Drugs / Calcitriol
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Calcitriol

Small molecule targets REN via inhibition

Developed for
psoriasis · chronic kidney disease · prostate cancer · end stage renal failure · vitamin D deficiency · diabetic kidney disease · non-small cell lung carcinoma · breast cancer
+59 more · proteinuria · secondary hyperparathyroidism · COVID-19 · Crohn disease · IgA glomerulonephritis · osteoporosis · renal osteodystrophy · secondary hyperparathyroidism of renal origin · systemic lupus erythematosus · acute kidney injury · adenomatous colon polyp · arterial disorder · attention deficit-hyperactivity disorder · autoimmune disease · benign vascular tumor · bone disorder · bone resorption disease · brain hypoxia - ischemia · calcinosis · castration-resistant prostate carcinoma · chemotherapy-induced alopecia · chronic renal failure syndrome · Friedreich ataxia · glomerulonephritis · hemophilia · HIV infectious disease · hormone-resistant prostate carcinoma · hypercalcemia disease · hyperphosphatemia · hypertensive disorder · hypoparathyroidism · infectious disease with sepsis · intrahepatic cholangiocarcinoma · kidney failure · Klinefelter syndrome · lung cancer · lupus nephritis · myelodysplastic syndrome · neoplasm · oral cavity cancer · partial chromosome Y deletion · postmenopausal osteoporosis · prostate adenocarcinoma · rheumatoid arthritis · type 1 diabetes mellitus · type 2 diabetes mellitus · X-linked dominant hypophosphatemic rickets · X-linked hypophosphatemic rickets · anemia · asthma · autoimmune thrombocytopenia · basal cell carcinoma · cardio-renal syndrome · chronic transplant rejection · disease of bone structure · malignant pancreatic neoplasm · pityriasis alba · prediabetes syndrome · substance-related disorder
Investigated by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · Novacea · Galderma R&D · National Cancer Institute (NCI) · Abbott · Seoul National University Hospital
+76 more · Aventis Pharmaceuticals · Boston University · Brigham and Women's Hospital · Chinese University of Hong Kong · Hamad Medical Corporation · Massachusetts General Hospital · National Center for Research Resources (NCRR) · Roswell Park Cancer Institute · Stanford University · University of Rochester · University of Washington · Weill Cornell Medical College in Qatar · Al-Azhar University · Amgen · Atlanta VA Medical Center · BPGbio · Berta Alemany · Campus-Bio-Medico University · Carlos III Health Institute · Chulalongkorn University · Colotech A/S · Columbia University · David Leaf · Department of Medical Services Ministry of Public Health of Thailand · Donald Trump, MD · Emory University · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Frontier Medical and Dental College, Abbotabad · Fujian Academy of Traditional Chinese Medicine · Ghufran Dhari Awad · Guilan University of Medical Sciences · Huashan Hospital · Hvidovre University Hospital · Indonesia University · Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta · Institut de Recerca Biomèdica de Lleida · Instituto Brasileiro de Controle do Cancer · Khon Kaen University · MIPO Clinic · Mahidol University · Medical University of South Carolina · Memorial Sloan Kettering Cancer Center · Merck Sharp & Dohme LLC · National Institute for Health Research, United Kingdom · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · National Institute of Neurological Disorders and Stroke (NINDS) · National Kidney Foundation, United States · National Science and Technology Development Agency, Thailand · National Taiwan University Hospital · OHSU Knight Cancer Institute · OPKO Health, Inc. · Peking Union Medical College Hospital · Peking University First Hospital · Postgraduate Institute of Dental Sciences Rohtak · RenJi Hospital · Satellite Healthcare · Statistika Consultoria Ltda · Taixing People's Hospital · Teva GTC · Universitas Sebelas Maret · Universitat de Lleida · University of Alabama at Birmingham · University of California, Los Angeles · University of California, San Francisco · University of Colorado, Denver · University of Michigan Rogel Cancer Center · University of Pittsburgh · University of Sao Paulo General Hospital · University of Utah · VA Office of Research and Development · Weill Medical College of Cornell University · Winthrop University Hospital · Xue-chun Lu · Yale University · all 82 on the full record

