Drugs / Calcifediol
Calcifediol
also known as
CTAP101 · 25(OH)D · 25-hydroxyvitamin D3 · CTAP101 Capsules · Hidroferol · 25(OH)-cholecalciferol · 25(OH)D3 · 25-hydroxyvitamin D · +7 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed non-renal secondary hyperparathyroidism 3 milestones | |||||
| Filed | Other | RAYALDEE | non-renal secondary hyperparathyroidism | 2019-08-07 | “RAYALDEE Marketing Authorization Application filed by Vifor Fresenius in Switzerland.” opko.com ↗ |
| Filed | US (FDA) | RAYALDEE | non-renal secondary hyperparathyroidism | 2016-04-22 | “the U.S. Food and Drug Administration (FDA) had accepted our New Drug Application (NDA) for Rayaldee™ for full review” opko.com ↗ “OPKO submitted a New Drug Application (NDA) for RAYALDEE ® to the US Food and Drug Administration (FDA) in 2015” opko.com ↗ “FDA has accepted OPKO’s resubmission on April 22, 2016 of the New Drug Application (NDA) for RAYALDEE” opko.com ↗ |
| Rejected (CRL) | US (FDA) | RAYALDEE | non-renal secondary hyperparathyroidism | 2016-03-29 | “FDA has issued a complete response letter (CRL) to the Company’s New Drug Application (NDA) for RAYALDEE ® (calcifediol)” opko.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | CALDEROL | — | 1980-08-05 | fda.gov ↗ |
Trials 19
News releases announcing trial results or a regulatory action · 19
| Date | Issuer | Release |
|---|---|---|
| 2023-11-02 | OPKO Health, Inc. | Results New Clinical Data on OPKO Health’s RAYALDEE® (ER Calcifediol) Presented at Kidney Week 2023 opko.com ↗
These data, presented in a poster titled “Control of Secondary Hyperparathyroidism with Extended-release Calcifediol is Associated with Slower CKD Progression” (#TH-PO1152), indicate that early, sustained and effective treatment of secondary hyperparathyroidism (SHPT) with RAYALDEE is associated with significantly slower progression of chronic kidney disease (CKD) in pre-dialysis patients. |
| 2023-10-25 | OPKO Health, Inc. | Results OPKO Health to Present New Clinical Data on Rayaldee (ER Calcifediol) at Kidney Week 2023 opko.com ↗
The data demonstrate that RAYALDEE effectively and reliably raises serum levels of 25-hydroxyvitamin D (25D) and 1,25-dihydroxyvitamin D in non-dialysis patients with secondary hyperparathyroidism (SHPT), making it an attractive alternative to vitamin D hormone therapies (i.e., calcitriol, paricalcitol and doxercalciferol). |
| 2021-12-23 | OPKO Health, Inc. | Results OPKO Health Announces Topline Results from Phase 2 Trial Evaluating RAYALDEE to Treat Symptomatic COVID-19 Outpatients opko.com ↗
OPKO Health, Inc. (NASDAQ: OPK) announces preliminary topline results from its Phase 2 trial with RAYALDEE ® to treat mild-to-moderate COVID-19. |
| 2021-04-28 | OPKO Health, Inc. | Results OPKO Health Reports 2021 First Quarter Business Highlights and Financial Results opko.com ↗
Topline results from 44 subjects (33 Rayaldee; 11 placebo) demonstrated that the prohormone Rayaldee was well tolerated at a dose of 900 mcg/week, decreased intact parathyroid hormone (iPTH) versus placebo, and was activated to calcitriol (the active hormone) despite the lack of functional kidneys. |
| 2020-12-03 | Faes Farma, S.A. | Results La administración de calcifediol oral junto con el tratamiento de elección en pacientes COVID-19 hospitalizados podría reducir la severidad de la enfermedad faesfarma.com ↗
Se ha visto que el tratamiento con calcifediol, junto con el tratamiento por protocolo, podría reducir el riesgo de ingreso en UCI en pacientes hospitalizados por COVID-19, pudiendo este ser un buen tratamiento coadyuvante para disminuir la severidad de la enfermedad |
| 2020-10-14 | Faes Farma, S.A. | Results El Calcifediol evita el agravamiento de pacientes con coronavirus, según un estudio faesfarma.com ↗
el calcifediol, medicamento de Faes Farma , mejora el pronóstico del COVID-19, hasta reducir en un 97% el riesgo de ingreso en UCI de los pacientes más graves. |
| 2020-09-10 | Faes Farma, S.A. | Results Datos preliminares del estudio. La administración de calcifediol oral en pacientes COVID-19 hospitalizados redujo significativamente su riesgo de ingreso en UCI faesfarma.com ↗ |
