Calcifediol
Rayaldee (calcifediol) is a small molecule pharmaceutical. Calcifediol was first approved as Calderol on 1982-01-01.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Therapeutic Areas
No data
Trade Name
FDA
EMA
Rayaldee (discontinued: Calderol)
Drug Products
FDA
EMA
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 | 2024-01-19 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
No data
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
No data
Clinical
Clinical Trials
163 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
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 | 10 | 11 | 47 | 74 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | 2 | 1 | 5 | 3 | 3 | 14 |
| Chronic renal insufficiency | D051436 | — | N18 | 2 | 1 | 5 | 2 | 3 | 13 |
| Hyperparathyroidism | D006961 | EFO_0008506 | E21.3 | 2 | 1 | 5 | 2 | 1 | 11 |
| Secondary hyperparathyroidism | D006962 | EFO_1001173 | — | 2 | 1 | 5 | 2 | — | 10 |
| Rickets | D012279 | HP_0002748 | E55.0 | — | — | 2 | 2 | 6 | 10 |
| Avitaminosis | D001361 | EFO_0005878 | E56.9 | — | — | 2 | 2 | 6 | 10 |
| Renal insufficiency | D051437 | HP_0000083 | N19 | 1 | 1 | 1 | 4 | 3 | 9 |
| Covid-19 | D000086382 | — | — | — | 3 | 2 | 1 | 3 | 8 |
| Neoplasm metastasis | D009362 | EFO_0009708 | — | — | 1 | 4 | 2 | — | 7 |
Show 31 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteoporosis | D010024 | HP_0000939 | M81.0 | — | 1 | 1 | — | 4 | 6 |
| Premature birth | D047928 | EFO_0003917 | O60 | — | — | 1 | — | 3 | 4 |
| Infertility | D007246 | HP_0000789 | — | — | 1 | 1 | — | 1 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | 1 | 2 |
| Communicable diseases | D003141 | — | — | — | — | 1 | — | 1 | 2 |
| 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 disease | D003327 | — | — | — | — | 1 | — | — | 1 |
| Coronary artery disease | D003324 | — | I25.1 | — | — | 1 | — | — | 1 |
Show 13 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Metabolic bone diseases | D001851 | HP_0000938 | — | 1 | 2 | — | — | 1 | 3 |
| Liver cirrhosis | D008103 | EFO_0001422 | K74.0 | — | 1 | — | — | 1 | 2 |
| Critical illness | D016638 | — | — | — | 1 | — | — | 1 | 2 |
| 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 |
| Syndrome | D013577 | — | — | — | 1 | — | — | — | 1 |
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | 1 | — | — | — | 1 |
| Wounds and injuries | D014947 | — | T14.8 | — | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Fibrosis | D005355 | — | — | 1 | — | — | — | 1 | 2 |
| 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 |
| Malabsorption syndromes | D008286 | EFO_0009554 | K90 | 1 | — | — | — | — | 1 |
| Herpes zoster | D006562 | EFO_0006510 | B02 | 1 | — | — | — | — | 1 |
| Chickenpox | D002644 | EFO_0007204 | B01 | 1 | — | — | — | — | 1 |
| Immunosenescence | D000068884 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 3 | 3 |
| Inflammatory bowel diseases | D015212 | EFO_0003767 | — | — | — | — | — | 3 | 3 |
| Leiomyoma | D007889 | HP_0000131 | D25 | — | — | — | — | 2 | 2 |
| Myofibroma | D047708 | — | — | — | — | — | — | 2 | 2 |
| Cardiometabolic risk factors | D000083202 | — | — | — | — | — | — | 2 | 2 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | — | — | — | 2 | 2 |
| Gestational diabetes | D016640 | HP_0009800 | O24.4 | — | — | — | — | 2 | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | — | — | — | 1 | 1 |
| Lactation | D007774 | — | — | — | — | — | — | 1 | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | — | — | — | — | 1 | 1 |
Show 60 more
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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) |
Target
No data
Variants
No data
Financial
Revenue by drug
$
€
£
₣
Rayaldee – Opko Health
Mock data
Subscribe for the real data
Subscribe for the real data
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Estimated US medical usage
Calcifediol
Total medical expenditures per year (USD, in millions)
Mock data
Subscribe for the real data
Subscribe for the real data
Number of persons purchased
Mock data
Subscribe for the real data
Subscribe for the real data
Number of purchases
Mock data
Subscribe for the real data
Subscribe for the real data
Refill frequency
Mock data
Subscribe for the real data
Subscribe for the real data
Price per prescription (USD)
Mock data
Subscribe for the real data
Subscribe for the real data
Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 4,494 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
449 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use