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Micafungin sodium (Mycamine), as a novel echinocandin antifungal drug, has become an important choice in the global antifungal treatment field since its first launch in Japan in 2002. Its unique chemical structure and mechanism of action make it significantly advantageous in the treatment of invasive fungal infections (IFI). The indications are fungal infections caused by Aspergillus and Candida, respiratory fungal diseases, and gastrointestinal fungal diseases. Clinically, it is also used in combination with amphotericin and triazole antifungal drugs. At present, reports on its purification, desalination, and concentration mainly use ion exchange chromatography columns. Ion exchange chromatography is a time-consuming and labor-intensive purification process.
Our product
Micafungin sodium +. COA
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Certificate of Analysis |
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Compound name |
Micafungin sodium | |
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CAS No. |
208538-73-2 | |
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Grade |
Pharmaceutical grade | |
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Quantity |
Customized | |
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Packaging standard |
Customized | |
| Manufacturer | Shaanxi BLOOM TECH Co., Ltd | |
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Lot No. |
202601090056 | |
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MFG |
Jan 9th 2026 | |
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EXP |
Jan 8th 2029 | |
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Structure |
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Item |
Enterprise standard |
Analysis result |
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Appearance |
White or almost white powder |
Conformed |
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Water content |
≤4.5% |
0.30% |
| Loss on drying |
≤1.0% |
0.15% |
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Heavy Metals |
Pb≤0.5ppm |
N.D. |
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As≤0.5ppm |
N.D. | |
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Hg≤0.5ppm |
N.D. | |
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Cd≤0.5ppm |
N.D. | |
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Purity (HPLC) |
≥99.0% |
99.5% |
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Single impurity |
<0.8% |
0.48% |
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Total microbial count |
≤750cfu/g |
80 |
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E. Coli |
≤2MPN/g |
N.D. |
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Salmonella |
N.D. | N.D. |
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Ethanol (by GC) |
≤5000ppm |
400ppm |
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Storage |
Store in a sealed, dark and dry place at-20 degrees |
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| Chemical Formula | C56H72N9NaO23S |
| Exact Mass | 1291.42 |
| Molecular Weight | 1292.27 |
| m/z | 1291.42 (100.0%), 1292.42 (60.6%), 1293.43 (18.0%), 1270.44 (4.7%), 1270.43 (4.5%), 1269.43 (3.3%), 1271.44 (2.9%), 1271.43 (2.7%), 1271.44 (2.7%), 1270.43 (2.0%) |
| Elemental Analysis | C, 52.05; H, 5.46; N ,9.76; Na ,1.78; O, 28.48; S, 2.48 |
Micafungin sodium not only has high activity against Candida and Aspergillus genera, but also against azole and amphotericin B resistant strains. It can be used alone or in combination with other antifungal drugs to treat candidiasis and aspergillosis in patents with immune deficiency. It has also been found to be effective in preventing fungal infections in patents undergoing stem cell transplantation. The efficacy of mycamine in combination with other antifungal drugs for fungal infections is receiving widespread attention, but specific clinical research results have not been reported yet.
A Japanese open label study was conducted on 70 patents with invasive aspergillosis and candidiasis. The effective rate of mycamine for aspergillosis was 57.1%, and the incidence of adverse events related to mycamine was 17.9%, but no dose related adverse events occurred. The research results indicate that the use of mycamine in the treatment of invasive aspergillosis is effective and completely tolerable. In another clinical study involving 22% of children, the results showed similar therapeutic effects between children and adults.
Research in Japan has shown that the success rate of this product in treating invasive pulmonary aspergillosis is 59% (13/22), with 67% (6/9) being chronic necrotizing pulmonary aspergillosis and 55% (12/22) being pulmonary aspergillosis.Another experiment showed that this product is safe and effective for early and salvage treatment of high-risk patents with invasive pulmonary aspergillosis.
For patents with fungal corneal ulcers, 0.1% eye drops of this product were applied topically, starting once per hour. After epithelial formation, the dosage was changed to five eye drops per day. The medication was continued for one month after the disappearance of interstitial infiltration, and all patents recovered their vision. Yeast was found in the eye ulcer smears of the patents, with 2 cases being positive for ulcer related Candida reactions. Indicating that 0.1% of this product's eye drops have a good therapeutic effect on yeast related corneal ulcers.
