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Desmopressin acetate injection is a sterile clinical injectable preparation with desmopresin acetate as the core active ingredient (CAS: 16789-98-3). As a chemically synthesized antidiuretic hormone analogue and vasopressin derivative, it has an optimized molecular structure that delivers potent antidiuretic effects with negligible vasoconstrictive side effects. Its raw material is white crystalline powder with good water solubility, and the finished preparation is a clear, colorless sterile aqueous solution. The product maintains stable chemical properties and biological activity under sealed, dark and low-temperature storage at −20°C, while high temperature and humid conditions may cause structural degradation and reduced efficacy.
This drug functions by regulating human water-salt metabolism, reducing urine output, increasing urine osmotic pressure and decreasing plasma osmotic pressure. It is primarily indicated for central polyuric syndrome, improving patients' polyuria and nocturia symptoms via hormone replacement therapy and optimizing their quality of life. Furthermore, it can be used for intraoperative bleeding control and preoperative bleeding prevention. It is suitable for patients with congenital or drug-induced platelet dysfunction, uremia, cirrhosis and unexplained prolonged bleeding time, and can also assist in preventing and treating bleeding during minor surgeries in patients with mild hemophilia A.
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Desmopressin Acetate COA
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| Certificate of Analysis | ||
| Compound name | Desmopressin Acetate | |
| Grade | Pharmaceutical grade | |
| CAS No. | 16789-98-3 | |
| Quantity | 60g | |
| Packaging standard | PE bag+Al foil bag | |
| Manufacturer | Shaanxi BLOOM TECH Co., Ltd | |
| Lot No. | 202601090055 | |
| 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% | 0.48% |
| Loss on drying | ≤1.0% | 0.30% |
| 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: | C50H72N14O16S2 |
| Exact Mass: | 1188 |
| Molecular Weight: | 1189 |
| m/z: | 1188 (100.0%), 1189 (49.8%), 1070 (12.1%), 1070 (9.0%), 1069 (5.2%), 1071 (4.5%), 1070 (2.6%), 1070 (2.5%), 1069 (1.6%), 1071 (1.2%), 1071 (1.1%), 1072 (1.1%) |
| Elemental Analysis: | C, 51.67; H, 6.03; N, 18.34; O, 17.96; S, 6.00 |
Application in the treatment of central polyuric syndrome
(1) Disease Overview and Treatment Needs
Central polyuric syndrome is a syndrome caused by a deficiency of antidiuretic hormone (ADH) in the pituitary gland, characterized by thirst and frequent urination. Insufficient secretion of antidiuretic hormone in the patient's body or insensitivity of the kidneys to it can cause dysfunction in the reabsorption of water by the renal tubules, leading to clinical symptoms such as polyuria, thirst, and excessive drinking.
This disease seriously affects the quality of life of patients, therefore effective treatment methods are needed to reduce urine excretion, increase urine osmotic pressure, reduce plasma osmotic pressure, and alleviate related symptoms.
(2) Specific application methods
Dosage form selection: There are many dosage forms of desmopressin acetate injection available, including oral tablets, nasal spray, subcutaneous or intravenous injection, etc. Among them, oral tablets are convenient to use and are one of the commonly used dosage forms.
Nasal spray inhalation can take effect quickly; Intramuscular and intravenous injections are suitable for patients who require rapid symptom control or are unable to take orally.Medication precautions: Due to its restriction on urine excretion, fluid intake must be strictly restricted during treatment, especially for children and elderly patients, to avoid excessive water intake leading to water poisoning and hyponatremia.
(3) Therapeutic effect and case studies
Related medical research and clinical practice data show that after standardized use, about 83% of patients with central polyuric syndrome can significantly improve their symptoms, significantly reduce urine output, and improve their quality of life. For example, in practical clinical practice, many patients experience a significant reduction in frequent urination frequency and a relief of thirst after treatment, and are able to restore their normal pace of life and work.
