Infuvite adult, Fosavance(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)
Alendronate sodium
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Cholecalciferol
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 |
|---|---|---|
| a and d plus e | C200263 | 2024-08-08 |
| astonea | C200263 | 2024-06-25 |
| bio no more yeast infection (helps improve vaginal yeast infection, fermented cabbage powder) | unapproved drug other | 2024-03-19 |
| derma e vitamin c weightless moisturizer | C200263 | 2024-05-24 |
| fosamax plus d | New Drug Application | 2024-04-17 |
| lancome paris uv expert aquagel defense 50 plus sunscreen broad spectrum spf 50 plus primer and moisturizer with antioxidant vitamin e | C200263 | 2024-06-25 |
| m-natal plus | unapproved drug other | 2024-06-21 |
| multi-vit-flor | unapproved drug other | 2024-04-30 |
| multivitamin with fluoride | unapproved drug other | 2024-08-01 |
| nestabs one | unapproved drug other | 2024-08-08 |
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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
4333 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 | 46 | 75 | 71 | 92 | 470 | 730 |
| Osteoporosis | D010024 | HP_0000939 | M81.0 | 12 | 25 | 45 | 33 | 73 | 184 |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 9 | 7 | 12 | 86 | 115 |
| Covid-19 | D000086382 | — | U07.1 | 8 | 16 | 17 | 7 | 58 | 102 |
| Healthy volunteers/patients | — | — | — | 35 | 4 | 3 | 2 | 56 | 99 |
| Chronic renal insufficiency | D051436 | — | N18 | 8 | 16 | 17 | 25 | 28 | 89 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 4 | 15 | 10 | 14 | 46 | 84 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 25 | 31 | 15 | 1 | 23 | 83 |
| Neoplasms | D009369 | — | C80 | 35 | 20 | 11 | 4 | 11 | 69 |
| Metabolic bone diseases | D001851 | HP_0000938 | — | 3 | 7 | 6 | 12 | 38 | 64 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Colorectal neoplasms | D015179 | — | — | 12 | 28 | 17 | — | 14 | 58 |
| Aging | D000375 | GO_0007568 | R41.81 | 3 | 3 | 2 | — | 24 | 31 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | 12 | 17 | 3 | — | 4 | 29 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 2 | 1 | 4 | — | 21 | 28 |
| Lymphoma | D008223 | — | C85.9 | 10 | 9 | 3 | — | 2 | 22 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 6 | 7 | — | 10 | 21 |
| Melanoma | D008545 | — | — | 7 | 7 | 2 | — | 7 | 20 |
| Leukemia | D007938 | — | C95 | 5 | 13 | 3 | — | — | 18 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 3 | 2 | 1 | — | 12 | 17 |
| Bone density | D015519 | EFO_0003923 | M85 | — | 2 | 1 | — | 15 | 17 |
Show 202 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hepatitis d | D003699 | EFO_0007304 | — | 1 | 6 | — | — | 5 | 12 |
| Renal cell carcinoma | D002292 | EFO_0000376 | — | 8 | 5 | — | — | — | 11 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 7 | 5 | — | — | 1 | 11 |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | — | — | 10 | 11 |
| Exercise | D015444 | EFO_0000483 | — | — | 1 | — | — | 8 | 9 |
| Osteoarthritis | D010003 | EFO_0002506 | M15-M19 | — | 1 | — | — | 7 | 8 |
| Hematopoietic stem cell transplantation | D018380 | — | — | 3 | 3 | — | — | 3 | 7 |
| Autoimmune diseases | D001327 | HP_0002960 | M30-M36 | — | 3 | — | — | 4 | 7 |
| Nutrition disorders | D009748 | EFO_0001069 | — | 1 | 2 | — | — | 5 | 7 |
| Thyroid neoplasms | D013964 | EFO_0003841 | — | — | 1 | — | — | 5 | 6 |
Show 222 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Periodontitis | D010518 | EFO_0000649 | K05.3 | 1 | — | — | — | 9 | 10 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | 1 | — | — | — | 8 | 9 |
| Heart disease risk factors | D000082742 | — | — | 2 | — | — | — | 5 | 7 |
| Periodontal diseases | D010510 | — | K05.6 | 1 | — | — | — | 6 | 7 |
| Nutritional status | D009752 | — | — | 1 | — | — | — | 5 | 6 |
| Morbid obesity | D009767 | EFO_0001074 | — | 1 | — | — | — | 5 | 6 |
| Gingivitis | D005891 | HP_0000230 | K05.10 | 1 | — | — | — | 4 | 5 |
| Thyroid diseases | D013959 | HP_0000820 | E00-E07 | 1 | — | — | — | 4 | 5 |
| Ovarian epithelial carcinoma | D000077216 | — | — | 2 | — | — | — | 2 | 4 |
| Pharmacokinetics | D010599 | — | — | 3 | — | — | — | 1 | 4 |
Show 48 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Weight loss | D015431 | HP_0001824 | — | — | — | — | — | 9 | 9 |
| Post-acute covid-19 syndrome | D000094024 | — | — | — | — | — | — | 9 | 9 |
| Healthy diet | D000072001 | — | — | — | — | — | — | 9 | 9 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | — | — | — | 8 | 8 |
| Cerebral palsy | D002547 | — | G80 | — | — | — | — | 6 | 6 |
| Wounds and injuries | D014947 | — | T14.8 | — | — | — | — | 6 | 6 |
| Vitamin b 12 deficiency | D014806 | EFO_0000734 | E53.8 | — | — | — | — | 5 | 5 |
| Body composition | D001823 | — | — | — | — | — | — | 5 | 5 |
| Body weight changes | D001836 | — | — | — | — | — | — | 5 | 5 |
| Healthy aging | D000073656 | — | — | — | — | — | — | 5 | 5 |
Show 412 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) |
Target
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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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PubMed Central
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Safety
Black-box Warning
Black-box warning for: Nestabs one
Adverse Events
Top Adverse Reactions
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16,909 adverse events reported
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