vitamin d3

Small moleculeapproved

Approved

May 18, 2000

Cholecalciferol (/ˌkoʊləkælˈsɪfərɒl/) (vitamin D3) is one of the five forms of vitamin D. Cholecalciferol is a steroid hormone that has long been known for its important role in regulating body levels of calcium and phosphorus, in mineralization of bone, and for the assimilation of Vitamin A. The classical manifestation of vitamin D deficiency is rickets, which is seen in children and results in bony deformities including bowed long bones. Most people meet at least some of their vitamin D needs through exposure to sunlight. Ultraviolet (UV) B radiation with a wavelength of 290–320 nanometers penetrates uncovered skin and converts cutaneous 7-dehydrocholesterol to previtamin D3, which in turn becomes vitamin D3. In supplements and fortified foods, vitamin D is available in two forms, D2 (ergocalciferol) and D3 (cholecalciferol) that differ chemically only in their side-chain structure. Vitamin D2 is manufactured by the UV irradiation of ergosterol in yeast, and vitamin D3 is manufactured by the irradiation of 7-dehydrocholesterol from lanolin and the chemical conversion of cholesterol. The two forms have traditionally been regarded as equivalent based on their ability to cure rickets and, indeed, most steps involved in the metabolism and actions of vitamin D2 and vitamin D3 are identical. Both forms (as well as vitamin D in foods and from cutaneous synthesis) effectively raise serum 25(OH) D levels. Firm conclusions about any different effects of these two forms of vitamin D cannot be drawn. However, it appears that at nutritional doses, vitamins D2 and D3 are equivalent, but at high doses, vitamin D2 is less potent. The American Academy of Pediatrics (AAP) recommends that exclusively and partially breastfed infants receive supplements of 400 IU/day of vitamin D shortly after birth and continue to receive these supplements until they are weaned and consume ≥1,000 mL/day of vitamin D-fortified formula or whole milk. Cholecalciferol is used in diet supplementary to treat Vitamin D Deficiency. Cholecalciferol is inactive: it is converted to its active form by two hydroxylations: the first in the liver, the second in the kidney, to form calcitriol, whose action is mediated by the vitamin D receptor, a nuclear receptor which regulates the synthesis of hundreds of enzymes and is present in virtually every cell in the body. Calcitriol increases the serum calcium concentrations by increasing GI absorption of phosphorus and calcium, increasing osteoclastic resorption, and increasing distal renal tubular reabsorption of calcium. Calcitriol appears to promote intestinal absorption of calcium through binding to the vitamin D receptor in the mucosal cytoplasm of the intestine. Subsequently, calcium is absorbed through formation of a calcium-binding protein. — NCATS

Clinical trial activity

1,689 trials · 1,098 clinical orgs · 5 marketing orgs

Phase 1

179

Phase 2

521

Phase 3

289

Phase 4

246

Earliest trial started Oct 1, 1992 (NCT00357643)

Timeline

1990s

Jan 1, 1992
Earliest Phase 3 Sponsor(trial)
Jan 1, 1998
Earliest Phase 1 Sponsor(trial)
Jan 1, 1998
Earliest Phase 2 Sponsor(trial)

2000s

May 18, 2000
Novartis — Earliest FDA Approval
May 18, 2000
Sandoz — NDA Secondary Org
May 18, 2000
Novartis — NDA Secondary Org
May 18, 2000
Novartis — NDA Organization
Apr 7, 2005
Merck — NDA Secondary Org
Apr 7, 2005
Organon — NDA Secondary Org

2020s

Apr 9, 2026
Apotex — Marketing Organization

Indications

Approved for

Vitamin D Deficiency

Studied for

Mechanism of action

Vitamin D receptorINHIBITOR
VDR inhibitor
- Vitamin D3 receptor (VDR) ↗

Combination products

fosamax plus
with alendronic acid
infuvite
with vitamin e, folic acid, cyanocobalamin, vitamin c, nicotinamide, thiamine, vitamin k, biotin, panthenol, pyridoxine, riboflavin, vitamin a
Also known as infuvite pediatric, infuvite pediatric (pharmacy bulk package)

Approval history

approvedMay 18, 2000

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)CCC[C@@H](C)[C@H]1CC[C@@H]2[C@]1(C)CCC\C2=C/C=C3/C[C@H](O)CCC3=C

Mol. weight: 384.6377 g/mol
Lipinski Ro5: 1 violation(s)
Rule of 3: No
Chirality: Single Stereoisomer
Inorganic: No
Polymer: No
Delivery: Oral, Parenteral
Availability: Prescription Only

Oral

Yes

Parenteral

Yes

Topical

Sources

Also known as

1,25-dihydroxy-22-oxavitamin d3
19 nor vitamin d
19 nor vitamin d
1alpha,25-dihydroxy-22-oxavitamin d3
1alpha,25-dihydroxy-22-oxavitamin d3
(1s,3z)-3-[(2e)-2-[(1r,3ar,7as)-7a-methyl-1-[(2r)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylidene-cyclohexan-1-ol
(1s,3z)-3-[(2e)-2-[(1r,3ar,7as)-7a-methyl-1-[(2r)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylidene-cyclohexan-1-ol
(1s,3z)-3-[(2e)-2-[(1r,3as,7ar)-7a-methyl-1-[(2r)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol
(1s,3z)-3-[(2e)-2-[(1r,3as,7ar)-7a-methyl-1-[(2r)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1h-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol
22-oxa-1,25-dihydroxyvitamin d3
22-oxacalcitriol
22-oxacalcitriol
22-oxacalcitriol
22-oxacalcitriol
22-oxacalcitriol
22-oxa-calcitriol
22-oxacalcitrol
22-oxacalcitrol
(3β,5z,7e)-9,10-secocholesta-5,7,10(19)-trien-3-ol
(3β,5z,7e)-9,10-secocholesta-5,7,10(19)-trien-3-ol
(5z,7e)-(3s)-9,10-secocholesta-5,7,10(19)-trien-3-ol
(5z,7e)-(3s)-9,10-secocholesta-5,7,10(19)-trien-3-ol
accrete d3
aciferol d3
activated 7-dehydrocholesterol
activated 7-dehydrocholesterol
adcal-d3
alendronate sodium trihydrate / colecalciferol
alendronic acid / colecalciferol
arachitol
aviticol
biolife vitamin d3
bio-vitamin d3
cacit d3
calceos
calcichew d3
calcichew d3 fte
calcichew d3 once daily
calci-d
calciol
calciol
calciol
calcirol
caldrink d3
calfovit d3
cc
cc
cholecalciferol
cholecalciferol
cholecalciferol
cholecalciferol
cholecalciferol
cholecalciferol
colcalciferol
colecalciferol
colecalciferol
colecalciferol
colecalciferol
colecalciferol
colecalciferol
colecalciferolum
colecalciferolum
colecal d3
colekal-d3
colevit d3
ctap101
cubicole d3
d3-50
d3 lemon melts
dekristol
desunin
dlux 400
d-max
dp-r206
dp-r206
d-tracetten
d-tracetten
d-vit3
e-d3
evacal d3
fultium-d3
fultium daily d3
high dose aspirin & vitamin d
hux d3
invita d3
iso d3
kora liquid
maxacalcitol
maxacalcitol
maxacalcitol
maxacalcitol
maxacalcitol
maxacalcitol
maxacalcitriol
natecal d3
nature's remedy vitamin d3
neo-d
nphd3
oct
oct
oleovitamin d3
oleovitamin d3
osteocaps d3
oxarol
oxarol
plenachol
prezios
prezios
pro d3
pro d3 folic
pro d3 forte
provitamin d(3)
royalvit d3
sch-209579
sch-209579
stexerol-d3
stivit-d3
sunvit-d3 1,000
sunvit-d3 10,000
sunvit-d3 2,000
sunvit-d3 20,000
sunvit-d3 3,000
sunvit-d3 400
sunvit-d3 5,000
sunvit-d3 50,000
sunvit-d3 800
synervit-d3
theical d-3
thorens
vigantol
vigantol
vigantol
vigantoletten
vigantoletten
vigantoletten 500
vigantol oil
vigantol oil
viosterol
viosterol
viosterol in oil
viosterol in oil
vita-d3
vitamin d
vitamin d
vitamin d
vitamin d
vitamin-d
vitamin-d
(+)-vitamin d3
(+)-vitamin d3
vitamin d3
vitamin d3
vitamin d3
vitamin d3
vitamin d3
vitamin d3
vitamin d3
vitamin d3
vitamin d 3
vitamin d 3
vitamin d-3
vitamin d-3
vitamin d nos
vitamin d, unspecified form
vit d3 streuli
zymad

Clinical trials

NCT ID	Phase	Start date	Sponsor(s)
NCT07269457	Phase 2	Jan 2, 2026	Lagos State University
NCT07305519	N/A	Jan 1, 2026	University of Roma La Sapienza
NCT07293910	Phase 2	Dec 20, 2025	Tanta University
NCT07177157	Phase 1	Oct 31, 2025	London Health Sciences Centre
NCT07288619	N/A	Oct 15, 2025	University of Health Sciences Lahore
NCT07196670	Phase 4	Sep 30, 2025	Cairo University
NCT07120997	N/A	Sep 30, 2025	California Dried Plum Board, Pennsylvania State University, United States Department of Agriculture, University of Georgia
NCT07053657	N/A	Sep 15, 2025	Anhui Medical University
NCT07006714	Phase 4	Sep 8, 2025	University of Miami
NCT07269223	N/A	Sep 2, 2025	University of Veterinary and Animal Sciences, Lahore
NCT07127796	N/A	Sep 1, 2025	University of Bologna
NCT07096037	N/A	Sep 1, 2025	University of Sousse
NCT07288801	Phase 4	Aug 9, 2025	Nishtar Medical University
NCT07245277	Phase 4	Aug 2, 2025	Padjadjaran University
NCT06993064	N/A	Aug 1, 2025	Universidad Autonoma del Estado de Mexico
NCT07115342	N/A	Aug 1, 2025	Tanta University
NCT07085598	N/A	Jul 31, 2025	Bangladesh Medical University
NCT07084597	N/A	Jul 31, 2025	Bangladesh Medical University
NCT07065877	N/A	Jul 20, 2025	Suez Canal University
NCT07096414	N/A	Jul 19, 2025	Bangladesh Medical University

Showing 20 of 1,689 trials

Page 1 / 85

Organizations

Research & Development (1,098)

Organization	Org type	Trials	As lead sponsor	Phases	Earliest year
Harvard University	Academic/Hospital	71	58	5	2004
National Cancer Institute (NCI)	Government	39	8	4	1999
Cairo University	Academic/Hospital	28	26	5	2011
National Institutes of Health (NIH)	Government	26	3	5	1992
University of Toronto	Academic/Hospital	24	20	3	2004
Emory University	Academic/Hospital	22	16	5	2005
Medical University of South Carolina	Academic/Hospital	21	3	5	2004
University of London	Academic/Hospital	21	15	4	2007
Ain Shams University	Academic/Hospital	20	19	5	2012
National Institute on Aging (NIA)	Government	20	1	4	1999
University of Copenhagen	Academic/Hospital	20	19	4	2007
Department of Veteran Affairs	Government	19	17	4	2005
Merck	For profit	19	16	4	2002
National Heart, Lung, and Blood Institute (NHLBI)	Government	19	1	4	1999
University of Wisconsin	Academic/Hospital	18	15	5	1998
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Government	17	2	5	2003
Case Western Reserve University	Academic/Hospital	16	14	5	2003
Columbia University	Academic/Hospital	16	12	4	2003
Creighton University	Academic/Hospital	16	14	4	2000
Aarhus University	Academic/Hospital	15	14	4	2005

1,098 organizations

Page 1 / 55

Marketing (7)

Organization	Org type	Relationship	Date
Apotex	For profit	MKTG	Apr 9, 2026
Merck	For profit	NDA2	Apr 7, 2005
Novartis	For profit	NDA2	May 18, 2000
Novartis	For profit	NDA	May 18, 2000
Organon	For profit	NDA2	Apr 7, 2005
Organon	For profit	SYN	Apr 7, 2005
Sandoz	For profit	NDA2	May 18, 2000