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Calcitriol | CAS No: 32222-06-3 | GMP-certified suppliers
A medication that supports management of vitamin D deficiency, rickets, hypoparathyroidism, dialysis‑related hypocalcemia, and helps maintain bone health in osteoporosis.
Therapeutic categories
Alimentary Tract and MetabolismAntipsoriaticsAntipsoriatics for Topical UseBone Density Conservation AgentsCalcium-Regulating Hormones and AgentsCholestanes
Generic name
Calcitriol
Molecule type
small molecule
CAS number
32222-06-3
DrugBank ID
DB00136
Approval status
Approved drug, Nutraceutical drug
ATC code
D05AX03
Primary indications
- Used to treat vitamin D deficiency or insufficiency, refractory rickets (vitamin D resistant rickets), familial hypophosphatemia and hypoparathyroidism, and in the management of hypocalcemia and renal osteodystrophy in patients with chronic renal failure undergoing dialysis
- Also used in conjunction with calcium in the management and prevention of primary or corticosteroid-induced osteoporosis
Product Snapshot
- Calcitriol is available as an oral small‑molecule formulation, injectable solution for parenteral use, and topical dosage forms
- It is used for vitamin D–related metabolic disorders including deficiency states, hypocalcemia, renal osteodystrophy, and osteoporosis management
- It is approved in the US and Canada, with some products also positioned as nutraceuticals
Clinical Overview
Calcitriol (CAS 32222-06-3) is the active metabolite of vitamin D3 and a secosteroid that regulates calcium and phosphate homeostasis. It is formed from 25‑hydroxyvitamin D in the kidney by CYP27B1 and is the most potent circulating vitamin D derivative. Endogenous production is stimulated by parathyroid hormone, low serum calcium, and low phosphate. Calcitriol acts through the nuclear vitamin D receptor to modulate transcription in tissues including the intestine, bone, kidney, and immune cells.
Clinically, calcitriol is used in vitamin D deficiency states, refractory rickets, familial hypophosphatemia, hypoparathyroidism, and the management of hypocalcemia and renal osteodystrophy in dialysis patients. It is also used with calcium for primary or corticosteroid‑induced osteoporosis. Topical formulations are used for mild to moderate plaque psoriasis.
Calcitriol increases serum calcium by promoting intestinal absorption, renal tubular reabsorption, and mobilization of skeletal calcium stores. Pharmacologic effects typically persist for 3 to 5 days after dosing. Additional documented actions include regulation of keratinocyte proliferation and differentiation in psoriasis, modulation of cytokine responses, and influence on immune cell activation through VDR‑mediated transcription. Experimental studies show effects on differentiation and proliferation in several malignant cell lines, although hypercalcemia has limited systemic oncology dosing.
Absorption is efficient after oral administration, and calcitriol circulates bound to vitamin D binding protein. It is metabolized primarily by hepatic and extrahepatic hydroxylation pathways and eliminated largely via biliary excretion. The compound is both a substrate and inducer of CYP3A pathways. Toxicity is mainly related to hypercalcemia and hypercalciuria, which may lead to nephrocalcinosis, renal impairment, or soft tissue calcification. Careful titration and monitoring of serum calcium, phosphate, and renal function are required.
Calcitriol is marketed in oral, injectable, and topical forms, including products such as Rocaltrol, Calcijex, and Decostriol. For API procurement, emphasis should be placed on controlling secosteroid isomer content, light‑sensitive degradation pathways, and compliance with pharmacopeial assays for potency, impurities, and stability.
Clinically, calcitriol is used in vitamin D deficiency states, refractory rickets, familial hypophosphatemia, hypoparathyroidism, and the management of hypocalcemia and renal osteodystrophy in dialysis patients. It is also used with calcium for primary or corticosteroid‑induced osteoporosis. Topical formulations are used for mild to moderate plaque psoriasis.
Calcitriol increases serum calcium by promoting intestinal absorption, renal tubular reabsorption, and mobilization of skeletal calcium stores. Pharmacologic effects typically persist for 3 to 5 days after dosing. Additional documented actions include regulation of keratinocyte proliferation and differentiation in psoriasis, modulation of cytokine responses, and influence on immune cell activation through VDR‑mediated transcription. Experimental studies show effects on differentiation and proliferation in several malignant cell lines, although hypercalcemia has limited systemic oncology dosing.
