Calcitriol
Calcitriol, Rocaltrol, Vectical (calcitriol) is a small molecule pharmaceutical. Calcitriol was first approved as Rocaltrol on 1982-01-01. It is used to treat hyperparathyroidism, hypocalcemia, psoriasis, rickets, and vitamin e deficiency in the USA. The pharmaceutical is active against vitamin D3 receptor.
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Therapeutic Areas
Trade Name
FDA
EMA
Calcitriol, Rocaltrol, Vectical (discontinued: Calcijex, Calcitriol)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Calcitriol
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| VECTICAL | Galderma | N-022087 RX | 2009-01-23 | 1 products, RLD, RS |
| ROCALTROL | Validus Pharmaceuticals | N-018044 RX | 1982-01-01 | 2 products, RLD |
| ROCALTROL | Validus Pharmaceuticals | N-021068 RX | 1998-11-20 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| calcitriol | ANDA | 2025-09-25 |
| calcitrol | NDA authorized generic | 2023-05-15 |
| rocaltrol | New Drug Application | 2023-12-15 |
| vectical | New Drug Application | 2024-10-24 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CALCITRIOL, VECTICAL, GALDERMA LABS LP | |||
| 2023-07-17 | NPP | ||
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
— A11CC04: Calcitriol
D: Dermatologicals
— D05: Antipsoriatics
— D05A: Antipsoriatics for topical use
— D05AX: Other antipsoriatics for topical use in atc
— D05AX03: Calcitriol
HCPCS
Code | Description |
|---|---|
| J0636 | Injection, calcitriol, 0.1 mcg |
Clinical
Clinical Trials
188 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Chronic renal insufficiency | D051436 | — | N18 | 1 | — | 4 | 13 | 4 | 22 |
| Kidney diseases | D007674 | EFO_0003086 | N08 | — | 1 | 3 | 9 | 7 | 20 |
| Secondary hyperparathyroidism | D006962 | EFO_1001173 | — | — | 1 | 3 | 9 | 4 | 17 |
| Hyperparathyroidism | D006961 | EFO_0008506 | E21.3 | — | 1 | 3 | 6 | 5 | 15 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 1 | 4 | 2 | 6 | 2 | 15 |
| Vitamin d deficiency | D014808 | EFO_0003762 | E55 | 1 | 1 | 2 | 4 | 7 | 15 |
| Chronic kidney failure | D007676 | EFO_0003884 | N18.6 | — | 3 | 2 | 3 | 4 | 12 |
| Osteoporosis | D010024 | EFO_0003882 | M81.0 | 3 | 2 | 3 | 3 | 1 | 11 |
| Metabolic bone diseases | D001851 | — | — | — | 3 | 1 | 3 | 1 | 7 |
| Neoplasms | D009369 | — | C80 | 5 | 1 | — | 1 | — | 7 |
Show 37 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Prostatic neoplasms | D011471 | — | C61 | 3 | 11 | 2 | — | 1 | 15 |
| Hypocalcemia | D006996 | HP_0002901 | E83.51 | — | 3 | 1 | — | 5 | 9 |
| Hypoparathyroidism | D007011 | — | E20 | — | 1 | 1 | — | 3 | 5 |
| Rickets | D012279 | EFO_0005583 | E55.0 | 1 | 1 | 1 | — | 1 | 4 |
| Nephrolithiasis | D053040 | — | N20.0 | — | 1 | 1 | — | 2 | 4 |
| Hypophosphatemic rickets | D063730 | — | E83.31 | 1 | — | 1 | — | 1 | 3 |
| Calcium metabolism disorders | D002128 | EFO_0005769 | E83.5 | — | — | 1 | — | 1 | 2 |
| Hypercalciuria | D053565 | — | R82.994 | — | 1 | 1 | — | — | 2 |
| Nephrocalcinosis | D009397 | — | — | — | 1 | 1 | — | — | 2 |
| Adenomatous polyps | D018256 | — | D28 | — | — | 1 | — | — | 1 |
Show 12 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypertension | D006973 | EFO_0000537 | I10 | 1 | 1 | — | — | 1 | 3 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 3 | — | — | — | 3 |
| Lung neoplasms | D008175 | — | C34.90 | 2 | 2 | — | — | 1 | 3 |
| Diabetes mellitus | D003920 | EFO_0000400 | E08-E13 | — | 1 | — | — | 2 | 3 |
| Kidney calculi | D007669 | EFO_0004253 | N20 | — | 1 | — | — | 2 | 3 |
| Breast neoplasms | D001943 | EFO_0003869 | C50 | — | 2 | — | — | 1 | 3 |
| Castration-resistant prostatic neoplasms | D064129 | — | — | — | 2 | — | — | — | 2 |
| Pancreatic neoplasms | D010190 | EFO_0003860 | C25 | — | 2 | — | — | — | 2 |
| Crohn disease | D003424 | EFO_0000384 | K50 | 1 | 1 | — | — | 1 | 2 |
| Myelodysplastic syndromes | D009190 | — | D46 | — | 2 | — | — | — | 2 |
Show 30 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 1 | — | — | — | 2 | 3 |
| Attention deficit disorder with hyperactivity | D001289 | EFO_0003888 | F90 | 2 | — | — | — | — | 2 |
| Glycosuria | D006029 | — | R81 | 1 | — | — | — | — | 1 |
| Polyps | D011127 | EFO_0000662 | — | 1 | — | — | — | — | 1 |
| Prediabetic state | D011236 | EFO_1001121 | R73.03 | 1 | — | — | — | — | 1 |
| Glucose intolerance | D018149 | HP_0000833 | R73.03 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Hypoxia | D000860 | — | R09.02 | 1 | — | — | — | — | 1 |
| Brain diseases | D001927 | — | G93.40 | 1 | — | — | — | — | 1 |
| Brain ischemia | D002545 | EFO_0003883 | I67.82 | 1 | — | — | — | — | 1 |
Show 8 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Obesity | D009765 | EFO_0001073 | E66.9 | — | — | — | — | 2 | 2 |
| Tissue preservation | D014021 | — | — | — | — | — | — | 2 | 2 |
| Retinal diseases | D012164 | — | H35.9 | — | — | — | — | 1 | 1 |
| Hiv seropositivity | D006679 | — | — | — | — | — | — | 1 | 1 |
| Insulin resistance | D007333 | EFO_0002614 | E88.819 | — | — | — | — | 1 | 1 |
| Thyroid diseases | D013959 | — | E00-E07 | — | — | — | — | 1 | 1 |
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | — | — | — | — | 1 | 1 |
| Child development | D002657 | — | — | — | — | — | — | 1 | 1 |
| Periodontitis | D010518 | EFO_0000649 | K05.3 | — | — | — | — | 1 | 1 |
| Aggressive periodontitis | D010520 | EFO_0006342 | K05.2 | — | — | — | — | 1 | 1 |
Show 14 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Calcitriol |
| INN | calcitriol |
| Description | Calcitriol is a hydroxycalciol that is calcidiol in which the pro-S hydrogen of calcidiol is replaced by a hydroxy group. It is the active form of vitamin D3, produced fom calciol via hydoxylation in the liver to form calcidiol, which is subsequently oxidised in the kidney to give calcitriol. It has a role as a bone density conservation agent, an antipsoriatic, an immunomodulator, an antineoplastic agent, a calcium channel modulator, a nutraceutical, a calcium channel agonist, a metabolite, a hormone, a human metabolite and a mouse metabolite. It is a hydroxycalciol, a member of D3 vitamins and a triol. |
| Classification | Small molecule |
| Drug class | vitamin D analogs |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | C=C1/C(=C\C=C2/CCC[C@@]3(C)[C@H]2CC[C@@H]3[C@H](C)CCCC(C)(C)O)C[C@@H](O)C[C@@H]1O |
Identifiers
| PDB | — |
| CAS-ID | 32222-06-3 |
| RxCUI | — |
| ChEMBL ID | CHEMBL846 |
| ChEBI ID | 17823 |
| PubChem CID | 5280453 |
| DrugBank | DB00136 |
| UNII ID | FXC9231JVH (ChemIDplus, GSRS) |
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Calcitriol
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Safety
Black-box Warning
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Adverse Events
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3,340 adverse events reported
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