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Rocaltrol

(Calcitriol)

ApprovedSmall molecule

Alnylam Pharmaceuticals

Calcitriol is used to treat low calcium levels in the blood, particularly in people with kidney disease or parathyroid problems, and also helps treat certain types of psoriasis and eczema when applied to the skin.[2] Rocaltrol is currently approved and in use across 55 indications[4].[1]

Rocaltrol is one of 1129 small molecule programs targeting Calcification. It is currently in Approved.

55

Indications

77

Total Trials

3

Active Trials

1,128

Competitors

4

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

CalcificationActive, not recruiting

Systemic Lupus ErythematosusApproved

Hypophosphatemic RicketsApproved

Familial Adenomatous PolyposisApproved

Bone DiseaseActive, not recruiting

Basal Cell CarcinomaActive, not recruiting

Lung CancerActive, not recruiting

Cholestatic Liver DiseaseRecruiting

Bone DensityActive, not recruiting

Attention Deficit Hyperactivity DisorderApproved

CalcificationApproved

Active, not recruiting

Systemic Lupus ErythematosusApproved

Approved

Hypophosphatemic RicketsApproved

Approved

Familial Adenomatous PolyposisApproved

Approved

Bone DiseaseApproved

Active, not recruiting

Basal Cell CarcinomaPhase 2

Active, not recruiting

Lung CancerPhase 1/Phase 2

Active, not recruiting

Cholestatic Liver DiseaseApproved

Recruiting

Bone DensityPreclinical

Active, not recruiting

Attention Deficit Hyperactivity DisorderApproved

Approved

Showing 10 of 55 indications

Competition

Competitive Landscape

2828 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Rocaltrol

Alnylam Pharmaceuticals

Tykerb

Avastin

BBio-Thera Solutions

DATROWAY

Cymbalta

Alnylam Pharmaceuticals

MS Contin

MS Contin

HHikma Pharmaceuticals LLC

Zinecard

CChildren's Oncology Group

Spravato

Sporanox

SSebela Pharmaceuticals Development LLC

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

ApprovedRecruiting

Cholestatic Liver Disease

NCT07670611

Clinical

Trials by Indication[1]

Psoriasis7 trials

Study of Topical Calcitriol in Children With Psoriasis

Completed·NNational Center for Research Resources (NCRR)·N/A·NCT00006275·20 enrolled

Study of Topical Calcitriol or Oral Calcitriol in Patients With Psoriasis

Withdrawn·NNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·N/A·NCT00004468

Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis

Completed·GGalderma R&D·Phase 3·NCT00658788·305 enrolled

Show 4 more trials

Study to Evaluate Vectical in Combination With Clobex Spray to Treatment Plaque Psoriasis

Completed·EEmer, Jason, M.D.·Phase 4·NCT01205880·12 enrolled

Plaque Psoriasis Study in Pediatric Subjects

Completed·GGalderma R&D·Phase 4·NCT02186665·19 enrolled

A Study to Evaluate and Compare the Efficacy and Pharmacokinetics of MK-0873 for the Treatment of Plaque Psoriasis (MK-0873-022)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT01235728·24 enrolled

Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis

Completed·GGalderma R&D·Phase 4·NCT02125279·54 enrolled

Chronic Kidney Disease4 trials

Study to Evaluate Safety of Vitamin D Receptor Activators in Patients Ages 0 to 16 With Chronic Kidney Disease Stage 5 Receiving Peritoneal Dialysis Within Current Clinical Practice

Terminated· AbbVie logo

AbbVie··NCT01134315·61 enrolled

Effect of Vitamin D Supplement on Osteoprotegin Expression and Disease Progression in Patients With Chronic Kidney Disease Stage 1 and 2

Unknown status·—·Phase 4·NCT01561222·300 enrolled

hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

Withdrawn·MMassachusetts General Hospital·N/A·NCT01026363

Show 1 more trial

Vitamin D and Arterial Function in Patients With Chronic Kidney Disease

Completed·UUniversity of Colorado, Denver·Phase 3·NCT01384539·128 enrolled

Kidney Disease3 trials

Anti-proteinuric Effect of Calcitriol in Non-diabetic Kidney Disease Patients

Unknown status·SSeoul National University Hospital·Phase 4·NCT01512862·240 enrolled