| 2020-09-08 | Faes Farma, S.A. | Results Investigadores del IMIBIC y Hospital Reina Sofía de Córdoba demuestran que la administración de Calcifediol en pacientes hospitalizados por COVID-19 reduce su necesidad de ingreso en UCI faesfarma.com ↗
Investigadores del Instituto Maimónides de Investigación Biomédica de Córdoba y del Hospital Universitario Reina Sofía, han demostrado que la administración de Calcifediol, metabolito más activo del sistema endocrino de la vitamina D a pacientes hospitalizados de COVID-19 reduce significativamente su necesidad de ingreso en Unidades de cuidados intensivos (UCI). |
| 2020-06-01 | OPKO Health, Inc. | Regulatory FDA Authorizes OPKO Health Clinical Trial Evaluating RAYALDEE in COVID-19 Patients opko.com ↗
OPKO Health, Inc. (NASDAQ: OPK) today announced that the U.S. Food and Drug Administration (FDA) has authorized OPKO to undertake a Phase 2 trial with RAYALDEE ® as a treatment for patients with mild-to-moderate COVID-19. |
| 2020-03-25 | OPKO Health, Inc. | Results OPKO Health Reports Interim Results for Two Ongoing RAYALDEE Studies opko.com ↗
Interim results from 20 subjects who have completed at least 3 months of treatment indicate that all three goals are being met. |
| 2018-07-16 | OPKO Health, Inc. | Regulatory OPKO Partner Vifor Fresenius Receives Marketing Approval for RAYALDEE in Canada opko.com ↗
OPKO Health, Inc. (NASDAQ:OPK) announced today that the Company’s partner Vifor Fresenius Medical Care Renal Pharma (VFMCRP) has received approval from Health Canada to market RAYALDEE ® in Canada for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency. |
| 2016-11-17 | OPKO Health, Inc. | Results OPKO Presents Data on RAYALDEE® at ASN Kidney Week 2016 opko.com ↗
Plasma intact parathyroid hormone (iPTH) levels were effectively suppressed by RAYALDEE in AA patients and nAA patients versus placebo treatment. |
| 2016-06-21 | OPKO Health, Inc. | Regulatory FDA Approves New Drug Application for RAYALDEE® to Treat Secondary Hyperparathyroidism Associated with Vitamin D Insufficiency in Stage 3-4 Chronic Kidney Disease opko.com ↗
OPKO Health, Inc. (NYSE:OPK) announced that the U.S. Food and Drug Administration (FDA) has approved RAYALDEE ® (calcifediol) extended release capsules for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. |
| 2016-04-28 | OPKO Health, Inc. | Results OPKO Presents Additional Data on RAYALDEE® at National Kidney Foundation Spring Clinical Meetings 2016 opko.com ↗
The data showed that plasma levels of intact parathyroid hormone (iPTH) continued to fall as serum levels of 25-hydroxyvitamin D (25D) rose above 30 ng/mL, a level considered sufficient for CKD patients in published clinical practice guidelines. |
| 2016-04-27 | OPKO Health, Inc. | Regulatory FDA Accepts Resubmission of New Drug Application for RAYALDEE® opko.com ↗ |
| 2016-04-01 | OPKO Health, Inc. | Results OPKO Presents Additional Data on RAYALDEE® at ENDO 2016 opko.com ↗
The data showed that mean plasma levels of intact parathyroid hormone (iPTH) and other markers of elevated bone metabolism gradually fell with RAYALDEE treatment as serum total 25-hydroxyvitamin D (25D) rose above 30 ng/mL, a level considered sufficient for chronic kidney disease (CKD) patients in published clinical practice guidelines. |
| 2016-03-31 | OPKO Health, Inc. | Results OPKO Presents Additional Data on RAYALDEE® to Treat Secondary Hyperparathyroidism in Chronic Kidney Disease opko.com ↗
These data suggest that patients with stage 3 or 4 CKD require higher levels of serum 25D than previously thought in order to reach vitamin D sufficiency and to optimally control elevated iPTH. |
| 2016-03-30 | OPKO Health, Inc. | Regulatory OPKO Receives Complete Response Letter from FDA for RAYALDEE® New Drug Application opko.com ↗ |
| 2015-11-05 | OPKO Health, Inc. | Results Additional Phase 3 Data Supporting OPKO’s Rayaldee as a Treatment for Secondary Hyperparathyroidism in Chronic Kidney Disease to be Presented at Kidney Week 2015 opko.com ↗
The data showed that plasma levels of intact parathyroid hormone (iPTH) continued to fall as serum levels of 25-hydroxyvitamin D (25D) rose above 30 ng/mL, a level considered sufficient for CKD patients in published clinical practice guidelines. |
All press releases naming this drug 40 releases
