Calcitriol
Small molecule targets REN via inhibition
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | VECTICAL | — | 2020-07-17 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | CALCIJEX | — | 1996-10-22 – 2001-11-16 | fda.gov ↗ |
| Label expansions (3) | US (FDA) | ROCALTROL | — | 1982-04-22 – 1998-11-20 | fda.gov ↗ |
| Approved | US (FDA) | ROCALTROL | — | 1978-08-17 | fda.gov ↗ |
Trials 93 · started per year
Also used as a comparator or background therapy in 34 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04826133 Comparator | Mar 2019 → Jan 2020 | substance-related disorder | Yale University | Terminated | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT04286529 Comparator | Oct 2020 → May 2021 | prediabetes syndrome | Mayo Clinic | Terminated | No outcome recorded |
| Phase 1 | NCT00925704 Comparator | Jun → Jul 2009 | — | Shire | Completed | No outcome recorded |
| Phase 1 | NCT00298545 Comparator | Nov 2005 → May 2009 | adenocarcinoma, colorectal adenoma, polyp | Rockefeller University | Completed | No outcome recorded |
| Phase 1 | NCT01969656 Comparator | ? → Jun 2004 | postmenopausal osteoporosis | Deltanoid Pharmaceuticals | Completed | No outcome recorded |
| Phase 24 trials | ||||||
| Phase 2 | NCT01358045 Comparator | Nov 2011 → Feb 2013 | basal cell carcinoma | Maastricht University Medical Center | Completed | No outcome recorded |
| Phase 2 | NCT00623974 Background | May 2008 → Jun 2010 | — | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT00536770 Comparator | Sep 2007 → ? | malignant pancreatic neoplasm | Novacea | Suspended | No outcome recorded |
| Phase 2 | NCT00960635 Comparator | Jun 2001 → Aug 2008 | type 1 diabetes mellitus | Institute of Diabetes Research, Helmholtz Zentrum München | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT06046820 Comparator | Nov 2023 → Jan 2026 overdue | arterial calcification of infancy, autosomal recessive hypophosphatemic rickets | Inozyme Pharma | Active not recruiting | No outcome recorded |
| Phase 3 | NCT02859896 Comparator | Jan 2017 → Jun 2025 | secondary hyperparathyroidism of renal origin | Sanofi | Terminated | No outcome recorded |
| Phase 3 | NCT01656512 Comparator | Oct 2011 → Jan 2014 | osteoporosis | Children's Cancer Hospital Egypt 57357 | Completed | No outcome recorded |
| Phase 3 | NCT00658788 Comparator | Mar 2008 → Jan 2009 | psoriasis | Galderma R&D | Completed | No outcome recorded |
| Phase 3 | NCT00004402 Background | Nov 1999 → Jun 2000 | osteopetrosis | FDA Office of Orphan Products Development | Completed | No outcome recorded |
| Phase 3 | NCT00000412 Comparator | Sep 1997 → Apr 2002 | osteoporosis | Columbia University | Completed | No outcome recorded |
| Phase 413 trials | ||||||
| Phase 4 | NCT05902078 Comparator | Sep 2023 → Jun 2025 | disease of bone structure, postmenopausal osteoporosis | Shanghai Jiao Tong University Affiliated Sixth People's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04094805 Comparator | Oct 2020 → Mar 2021 | autoimmune thrombocytopenia | Shandong University | Unknown | No outcome recorded |
| Phase 4 | NCT01748396 Background | Jul 2012 → Jan 2013 | chronic kidney disease | Seoul National University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01350934 Comparator | Jun 2011 → Jan 2013 | postmenopausal osteoporosis | Organon and Co | Completed | No outcome recorded |
| Phase 4 | NCT01181531 Comparator | Oct 2010 → Jul 2012 | secondary hyperparathyroidism | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT01768351 Comparator | Oct 2010 → Mar 2011 | anemia, chronic kidney disease | Federico II University | Completed | No outcome recorded |
| Phase 4 | NCT01205880 Comparator | Dec 2009 → Jan 2010 | psoriasis | Emer, Jason, M.D. | Completed | No outcome recorded |
| Phase 4 | NCT01265615 Comparator | Oct 2009 → Apr 2010 | cardio-renal syndrome, chronic transplant rejection | Ural State Medical University | Completed | No outcome recorded |