Regulatory milestones approvals, filings & regulatory actions · 7 recorded

MilestoneJurisdictionBrandIndicationDateSentence 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 84 · started per year

today
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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 05 trials · 1 missed
Phase 0 NCT03563235 Sep 2019 → Sep 2021 postmenopausal osteoporosis Fujian Academy of Traditional Chinese Medicine Unknown No outcome recorded
Phase 0 NCT03748966 Mar 2019 → Mar 2025 X-linked dominant hypophosphatemic rickets Massachusetts General Hospital Completed No outcome recorded
Phase 0 NCT04643821 Jan 2015 → Apr 2017 brain hypoxia - ischemia Medical University of South Carolina Completed No outcome recorded
Phase 0 NCT01988116 Oct 2013 → Jun 2015 anemia due to chronic disorder, chronic kidney disease University of Alabama at Birmingham Completed Missed primary
Phase 0 NCT00585442 May 2007 → Jun 2008 hypertensive disorder, vitamin D deficiency University of Utah Terminated No outcome recorded
Phase 17 trials
Phase 1 NCT06209229 May 2022 → May 2023 non-small cell lung carcinoma MIPO Clinic Completed No outcome recorded
Phase 1 NCT04386811 Aug → Sep 2020 attention deficit-hyperactivity disorder Yale University Terminated No outcome recorded Stop: Business
Phase 1 NCT01588522 Sep 2012 → Feb 2017 chemotherapy-induced alopecia BPGbio Completed No outcome recorded
Phase 1 NCT01526278 Oct 2011 → Jul 2012 osteoporosis Yuyu Pharma, Inc. Completed No outcome recorded
Phase 1 NCT01235728 Nov 2010 → Apr 2011 psoriasis Merck Sharp & Dohme LLC Completed No outcome recorded
Phase 1 NCT00055263 Mar 2002 → ? neoplasm Novacea Completed No outcome recorded
Phase 1 NCT00004928 Oct 1999 → Oct 2004 prostate cancer Memorial Sloan Kettering Cancer Center Completed No outcome recorded
Phase 1/26 trials · 1 missed
Phase 1/2 NCT05920512 Apr 2022 → Apr 2025 hemophilia Xue-chun Lu Unknown No outcome recorded
Phase 1/2 NCT00953849 Nov 2009 → Dec 2015 oral cavity cancer VA Office of Research and Development Completed No outcome recorded
Phase 1/2 NCT00794547 Dec 2008 → Oct 2011 non-small cell lung carcinoma University of Michigan Rogel Cancer Center Terminated Missed primary
Phase 1/2 NCT00536991 Oct 2006 → Oct 2016 prostate adenocarcinoma Roswell Park Cancer Institute Terminated No outcome recorded Stop: Enrollment
Phase 1/2 NCT00287170 Jul 2006 → Dec 2007 Crohn disease Teva GTC Completed No outcome recorded
Phase 1/2 NCT00066885 Jun 2003 → Dec 2005 non-small cell lung carcinoma Novacea Completed No outcome recorded
Phase 220 trials · 3 missed
Phase 2 NCT07842120 Apr → Dec 2026 expected — Ghufran Dhari Awad Recruiting No outcome recorded
Phase 2 NCT06288451 Mar 2024 → Feb 2027 expected chronic renal failure syndrome, renal osteodystrophy University of Washington Active not recruiting No outcome recorded
Phase 2 NCT05765617 Jul → Sep 2021 COVID-19 Universitas Sebelas Maret Completed No outcome recorded
Phase 2 NCT02962102 Apr 2017 → Jul 2020 acute kidney injury David Leaf Completed Missed primary
Phase 2 NCT03261336 Jan 2017 → Feb 2018 castration-resistant prostate carcinoma Donald Trump, MD Terminated No outcome recorded Stop: Enrollment
Phase 2 NCT02224144 Aug 2014 → Oct 2016 bone resorption disease, calcinosis, end stage renal failure Columbia University Completed No outcome recorded
Phase 2 NCT02061384 Aug 2014 → Dec 2018 Klinefelter syndrome, partial chromosome Y deletion University of Washington Completed No outcome recorded
Phase 2 NCT01863641 Apr → Oct 2013 systemic lupus erythematosus Guilan University of Medical Sciences Unknown No outcome recorded
Phase 2 NCT01689441 Feb 2013 → Feb 2014 infectious disease with sepsis Brigham and Women's Hospital Completed Missed primary
Phase 2 NCT01293682 Nov 2010 → Aug 2018 breast cancer University of Rochester Completed No outcome recorded