Absorption is efficient after oral administration, and calcitriol circulates bound to vitamin D binding protein. It is metabolized primarily by hepatic and extrahepatic hydroxylation pathways and eliminated largely via biliary excretion. The compound is both a substrate and inducer of CYP3A pathways. Toxicity is mainly related to hypercalcemia and hypercalciuria, which may lead to nephrocalcinosis, renal impairment, or soft tissue calcification. Careful titration and monitoring of serum calcium, phosphate, and renal function are required.
Calcitriol is marketed in oral, injectable, and topical forms, including products such as Rocaltrol, Calcijex, and Decostriol. For API procurement, emphasis should be placed on controlling secosteroid isomer content, light‑sensitive degradation pathways, and compliance with pharmacopeial assays for potency, impurities, and stability.
Identification & chemistry
| Generic name | Calcitriol |
|---|---|
| Molecule type | Small molecule |
| CAS | 32222-06-3 |
| UNII | FXC9231JVH |
| DrugBank ID | DB00136 |
Pharmacology
| Summary | Calcitriol is the active form of vitamin D3 that binds the vitamin D receptor to regulate transcription of genes involved in calcium homeostasis, cell proliferation, and immune function. Through VDR–RXR complexes, it promotes intestinal calcium absorption and modulates epidermal, immune, and malignant cell behavior by influencing differentiation and growth pathways. Its pharmacodynamic profile reflects combined calcitrophic, antiproliferative, and immunomodulatory actions across multiple tissues. |
|---|---|
| Mechanism of action | The mechanism of action of calcitriol in the treatment of psoriasis is accounted for by their antiproliferative activity for keratinocytes and their stimulation of epidermal cell differentiation. The anticarcinogenic activity of the active form of Calcitriol appears to be correlated with cellular vitamin D receptor (VDR) levels. Vitamin D receptors belong to the superfamily of steroid-hormone zinc-finger receptors. VDRs selectively bind 1,25-(OH)<sub>2</sub>-D3 and retinoic acid X receptor (RXR) to form a heterodimeric complex that interacts with specific DNA sequences known as vitamin D-responsive elements. VDRs are ligand-activated transcription factors. The receptors activate or repress the transcription of target genes upon binding their respective ligands. It is thought that the anticarcinogenic effect of Calcitriol is mediated via VDRs in cancer cells. The immunomodulatory activity of calcitriol is thought to be mediated by vitamin D receptors (VDRs) which are expressed constitutively in monocytes but induced upon activation of T and B lymphocytes. 1,25-(OH)<sub>2</sub>-D3 has also been found to enhance the activity of some vitamin D-receptor positive immune cells and to enhance the sensitivity of certain target cells to various cytokines secreted by immune cells. A study suggests that calcitriol plays an immunoregulatry role by suppressing the aryl hydrocarbon receptor (AhR) expression in human Th9, a pro-inflammatory CD4 T cell subset . This suppression subsequently leads to repressed expression of BATF, a transcription factor essential for Th9 . Calcitriol has also been found to induce monocyte differentiation and to inhibit lymphocyte proliferation and production of cytokines, including interleukin IL-1 and IL-2, as well as to suppress immunoglobulin secretion by B lymphocytes. |
| Pharmacodynamics | Calcitriol is a biologically active calcitrophic hormone with anti-osteoporotic, immunomodulatory, anticarcinogenic, antipsoriatic, antioxidant, and mood-modulatory activities. Its main sites of action are the intestine, bone, kidney and parathyroid hormone [FDA Label]. Calcitriol is a ligand for the vitamin D nuclear receptor, which is expressed in, but not limited to, gastrointestinal (GI) tissues, bones, and kidneys . As an active form of vitamin D<sub>3</sub>, calcitriol elevates the plasma levels of calcium by stimulating intestinal calcium uptake, increasing reabsorption of calcium by the kidneys, and possibly increasing the release of calcium from skeletal stores. The duration of pharmacologic activity of a single dose of exogenous calcitriol is expected to be about 3 to 5 days [FDA Label]. In addition to its important role in calcium metabolism, other pharmacological effects of calcitriol have been studied in various conditions including cancer models. Various studies demonstrated expression of vitamin D receptors in cancer cell lines, including mouse myeloid leukemia cells . Calcitriol has been found to induce differentiation and/or inhibit cell proliferation _in vitro_ and _in vivo_ in many cell