| Phase 4 | NCT00823303 Comparator | Feb 2009 → May 2013 | chronic kidney disease, secondary hyperparathyroidism | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 4 | NCT00752102 Comparator | Sep 2008 → Oct 2013 | calcinosis, chronic kidney disease, vitamin D deficiency | Joslin Diabetes Center | Completed | No outcome recorded |
| Phase 4 | NCT00712205 Comparator | Aug 2008 → Aug 2010 | asthma | Kantonsspital Baselland Bruderholz | Unknown | No outcome recorded |
| Phase 4 | NCT01388517 Comparator | Jan 2008 → Aug 2010 | pityriasis alba | Autonomous University of San Luis Potosí | Completed | No outcome recorded |
| Phase 4 | NCT00497900 Background | Aug 2007 → Sep 2011 | heart failure, vitamin D deficiency | Hvidovre University Hospital | Completed | No outcome recorded |
| Phase not applicable6 trials | ||||||
| — | NCT07640347 Comparator | Jul 2026 → May 2027 expected | secondary hyperparathyroidism of renal origin | Chittagong Medical College | Not yet recruiting | No outcome recorded |
| — | NCT05252884 Comparator | Jun 2022 → Oct 2024 | goiter, hyperthyroidism, thyroid cancer, thyroiditis | Centro de Excelencia en Enfermedades de Cabeza y Cuello | Completed | No outcome recorded |
| — | NCT04637360 Background | Jan → Dec 2018 | secondary hyperparathyroidism of renal origin | Min-Sheng General Hospital | Completed | No outcome recorded |
| — | NCT02273570 Background | Mar 2015 → Dec 2016 | secondary hyperparathyroidism of renal origin | Azienda Ospedaliera Sant'Anna | Unknown | No outcome recorded |
| — | NCT00800358 Comparator | Nov 2008 → Oct 2009 | chronic kidney disease, secondary hyperparathyroidism | Penang Hospital, Malaysia | Completed | No outcome recorded |
| — | NCT00459563 Comparator | Mar 2007 → Dec 2011 | hypertensive disorder | Atlanta VA Medical Center | Withdrawn | No outcome recorded |
Evidence & citations 24 cited values
Every value below carries the sentence it was read from. 131 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Calcitriol | “The participants were randomized to 1 of 3 daily treatments: (1) 0.5-1.0 µg calcitriol and 1200 IU (30 µg) cholecalciferol, (2) 1200 IU cholecalciferol, (3) placebo.” PMID 22592096 ↗ May 2012111“Traditional vitamin D therapy (eg, calcitriol, paricalcitol, alfacalcidol, doxercalciferol), to manage secondary hyperparathyroidism (SHPT)” NCT01181531 ↗ “Conventional therapy is defined as oral phosphate supplements and calcitriol or other active forms of vitamin D3 (or analogs).” NCT06046820 ↗ “Sodium valproate extended-release tablets 0.5g/day; sirolimus tablets 1mg/day and calcitriol capsules 0.25μg/day.” NCT05920512 ↗ “DN-101 is a pill containing calcitriol, a chemical related to vitamin D that is immediately active in your body.” NCT00055263 ↗ “Patients receive oral calcitriol weekly for 3 consecutive days and zoledronate IV monthly.” NCT00004928 ↗ “Calcitriol- 5000 units in the morning before meals every other day 21 days” NCT06209229 ↗ “Dose of Vitamin D ( calcitriol; one alpha) 800-1000 International Unit” NCT01656512 ↗ “any active vitamin D available in Italy (calcitriol and paricalcitol-” NCT02273570 ↗ “calcitriol ointment 3µg/g and clobetasol propionate spray 0.05%” NCT00988637 ↗ “Patients receive oral high dose pulse calcitriol on day 1” NCT00182741 ↗ “Alendronate 5mg + calcitriol 0.5 μg” NCT01526278 ↗ “Dietary Supplement: Calcitriol” NCT02410005 ↗ “4 MCg calcitriol” NCT06464718 ↗ “* calcitriol” NCT01313221 ↗ “Calcitriol” NCT00536991 ↗ |
| Known as | 1, 25 dihydroxycholecalciferol | “In vitro and in vivo calcitriol (1, 25 dihydroxycholecalciferol) is antiproliferative and potentiates the antitumor effects of cytotoxic agents” NCT00794547 ↗2“Calcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day” NCT01237028 ↗ |
| Known as | 1,25-(OH)2D3 | “In previously treated patients maintenance vitamin D will be gradually replaced with 1,25(OH)2D3.” NCT00001151 ↗3“calcitriol (the active form of vitamin D, 1.25-dihydroxyvitamin D3 \[1,25-(OH)2D3\] )” NCT01120119 ↗ “Calcitriol (1,25(OH)2D3) 0.25mcg capsule daily for eight weeks.” NCT04286529 ↗ |