(4) The advantages and applicable scenarios of different dosage forms
Oral tablets:
As the world's first oral product, they are the standard treatment for central polyuric syndrome and have over 40 years of clinical experience. Its advantages lie in convenient administration, high patient compliance, and suitability for long-term treatment. For patients with relatively stable conditions who can take medication on time, oral tablets are an ideal choice.
Nasal spray: it can take effect quickly and is suitable for patients who need to relieve symptoms quickly. For example, when patients suddenly have severe thirst and polyuria, the use of nasal spray can quickly increase the reabsorption of water by the kidneys and reduce the excretion of urine.
Injection type: Subcutaneous or intravenous injection is suitable for patients who cannot take oral medication, such as those in a coma or with gastrointestinal dysfunction. In some emergency situations, such as severe dehydration and electrolyte imbalance caused by central polyuric syndrome, intravenous injection can quickly stabilize the condition.
(6) Progress in new dosage forms
Recently, Eton Pharmaceuticals announced that the US Food and Drug Administration (FDA) has approved its developed Desmoda acetate vasopressin oral solution for the treatment of central polyuric syndrome in adults and children. The Desmoda approved this time is the first oral liquid formulation of the standard therapeutic drug. Compared to traditional tablets, liquid formulations can achieve more flexible dosage adjustments, especially suitable for the treatment of diabetes insipidus that requires precise titration to maintain water salt balance.
Application in the treatment of nocturnal enuresis
(1) Disease Overview and Treatment Needs
Nocturnal enuresis is common in children, with a incidence rate of about 2% -15%, and an annual self remission rate of 15%. The main manifestation of this disease is bedwetting at night and normal urination during the day, without any anatomical or functional abnormalities in the urinary and nervous systems. However, if left untreated, the severity of enuresis worsens with age, seriously affecting the physical and mental health of the affected child.
Children with autism often exhibit fear, impatience, inferiority complex, anxiety, lack of courage, poor social adaptability, and even serious mental and psychological problems (such as depression, autism, ADHD, etc.), which can persist into adulthood. Therefore, seeking effective treatment methods is crucial for improving the quality of life and mental health of pediatric patients.
(2) Specific application methods
Combination therapy: The 4th International Urinary Incontinence Advisory Committee (ICI) Level A recommends desmopressin acetate injection as a night enuresis treatment drug. When awakening is ineffective or cannot be treated with awakening therapy, it is a safe and effective alternative treatment for enuresis in children. It is a first-line drug for treating primary enuresis, especially suitable for children with nocturia and high bladder capacity. Meanwhile, the diagnosis and treatment guidelines released by ICCS in 2010 recommended that behavioral therapy should be used as the basis for all treatments for children with enuresis.
Therefore, when treating nocturnal enuresis, it is often combined with behavioral therapy, such as dietary guidance, psychological counseling, bladder urination training, and recording of urination frequency. For example, parents need to help their children establish regular urination habits and avoid excessive pressure that can cause psychological stress;
Adjust your sleep schedule to avoid excessive excitement before bedtime; Perform bladder function training such as timed urination and pelvic floor muscle exercises.
Mechanism of Action
Antidiuretic pathway: Circulating drug reaches the basolateral side of renal distal collecting ducts and specifically binds to V2 receptors, activating G protein-coupled adenylyl cyclase and elevating intracellular cAMP concentration to stimulate protein kinase A. The kinase phosphorylates downstream target proteins, prompting intracellular vesicles loaded with aquaporin 2 (AQP2) to translocate and fuse with the luminal epithelial membrane of renal tubules. A
sharp increase in membrane-bound AQP2 enables free water in primary urine within tubules to be reabsorbed into the bloodstream along the osmotic gradient, resulting in concentrated urine, drastically reduced urine volume and elevated urine osmolality.Its long-lasting antidiuretic potency far exceeds endogenous arginine vasopressin, and it is clinically indicated for central diabetes insipidus and nocturnal enuresis.Coagulation and hemostatic pathway: Circulating drug activates V2 receptors on the surface of vascular endothelial cells, stimulating endothelial Weibel-Palade bodies to release von Willebrand factor (vWF) and coagulation factor Ⅷ.
