TheraRadar
Data updated: May 26, 2026

CALCITRIOL

Endocrine Approved 2001-10-12

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

Source: FDA Label • SAGENT PHARMS
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
19
Indications
--
Phase 3 Trials
24
Years on Market

Details

Status
Discontinued
First Approved
2001-10-12
Routes
INJECTION, ORAL
Dosage Forms
INJECTABLE, CAPSULE, SOLUTION

Companies

SAGENT PHARMS GLAND Fresenius Kabi ONESOURCE SPECIALTY AMNEAL PHARMS Hikma Teva LONG GROVE PHARMS BIONPHARMA AM REGENT Sun Pharma HUMANWELL PURACAP ANDA REPOSITORY RISING ROCKWELL MEDCL Pfizer
Active Ingredient: CALCITRIOL

CALCITRIOL Approval History

2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
53 FDA actions from 2001 to 2026
Feb 2026 ORIGINAL
Update
FDA Letter
Jul 2023 ORIGINAL
Update
Feb 2020 ORIGINAL
Update

What CALCITRIOL Treats

7 indications

CALCITRIOL is approved for 7 conditions since its original approval in 2001. 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

CALCITRIOL Competitive Set

Pro

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 CALCITRIOL

3 of 10

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

ROCALTROL
CALCITRIOL
7 shared
ESJAY PHARMA
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
🔬

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.

CALCITRIOL FDA Label Details

Indications & Usage

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

Looking for the branded version?

ROCALTROL

Full clinical data, patents, trials, and competitive landscape for calcitriol.

See ROCALTROL

Data Sources

FDA Approval: ANDA077102 → Label: DailyMed → Trials: ClinicalTrials.gov →

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