Shaanxi BLOOM Tech Co., Ltd. is one of the most experienced manufacturers and suppliers of etelcalcetide injection in China. Welcome to wholesale bulk high quality etelcalcetide injection for sale here from our factory. Good service and reasonable price are available.
Etelcalcetide (CAS: 1262152-18-9) is a synthetic peptide compound with reliable physicochemical properties and good stability under specified storage conditions. It is mostly prepared into liquid injection formulations, which remain chemically stable when sealed and stored at low temperature away from strong light and high humidity, effectively retaining its original molecular structure and pharmacological activity throughout the shelf life.
Etelcalcetide injection is a novel calcium mimetic agent also known as AMG416. This active substance can specifically bind to and activate calcium-sensitive receptors distributed on the parathyroid gland. This targeted action suppresses the excessive secretion of parathyroid hormone (PTH) and steadily lowers circulating PTH levels in the body. Given its precise mechanism of action and satisfactory safety profile, it boasts promising application prospects in the research and development of innovative therapeutics for secondary hyperparathyroidism.
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Etelcalcetide COA
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| Certificate of Analysis | ||
| Compound name | Etelcalcetide | |
| Grade | Pharmaceutical grade | |
| CAS No. | 1262780-97-1 | |
| Quantity | 40g | |
| Packaging standard | PE bag+Al foil bag | |
| Manufacturer | Shaanxi BLOOM TECH Co., Ltd | |
| Lot No. | 202601090057 | |
| MFG | Jan 9th 2026 | |
| EXP | Jan 8th 2029 | |
| Structure |
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| Item | Enterprise standard | Analysis result |
| Appearance | White or almost white powder | Conformed |
| Water content | ≤5.0% | 0.47% |
| Loss on drying | ≤1.0% | 0.35% |
| Heavy Metals | Pb≤0.5ppm | N.D. |
| As≤0.5ppm | N.D. | |
| Hg≤0.5ppm | N.D. | |
| Cd≤0.5ppm | N.D. | |
| Purity (HPLC) | ≥99.0% | 99.90% |
| Single impurity | <0.8% | 0.56% |
| Total microbial count | ≤750cfu/g | 170 |
| E. Coli | ≤2MPN/g | N.D. |
| Salmonella | N.D. | N.D. |
| Ethanol (by GC) | ≤5000ppm | 400ppm |
| Storage | Store in a sealed, dark, and dry place below -20°C | |
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| Chemical Formula: | C38H73N21O10S2 |
| Exact Mass: | 1048 |
| Molecular Weight: | 1048 |
| m/z: | 1048 (100.0%), 1049 (41.1%), 1050 (9.0%), 1050 (8.2%), 1049 (7.8%), 1051 (3.7%), 1050 (3.2%), 1050 (2.1%), 1049 (1.6%), 1051 (1.1%) |
| Elemental Analysis: | C, 43.54; H, 7.02; N, 28.06; O, 15.26; S, 6.12 |
Notably, this drug has obtained official approval from the FDA for treating secondary hyperparathyroidism in adult patients receiving hemodialysis. This milestone approval represents the first new therapeutic option for dialysis patients suffering from this condition in nearly 12 years, bringing a valuable alternative for clinical treatment.
Etelcalcetide injection, also known as AMG416, is a calcium sensitive receptor (CaSR) agonist with specific uses in the medical field. The following will provide a detailed introduction to its uses and related information.
Main purpose
(1) Treatment of secondary hyperparathyroidism (SHPT)
Mainly used to treat secondary hyperparathyroidism in dialysis patients with chronic kidney disease (CKD). Secondary hyperparathyroidism is one of the common complications of chronic kidney failure. Due to impaired renal function, the kidney's ability to regulate the metabolism of calcium, phosphorus, and vitamin D decreases, leading to excessive secretion of parathyroid hormone (PTH) by the parathyroid gland. Excessive secretion of PTH can dissolve phosphorus and calcium in the bones and accumulate in the cardiovascular system, causing hyperkalemia, hyperphosphatemia, and arteriosclerosis, leading to cardiovascular disease.
By intravenous administration, calcium sensitive receptors on parathyroid cells are bound and activated, enhancing their sensitivity to extracellular calcium ions. This allows parathyroid cells to perceive calcium signals at lower calcium ion concentrations, thereby inhibiting the synthesis and secretion of PTH and reducing PTH levels in the blood. Multiple clinical trials have confirmed the effectiveness and safety of verapamil in treating SHPT in CKD dialysis patients. For example, in hemodialysis patients with moderate to severe hyperparathyroidism, treatment with verapamil significantly reduces PTH levels, and the efficacy is better than placebo and not lower than cinacalcet.