High-molecular-weight vWF bridges platelets and collagen fibers at vascular injury sites to strengthen platelet adhesion and aggregation. Meanwhile, secreted factor Ⅷ compensates for endogenous factor deficiency and boosts coagulation activity, making the drug suitable for perioperative hemostasis in mild hemophilia A and type 1 von Willebrand disease. However, endothelial reserves of vWF and factor Ⅷ are limited. Repeated short-interval administration depletes these reserves and leads to transient tolerance accompanied by reduced efficacy.
Fmoc solid-phase peptide synthesis (SPPS) serves as the dominant manufacturing route. Using amino amide resin as the solid support, nine amino acids with side chains protected by Trt and Pbf groups are sequentially coupled from the C-terminus to the N-terminus, including the special fragments Mpa (Trt) and D-Arg (Pbf).
Linear peptide resin is assembled via continuous condensation reactions. Trifluoroacetic acid (TFA) cleavage removes the resin carrier and all protecting groups to yield crude linear peptide.
Under weakly alkaline aqueous conditions, hydrogen peroxide or potassium ferricyanide is applied for oxidation to form the characteristic disulfide ring between the 1st and 6th thiol groups.
The crude product is purified by reversed-phase HPLC, followed by salt conversion in acetate buffer and lyophilization to obtain finished desmopressin acetate injection.
This process generates minimal byproducts and facilitates large-scale production, delivering markedly higher yields than conventional liquid-phase synthesis. Pre-purification prior to oxidation reduces the formation of deletion peptide impurities.
References
The description of disease characteristics (symptoms such as thirst and frequent urination, polyuria, irritability, and excessive drinking) comes from medical textbooks, such as the clinical manifestations of central polyuric syndrome described in "Internal Medicine".
Based on the investigation and analysis of patients' living conditions in numerous clinical studies, including the impact on quality of life and treatment needs, relevant research is commonly found in medical journals such as the Chinese Journal of Endocrinology and Metabolism.
Dose adjustment: Data on initial dose and dose adjustment range for adults and children are sourced from clinical research literature. These studies have determined a reasonable dose range through extensive case observation and analysis, commonly found in journals such as Clinical Pediatrics.
Effects of desmopresin acetate and pituitrin on proliferation, contraction, and secretion of hepatic stellate cells (https://pmc.ncbi.nlm.nih.gov/articles/PMC12770225/)
FAQ
What does desmopresin acetate injection do?
It is used to treat central cranial diabetes insipidus. This is a condition that causes the body to lose too much fluid and become dehydrated. It is also used to control bedwetting (nocturnal enuresis), and the frequent urination and increased thirst caused by certain types of brain injury or brain surgery.
Why is desmopresin banned?
DDAVP isn't universally banned but is prohibited in sports by the World Anti-Doping Agency (WADA) because it's a diuretic and masking agent, helping athletes temporarily alter blood concentration (hemodilution) to hide performance-enhancing drugs or lose weight for speed sports. Its use in certain nasal forms for bedwetting (enuresis) was restricted in some countries due to serious risks like severe hyponatremia (low blood sodium) and seizures, leading to recalls and shifts to oral forms.
What to avoid when taking desmopresin?
If you are taking desmopressin to treat bed-wetting, your doctor will probably tell you to avoid drinking for at least one hour before you take desmopressin and at least 8 hours after you take desmopressin. Follow your doctor's directions carefully to prevent serious side effects.
What happens if you drink after taking desmopresin?
If your child consumes a large amount of liquid within one hour before bedtime and then takes desmopressin as directed, the excess fluid ingested cannot be efficiently excreted from the body through normal urinary output. Instead, these surplus bodily fluids will gradually accumulate inside the tissues and circulatory system, resulting in noticeable fluid retention. This abnormal buildup of water may further trigger a medical condition known as hyponatremia, which refers to an abnormally low concentration of sodium in the blood. Common warning signs of hyponatremia typically include persistent headaches, general malaise, nausea and recurrent vomiting.
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