2) Oral, pharyngeal, and esophageal candidiasis
Intravenous infusion of 12.5, 50, 75, and 100mg/d of this product was used to treat 120 AIDS patents with esophageal candidiasis. The results showed that all patents' symptoms improved, especially in the 75mg/d and 100mg/d dose groups, where the therapeutic effect was particularly significant. Intravenous infusion of this product has significant therapeutic effects on HIV positive patents infected with esophageal Candida. In an international multicenter, double-blind study involving 523 HIV patents infected with esophageal candidiasis, the efficacy of a single dose of 150mg/d of this product was compared with that of fluconazole 200mg/d for 14 days.
The results showed that the two had similar efficacy, with clinical cure rates of 94.2% and 94.6%, respectively. After 2-4 weeks of treatment, the recurrence rates were 15.2% and 11.3%, respectively. AIDS patents with esophageal candidiasis were given mycamine50, 25 and 12.5 mg/d respectively, and the efficacy decreased with the decrease of the dose. The therapeutic effect of mycamine shows a certain dose dependence, with a clinical dose of ≥ 50mg/d. At high doses, the disappearance of symptoms occurs faster and more completely.
3) Candidemia
In an open label study involving 119 patents (101 adults and 18 children), 60 out of 68 patents (88.2%) were newly infected with candidal bacteremia, and 39 out of 51 patents (76.5%) had refractory candidal bacteremia. Adults (50-100) mg/d and children (1-2) mg/kg were given an average treatment dose of 71mg, with an average course of 20 days. The results showed that the efficacy of this product in treating candidal bacteremia was 83.2%, and 86% of patents did not experience neutropenia.
The response rates to different types of Candida varied: Candida albicans was 85% (39/46), Candida albicans was 93% (28/30), and Candida parapsilosis was 86% (18/21). The sentence is:. Twelve cases of malignant hematological diseases complicated with invasive fungal diseases were reported in China, with a total clinical effective rate of 66.7% using a dose of 100mg/d. The effective rates for clinically diagnosed cases and suspected cases were 57.1% (4/7) and 80% (4/5), respectively, with an onset time of 1-5 days.
4) Preventive medication
Since the early 1990s, fluconazole has been commonly used to prevent fungal infections, leading to the emergence of some fluconazole resistant bacteria. A randomized, double-blind, comparative phase III clinical trial was conducted using fluconazole as a control drug to evaluate the efficacy of mycamine as an antifungal prophylaxis in patents with neutropenia undergoing hematopoietic stem cell transplantation. The results showed that the total effective rate of mycamine was significantly higher than fluconazole, at 80.0% and 73.5%, respectively, and the treatment course was shorter.Mycamine can effectively prevent fungal infections in patents with neutropenia.
The US FDA has approved this product for the prevention and treatment of esophageal candidiasis and pre transplant candidiasis in blood stem cell transplantation. The recommended dosage for adults is 50mg/d as a preventive medication before stem cell transplantation; The dosage for treating esophageal candidiasis is 150mg/d, administered intravenously for 1 hour. Further research is needed to determine whether micafungin sodium can be used as a preoperative preventive medication for hematopoietic stem cell transplant recipients and improve their long-term survival rate.
pharmacokinetics
1. Animals
The study on 14C labeled mycamine administered intravenously to mice at a dose of 1mg/kg showed that mycamine can be widely distributed in various organs throughout the body, especially in the lungs and kidneys, which may be the main organs affected by deep fungi. At the same time, the study showed that although inflammation caused by fungal infection can induce drug entry into brain tissue, the ability of mycamine to enter brain tissue is poor (only 2% of blood drug concentration).
The results showed that the tissue drug concentration of micafungin was linear when the dosage was 0.5-2mg/kg, and it was enriched in the plasma and tissues of the common site of invasive fungal infection. The main excretion pathway is through bile excretion.
2. Human body
It has poor oral absorption and can only be administered intravenously.
