Cholecalciferol
Adrovance, Alendronic Acid / Colecalciferol, Fosamax D, Fosavance, Infuvite, Vantavo (cholecalciferol) is a small molecule pharmaceutical. Cholecalciferol was first approved as Infuvite adult on 2000-05-18. It is used to treat cardiovascular diseases, chronic kidney failure, crohn disease, familial hypophosphatemic rickets, and hypoparathyroidism amongst others in the USA. It has been approved in Europe to treat postmenopausal osteoporosis.
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Commercial
Therapeutic Areas
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Trade Name
FDA
EMA
Combinations
Fosamax d, Infuvite
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Alpha-tocopherol acetate
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Ascorbic acid
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Biotin
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Cholecalciferol
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Cyanocobalamin
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Dexpanthenol
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Folic acid
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Niacinamide
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Pyridoxine hydrochloride
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Riboflavin 5'-phosphate sodium
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Thiamine hydrochloride
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Vitamin a palmitate
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Vitamin k
Ascorbic acid
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Biotin
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Cholecalciferol
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Cyanocobalamin
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Dexpanthenol
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Folic acid
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Niacinamide
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Pyridoxine
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Riboflavin
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Thiamine
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Tocopherol acetate
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Vitamin a
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Vitamin k
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| 3 pack family dollar instant hand sanitizers | OTC monograph not final | 2014-11-28 |
| a and d | OTC monograph final | 2020-01-07 |
| a and d plus e | C200263 | 2024-08-08 |
| adult infuvite multiple vitamins | New Drug Application | 2019-05-14 |
| adult infuvite multiple vitamins for infusion pharmacy bulk | New Drug Application | 2013-01-01 |
| ag international | OTC monograph final | 2019-07-23 |
| allevia | unapproved drug other | 2025-02-27 |
| ameriderm | OTC monograph final | 2022-01-13 |
| animi-3 | unapproved drug other | 2013-02-06 |
| animi-3 with vitamin d | unapproved drug other | 2011-05-23 |
Show 182 more
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
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ATC Codes
A: Alimentary tract and metabolism drugs
— A11: Vitamins
— A11C: Vitamin a and d, incl. combinations of the two
— A11CC: Vitamin d and analogues
— A11CC05: Colecalciferol
— A11CC55: Colecalciferol, combinations
M: Musculo-skeletal system drugs
— M05: Drugs for treatment of bone diseases
— M05B: Drugs affecting bone structure and mineralization
— M05BB: Bisphosphonates, combinations affecting bone structure and mineralization
— M05BB03: Alendronic acid and colecalciferol
— M05BB04: Risedronic acid, calcium and colecalciferol, sequential
— M05BB05: Alendronic acid, calcium and colecalciferol, sequential
— M05BB07: Risedronic acid and colecalciferol
— M05BB08: Zoledronic acid, calcium and colecalciferol, sequential
— M05BB09: Ibandronic acid and colecalciferol
— M05BX: Other drugs affecting bone structure and mineralization in atc
— M05BX53: Strontium ranelate and colecalciferol
HCPCS
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Clinical
Clinical Trials
4506 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | 49 | 79 | 75 | 99 | 515 | 793 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | 14 | 30 | 59 | 50 | 103 | 252 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 10 | 27 | 24 | 37 | 58 | 146 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | 12 | 32 | 21 | 16 | 71 | 140 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 9 | 8 | 13 | 96 | 127 |
| Covid-19 | D000086382 | — | U07.1 | 8 | 20 | 19 | 11 | 65 | 119 |
| Chronic renal insufficiency | D051436 | — | N18 | 10 | 22 | 21 | 31 | 39 | 114 |
| Leukemia | D007938 | — | C95 | 30 | 56 | 29 | 3 | 8 | 110 |
| Healthy volunteers/patients | — | — | — | 35 | 4 | 3 | 2 | 56 | 99 |
| Syndrome | D013577 | — | — | 12 | 28 | 10 | 15 | 42 | 98 |
Show 383 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 13 | 31 | 18 | — | 15 | 64 |
| Myeloid leukemia | D007951 | — | C92 | 18 | 23 | 3 | — | 1 | 36 |
| Aging | D000375 | GO_0007568 | R41.81 | 3 | 3 | 2 | — | 24 | 31 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 12 | 17 | 3 | — | 4 | 30 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 2 | 1 | 4 | — | 22 | 29 |
