Calcifediol
Rayaldee (calcifediol) is a small molecule pharmaceutical. Calcifediol was first approved as Calderol on 1982-01-01.
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Trade Name
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Rayaldee (discontinued: Calderol)
Drug Products
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Calcifediol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RAYALDEE | Eirgen Pharma | N-208010 RX | 2016-06-17 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| rayaldee | New Drug Application | 2021-04-30 |
Indications
FDA
EMA
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Agency Specific
FDA
EMA
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Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Calcifediol, Rayaldee, Eirgen | |||
| 9861644 | 2034-03-14 | DP | |
| 10300078 | 2034-03-14 | DP | |
| 10357502 | 2034-03-14 | DP | |
| 11253528 | 2034-03-14 | DP | |
| 8426391 | 2028-08-27 | U-1872 | |
| 8361488 | 2028-07-19 | DP | |
| 8207149 | 2028-04-25 | U-1871 | |
| 8778373 | 2028-04-25 | U-1873 | |
| 9408858 | 2028-04-25 | U-1888 | |
| 9498486 | 2028-04-25 | U-1920 | |
| 9925147 | 2028-04-25 | DP | U-2255, U-2256, U-2257, U-2258, U-2259 |
| 11154509 | 2028-04-25 | U-3248 | |
| 8906410 | 2027-02-02 | DP | |
| 9943530 | 2027-02-02 | U-2274 | |
| 10213442 | 2027-02-02 | DP | |
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
— A11CC06: Calcifediol
H: Systemic hormonal preparations, excl. sex hormones and insulins
— H05: Calcium homeostasis
— H05B: Anti-parathyroid agents
— H05BX: Other anti-parathyroid agents in atc
— H05BX05: Calcifediol
HCPCS
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Clinical
Clinical Trials
163 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 | 3 | 5 | 8 | 9 | 39 | 62 |
| Secondary hyperparathyroidism | D006962 | EFO_1001173 | — | 3 | 2 | 6 | 2 | — | 12 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | 2 | 2 | 2 | 3 | 8 |
| Obesity | D009765 | EFO_0001073 | E66.9 | — | 1 | — | 1 | 4 | 6 |
| Insulin resistance | D007333 | HP_0000855 | E88.819 | 1 | 1 | — | 1 | 1 | 4 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | 1 | 1 | 1 | 2 | — | 4 |
| Cardiovascular diseases | D002318 | HP_0001626 | — | — | — | — | 1 | 3 | 4 |
| Hypocalcemia | D006996 | HP_0002901 | E83.51 | 1 | — | — | 1 | 1 | 3 |
| Inflammation | D007249 | MP_0001845 | — | 1 | — | 1 | 1 | — | 3 |
| Chronic kidney disease-mineral and bone disorder | D012080 | EFO_1001152 | N25.0 | — | — | 1 | 1 | — | 2 |
Show 14 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic renal insufficiency | D051436 | — | N18 | 3 | 2 | 6 | — | 1 | 11 |
| Covid-19 | D000086382 | — | U07.1 | — | 3 | 2 | — | 2 | 6 |
| Osteoporosis | D010024 | HP_0000939 | M81.0 | — | 1 | 1 | — | 4 | 6 |
| Healthy volunteers/patients | — | — | — | — | — | 1 | — | 1 | 2 |
| Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | 2 | — | — | 2 |
| Male infertility | D007248 | EFO_0004248 | N46 | — | 1 | 1 | — | — | 1 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | 1 | — | — | 1 |
| Kidney transplantation | D016030 | — | — | — | — | 1 | — | — | 1 |
| Premature infant diseases | D007235 | — | — | — | — | 1 | — | — | 1 |
| Memory disorders | D008569 | — | — | — | — | 1 | — | — | 1 |
Show 3 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | — | 1 | 2 |
| Critical illness | D016638 | — | — | — | 1 | — | — | 1 | 2 |
| Metabolic bone diseases | D001851 | HP_0000938 | — | 1 | 1 | — | — | — | 1 |
| Coronavirus | D017934 | — | — | — | 1 | — | — | — | 1 |
| Cytokine release syndrome | D000080424 | — | D89.83 | — | 1 | — | — | — | 1 |
| Sars-cov-2 | D000086402 | — | — | — | 1 | — | — | — | 1 |
| Severe acute respiratory syndrome | D045169 | EFO_0000694 | J12.81 | — | 1 | — | — | — | 1 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cystic fibrosis | D003550 | EFO_0000390 | E84 | 1 | — | — | — | 1 | 2 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | — | — | 1 | 2 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | — | — | — | — | 1 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 1 | — | — | — | — | 1 |
| Bone neoplasms | D001859 | EFO_0003820 | D16 | 1 | — | — | — | — | 1 |
| Herpes zoster | D006562 | EFO_0006510 | B02 | 1 | — | — | — | — | 1 |
| Immunosenescence | D000068884 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | — | — | 3 | 3 |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 2 | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 1 | 1 |
| Lactation | D007774 | — | — | — | — | — | — | 1 | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | — | 1 | 1 |
| Skin diseases | D012871 | — | L00-L99 | — | — | — | — | 1 | 1 |
| Impulsive behavior | D007175 | — | — | — | — | — | — | 1 | 1 |
| Female genital diseases | D005831 | EFO_0009549 | N85 | — | — | — | — | 1 | 1 |
| Cardiometabolic risk factors | D000083202 | — | — | — | — | — | — | 1 | 1 |
| Hemophilia b | D002836 | — | D67 | — | — | — | — | 1 | 1 |
Show 34 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Calcifediol |
| INN | calcifediol |
| Description | Calcidiol is a hydroxycalciol that is calciol in which the hydrogen at position 25 has been replaced by a hydroxy group. A prehormone resulting from the oxidation of calciol in the liver, it is further hydroxylated in the kidney to give calcitriol, the active form of vitamin D3. It has a role as a bone density conservation agent, a nutraceutical, a metabolite, a human metabolite and a mouse metabolite. It is a hydroxycalciol, a member of D3 vitamins and a diol. |
| 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)O.O |
Identifiers
| PDB | — |
| CAS-ID | 19356-17-3 |
| RxCUI | 1855064 |
| ChEMBL ID | CHEMBL3544909 |
| ChEBI ID | — |
| PubChem CID | 5283731 |
| DrugBank | DB00146 |
| UNII ID | T0WXW8F54E (ChemIDplus, GSRS) |
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Rayaldee – Opko Health
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Calcifediol
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Trends
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Safety
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Adverse Events
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248 adverse events reported
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