As report goes, mycamine75mg, Intravenous injection once a day for 7 days, the blood drug concentration reached steady state on the 4th day, and the plasma protein binding rate exceeded 99.8% on both the 1st and 7th days, indicating that repeated medication did not change the plasma protein binding rate of mycamine.Other studies have shown that the plasma AUC of the product varies proportionally with dose, but pharmacokinetic parameters such as elimination half-life (t1/2), steady-state volume of distribution (VSS), and total clearance (CL) do not change with dose.
The urine recovery rate is less than 1%, and most drugs are excreted from the intestine through bile and feces. Due to various physiological functions decline, the pharmacokinetic parameters of drugs often change in elderly people. However, a study comparing the pharmacokinetic characteristics of elderly people aged 66-78 and young people aged 20-24 after medication showed no significant difference in pharmacokinetic parameters between the two, indicating that there is no age-related effect on the pharmacokinetics of Micafenzin.
In addition, there was no change in the elimination half-life between healthy volunteers and patints with liver and kidney dysfunction, so it can be considered that there is no need to adjust the dosage of medication according to the patient's condition.
3. Metabolism
The clearance half-life of the product in healthy volunteers is 14-15 hours, while in adult patents undergoing bone marrow or peripheral stem cell transplantation, the clearance half-life is slightly shortened, ranging from 10.7-13.5 hours.
Mycamine0.5mg/kg was administered to children aged 2-17 with neutropenia on the first and fourth days, with a half-life of 12-13 hours. However, at a dose of 1mg/kg, the half-life changed from 12-13 hours after administration to 93 hours. It is mainly metabolized in the liver, with approximately 40% cleared in the form of its original form and metabolites in bile. About 15% of the drug is cleared by the kidneys in its prototype form, but the specific degree of metabolism is unclear.
R&D process and market access
Astellas Pharma Inc. in Japan was first approved for listing under the brand name "Mycamine" ®).
Approved by the US FDA for the prevention and treatment of esophageal candidiasis, bone marrow transplantation, and neutropenia in AIDS patients.
Micafungin sodium was approved in China and the indications were expanded to include fungal infections, respiratory fungal diseases, and gastrointestinal fungal diseases.
The global market size will reach 621 million US dollars in 2022, and is expected to increase to 948 million US dollars in 2029, with a compound annual growth rate (CAGR) of 6.2%.
Mycamine is manufactured via a semi-synthetic process consisting of microbial fermentation to construct the cyclic lipopeptide core, chemical synthesis of side chains, enzymatic deacylation, amide coupling and sodium salt purification. No fully chemical synthetic route is available for this product.
Fermentation production of precursor FR901379
Submerged fermentation of Coleophoma empetri is performed to biosynthesize sulfonated cyclic lipopeptide FR901379 carrying a palmitoyl side chain. Pure fermented precursor is obtained through solvent extraction and chromatographic purification.
Enzymatic removal of long-chain fatty acids
Streptomyces lipase is applied to selectively cleave the palmitoyl side chain to yield core scaffold FR179642. Elimination of the lipophilic long alkyl chain exposes amino groups for subsequent coupling reactions.
Synthesis of aromatic side chain
4-[5-(4-pentyloxyphenyl)isoxazol-3-yl]benzoic acid is prepared from 4-pentyloxyphenylacetylene via cyclization and hydrolysis, which is condensed with HOBt to generate an activated acylating reagent.
Amide coupling to form free micafungin
Under DMAP catalysis, the activated ester undergoes condensation with the amino groups of FR179642 under low temperature and light-shielded conditions. Reverse-phase chromatography is adopted to remove unreacted side chain fragments and polypeptide impurities.
Salt formation and purification
Free micafungin is dissolved in a water/acetonitrile mixture. Dilute weak alkaline sodium bicarbonate solution is added dropwise to adjust the system to weak acidity, converting free micafungin into mycamine. Final injectable-grade drug substance is acquired after low-temperature lyophilization and sterile membrane filtration.
FAQ
What is micafungin sodium used for?
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Micafungin is an antifungal agent used for the treatment of candidemia, acute disseminated candidiasis, and certain other invasive Candida infections, and for the prophylaxis of Candida infections during stem cell transplantation.
What does Mycomin treat?
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See full prescribing information for MYCAMINE®. ® is an echinocandin indicated in adult and pediatric patients for (1): Treatment of Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in adult and pediatric patients 4 months of age and older.
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