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Eldecalcitol | CAS No: 104121-92-8 | GMP-certified suppliers
A medication that supports osteoporosis treatment by enhancing bone density and strength through vitamin D analog activity to reduce fracture risk in patients with decreased bone mineral density.
Therapeutic categories
Primary indications
- Investigated for use/treatment in osteoporosis
Product Snapshot
- Eldecalcitol is an oral small molecule formulation
- It is primarily investigated for therapeutic use in osteoporosis management
- The compound remains in the investigational stage with no current approvals from major regulatory agencies
Clinical Overview
Pharmacologically, eldecalcitol acts as a vitamin D receptor (VDR) agonist. Its molecular structure is modified at the 2β position with a hydroxypropoxy group, distinguishing it from native 1α,25-dihydroxyvitamin D3 . This modification results in reduced affinity for VDR compared to 1,25(OH)2D3, but increased binding to vitamin D-binding protein, contributing to a prolonged plasma half-life. The sustained presence in circulation supports its biological activity over extended periods.
Mechanistically, eldecalcitol inhibits bone resorption by modulating osteoclast activity, thereby enhancing bone mass and strength. In estrogen-deficient animal models of osteoporosis, it demonstrated greater potency in reducing bone resorption compared to alfacalcidol, another vitamin D analog. Clinical studies involving osteoporotic patients, supplemented with vitamin D3, revealed that eldecalcitol administration effectively increased BMD in the lumbar spine and hip regions.
Key absorption, distribution, metabolism, and excretion (ADME) parameters underlying eldecalcitol’s pharmacokinetic profile include its high affinity for circulating vitamin D-binding protein, leading to an extended plasma half-life. Detailed metabolism and clearance data remain limited in public sources.
Safety considerations include the potential for hypercalcemia typical of vitamin D analogs, necessitating monitoring of serum calcium levels during therapy. Other toxicity profiles have not been fully elucidated due to its investigational status.
Eldecalcitol has been studied primarily in Japan and remains investigational globally with no broad regulatory approvals to date. It is classified among bone density conservation agents and vitamin D analogues.
For API procurement, sourcing should prioritize suppliers with demonstrated capability in producing high-purity secosteroid compounds under stringent regulatory and quality standards. Batch consistency, impurity profiling, and stability data are critical for ensuring suitability in pharmaceutical development programs targeting osteoporosis.
Identification & chemistry
| Generic name | Eldecalcitol |
|---|---|
| Molecule type | Small molecule |
| CAS | 104121-92-8 |
| UNII | I2JP8UE90H |
| DrugBank ID | DB05295 |
Pharmacology
| Summary | Eldecalcitol is a vitamin D3 analog that selectively binds to the vitamin D receptor (VDR) with moderate affinity, modulating calcium and bone metabolism. It exhibits increased plasma half-life due to higher affinity for vitamin D-binding protein compared to native 1,25-dihydroxyvitamin D3. Its pharmacodynamic profile supports enhancement of bone mass and strength, making it relevant for osteoporosis treatment. |
|---|---|
| Mechanism of action | Eldecalcitol [1a,25-DIHYDROXY-2ß-(3-hydroxypropoxy)vitamin D3] is an analog of 1a,25-dihydroxyvitamin D3 [1,25(OH)2D3], bearing a hydroxypropoxy residue at the 2b position. Eldecalcitol is also effective in increasing bone mass and was able to enhance bone strength in rodents. It binds to the vitamin D receptor (VDR) with less affinity but binds to vitamin D-binding protein with higher affinity than 1,25(OH)2D, showing a long half-life in plasma. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Vitamin D3 receptor | Humans |
Formulation & handling
- Eldecalcitol is a small molecule with low water solubility, suitable for oral formulation development. Its secosteroid structure suggests stability considerations related to light and oxidation exposure. Due to its moderate lipophilicity (LogP 3.67), formulation strategies may require solubilizers or lipid-based carriers for enhanced bioavailability.
Regulatory status
Eldecalcitol is a type of Vitamin D analogues
Vitamin D analogues belong to the pharmaceutical category of active pharmaceutical ingredients (APIs) and are widely used in the medical field. These analogues are synthetic compounds designed to mimic the effects of natural vitamin D, a vital nutrient for human health. Vitamin D plays a crucial role in maintaining proper bone health, regulating calcium and phosphorus levels, and supporting the immune system.
Pharmaceutical companies produce various types of vitamin D analogues, each with distinct properties and applications. These analogues are designed to target specific receptors in the body, mimicking the actions of natural vitamin D. By interacting with these receptors, vitamin D analogues can effectively regulate calcium absorption and metabolism, promoting optimal bone health.
One of the significant advantages of using vitamin D analogues as APIs is their enhanced stability and bioavailability compared to natural vitamin D. This allows for better control over dosage and ensures consistent therapeutic effects. Moreover, pharmaceutical-grade analogues undergo rigorous quality control measures to guarantee their purity, safety, and efficacy.
Medical professionals prescribe vitamin D analogues to patients with vitamin D deficiencies, osteoporosis, psoriasis, and other related conditions. These APIs are available in various formulations, including oral tablets, capsules, and topical creams, allowing for flexible and convenient administration.
In summary, vitamin D analogues are a vital category of pharmaceutical APIs widely used to address vitamin D deficiencies and related health conditions. Their synthetic nature, enhanced stability, and targeted actions make them an effective option for maintaining bone health and supporting overall well-being.
Eldecalcitol API manufacturers & distributors
Compare qualified Eldecalcitol API suppliers worldwide. We currently have 4 companies offering Eldecalcitol API, with manufacturing taking place in 1 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, GMP, MSDS, USDMF, WC | 229 products |
| ChemExpress | Producer | United States | China | CoA, ISO9001, MSDS, WC | 197 products |
| Heron (Shanghai) Pharmace... | Producer | China | China | CoA, GMP | 9 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | BSE/TSE, CoA, ISO9001, MSDS, USDMF, WC | 757 products |
When sending a request, specify which Eldecalcitol 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 Eldecalcitol 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.