types, such as malignant cell lines carcinomas of the breast, prostate, colon, skin, and brain, myeloid leukemia cells, and others . In early human prostate cancer trials, administration of 1.5 µg/d calcitriol in male participants resulted in a reduction in the rate of PSA rise in most participants, however it was coincided with dose-limiting hypercalcemia in most participants . Hypercalcemia and hypercalcuria were evident in numerous initial trials, and this may be due to these trials not testing the drug at concentrations that are active in preclinical systems . Findings from preclinical data show an additive or synergistic antineoplastic action of calcitriol when combined with agents including dexamethasone, retinoids, and radiation, as well as several cytotoxic chemotherapy drugs such as platinum compounds . Vitamin D deficiency has long been suspected to increase the susceptibility to tuberculosis. The active form of calcitriol, 1,25-(OH)<sub>2</sub>-D3, has been found to enhance the ability of mononuclear phagocytes to suppress the intracellular growth of <i>Mycobacterium tuberculosis</i>. 1,25-(OH)<sub>2</sub>-D3 has demonstrated beneficial effects in animal models of such autoimmune diseases as rheumatoid arthritis. Vitamin D appears to demonstrate both immune-enhancing and immunosuppressive effects. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Vitamin D3 receptor | Humans | agonist |
| Homeobox protein Hox-A10 | Humans |
ADME / PK
| Absorption | Upon administration, calcitriol is rapidly absorbed from the intestines. When a single oral dose of 0.5 mcg of calcitriol was administered, the mean serum concentrations of calcitriol rose from a baseline value of 40.0±4.4 (SD) pg/mL to 60.0±4.4 pg/mL at 2 hours, and declined to 53.0±6.9 at 4 hours, 50±7.0 at 8 hours, 44±4.6 at 12 hours and 41.5±5.1 at 24 hours [FDA Label]. Following administration of single doses of 0.25 to 1.0 mcg of calcitriol, the peak plasma concentrations were reached within 3 to 6 hours [FDA Label]. In a pharmacokinetic study, the oral bioavailability was 70.6±5.8% in healthy male volunteers and 72.2±4.8% in male patients with uraemia . |
|---|---|
| Half-life | After administration of single oral doses, the elimination half life was 5-8 hours [FDA Label]. |
| Protein binding | Calcitriol is approximately 99.9% bound in blood, mostly by an alpha-globulin vitamin D binding protein [FDA Label]. |
| Metabolism | Metabolism of calcitriol involves two pathways [FDA Label]. The first pathway involves 24-hydroxylase activity in the kidney; this enzyme is also present in many target tissues which possess the vitamin D receptor such as the intestine. The end product of this pathway is a side chain shortened metabolite, calcitroic acid. The second pathway involves the conversion of calcitriol via the stepwise hydroxylation of carbon-26 and carbon-23, and cyclization to yield ultimately 1a,25R(OH)<sub>2</sub>-26,23S-lactone D3, which appears to be the major metabolite circulating in humans. Ohter identified metabolites of calcitriol include 1α, 25(OH)2-24-oxo-D3; 1α, 23,25(OH)3-24-oxo-D3; 1α, 24R,25(OH)3D3; 1α, 25S,26(OH)3D3; 1α, 25(OH)2-23-oxo-D3; 1α, 25R,26(OH)3-23-oxo-D3 and 1α, (OH)24,25,26,27-tetranor-COOH-D3 [FDA Label]. |
| Route of elimination | In normal subjects, approximately 27% and 7% of the radioactivity appeared in the feces and urine, respectively, within 24 hours [FDA Label]. Calcitriol undergoes enterohepatic recycling and biliary excretion. The metabolites of calcitriol are excreted primarily in feces. Cumulative excretion of radioactivity on the sixth day following intravenous administration of radiolabeled calcitriol averaged 16% in urine and 49% in feces [FDA Label]. |
| Volume of distribution | Upon intravenous administration, the volume of distribution of calcitriol was 0.49±0.14 L/kg in healthy male volunteers and 0.27±0.06 l/kg in uraemic male patients participating in a pharmacokinetic study . There is some evidence that calcitriol is transferred into human milk at low levels (ie, 2.2±0.1 pg/mL) in mothers [FDA Label]. Calcitriol from maternal circulation may also enter the fetal circulation [FDA Label]. |
| Clearance | The metabolic clearance rate was 23.5±4.34 ml/min in healthy male volunteers and 10.1±1.35 ml/min in male patients with uraemia . In the pediatric patients undergoing peritoneal dialysis receiving dose of 10.2 ng/kg (SD 5.5 ng/kg) for 2 months, the clearance rate was 15.3 mL/hr/kg [FDA Label]. |
Formulation & handling
- Calcitriol is a small, highly lipophilic secosteroid with very low aqueous solubility, requiring solubilized or oily vehicles for oral capsules and IV solutions.
- Formulations should protect from light and oxidation, as the secosteroid structure is photosensitive and prone to degradation.
- Topical and oral presentations benefit from stabilizing excipients to maintain potency, while IV solutions require appropriate solubilizers to ensure clear, stable preparations.
Regulatory status
| Lifecycle | The active ingredient’s core U.S. patents expired in 2020, indicating that the product is now in a mature post‑exclusivity phase. With availability in the United States and Canada, the market is characterized by established competition and stable generic presence. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Multiple manufacturers and packagers supply calcitriol, indicating that originator involvement is limited and the current market is dominated by established generic producers. Branded products such as Calcijex have been marketed primarily in the United States and Canada, with no broad presence noted in other regions. Key US patents expired in 2020, supporting the availability of existing generic competition across dosage forms. |
|---|
Safety
| Toxicity | LD<sub>50</sub> (oral, rat) = 620 μg/kg; LD<sub>50</sub> (intraperitoneal, rat) > 5 mg/kg [MSDS]. Symptoms of calcitriol toxicity mirrors the early and late signs and symptoms of vitamin D intoxication associated with hypercalcemia . Early signs include weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain and metallic taste. Late signs are characterized by polyuria, polydipsia, anorexia, weight loss, nocturia, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, albuminuria, hypercholesterolemia, elevated SGOT and SGPT, ectopic calcification, hypertension, cardiac arrhythmias and, rarely, overt psychosis . |
|---|
High Level Warnings:
- High acute toxicity in rodents (oral LD50 ~620 micrograms/kg)
- Handle with measures appropriate for potent vitamin D analogs to prevent exposure
- Risk of hypercalcemia-related adverse effects
Certificate of Analysis
A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
Calcitriol is a type of Vitamins
Vitamins are an essential subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) that play a crucial role in maintaining optimal health and well-being. These organic compounds are required in small quantities by the human body to support various metabolic processes and ensure proper functioning of bodily systems. Vitamins can be broadly classified into two groups: fat-soluble vitamins (such as vitamins A, D, E, and K) and water-soluble vitamins (including vitamin C and B-complex vitamins). Each vitamin has a specific role and function within the body.
Pharmaceutical APIs in the vitamin subcategory are carefully synthesized or extracted to meet stringent quality standards and ensure purity, efficacy, and safety. They are used as active ingredients in the formulation of various pharmaceutical products, including dietary supplements, fortified foods, and pharmaceutical formulations.
Vitamin APIs are commonly utilized in the pharmaceutical industry for their therapeutic benefits. For instance, vitamin D API is widely prescribed to treat deficiencies and maintain optimal bone health, while vitamin C API is utilized for its antioxidant properties and immune-boosting effects. B-complex vitamins, such as vitamin B12 API, are essential for energy production and nerve function.
Overall, vitamins are integral to maintaining good health, and pharmaceutical APIs in this subcategory play a vital role in providing these essential nutrients to individuals through various pharmaceutical and dietary applications.
Calcitriol (Vitamins), classified under Therapeutic Nutrients/Minerals/Electrolyte
Therapeutic Nutrients/Minerals/Electrolytes: A Comprehensive Technical DescriptionTherapeutic nutrients, minerals, and electrolytes are a vital category of pharmaceutical active pharmaceutical ingredients (APIs) used to support and enhance overall health and well-being. These compounds play a crucial role in maintaining the body's physiological balance, aiding in various metabolic processes, and addressing specific deficiencies.
Therapeutic nutrients encompass a broad range of substances, including vitamins, minerals, and electrolytes. Vitamins are organic compounds required in small quantities for proper bodily functions and are essential for growth, development, and disease prevention. Minerals, on the other hand, are inorganic substances that support numerous physiological processes, such as bone formation, nerve function, and energy production.
Electrolytes are minerals that carry an electric charge when dissolved in bodily fluids, including sodium, potassium, calcium, magnesium, and chloride. They play a crucial role in maintaining proper hydration, nerve impulses, muscle contractions, and pH balance.