| Wounds and injuries | D014947 | — | T14.8 | 1 | 7 | 4 | — | 15 | 25 |
| Melanoma | D008545 | — | — | 8 | 9 | 3 | — | 8 | 24 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 6 | 7 | 8 | — | 3 | 22 |
| Bone density | D015519 | EFO_0003923 | M85 | 1 | 2 | 1 | — | 18 | 21 |
| Hepatitis d | D003699 | EFO_0007304 | — | 1 | 9 | 4 | — | 7 | 20 |
Show 273 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Periodontitis | D010518 | EFO_0000649 | K05.3 | 1 | 2 | — | — | 19 | 22 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 8 | 6 | — | — | 3 | 14 |
| Thyroid diseases | D013959 | — | E00-E07 | 1 | 1 | — | — | 10 | 12 |
| Colitis | D003092 | EFO_0003872 | K52.9 | 2 | 1 | — | — | 10 | 12 |
| Ulcer | D014456 | MPATH_579 | — | 2 | 1 | — | — | 10 | 12 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 8 | 5 | — | — | — | 11 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | — | — | 10 | 11 |
| Exercise | D015444 | EFO_0000483 | — | — | 1 | — | — | 9 | 10 |
| Autoimmune diseases | D001327 | EFO_0000540 | M30-M36 | — | 4 | — | — | 5 | 9 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 1 | — | — | 8 | 9 |
Show 277 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypercholesterolemia | D006937 | — | — | 1 | — | — | — | 8 | 9 |
| Periodontal diseases | D010510 | — | K05.6 | 1 | — | — | — | 7 | 8 |
| Heart disease risk factors | D000082742 | — | — | 2 | — | — | — | 5 | 7 |
| Nutritional status | D009752 | — | — | 1 | — | — | — | 5 | 6 |
| Morbid obesity | D009767 | EFO_0001074 | — | 1 | — | — | — | 5 | 6 |
| Gingivitis | D005891 | — | K05.10 | 1 | — | — | — | 5 | 6 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 3 | — | — | — | 2 | 5 |
| Pharmacokinetics | D010599 | — | — | 3 | — | — | — | 1 | 4 |
| Diet therapy | D004035 | — | — | 1 | — | — | — | 3 | 4 |
| Gastrointestinal microbiome | D000069196 | — | — | 2 | — | — | — | 2 | 4 |
Show 56 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Post-acute covid-19 syndrome | D000094024 | — | — | — | — | — | — | 9 | 9 |
| Healthy diet | D000072001 | — | — | — | — | — | — | 9 | 9 |
| Cerebral palsy | D002547 | — | G80 | — | — | — | — | 8 | 8 |
| Urinary incontinence | D014549 | — | R32 | — | — | — | — | 8 | 8 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | — | 8 | 8 |
| Back pain | D001416 | — | M54 | — | — | — | — | 8 | 8 |
| Enuresis | D004775 | — | R32 | — | — | — | — | 7 | 7 |
| Body weight changes | D001836 | — | — | — | — | — | — | 6 | 6 |
| Body composition | D001823 | — | — | — | — | — | — | 6 | 6 |
| Gastrointestinal diseases | D005767 | — | — | — | — | — | — | 6 | 6 |
Show 493 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cholecalciferol |
| INN | colecalciferol |
| Description | Calciol is a hydroxy seco-steroid that is (5Z,7E)-9,10-secocholesta-5,7,10(19)-triene in which the pro-S hydrogen at position 3 has been replaced by a hydroxy group. It is the inactive form of vitamin D3, being hydroxylated in the liver to calcidiol (25-hydroxyvitamin D3), which is then further hydroxylated in the kidney to give calcitriol (1,25-dihydroxyvitamin D3), the active hormone. It has a role as a human metabolite and a geroprotector. It is a seco-cholestane, a hydroxy seco-steroid, a member of D3 vitamins, a secondary alcohol and a steroid hormone. |
| Classification | Small molecule |
| Drug class | vitamin D analogs |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C=C1CC[C@H](O)C/C1=C/C=C1\CCC[C@@]2(C)[C@H]1CC[C@@H]2[C@H](C)CCCC(C)C |
Identifiers
| PDB | — |
| CAS-ID | 67-97-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1042 |
| ChEBI ID | 28940 |
| PubChem CID | 5280795 |
| DrugBank | DB00169 |
| UNII ID | 1C6V77QF41 (ChemIDplus, GSRS) |
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Variants
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Financial
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Estimated US medical usage
Cholecalciferol
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Alendronate
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Cholecalciferol
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Cholecalciferol
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Folic acid
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Trends
PubMed Central
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Safety
Black-box Warning
Black-box warning for: Citranatal, Citranatal 90 dha, Citranatal assure, Citranatal b-calm, Citranatal dha, Citranatal essence, Citranatal harmony, Citranatal harmony 2.1, Citranatal harmony 3.0, Citranatal medley, Citranatal rx, Healthy mamabe well rounded, Marnatal f, Moms choice rx, Natafort, Nestabs, Nestabs dha, Nestabs one, O-cal prenatal vitamin, Omega-3 well pack, Pnv prenatal plus multivitamin, Pnv prenatal vitamin, Pnv-dha, Pnv-omega, Pnv-select, Pr natal 400, Pr natal 400 ec, Pr natal 430, Pr natal 430 ec, Pre-tabs dha, Prenata, Prenatal plus multivitamin plus dha minicaps, Prenate dha, Prenate elite, Prenate enhance, Prenate essential, Prenate mini, Prenate pixie, Prenate restore, Primacare, Select ob, Select-ob plus dha, Tristart dha, Vitafol, Vitafol fe plus, Vitafol ob, Vitafol-ob plus dha
Adverse Events
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20,687 adverse events reported
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