
Highest Development Status : Phase II
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable