All FDA-approved EMA-approved PMDA-approved
Target Card Uniprot Example: P23975

calcifediol 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
Vitamin D analogues/derivatives	464	19356-17-3

Description:

Molecule

Description

Molfile Inchi Smiles Synonyms: calcifediol calcidiol calderol

The major circulating metabolite of VITAMIN D3. It is produced in the LIVER and is the best indicator of the body's vitamin D stores. It is effective in the treatment of RICKETS and OSTEOMALACIA, both in azotemic and non-azotemic patients. Calcifediol also has mineralizing properties. Molecular weight: 400.65 Formula: C27H44O2 CLOGP: 7.27 LIPINSKI: 1 HAC: 2 HDO: 2 TPSA: 40.46 ALOGS: -5.26 ROTB: 6 Status: OFP Legend: OFP - off patent OFM - off market ONP - on patent

Drug dosage:

Dose	Unit	Route
30	mcg	O

ADMET properties:

None

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value	Unit	Confidence	Similarity
kinase-safety-class	ACVR2B,BRAF,CAMK2D,CDK5,EIF2AK3,ERBB2,GRK2,ITK,MAPK10,NTRK2,PDK1,PDK2,PDK4,PRKDC,TEK,TGFBR1	16
pfas-class	PFAS structural alert (1 = True, 0 = False)	0

Approvals:

Date	Agency	Company	Orphan
Aug. 5, 1980	FDA

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Drug interaction	96.45	25.65	80	3229	276373	90348765
Death	61.18	25.65	79	3230	456472	90168666
Hyponatraemia	51.38	25.65	41	3268	133497	90491641
Hypertransaminasaemia	44.52	25.65	18	3291	15807	90609331
Ischaemic stroke	41.82	25.65	19	3290	22147	90602991
Prinzmetal angina	40.22	25.65	9	3300	1036	90624102
Parkinsonism	39.57	25.65	16	3293	14049	90611089
Dialysis	39.31	25.65	15	3294	11314	90613824
Craniocervical syndrome	37.86	25.65	6	3303	104	90625034
Somnolence	35.72	25.65	41	3268	209043	90416095
Acute kidney injury	34.55	25.65	50	3259	320337	90304801
COVID-19	33.83	25.65	36	3273	168807	90456331
Thoracic vertebral fracture	33.31	25.65	11	3298	5463	90619675
Spinal fracture	32.69	25.65	16	3293	22000	90603138
Hospitalisation	32.41	25.65	31	3278	128069	90497069
Hyperkalaemia	31.69	25.65	23	3286	64941	90560197
Hypervitaminosis D	31.17	25.65	5	3304	94	90625044
Myocardial oedema	29.41	25.65	6	3303	445	90624693
Vitreous detachment	28.28	25.65	8	3301	2370	90622768
Intracranial haemangioma	27.87	25.65	4	3305	34	90625104
Antisocial behaviour	27.78	25.65	6	3303	586	90624552
Sensorimotor disorder	26.33	25.65	6	3303	749	90624389

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Death	70.32	25.51	92	1706	471093	42148444
Plasma cell myeloma refractory	62.57	25.51	14	1784	1396	42618141
Thoracic vertebral fracture	36.27	25.51	10	1788	2338	42617199
Acute kidney injury	35.91	25.51	59	1739	367278	42252259
Intracranial pressure increased	33.47	25.51	11	1787	4663	42614874
Sopor	28.55	25.51	13	1785	13189	42606348
Macroglossia	27.79	25.51	6	1792	506	42619031
Rhabdomyolysis	27.09	25.51	24	1774	77995	42541542
Oliguria	26.08	25.51	11	1787	9302	42610235