Pharmaceutical APIs in the Therapeutic Nutrients/Minerals/Electrolyte category are designed to address specific deficiencies or imbalances in the body. These APIs are often used in the formulation of dietary supplements, nutritional products, and therapeutic treatments. They are manufactured under stringent quality control guidelines to ensure purity, potency, and bioavailability.
Therapeutic nutrients/minerals/electrolytes APIs are available in various forms, including tablets, capsules, powders, and liquid formulations. They are formulated to meet specific dosage requirements and can be combined with other ingredients for targeted health benefits.
Overall, therapeutic nutrients, minerals, and electrolytes APIs are essential components in maintaining optimal health. Their use helps address deficiencies, support bodily functions, and promote overall well-being. Pharmaceutical companies and healthcare professionals rely on these high-quality APIs to develop effective and safe products that contribute to a healthier population.
Calcitriol API manufacturers & distributors
Compare qualified Calcitriol API suppliers worldwide. We currently have 14 companies offering Calcitriol API, with manufacturing taking place in 9 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, MSDS, USDMF | 243 products |
| CARBOGEN AMCIS | Producer | Netherlands | Netherlands | BSE/TSE, cDMF, CEP, CoA, FDA, GMP, ISO14001, ISO9001, MSDS, USDMF | 15 products |
| Cerbios-Pharma | Producer | Switzerland | Switzerland | CEP, CoA, FDA, GMP, USDMF | 9 products |
| ChemExpress | Producer | United States | China | CoA, ISO9001, MSDS, WC | 197 products |
| D. K. Pharmachem | Producer | India | India | CoA, WC | 2 products |
| Formosa Labs | Producer | Taiwan | Taiwan | CEP, CoA, FDA, GMP, JDMF, USDMF | 36 products |
| G.C. Chemie Pharmie Ltd | Producer | India | India | CoA | 21 products |
| Heron (Shanghai) Pharmace... | Producer | China | China | CoA, GMP | 9 products |
| Instytut Farma | Producer | Poland | Poland | CEP, CoA, GMP | 3 products |
| Jesalis Pharma | Producer | Germany | Germany | CEP, CoA, GMP | 1 products |
| Mahalaxmi Chemi Pharm | Producer | India | India | CoA | 13 products |
| Microbiopharm Japan | Producer | Japan | Japan | CEP, CoA, FDA, JDMF, USDMF | 5 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sichuan Neijiang Huixin P... | Producer | China | China | CoA | 3 products |
When sending a request, specify which Calcitriol API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Calcitriol API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
Frequently asked questions about Calcitriol API
Sourcing
What matters most when sourcing GMP-grade Calcitriol?
Key considerations include confirming GMP compliance and meeting US and Canadian regulatory expectations for the intended dosage form. Because multiple established generic manufacturers supply Calcitriol, verifying the supplier’s quality systems, audit history, and documentation practices is essential. Ensuring consistent batch traceability and clear evidence of regulatory‑grade manufacturing should guide final sourcing decisions.
Which documents are typically required when sourcing Calcitriol API?
Request the core API documentation set: CoA (14 companies), GMP (7 companies), CEP (6 companies), USDMF (5 companies), FDA (4 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Calcitriol API?
Known or reported manufacturers for Calcitriol: ChemExpress, CARBOGEN AMCIS, Heron (Shanghai) Pharmaceutical Science and Technology Co., Ltd., AXXO GmbH. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Calcitriol API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Calcitriol manufacturers?
Audit reports may be requested for Calcitriol: 2 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Calcitriol API on Pharmaoffer?
Reported supplier count for Calcitriol: 14 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Calcitriol API?
Production countries reported for Calcitriol: China (4 producers), India (3 producers), Netherlands (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Calcitriol usually hold?
Common certifications for Calcitriol suppliers: CoA (14 companies), GMP (7 companies), CEP (6 companies), USDMF (5 companies), FDA (4 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Calcitriol (CAS 32222-06-3) used for?
Calcitriol is used to treat disorders of calcium and phosphate balance, including vitamin D deficiency states, hypocalcemia, hypoparathyroidism, refractory rickets, familial hypophosphatemia, and renal osteodystrophy in dialysis patients. It is also used with calcium for osteoporosis and in topical form for mild to moderate plaque psoriasis. Its therapeutic effects derive from vitamin D receptor–mediated regulation of calcium absorption, bone turnover, and keratinocyte and immune cell function.