| Known as | 1,25-D3 | “Preclinical studies demonstrated antiproliferative synergy of 1,25-D3 (calcitriol) with cisplatin.” PMID 23435876 ↗ Feb 2013 |
| Known as | 1,25-dihydroxyvitamin 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 ↗3“We investigated whether administration of 1,25-dihydroxyvitamin D (calcitriol) to critically ill patients with sepsis would have beneficial effects on markers of innate...” PMID 25029202 ↗ Sep 2014 “calcitriol (1,25-dihydroxyvitamin D, the active form of vitamin D)” NCT00427804 ↗ |
| Known as | 1,25-dihydroxyvitamin D3 | “Calcitriol, an active form of vitamin D (1,25-dihydroxyvitamin-D3), is commonly used for the treatment of secondary hyperparathyroidism in patients with advanced chronic kidney...” NCT01512862 ↗6“Patients diagnosed with these disorders will be evaluated and treated with high doses of another form of Vitamin D (1,25-dihydroxyvitamin D3).” NCT00001151 ↗ “A Phase I Study of 1,25 Dihydroxy-Vitamin D3 (Calcitriol) in Patients With Prostate Cancer” NCT00004928 ↗ “calcitriol (the active form of vitamin D, 1.25-dihydroxyvitamin D3 \[1,25-(OH)2D3\] )” NCT01120119 ↗ “1, 25 dihydroxy vitamin D3 (Calcitriol)” NCT00298545 ↗ “1,25-dihydroxy-vitamin D3 (calcitriol)” NCT00960635 ↗ |
| Known as | 1,25-dihydroycholecalciferol | “Usual doses of 1,25-dihydroycholecalciferol are 0.25-1 ug per day.” NCT00001151 ↗ |
| Known as | 1,25D | “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 | 1a -25-dihydroxycholecalciferol | “Daily dose of 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol, Rocaltrol; Roche, Basel, Switzerland), 75 mg acetylsalicylic acid (ASA), and 1250 mg calcium carbonate (CaCO3).” NCT00486512 ↗ |
| Known as | Calcijex | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00062699 ↗ |
| Known as | CD 2027 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00763555 ↗ |
| Known as | Compound 31543 | “Compound 31543 (topical calcitriol)” NCT01588522 ↗ |
| Known as | DN-101 | “OBJECTIVE: To evaluate the preliminary efficacy, safety, and impact on quality of life (QoL) of high-dose calcitriol (DN-101) combined with mitoxantrone and glucocorticoids in...” PMID 18782306 ↗ Sep 20084“DN-101 is a unique formulation of calcitriol specifically designed for use in cancer.” NCT00066885 ↗ “calcitriol alone (DN101, 45 micrograms once weekly)” NCT00482157 ↗ “investigational study drug DN-101 (calcitriol)” NCT00536770 ↗ “DN-101 (calcitriol) - Drug” NCT00285675 ↗ |
| Known as | one alpha | “Dose of Vitamin D ( calcitriol; one alpha) 800-1000 International Unit” NCT01656512 ↗ |
| Known as | palicalcitol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05720273 ↗ |
| Known as | Rocaltrol | “We will enroll patients who have undergone cardiac transplantation into a randomized, double-blind, 12-month study of the efficacy and safety of calcitriol (Rocaltrol) and...” NCT00000412 ↗3“Daily dose of 0.5 mg calcitriol (1a -25-dihydroxycholecalciferol, Rocaltrol; Roche, Basel, Switzerland), 75 mg acetylsalicylic acid (ASA), and 1250 mg calcium carbonate (CaCO3).” NCT00486512 ↗ “Daily vitamin D (cholecalciferol) tablets and rocaltrol” NCT00497900 ↗ |
| Known as | Vectical | “Vectical™ (Calcitriol) Ointment 3 µg/g and Clobex® (Clobetasol Propionate) Spray, 0.05%” NCT00988637 ↗ |
| Known as | Vit.D3 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06141239 ↗ |
| Known as | vitamin D3 | “topical petrolatum (Vaseline) with calcitriol (vitamin D3) on a psoriatic lesion daily” NCT00004468 ↗ |
| Known as | vitaminD | “Dose of Vitamin D ( calcitriol; one alpha) 800-1000 International Unit” NCT01656512 ↗ |
| Action | Inhibit | “vitamin D inhibition of renin transcription” NCT00585442 ↗ |
| Modality | Small molecule | “DN-101 is a pill containing calcitriol, a chemical related to vitamin D” NCT00055263 ↗ |
| Route | Oral | “will be administered orally” NCT00001151 ↗ |
| Target | REN | “vitamin D inhibition of renin transcription” NCT00585442 ↗ |