The Effects of Calcitriol on Biomarkers in Diabetic Kidney Disease Patients

Unknown status·IIndonesia University·N/A·NCT05298163·120 enrolled

An Open-Label, Randomized, Parallel Group Study to Assess the Safety and Efficacy of Hectorol® (Doxercalciferol Capsules) in Pediatric Patients With Chronic Kidney Disease Stages 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis

Terminated· Sanofi logo

Sanofi·Phase 3·NCT02859896·21 enrolled

Vitamin D3 trials

Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity

Completed·VVA Office of Research and Development·Phase 1/2·NCT00953849·21 enrolled

The Effect of Inactive and Active Vitamin D on Serum Sclerostin/dickkopf1 Levels

Unknown status·SSeoul National University Hospital·Phase 4·NCT01765010·88 enrolled

Vitamin D and Cocaine Administration

Terminated·YYale University·Phase 1·NCT04826133·4 enrolled

Prostate Cancer3 trials

ASCENT: Androgen Independent Prostate Cancer Study of Calcitriol Enhancing Taxotere

Unknown status·NNovacea·Phase 2/3·NCT00043576·250 enrolled

A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer

Terminated·SStanford University·Phase 2·NCT00383487·20 enrolled

DN-101 in Combination With Docetaxel in Androgen-Independent Prostate Cancer (AIPC) (AIPC Study of Calcitriol Enhancing Taxotere [ASCENT-2])

Terminated·NNovacea·Phase 3·NCT00273338·1,200 enrolled

45 more indications

Secondary Hyperparathyroidism3 trials

Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)

Completed·WWashington University School of Medicine·Phase 4·NCT00823303·110 enrolled

Safety and Efficacy Study of Paricalcitol Versus Calcitriol in the Treatment of Secondary Hyperparathyroidism

Completed·PPenang Hospital, Malaysia·N/A·NCT00800358·69 enrolled

Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects

Terminated·AAbbott·Phase 4·NCT00664430·13 enrolled

Osteoporosis3 trials

Eldecalcitol and Calcitriol in Postmenopausal Women With Low Bone Mineral Density or Mild Osteoporosis

Recruiting·SShanghai Jiao Tong University Affiliated Sixth People's Hospital·Phase 4·NCT05902078·300 enrolled

A Study to Evaluate Alendronate Sodium /Vitamin D3 Combination Tablets(FOSAMAX PLUS) Versus Calcitriol in the Treatment of Osteoporosis in Postmenopausal Women in China (MK-0217A-264)

Completed·OOrganon and Co·Phase 4·NCT01350934·219 enrolled

Osteoporosis Prevention After Heart Transplant

Completed·—·Phase 3·NCT00000412·149 enrolled

COVID-192 trials

Calcitriol Supplementation in COVID-19 Patients

Unknown status·RRenJi Hospital·N/A·NCT05415254·86 enrolled

Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients

Completed·UUniversitas Sebelas Maret·Phase 2·NCT05765617·16 enrolled

Breast Cancer2 trials

Gene Expression Profile of Breast Cancer Samples After Vitamin D Supplementation

Unknown status·UUniversity of Sao Paulo General Hospital·N/A·NCT00926315·60 enrolled

Effects of High Dose Calcitriol in Breast Cancer Patients

Completed·UUniversity of Rochester·Phase 2·NCT01293682·12 enrolled

Nephropathy2 trials

Calcitriol in the Treatment of Immunoglobulin A Nephropathy

Unknown status·PPeking University First Hospital·Phase 4·NCT00862693·40 enrolled

Calcitriol in the Treatment of Immunoglobulin A (IgA) Nephropathy

Completed·—·Phase 4·NCT00319761·10 enrolled

X-linked hypophosphatemia2 trials

Calcitriol Monotherapy for X-Linked Hypophosphatemia

Active, not recruiting·MMassachusetts General Hospital·Phase 1·NCT03748966·20 enrolled

Using Different Doses of Active Vitamin D Combined With Neutral Phosphate in Children With X-linked Hypophosphatemia

Unknown status·PPeking Union Medical College Hospital·Phase 4·NCT03820518·100 enrolled

Lupus Nephritis2 trials

The Effect of Calcitriol on Progress and Activity of Lupus Nephritis

Unknown status·GGuilan University of Medical Sciences·Phase 2·NCT01863641·50 enrolled