Which therapeutic class does Calcitriol fall into?
Calcitriol belongs to the following therapeutic categories: Alimentary Tract and Metabolism, Antipsoriatics, Antipsoriatics for Topical Use, Bone Density Conservation Agents, Calcium-Regulating Hormones and Agents. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Calcitriol mainly prescribed for?
The primary indications for Calcitriol: Used to treat vitamin D deficiency or insufficiency, refractory rickets (vitamin D resistant rickets), familial hypophosphatemia and hypoparathyroidism, and in the management of hypocalcemia and renal osteodystrophy in patients with chronic renal failure undergoing dialysis, Also used in conjunction with calcium in the management and prevention of primary or corticosteroid-induced osteoporosis. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Calcitriol work?
The mechanism of action of Calcitriol in the treatment of psoriasis is accounted for by their antiproliferative activity for keratinocytes and their stimulation of epidermal cell differentiation. The anticarcinogenic activity of the active form of Calcitriol appears to be correlated with cellular vitamin D receptor (VDR) levels. Vitamin D receptors belong to the superfamily of steroid-hormone zinc-finger receptors. VDRs selectively bind 1,25-(OH)2-D3 and retinoic acid X receptor (RXR) to form a heterodimeric complex that interacts with specific DNA sequences known as vitamin D-responsive elements. VDRs are ligand-activated transcription factors. The receptors activate or repress the transcription of target genes upon binding their respective ligands. It is thought that the anticarcinogenic effect of Calcitriol is mediated via VDRs in cancer cells. The immunomodulatory activity of Calcitriol is thought to be mediated by vitamin D receptors (VDRs) which are expressed constitutively in monocytes but induced upon activation of T and B lymphocytes. 1,25-(OH)2-D3 has also been found to enhance the activity of some vitamin D-receptor positive immune cells and to enhance the sensitivity of certain target cells to various cytokines secreted by immune cells.
A study suggests that Calcitriol plays an immunoregulatry role by suppressing the aryl hydrocarbon receptor (AhR) expression in human Th9, a pro-inflammatory CD4 T cell subset . This suppression subsequently leads to repressed expression of BATF, a transcription factor essential for Th9 . Calcitriol has also been found to induce monocyte differentiation and to inhibit lymphocyte proliferation and production of cytokines, including interleukin IL-1 and IL-2, as well as to suppress immunoglobulin secretion by B lymphocytes.
What should someone know about the safety or toxicity profile of Calcitriol?
Calcitriol has high acute toxicity in rodents and should be handled with controls appropriate for potent vitamin D analogs. Its main safety concern is hypercalcemia and hypercalciuria, which can lead to nephrocalcinosis, renal impairment, or soft‑tissue calcification. Because pharmacologic effects persist for several days, careful dose titration and monitoring of serum calcium, phosphate, and renal function are required.
What are important formulation and handling considerations for Calcitriol as an API?
Calcitriol’s very low aqueous solubility requires solubilized or oily vehicles for oral and topical products, and suitable solubilizers for clear IV solutions. The molecule is photosensitive and susceptible to oxidation, so formulations should include light protection and stabilizing excipients. Handling should minimize exposure to light and oxidative conditions to preserve potency. High protein binding and lipophilicity do not alter basic handling needs but reinforce the importance of consistent solubilization.
Is Calcitriol a small molecule?
Calcitriol is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Calcitriol?
Oral Calcitriol is sensitive to light and oxidation, so formulations require protection from photodegradation and oxidative loss of potency. Its very low aqueous solubility also necessitates solubilized or oily vehicles to maintain a stable, uniform dose. Stabilizing excipients are used to help preserve potency throughout shelf life.
Regulatory
Where is Calcitriol approved or in use globally?
Calcitriol is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Calcitriol right now?
Calcitriol is regulated as an approved active pharmaceutical ingredient in both the United States and Canada, with established pathways for finished‑dose product submissions. Patent status is product‑specific and depends on individual formulation or process filings rather than the API itself.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Calcitriol procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Calcitriol. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Calcitriol included in the PRO Data Insights coverage?
PRO Data Insights coverage for Calcitriol: 932 verified transactions across 205 suppliers and 153 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Calcitriol?
Market report availability for Calcitriol: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
