Infuvite adult, Fosavance(cholecalciferol)
Adrovance, 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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Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| musculoskeletal diseases | D009140 |
| digestive system diseases | D004066 |
| respiratory tract diseases | D012140 |
| urogenital diseases | D000091642 |
| cardiovascular diseases | D002318 |
| hereditary congenital and neonatal diseases and abnormalities | D009358 |
| skin and connective tissue diseases | D017437 |
| nutritional and metabolic diseases | D009750 |
| endocrine system diseases | D004700 |
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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
+
Cholecalciferol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| FOSAMAX PLUS D | Organon | N-021762 RX | 2005-04-07 | 2 products, RLD |
Alpha-tocopherol acetate
+
Ascorbic acid
+
Biotin
+
Cholecalciferol
+
Cyanocobalamin
+
Dexpanthenol
+
Folic acid
+
Niacinamide
+
Pyridoxine hydrochloride
+
Riboflavin 5'-phosphate sodium
+
Thiamine hydrochloride
+
Vitamin a palmitate
+
Vitamin k
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| INFUVITE ADULT | Sandoz | N-021163 RX | 2000-05-18 | 2 products, RLD, RS |
Ascorbic acid
+
Biotin
+
Cholecalciferol
+
Cyanocobalamin
+
Dexpanthenol
+
Folic acid
+
Niacinamide
+
Pyridoxine
+
Riboflavin
+
Thiamine
+
Tocopherol acetate
+
Vitamin a
+
Vitamin k
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adult infuvite multiple vitamins | New Drug Application | 2016-10-28 |
| fosamax plus d | New Drug Application | 2021-08-31 |
| growth supportpatch, hautuki | unapproved drug other | 2023-05-22 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| cardiovascular diseases | EFO_0000319 | D002318 | I98 |
| chronic kidney failure | EFO_0003884 | D007676 | N18.6 |
| crohn disease | EFO_0000384 | D003424 | K50 |
| familial hypophosphatemic rickets | — | D053098 | — |
| hypoparathyroidism | — | D007011 | E20 |
| lung neoplasms | — | D008175 | C34.90 |
| osteoporosis | EFO_0003882 | D010024 | M81.0 |
| psoriasis | EFO_0000676 | D011565 | L40 |
| skin neoplasms | EFO_0004198 | D012878 | C44 |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
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
No data
Clinical
Clinical Trials
1668 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 | 37 | 61 | 45 | 69 | 240 | 432 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | 9 | 18 | 28 | 21 | 27 | 101 |
| Covid-19 | D000086382 | U07.1 | 3 | 6 | 11 | 5 | 34 | 58 | |
| Obesity | D009765 | EFO_0001073 | E66.9 | 2 | 5 | 3 | 9 | 29 | 48 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 3 | 11 | 6 | 9 | 17 | 42 |
| Healthy volunteers/patients | — | 7 | 2 | 3 | 2 | 23 | 36 | ||
| Asthma | D001249 | EFO_0000270 | J45 | 4 | 9 | 8 | 4 | 11 | 34 |
| Chronic renal insufficiency | D051436 | N18 | 2 | 4 | 6 | 10 | 14 | 34 | |
| Metabolic bone diseases | D001851 | HP_0000938 | 3 | 5 | 4 | 9 | 14 | 33 | |
| Postmenopausal osteoporosis | D015663 | EFO_0003854 | — | 4 | 6 | 13 | 7 | 30 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 8 | 19 | 10 | — | 4 | 36 |
| Prostatic neoplasms | D011471 | C61 | 2 | 12 | 6 | — | 3 | 22 | |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | 3 | 2 | 2 | — | 8 | 14 | |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 9 | 4 | — | 2 | 13 |
| Tuberculosis | D014376 | EFO_0000774 | A15-A19 | — | 4 | 2 | — | 7 | 13 |
| Colorectal neoplasms | D015179 | 1 | 6 | 2 | — | 6 | 12 | ||
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | 1 | 1 | 3 | — | 6 | 11 |
| Neoplasms | D009369 | C80 | 3 | 1 | 5 | — | 2 | 10 | |
| Aging | D000375 | GO_0007568 | R41.81 | 1 | 1 | 1 | — | 8 | 10 |
| Spinal cord injuries | D013119 | EFO_1001919 | 1 | 5 | 3 | — | 4 | 10 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hyperparathyroidism | D006961 | EFO_0008506 | E21.3 | 1 | 1 | — | — | 4 | 6 |
| Bone density | D015519 | EFO_0003923 | M85 | — | 1 | — | — | 4 | 5 |
| Stress fractures | D015775 | M84.3 | — | 1 | — | — | 4 | 5 | |
| Atherosclerosis | D050197 | EFO_0003914 | I25.1 | — | 1 | — | — | 4 | 5 |
| Pre-eclampsia | D011225 | EFO_0000668 | O14 | 1 | 1 | — | — | 4 | 5 |
| Rectal neoplasms | D012004 | 1 | 1 | — | — | 2 | 4 | ||
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 1 | 2 | — | — | 1 | 4 |
| Female infertility | D007247 | EFO_0008560 | N97 | — | 1 | — | — | 3 | 4 |
| Hematopoietic stem cell transplantation | D018380 | 1 | 1 | — | — | 3 | 4 | ||
| Severe acute respiratory syndrome-related coronavirus | D045473 | NCBITaxon_227859 | 1 | 2 | — | — | — | 3 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Nutritional status | D009752 | 1 | — | — | — | 3 | 4 | ||
| Periodontitis | D010518 | EFO_0000649 | K05.3 | 1 | — | — | — | 3 | 4 |
| Periodontal diseases | D010510 | K05.6 | 1 | — | — | — | 3 | 4 | |
| Tibial fractures | D013978 | EFO_0003944 | S82.20 | 1 | — | — | — | 1 | 2 |
| Morbid obesity | D009767 | EFO_0001074 | 1 | — | — | — | 1 | 2 | |
| Thyroid diseases | D013959 | HP_0000820 | E00-E07 | 1 | — | — | — | 1 | 2 |
| Growth | D006128 | 1 | — | — | — | 1 | 2 | ||
| Breast density | D000071060 | 1 | — | — | — | — | 1 | ||
| Chronic progressive multiple sclerosis | D020528 | 1 | — | — | — | — | 1 | ||
| Pituitary acth hypersecretion | D047748 | EFO_1001110 | E24.0 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy complications | D011248 | — | — | — | — | 3 | 3 | ||
| Wounds and injuries | D014947 | T14.8 | — | — | — | — | 3 | 3 | |
| Renal dialysis | D006435 | EFO_0010690 | Z99.2 | — | — | — | — | 3 | 3 |
| Weight loss | D015431 | HP_0001824 | — | — | — | — | 3 | 3 | |
| Headache | D006261 | HP_0002315 | R51 | — | — | — | — | 2 | 2 |
| Allergic rhinitis | D065631 | J30.9 | — | — | — | — | 2 | 2 | |
| Vitamin k deficiency | D014813 | E56.1 | — | — | — | — | 2 | 2 | |
| Fracture healing | D017102 | — | — | — | — | 2 | 2 | ||
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | — | — | — | 2 | 2 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | — | — | 2 | 2 |
Show 140 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 | 2418 |
| ChEMBL ID | CHEMBL1042 |
| ChEBI ID | 28940 |
| PubChem CID | 5280795 |
| DrugBank | DB00169 |
| UNII ID | 1C6V77QF41 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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61,060 adverse events reported
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