The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria

Withdrawn·—·Phase 4·NCT00508898

Lung Cancer2 trials

Phase I/II Calcitriol in Lung Cancer

Terminated·UUniversity of Michigan Rogel Cancer Center·Phase 1/2·NCT00794547·34 enrolled

Calcitriol in Preventing Lung Cancer in Smokers and Former Smokers at High Risk of Lung Cancer

Completed·RRoswell Park Cancer Institute·N/A·NCT00690924·16 enrolled

Blood Pressure1 trial

Vitamin D and Blood Pressure

Withdrawn·—·N/A·NCT00459563

Neurocognitive Function1 trial

Vitamin D as a Therapeutic Adjunct in the Stimulant Treatment of ADHD: a Proof-of-concept Tele-health Study of Stimulant-induced Improvement in Neurocognitive Functioning.

Terminated·YYale University·Phase 1·NCT04386811·3 enrolled

Necrosis1 trial

Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption

Completed·—·N/A·NCT00427804·9 enrolled

Tuberous Sclerosis1 trial

Topical Rapamycin and Calcitriol for Angiofibroma of Tuberous Sclerosis

Completed·NNational Taiwan University Hospital·Phase 3·NCT03140449·52 enrolled

Tics1 trial

The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers

Completed· Takeda logo

Takeda·Phase 1·NCT00925704·41 enrolled

Acute Kidney Injury1 trial

Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury

Completed·DDavid Leaf·Phase 2·NCT02962102·150 enrolled

Growth1 trial

Phase II Randomized Study of the Effects of Growth Hormone on Children and Adolescents on Maintenance Dialysis

Completed·NNational Center for Research Resources (NCRR)·Phase 2·NCT00004340·109 enrolled

Kidney Transplant1 trial

Bone Mass and Strength After Kidney Transplantation

Completed·—·Phase 2·NCT02224144·61 enrolled

Anemia1 trial

Paricalcitol Effect on Anemia in CKD

Completed·FFederico II University·Phase 4·NCT01768351·60 enrolled

Bone Disease1 trial

Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol

Terminated·WWinthrop University Hospital·Phase 4·NCT01725113·16 enrolled

Osteopetrosis1 trial

Phase III Randomized Study of Interferon Gamma in Children With Severe, Congenital Osteopetrosis

Completed·FFDA Office of Orphan Products Development·Phase 3·NCT00004402·30 enrolled

Ataxia1 trial

Evaluation of the Effects of Calcitriol's in the Neurological Symptoms of Friedreich's Ataxia Patients

Completed·BBerta Alemany·Phase 4·NCT04801303·20 enrolled

Hypertensive1 trial

Effects of Vitamin D on Renin Expression in Hypertensive Patients

Terminated·UUniversity of Utah·Phase 1·NCT00585442·12 enrolled

Proteinuria1 trial

Oral Calcitriol for Reduction of Mild Proteinuria in Patients With CKD

Unknown status·HHuashan Hospital·Phase 4·NCT01820832·60 enrolled

Fasting Conditions1 trial

Bioequivalency Study of Calcitriol Tablets Under Fasting Conditions

Completed·RRoxane Laboratories·N/A·NCT00601328·36 enrolled

Diabetic Nephropathy1 trial

Clinical Trial Technology Development for the Validation of Surrogate Prognostic Markers in Patients With Diabetic Nephropathy

Unknown status·SSeoul National University Hospital·Phase 4·NCT01673204·276 enrolled

Type 2 Diabetes1 trial

An Intervention to Examine the Effect of Vitamin D on Urine Protein Levels in Type 2 Diabetes

Unknown status·HHamad Medical Corporation·Phase 3·NCT03216564·320 enrolled

Postmenopausal Women1 trial

Safety Study of an Oral Vitamin D Analog in Postmenopausal Women

Completed·DDeltanoid Pharmaceuticals·Phase 1·NCT01969656

Bone Density1 trial

Bone Markers and Bone Density Changes in Hyperperparathyroid Dialysis Patients Under Cinacalcet Treatment

Completed·MMin-Sheng General Hospital·N/A·NCT04637360·40 enrolled

IgA Nephropathy1 trial

Additive Renoprotective Effects of Oral Calcitriol in IgA Nephropathy Patients Taking Renin-Angiotensin System Blockers