Evidence & citations 18 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Calcifediol | “CTAP101 Capsules is an extended-release (ER) oral formulation of calcifediol which was approved as Rayaldee® ER Capsules in June 2016 by the United States (US) Food and Drug...” NCT05543928 ↗16“We aimed to assess the effectiveness of calcifediol in reducing mortality in patients with vitamin D insufficiency on hemodialysis compared to no additional therapy.” PMID 34173940 ↗ Jun 2021 “Calcifediol will be administered at a dose of 10 drops per day (as indicated for use) for 6 months or until vitamin D levels” NCT03403933 ↗ “Rayaldee (Calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected With SARS-CoV-2 (REsCue)” NCT04551911 ↗ “Calcifediol supplement administered orally in order to reach sufficiency levels (30 ng/ml)” NCT06634316 ↗ “Calcifediol Extended-Release Capsules” NCT03660800 ↗ |
| Known as | 25(OH)-cholecalciferol | “The best biomarker of vitamin D status is the serum or plasma level of the hydroxylated form or vitamin D, 25(OH)-cholecalciferol, also known as 25(OH)-vitamin D or calcifediol.” NCT06258850 ↗ |
| Known as | 25(OH)D | “24000 IU vitamin D3 orally and once per month plus 300 mcg 25(OH)D orally and once per month” NCT01017354 ↗ |
| Known as | 25(OH)D3 | “OBJECTIVES: We aimed to investigate the pharmacokinetics of oral 25-hydroxyvitamin D3 [25(OH)D3] and oral vitamin D3 in healthy participants with differing BMI and...” PMID 34008842 ↗ Sep 2021 |
| Known as | 25-hydroxyvitamin D | “The purpose of this study is to assess the efficacy of calcifediol (25-hydroxyvitamin D) and calcitriol (1,25-dihydroxyvitamin D) in preventing and reducing the severity of...” NCT02962102 ↗ |
| Known as | 25-hydroxyvitamin D3 | “pharmacokinetics of orally administered 25-hydroxyvitamin D3 and vitamin D3 in healthy adults with differing BMI and in adults with intestinal malabsorption.” PMID 34008842 ↗ Sep 20211“CTAP101 Oral Capsules/Calcifediol, calcidiol, 25-hydroxyvitamin D3, 900mcg/weekly for 26 weeks” NCT03602261 ↗ |
| Known as | 25-OH vitamin D3 | “Calcifediol (25-OH vitamin D3) in oral soft capsules (Hidroferol® 0,266 mg, equivalent to 15960 IU vitamin D).” NCT06258850 ↗ |
| Known as | 25D | “We conducted a phase 2, randomized, double-blind, multiple-dose, 3-arm clinical trial comparing oral calcifediol (25D), calcitriol (1,25D), and placebo among 150 critically ill...” PMID 40924491 ↗ Sep 2025 |
| Known as | calcidiol | “CTAP101 Oral Capsules/Calcifediol, calcidiol, 25-hydroxyvitamin D3, 900mcg/weekly for 26 weeks” NCT03602261 ↗ |
| Known as | CTAP101 | “CTAP101 Capsules is an extended-release (ER) oral formulation of calcifediol which was approved as Rayaldee® ER Capsules in June 2016 by the United States (US) Food and Drug...” NCT05543928 ↗ |
| Known as | CTAP101 Capsules | “CTAP101 Capsules is an extended-release (ER) oral formulation of calcifediol which was approved as Rayaldee® ER Capsules in June 2016 by the United States (US) Food and Drug...” NCT05543928 ↗1“This is a phase 2, single or multi-center, randomized, double-blind placebo-controlled study to evaluate the safety and efficacy of Rayaldee (CTAP101 Capsules) to treat adult...” NCT04551911 ↗ |
| Known as | Hidroferol | “Calcifediol (25-OH vitamin D3) in oral soft capsules (Hidroferol® 0,266 mg, equivalent to 15960 IU vitamin D).” NCT06258850 ↗1“Calcifediol (Hidroferol®) in 16,000-IU ampoules taken weekly by the oral route” NCT02805907 ↗ |
| Known as | Hydroferol | “Treatments: 1) Calcifediol Hydroferol® 0.266 mg once every 10 days for the first 12 weeks and once every two weeks for the following 12 weeks.” NCT06258850 ↗ |
| Known as | Rayaldee | “Rayaldee (Calcifediol) Extended-release Capsules to Treat Symptomatic Patients Infected With SARS-CoV-2 (REsCue)” NCT04551911 ↗ |
| Known as | Rayaldee ER Capsules | “CTAP101 Capsules is an extended-release (ER) oral formulation of calcifediol which was approved as Rayaldee® ER Capsules in June 2016 by the United States (US) Food and Drug...” NCT05543928 ↗ |
| Known as | Vitamin D | “Drug: Calcifediol (Vitamin D)” NCT03213886 ↗ |
| Action | Restore | “restoration of vitamin D status with calcifediol improves their symptomatology and prognosis” NCT06258850 ↗ |
| Route | Oral | “Single dose oral administration” NCT00888069 ↗ |