Phase 2/32 trials
Phase 2/3 NCT02410005 Oct 2014 → Sep 2015 diabetic kidney disease Weill Cornell Medical College in Qatar Terminated No outcome recorded
Phase 2/3 NCT00043576 Aug 2002 → Dec 2005 prostate cancer Novacea Unknown No outcome recorded
Phase 37 trials · 2 missed
Phase 3 NCT03216564 May 2017 → May 2019 diabetic kidney disease Hamad Medical Corporation Unknown No outcome recorded
Phase 3 NCT03140449 Sep 2013 → Nov 2016 benign vascular tumor National Taiwan University Hospital Completed No outcome recorded
Phase 3 NCT02282813 Apr 2013 → May 2015 chronic kidney disease, secondary hyperparathyroidism of renal origin, vitamin D deficiency OPKO Health, Inc. Completed No outcome recorded
Phase 3 NCT01384539 Jul 2011 → Sep 2015 arterial disorder, chronic kidney disease University of Colorado, Denver Completed No outcome recorded
Phase 3 NCT01313221 Apr 2011 → Dec 2012 psoriasis Amgen Completed Missed primary
Phase 3 NCT00486512 Jun 2007 → Nov 2010 adenomatous colon polyp Colotech A/S Terminated Missed primary
Phase 3 NCT00273338 Jan 2006 → Nov 2007 prostate cancer Novacea Terminated No outcome recorded
Phase 421 trials
Phase 4 NCT07670611 Apr → Jul 2026 overdue cholestasis, liver disorder, vitamin D deficiency Chulalongkorn University Recruiting No outcome recorded
Phase 4 NCT04801303 Aug 2021 → Sep 2022 Friedreich ataxia Berta Alemany Completed No outcome recorded
Phase 4 NCT03820518 Jan 2017 → Dec 2021 X-linked hypophosphatemic rickets Peking Union Medical College Hospital Unknown No outcome recorded
Phase 4 NCT01561222 Jul 2015 → Mar 2016 chronic kidney disease Taixing People's Hospital Unknown No outcome recorded
Phase 4 NCT02186665 Jul 2014 → Nov 2015 psoriasis Galderma R&D Completed No outcome recorded
Phase 4 NCT02125279 May 2014 → May 2018 psoriasis Galderma R&D Completed No outcome recorded
Phase 4 NCT01820832 Mar 2013 → Dec 2014 chronic kidney disease, proteinuria Huashan Hospital Unknown No outcome recorded
Phase 4 NCT01766440 Mar 2013 → Nov 2015 psoriasis Galderma R&D Completed No outcome recorded
Phase 4 NCT01765010 Jan → Mar 2013 osteoporosis Seoul National University Hospital Unknown No outcome recorded
Phase 4 NCT01725113 Nov 2012 → Dec 2013 hypercalcemia disease, hyperphosphatemia, kidney failure, secondary hyperparathyroidism Winthrop University Hospital Terminated No outcome recorded Stop: Business
Phase not applicable16 trials · 1 missed
— NCT07200349 Nov 2025 → Sep 2026 overdue — Al-Azhar University Not yet recruiting No outcome recorded
— NCT06464718 Jun → Dec 2022 — Frontier Medical and Dental College, Abbotabad Completed No outcome recorded
— NCT05415254 Jun → Aug 2022 COVID-19, vitamin D deficiency RenJi Hospital Unknown No outcome recorded
— NCT05298163 Apr → Oct 2022 diabetic kidney disease Indonesia University Unknown Mixed
— NCT04967469 Sep 2020 → Dec 2023 end stage renal failure Department of Medical Services Ministry of Public Health of Thailand Completed No outcome recorded
— NCT05202496 Nov 2019 → Apr 2021 — Postgraduate Institute of Dental Sciences Rohtak Completed No outcome recorded
— NCT01635062 Sep 2012 → Dec 2015 obesity disorder, type 2 diabetes mellitus Brigham and Women's Hospital Completed Missed primary
— NCT01237028 Mar 2011 → Aug 2016 IgA glomerulonephritis Yonsei University Completed No outcome recorded
— NCT01026363 Dec 2009 → Jul 2014 chronic kidney disease, vitamin D deficiency Massachusetts General Hospital Withdrawn No outcome recorded Stop: Enrollment
— NCT00690924 Jul 2008 → Mar 2017 lung cancer, nicotine dependence, precancerous condition Roswell Park Cancer Institute Completed No outcome recorded
Comparator or background therapy34 trials
Phase 0 NCT04826133 Comparator Mar 2019 → Jan 2020 substance-related disorder Yale University Terminated No outcome recorded Stop: Business
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