Completed·YYonsei University·N/A·NCT01237028·168 enrolled

Myelodysplastic Syndromes1 trial

Calcitriol and Dexamethasone in Patients With Myelodysplastic Syndromes

Completed·UUniversity of Pittsburgh·Phase 2·NCT00030069·32 enrolled

Postmenopausal Osteoporosis1 trial

Clinical Study on Treatment of Postmenopausal Osteoporosis (Kidney Deficiency and Blood Stasis Syndrome) With Xulin Jiangu Granules

Unknown status·FFujian Academy of Traditional Chinese Medicine·Phase 1·NCT03563235·60 enrolled

Insulin Secretion1 trial

Effect of 1,25-dihydroxyvitamin D3, Treatment on Insulin Secretion and Muscle Strength in Pre-diabetic Persons

Terminated·MMayo Clinic·Phase 1·NCT04286529·17 enrolled

Calcification1 trial

Vitamin D and Coronary Calcification Study

Completed·JJoslin Diabetes Center·Phase 4·NCT00752102·44 enrolled

Intrahepatic Cholangiocarcinoma1 trial

Calcitriol in Advanced Intrahepatic Cholangiocarcinoma

Unknown status·NNational Science and Technology Development Agency, Thailand·Phase 2·NCT01039181·28 enrolled

Physical Activity1 trial

Calcitriol, Physical Activity, and Bone Health in Cancer Survivors

Completed·UUniversity of Rochester·Phase 2·NCT00904033·41 enrolled

Clinical Trial1 trial

Clinical Trial of 0.0003% Calcitriol, 0.1% Tacrolimus, and Petrolatum for the Treatment of Pityriasis Alba

Completed·UUniversidad Autonoma de San Luis Potosí·Phase 4·NCT01388517·39 enrolled

OIC1 trial

RA-2 13-cis Retinoic Acid (Isotretinoin)

Completed·UUniversity of Washington·Phase 2·NCT02061384·20 enrolled

Basal Cell Carcinoma1 trial

Topical Vitamin D3, Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma

Completed·MMaastricht University Medical Center·Phase 2·NCT01358045·128 enrolled

Renal Transplant1 trial

Paricalcitol Versus Calcitriol for the Management of Renocardiac Syndrome in Renal Transplant Patients

Completed·UUral State Medical University·Phase 4·NCT01265615·109 enrolled

Hypocalcemia1 trial

Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT00623974·7 enrolled

Renal Failure1 trial

Comparison of Serum Calcium Level Between Preoperative Vitamin D and Non-vitamin D Regimen of Total Parathyroidectomy in End-stage Renal Failure Patients in Rajavithi Hospital

Completed·DDepartment of Medical Services Ministry of Public Health of Thailand·N/A·NCT04967469·60 enrolled

Type 1 Diabetes1 trial

Efficacy of Calcitriol in Recent Onset Type 1 Diabetes

Completed·—·Phase 2·NCT01120119

Sepsis1 trial

Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis

Completed·—·Phase 2·NCT01689441·67 enrolled

Asthma1 trial

Vitamin D for the Treatment of Severe Asthma

Unknown status·KKantonsspital Baselland Bruderholz·Phase 4·NCT00712205·20 enrolled

Cholestatic liver disease1 trial

Accelerated Correction of Vitamin D Deficiency in Cholestatic Children: a Comparative Trial of Vitamin D2 Monotherapy vs Combination Therapy With Calcitriol

Recruiting·CChulalongkorn University·Approved·NCT07670611·54 enrolled

Unspecified3 trials

The VALIDATE-D Study

Completed·—·N/A·NCT01635062·41 enrolled

Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol

Completed·SSeoul National University Hospital·Phase 4·NCT01748396·30 enrolled

Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002

Completed·OOPKO Health, Inc.·Phase 3·NCT02282813·298 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

ROCALTROL

NDA NDA018044

Sep 25, 1986

CALCIJEX

NDA NDA018874

Nov 20, 1998

ROCALTROL

NDA NDA021068

Jan 23, 2009

VECTICAL

NDA NDA022087

Sources

References

[1]
ClinicalTrials.gov — 77 trial records for Calcitriol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Rocaltrol drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Calcitriol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Calcitriol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA022087). U.S. Food & Drug Administration.
[6]
SEC EDGAR — Alnylam Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Vitamin D Receptor Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Alnylam Pharmaceuticals

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