Calcifediol
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | CALDEROL | — | 1980-08-05 | fda.gov ↗ |
Trials 21 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 8 trials
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2012-10-01 | Otsuka Pharmaceutical Development & Commercialization, Inc. | Super Vitamin D, Containing the Daily Optimum Dose of Vitamin D in One Single Tablet Launched from Nature Made® - America's Number One Dietary Supplement Brand otsuka.co.jp ↗ |
Evidence & citations 19 cited values
Every value below carries the sentence it was read from. 32 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 20212“Type of drug: 180 000 IU 25-OH-D3 vitamin oil (Vigantol) per month in the 0,1,2,3,6, month” NCT01535196 ↗ |
| 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 | “To determine whether correcting vitamin D deficiency with cholecalciferol (vitamin D3, D3) or calcifediol (25-hydroxyvitamin D3, 25(OH)D3) changes gut microbiome composition.” PMID 34343292 ↗ Nov 20212“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 2021 “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 ↗2“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 | Vigantol | “Type of drug: 180 000 IU 25-OH-D3 vitamin oil (Vigantol) per month in the 0,1,2,3,6, month” NCT01535196 ↗ |
| 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 ↗ |