(2) Improve calcium and phosphorus metabolism disorders
In addition to reducing PTH levels, it can also regulate calcium and phosphorus metabolism. It can promote the excretion of phosphorus by the kidneys, reduce blood phosphorus concentration, and decrease bone calcium release to maintain blood calcium stability. This is of great significance for improving bone metabolism abnormalities caused by hyperparathyroidism. For example, some patients gradually return to normal blood phosphorus levels and alleviate symptoms such as bone pain after receiving treatment with etelcalcetide injection.
(3) Relieve symptoms
Relieve bone pain and skin itching: It can help control excessive parathyroid hormone levels, thereby alleviating symptoms such as bone pain and skin itching caused by SHPT in patients. Bone pain is one of the common symptoms in SHPT patients, which seriously affects their quality of life. By reducing PTH levels and decreasing bone calcium release, verapamil can effectively alleviate bone pain symptoms. .
(4) Reduce the risk of complications
It can reduce the risk of complications such as vascular calcification. Vascular calcification is one of the common complications in CKD patients, closely related to the occurrence and death of cardiovascular disease. By regulating calcium and phosphorus metabolism, the deposition of calcium in the vascular wall is reduced, thereby lowering the risk of vascular calcification. For example, relevant studies have shown that the progression rate of vascular calcification in patients receiving treatment is significantly slowed down.
Advantages of medication
It has been developed as an intravenous injection, which can be reliably administered from the venous side of the dialysis circuit under the control of a doctor when returning to the bloodstream at the end of dialysis. This method of administration is not only convenient, but also ensures accurate dosage and timely use of the medication. Compared with oral medication, intravenous injection avoids the impact of gastrointestinal tract on drug absorption and improves the bioavailability of drugs.
(2) Low risk of drug interactions
The D-amino acid peptide backbone, which is almost unaffected by metabolic enzymes and contributes to its activity, is not metabolized in the body and can continue to function for a long time until it is removed during the next dialysis period. This reduces the risk of drug interactions when used in combination with other drugs, minimizing adverse reactions caused by drug interactions and adjusting treatment plans. For example, in clinical treatment, verapamil can be used in combination with vitamin D and its analogues, phosphate binders, and other drugs to better regulate calcium and phosphorus metabolism and reduce PTH levels.
Due to the convenient administration method and long duration of drug action, it can reduce the number of times patients take medication, thereby improving patient compliance and reducing their medication burden. For CKD dialysis patients who require long-term treatment, good compliance is crucial for maintaining treatment effectiveness and controlling the condition. These advantages of etelcalcetide injection can help improve patients' treatment compliance and enhance treatment efficacy.
References
Relevant information can be found on platforms such as Chemicalbook and WeChat public platform.
Relevant information can be obtained on platforms such as Chemicalbook and the official website of Hangzhou Gutuo Biotechnology Co., Ltd.
For relevant information, please refer to Chemicalbook (Booker Chemical Network), Zhihu column, etc.
etelcalcetide(https://www.cancer.gov/publications/dictionaries/cancer-drug/def/etelcalcetide)
FDA Approves Amgen's Parsabiv™ (Etelcalcetide), First New Treatment In More Than A Decade For Secondary Hyperparathyroidism In Adult Patients On Hemodialysis(https://investors.amgen.com/news-releases/news-release-details/fda-approves-amgens-parsabivtm-etelcalcetide-first-new-treatment/)
Frequently Asked Questions
What is etelcalcetide used for?
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Etelcalcetida injection is a specialized injectable medication primarily prescribed to manage secondary hyperparathyroidism among patients suffering from chronic kidney disease who rely on long-term dialysis therapy. Clinically, hyperparathyroidism refers to a common endocrine disorder triggered by the excessive secretion of parathyroid hormone (PTH). This hormone is synthesized and released in excess by the parathyroid glands, a group of small endocrine tissues located in the neck region, which will disrupt the body's normal metabolic balance.
What is the difference between cinacalcet and etelcalcetide?
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Parsabiv, the commercial name of etelcalcetida, demonstrates superior efficacy in lowering parathyroid hormone (PTH) concentrations compared with cinacalcet, which is marketed under the brand name Sensipar, particularly among patients receiving regular hemodialysis treatment. This advantage stems from its stronger pharmacological potency as well as its intravenous route of administration; unlike oral medications, injectable dosing delivered during medical procedures guarantees full treatment adherence and eliminates the issue of missed doses. In terms of dosing regimens, etelcalcetide is administered via injection three times per week in conjunction with routine hemodialysis sessions. In contrast, cinacalcet is an oral formulation that requires daily intake by patients. Despite their differences in potency, delivery method and dosage schedule, both therapeutic agents share similar safety profiles, with hypocalcemia and a range of adverse gastrointestinal reactions being the most commonly observed potential side effects during clinical use.
What are the key differences?
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