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Death	112.05	21.67	151	5112	698718	109885318
Drug interaction	107.10	21.67	125	5138	500058	110083978
Thoracic vertebral fracture	67.44	21.67	21	5242	6634	110577402
Dialysis	54.91	21.67	24	5239	19595	110564441
Acute kidney injury	52.75	21.67	102	5161	635328	109948708
Hyponatraemia	49.06	21.67	56	5207	217597	110366439
COVID-19	43.71	21.67	56	5207	245004	110339032
Hospitalisation	37.88	21.67	40	5223	142453	110441583
Respiratory tract infection	36.56	21.67	29	5234	71588	110512448
Craniocervical syndrome	36.27	21.67	6	5257	104	110583932
Sopor	35.61	21.67	22	5241	36524	110547512
Hypertransaminasaemia	32.63	21.67	18	5245	24237	110559799
Prinzmetal angina	30.92	21.67	9	5254	2260	110581776
Hypertensive crisis	29.83	21.67	17	5246	24355	110559681
Parkinsonism	28.57	21.67	16	5247	22171	110561865
Ischaemic stroke	28.41	21.67	20	5243	41243	110542793
Hypervitaminosis D	27.87	21.67	5	5258	142	110583894
Intracranial haemangioma	26.81	21.67	4	5259	34	110584002
Hypocalcaemia	26.16	21.67	23	5240	65343	110518693
Myocardial oedema	25.89	21.67	6	5257	617	110583419
Hypomagnesaemia	25.69	21.67	22	5241	60348	110523688
Vitreous detachment	25.29	21.67	8	5255	2657	110581379
Arteriospasm coronary	25.03	21.67	11	5252	9089	110574947
Antisocial behaviour	23.92	21.67	6	5257	862	110583174
Intracranial pressure increased	23.48	21.67	11	5252	10524	110573512
Colitis ischaemic	23.40	21.67	13	5250	17737	110566299
Oliguria	22.79	21.67	13	5250	18644	110565392
Hyperkalaemia	22.57	21.67	30	5233	135766	110448270
Sensorimotor disorder	22.13	21.67	6	5257	1166	110582870

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
ATC	A11CC06	ALIMENTARY TRACT AND METABOLISM VITAMINS VITAMIN A AND D, INCL. COMBINATIONS OF THE TWO Vitamin D and analogues
ATC	H05BX05	SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS CALCIUM HOMEOSTASIS ANTI-PARATHYROID AGENTS Other anti-parathyroid agents
MeSH PA	D014815	Vitamins
MeSH PA	D018977	Micronutrients
MeSH PA	D050071	Bone Density Conservation Agents
CHEBI has role	CHEBI:25212	metabolite
CHEBI has role	CHEBI:50646	bone density conservation agent
CHEBI has role	CHEBI:50733	nutraceutical
CHEBI has role	CHEBI:75771	mouse metabolite
CHEBI has role	CHEBI:77746	human metabolite

Related Drugs by ATC class:

A11CC Vitamin D and analogues 5 drugs

alfacalcidolcalcitriolcolecalciferoldihydrotachysterolergocalciferol

H05BX Other anti-parathyroid agents 5 drugs

cinacalcetdoxercalciferoletelcalcetideevocalcetparicalcitol

Drug Use | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Hypophosphatemia	indication	4996001
Hypocalcemia	indication	5291005
Renal osteodystrophy	indication	16726004	DOID:13068
Rickets	indication	41345002	DOID:10609
Vitamin D deficiency	off-label use	34713006
Hyperphosphatemia	contraindication	20165001	DOID:0050459
Hypervitaminosis D	contraindication	27712000	DOID:9971
Sarcoidosis	contraindication	31541009	DOID:11335
Hypercalcemia	contraindication	66931009	DOID:12678
Kidney disease	contraindication	90708001	DOID:557
Kidney stone	contraindication	95570007
Arteriosclerosis obliterans	contraindication	361133006	DOID:5160

🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent use
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9943530	Feb. 2, 2027	MAINTAINING SERUM 25-HYDROXYVITAMIN D AT A LEVEL OF AT LEAST 30 NG/ML WITH ORAL, SUSTAINED RELEASE 25-HYDROXYVITAMIN D
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	11154509	April 25, 2028	TREATING SECONDARY HYPERPARATHYROIDISM IN STAGE 3 OR 4 CKD WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENTS SERUM PARATHYROID HORMONE LEVEL WHILE AVOIDING PTH OVERSUPPRESSION
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8207149	April 25, 2028	TREATMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH STAGE 3 OR 4 CHRONIC KIDNEY DISEASE USING CONTROLLED RELEASE, ORAL 25-HYDROXYVITAMIN D
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8778373	April 25, 2028	ADMINISTRATION OF 25-HYDROXYVITAMIN D3 BY CONTROLLED RELEASE
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9408858	April 25, 2028	USE OF CONTROLLED RELEASE 25-HYDROXYVITAMIN D IN TREATING SECONDARY HYPERPARATHYROIDISM IN PATIENTS HAVING CHRONIC KIDNEY DISEASE
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9498486	April 25, 2028	USE OF SUSTAINED OR EXTENDED RELEASE ORAL 25-HYDROXYVITAMIN D3 IN TREATING SECONDARY HYPERPARATHROIDISM IN ADULT PATIENTS HAVING CHRONIC KIDNEY DISEASE STAGE 3 OR 4
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9925147	April 25, 2028	TREATING SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENTS SERUM PARATHYROID HORMONE LEVEL AND CMAX IS REDUCED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9925147	April 25, 2028	TREATING SECONDARY HYPERPARATHYROIDISM IN CHRONIC KIDNEY DISEASE WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D TO REDUCE THE PATIENTS SERUM PARATHYROID HORMONE LEVEL AND THE SUSTAINED RELEASE IS OVER AT LEAST 10 HOURS
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9925147	April 25, 2028	TREATING SECONDARY HYPERPARATHYROIDISM IN CKD WITH SUSTAINED RELEASE CALCIFEDIOL TO REDUCE THE PATIENTS SERUM PARATHYROID HORMONE LEVEL AND CMAX24HR/C24HR IS REDUCED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9925147	April 25, 2028	TREATING SECONDARY HYPERPARATHYROIDISM IN CKD WITH SUSTAINED RELEASE CALCIFEDIOL TO REDUCE THE PATIENTS SERUM PARATHYROID HORMONE LEVEL AND TMAX IS INCREASED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	9925147	April 25, 2028	TREATING SHPT IN CKD WITH SUSTAINED RELEASE CALCIFEDIOL TO REDUCE SERUM PARATHYROID HORMONE LEVEL AND CHANGE IN SERUM CONCENTRATION OF CALCIFEDIOL IN DOSE INTERVAL IS REDUCED COMPARED TO BOLUS IV INJECTION AND IMMEDIATE-RELEASE, ORAL DOSING
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	8426391	Aug. 27, 2028	USE OF SUSTAINED RELEASE 25-HYDROXYVITAMIN D IN TREATING PATIENTS HAVING 25-HYDROXYVITAMIN D INSUFFICIENCY OR DEFICIENCY
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	11801253	Sept. 7, 2030	TREATMENT OF SECONDARY HYPERPARATHYROIDISM WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D IN CHRONIC KIDNEY DISEASE PATIENTS RECEIVING CHOLESTYRAMINE
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	11801253	Sept. 7, 2030	TREATMENT OF SECONDARY HYPERPARATHYROIDISM WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D IN CHRONIC KIDNEY DISEASE PATIENTS RECEIVING CYP3A INHIBITORS
0.03MG	RAYALDEE	EIRGEN	N208010	June 17, 2016	RX	CAPSULE, EXTENDED RELEASE	ORAL	11801253	Sept. 7, 2030	TREATMENT OF SECONDARY HYPERPARATHYROIDISM WITH SUSTAINED RELEASE 25-HYDROXYVITAMIN D IN CHRONIC KIDNEY DISEASE PATIENTS RECEIVING PHENOBARBITAL OR OTHER ANTICONVULSANTS

Orange Book exclusivity data (new drug applications)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Vitamin D3 receptor	Nuclear hormone receptor	P11473	VDR_HUMAN	AGONIST				CHEMBL	CHEMBL
Sterol regulatory element-binding protein 1	Transcription factor	P36956	SRBP1_HUMAN		IC50	5.93		CHEMBL
Vitamin D3 receptor	Nuclear hormone receptor		VDR_MOUSE		EC50	6.22		CHEMBL

External reference:

ID	Source
4022405	VUID
N0000020410	NUI
D00122	KEGG_DRUG
63283-36-3	SECONDARY_CAS_RN
1889	RXNORM
C0006657	UMLSCUI
CHEBI:17933	CHEBI
CHEMBL3544909	ChEMBL_ID
DB00146	DRUGBANK_ID
6921	IUPHAR_LIGAND_ID
P6YZ13C99Q	UNII
5283731	PUBCHEM_CID
399	MMSL
4321	MMSL
d03127	MMSL
259337002	SNOMEDCT_US
88519001	SNOMEDCT_US
D002112	MESH_DESCRIPTOR_UI
4021905	VANDF
4022405	VANDF
001016	NDDF
P6YZ13C99Q	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Rayaldee	HUMAN PRESCRIPTION DRUG LABEL	1	70301-1001	CAPSULE, EXTENDED RELEASE	30 ug	ORAL	NDA	26 sections
Rayaldee	HUMAN PRESCRIPTION DRUG LABEL	1	70301-1002	CAPSULE, EXTENDED RELEASE	30 ug	ORAL	NDA	26 sections