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Etelcalcetide injection is a novel calcium mimetic agent. AMG416 binds and activates calcium sensitive receptors on the parathyroid gland, leading to a decrease in parathyroid hormone (PTH) levels. It has broad prospects in the development of new drugs for the effective treatment of secondary hyperparathyroidism.
The FDA has approved a new type of calcium mimetic drug for the treatment of secondary hyperparathyroidism in adult hemodialysis patients, marking the first time in nearly 12 years that a drug has been approved for the treatment of secondary hyperparathyroidism in dialysis patients.
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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 |
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.
Relevant research information can be obtained on platforms such as ChemicalBook and Sohu's public platform.
(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 and reducing the risk of bone diseases. For example, some patients gradually return to normal blood phosphorus levels and alleviate symptoms such as bone pain after receiving treatment with etelcalcetide injection.
For relevant information, please refer to Chemicalbook (Booker Chemical Network), Zhihu column, etc.
(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. Itchy skin is also a common problem for SHPT patients, and treatment with verapamil can improve the patient's skin condition and alleviate itching symptoms.
Improving quality of life: By improving calcium and phosphorus metabolism disorders and alleviating symptoms, verapamil can help improve patients' quality of life and prolong survival. After use, patients' physical discomfort symptoms will be reduced, and they can better engage in daily activities, and their psychological state will also be improved.
Relevant information can be found on platforms such as Chemicalbook and WeChat public platform.
(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.
Relevant information can be found in Chemicalbook (Booker Chemical Network) and other sources.
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.
Relevant information can be obtained on platforms such as Chemicalbook and the official website of Hangzhou Gutuo Biotechnology Co., Ltd.
(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.
Relevant information can be found in Chemicalbook (Booker Chemical Network) and other sources.
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.
Relevant information can be found on platforms such as Chemicalbook and WeChat public platform.
Frequently Asked Questions
What is etelcalcetide used for?
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Etelcalcetide injection is used to used to treat secondary hyperparathyroidism in patients with chronic kidney disease who are on dialysis. Hyperparathyroidism is a condition that is caused when the parathyroid glands located in the neck make too much parathyroid hormone (PTH).
What is the difference between cinacalcet and etelcalcetide?
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Parsabiv is generally more effective than cinacalcet (Sensipar) at reducing parathyroid hormone (PTH) levels in hemodialysis patients due to its higher potency and intravenous administration, which ensures 100% adherence. While etelcalcetide is given thrice-weekly at dialysis, cinacalcet is taken daily orally. Both carry risks of hypocalcemia and gastrointestinal side effects.
Key Differences:
Administration: Etelcalcetide is intravenous (IV) and given at the end of a hemodialysis session, improving compliance. Cinacalcet is an oral daily pill.
Efficacy: Etelcalcetide is more effective at lowering PTH levels. In studies, 68.2% of patients on etelcalcetide achieved >30% PTH reduction, compared to 57.7% on cinacalcet.
Mechanism: Both are calcimimetics, but etelcalcetide binds to the Calcium-Sensing Receptor (CaSR) in a way that does not require calcium to act, potentially explaining its superior potency.
Adherence: Intravenous administration solves the high non-adherence rate associated with daily oral medication.
Side Effects: Both can cause hypocalcemia, but it is more frequent with etelcalcetide. Both have similar rates of gastrointestinal side effects (nausea/vomiting).
Which to choose?
Etelcalcetide is often preferred in hemodialysis centers looking for higher effectiveness in managing refractory secondary hyperparathyroidism and where patient compliance with daily oral pills is a concern. However, cinacalcet is a well-established, effective oral option.
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