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2018-07-16 Rockwell Medical Technologies, Inc. Regulatory Calcitriol New Contract Manufacturing Submission Receives FDA Approval and Allows Rockwell Medical Commercialization of Calcitriol rockwellmed.com ↗
On July 11, 2018, Rockwell Medical received FDA approval of its Prior Approval Supplement for manufacturing Calcitriol.
2018-05-08 Rockwell Medical Technologies, Inc. Regulatory Rockwell Medical Update on Calcitriol New Manufacturing Submission to FDA rockwellmed.com ↗
2018-03-20 Takeda Results New Data Presented at the Endocrine Society’s 2018 Annual Meeting Advances Understanding of the Rare Disease Chronic Hypoparathyroidism takeda.com ↗
Oral calcium and calcitriol doses were reduced by 53.4% and 75.7%, respectively, while albumin-adjusted serum calcium levels were maintained within the target range.
2017-06-15 Yuyu Pharma, Inc. Results 유유제약, 골다공증 치료제 맥스마빌정 임상4상 골절예방효과 입증 yuyu.co.kr ↗
위 환자를 대상으로 맥스마빌정 투여 후 12개월 추적 관찰한 결과, 골다공증성 골절 발생율은 약 2.7%였고, 요추 골밀도 및 고관절 골밀도는 각각 5% 및 1.5% 개선되었다.
2009-02-03 Galderma R&D Regulatory Galderma wins FDA Approval for Vectical ™ Ointment galderma.com ↗
Galderma Laboratories, L.P. today announced that the U.S. Food and Drug Administration (FDA) has approved Vectical ™ (calcitriol) Ointment 3mcg/g, a unique vitamin D3 product for the treatment of mild-to-moderate plaque psoriasis in adults.

Evidence & citations 20 cited values

Every value below carries the sentence it was read from. 122 sources stand behind the page.

FieldValueCited 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 2012
112

“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 ↗

Show 102 more sources

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 ↗
1

“Calcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day” NCT01237028 ↗

Known as 1,25 Dihydroxy-Vitamin 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 ↗
4

“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-(OH)₂D₃ “Calcitriol (1,25-(OH)₂D₃) local injection • Agent: Calcitriol (1,25-(OH)₂D₃) Vitamin D3” NCT07842120 ↗
2

“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 ↗
2

“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 1,25D “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 ↗
1

NCT00073710 ↗

Known as Compound 31543 “Compound 31543 (topical calcitriol)” NCT01588522 ↗
Known as DN101 “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 2008
4

“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 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 ↗

NCT04094805 ↗

Known as Vectical “Vectical™ (Calcitriol) Ointment 3 µg/g and Clobex® (Clobetasol Propionate) Spray, 0.05%” NCT00988637 ↗
1

NCT01012713 ↗

Known as Vitamin D “Dose of Vitamin D ( calcitriol; one alpha) 800-1000 International Unit” NCT01656512 ↗
2

“acute calcitriol (vitaminD) administration” NCT04386811 ↗

“Vitamin D (Calcitriol)” NCT00482157 ↗

Known as vitamin D3 “topical petrolatum (Vaseline) with calcitriol (vitamin D3) on a psoriatic lesion daily” NCT00004468 ↗
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 “Twice daily oral calcitriol with 1000 mg Calcium carbonate supplementation” NCT00001304 ↗
Target REN “vitamin D inhibition of renin transcription” NCT00585442 ↗