TheraRadar
Data updated: May 26, 2026

ROCALTROL (calcitriol)

Renal Approved 1978-08-17

ROCALTROL is indicated for the treatment of Secondary Hyperparathyroidism; Metabolic Bone Disease; Chronic Renal Failure; Hypocalcemia; Osteitis Fibrosa Cystica; Hypoparathyroidism; Pseudohypoparathyroidism.

Source: FDA Label • ESJAY PHARMA
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
4
Indications
--
Phase 3 Trials
1
Priority Reviews
47
Years on Market

Details

Status
Prescription
First Approved
1978-08-17
Routes
ORAL
Dosage Forms
SOLUTION, CAPSULE

Companies

ESJAY PHARMA
Active Ingredient: CALCITRIOL

ROCALTROL Approval History

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Original
New Indication
New Form
Label Update
64 FDA actions from 1978 to 2013 · 1 indication expansions
May 2013 SUPPL
Mfg · Manufacturing (CMC)
Feb 2010 SUPPL
Label · Labeling
FDA Letter
Jul 2004 SUPPL
Label · Labeling
FDA Letter

What ROCALTROL Treats

7 indications

ROCALTROL is approved for 7 conditions since its original approval in 1978. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Secondary Hyperparathyroidism
  • Metabolic Bone Disease
  • Chronic Renal Failure
  • Hypocalcemia
  • Osteitis Fibrosa Cystica
  • Hypoparathyroidism
  • Pseudohypoparathyroidism
Source: FDA Label

ROCALTROL Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

YORVIPATH
ASCENDIS PHARMA
2024 1 indic.
CALCIUM GLUCONATE
B BRAUN
2017 1 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ROCALTROL

3 of 10

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

CALCITRIOL
CALCITRIOL
7 shared
SAGENT PHARMS
Shared indications:
Secondary HyperparathyroidismMetabolic Bone DiseaseChronic Renal Failure +4 more
NATPARA
PARATHYROID HORMONE
2 shared
NPS PHARMS INC
Shared indications:
HypocalcemiaHypoparathyroidism
CALCIUM GLUCONATE
CALCIUM GLUCONATE
1 shared
B BRAUN MEDICAL
Shared indications:
Hypocalcemia
View all 10 similar drugs Pro
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Clinical Trial Registry

28 trials
Trial Sponsor ID Phase Status Title
NCT02962102 ACTIVATE-AKI results posted 2016P002527 5K23DK106448 Ph 2 completed Activated Vitamin D for the Prevention and Treatment of Acute Kidney Injury
NCT02859896 LPS14314 U1111-1178-4657 Ph 3 terminated Safety and Efficacy of Hectorol in Pediatric Patients With Chronic Kidney Disease Stage 3 and 4 With Secondary Hyperparathyroidism Not Yet on Dialysis
NCT02224144 results posted AAAM7850 Ph 2 completed Bone Mass and Strength After Kidney Transplantation
NCT01350934 results posted 0217A-264 Ph 4 completed 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)
NCT04386811 2000028035 Ph 1 terminated 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.
NCT01725113 ECRIP results posted 12027 Ph 4 terminated Management of Mineral and Bone Disease in Hemodialysis-Calcitriol vs. Paricalcitol
NCT04801303 CalcitriolFA IdIBGI 2020-001092-32 Ph 4 completed Evaluation of the Effects of Calcitriol's in the Neurological Symptoms of Friedreich's Ataxia Patients
NCT05765617 NAP03 Ph 2 completed Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients
NCT01293682 results posted 25741 Ph 2 completed Effects of High Dose Calcitriol in Breast Cancer Patients
NCT02061384 RA-2 results posted STUDY00000564 Ph 2 completed RA-2 13-cis Retinoic Acid (Isotretinoin)
NCT00925704 results posted SPD405-129 Ph 1 completed The Pharmacokinetics of Rocaltrol When Administered Alone or in Combination With Fosrenol or Renvela in Healthy Volunteers
NCT02125279 results posted RD.06.SPR.18131 Ph 4 completed Long Term Safety and Efficacy Study of Calcitriol 3 mcg/g Ointment in Pediatric Subjects With Plaque Psoriasis
NCT01689441 results posted 2012P001755 Ph 2 completed Randomized Controlled Trial of Calcitriol vs. Placebo Among Critically-ill Patients With Sepsis
NCT00904033 results posted RSRB00025478 Ph 2 completed Calcitriol, Physical Activity, and Bone Health in Cancer Survivors
NCT01384539 results posted 11-0521 5K23DK087859 Ph 3 completed Vitamin D and Arterial Function in Patients With Chronic Kidney Disease
NCT00794547 results posted UMCC 2008.042 HUM 21242 Ph 1, Ph 2 terminated Phase I/II Calcitriol in Lung Cancer
NCT03140449 201306009MINB Ph 3 completed Topical Rapamycin and Calcitriol for Angiofibroma of Tuberous Sclerosis
NCT00953849 results posted CLIN-003-09S Ph 1, Ph 2 completed Vitamin D Plus Celecoxib Therapy to Stimulate Intratumoral Immune Reactivity
NCT02282813 results posted CTAP101-CL-3003 Ph 3 completed Extension Study of CTAP101-CL-3001 or CTAP101-CL-3002
NCT00508898 CRE-2007.261-T Ph 4 withdrawn The Efficacy and Safety of Calcitriol for the Treatment of Lupus Nephritis and Persistent Proteinuria
NCT01265615 results posted VDCRS03 Ph 4 completed Paricalcitol Versus Calcitriol for the Management of Renocardiac Syndrome in Renal Transplant Patients
NCT01358045 MEC 10-2-088 Ph 2 completed Topical Vitamin D3, Diclofenac or a Combination of Both to Treat Basal Cell Carcinoma
NCT00823303 PACE results posted 22095 Ph 4 completed Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)
NCT01768351 PCX1234 paranemia Ph 4 completed Paricalcitol Effect on Anemia in CKD
NCT01748396 SNUH-FGF23 Ph 4 completed Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol
NCT00623974 results posted 2006-0562 Ph 2 terminated Teriparatide (Forteo) in the Treatment of Patients With Postoperative Hypocalcemia
NCT01388517 PA-CALTAC Ph 4 completed Clinical Trial of 0.0003% Calcitriol, 0.1% Tacrolimus, and Petrolatum for the Treatment of Pityriasis Alba
NCT00664430 results posted W10-131 Ph 4 terminated Efficacy and Safety of Paricalcitol on the Treatment of Secondary Hyperparathyroidism in Calcitriol Resistant Dialysis Subjects
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ROCALTROL FDA Label Details

Indications & Usage

FDA Label (PDF)

ROCALTROL is indicated for the treatment of Secondary Hyperparathyroidism; Metabolic Bone Disease; Chronic Renal Failure; Hypocalcemia; Osteitis Fibrosa Cystica; Hypoparathyroidism; Pseudohypoparathyroidism.

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Data Sources

FDA Approval: NDA021068 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.