pharma · Nasopharyngeal Carcinoma · Hepatocellular Carcinoma
Xiyuan Hospital of China Academy of Chinese Medical Sciences
Chinese Academy of is a pharma organization headquartered in TAIZHOU, CN. Primary therapeutic focus areas include Nasopharyngeal Carcinoma, Hepatocellular Carcinoma, COVID-19, Breast Cancer, Coronary Artery Disease. Nova
Approved · small molecule · Aspergillosis
Micafungin sodium is an approved small-molecule antifungal agent administered by injection for the treatment of aspergillosis. The program, designated ACN-MA-MYC-registry-2013, is sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences and is currently terminated. Micafungin sodium has achieved regula
Internal code ACN-MA-MYC-registry-2013
Micafungin sodium is an approved small-molecule antifungal agent administered by injection for the treatment of aspergillosis. The program, designated ACN-MA-MYC-registry-2013, is sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences and is currently terminated. Micafungin sodium has achieved regulatory approval in the United States, with multiple manufacturers holding approved applications including Astellas, Baxter Healthcare, Teva Pharmaceuticals USA, Fresenius Kabi USA, and others. The drug is available under various brand names and has been approved through both new drug applications (NDAs) and abbreviated new drug applications (ANDAs), indicating a mature market with generic competition. The latest milestone was recorded on 2024-11-07, though specific details regarding this milestone are not yet disclosed. As an established approved therapy, micafungin represents a standard-of-care option in the antifungal treatment landscape, though the termination status of this particular registry program suggests a shift in research priorities or completion of intended study objectives.
Aspergillosis represents a significant clinical challenge, particularly in immunocompromised populations including hematologic malignancy patients, transplant recipients, and those with severe respiratory disease. The disease carries substantial morbidity and mortality, creating a persistent unmet medical need for effective antifungal therapies. Micafungin sodium addresses this need as an established treatment option with a well-characterized safety and efficacy profile. The presence of multiple approved manufacturers indicates robust market penetration and accessibility, though continued clinical registry work suggests ongoing efforts to characterize real-world effectiveness and safety outcomes in diverse patient populations. The competitive landscape includes emerging therapies such as olorofim (phase 3) and other investigational agents, indicating continued innovation in antifungal treatment. For healthcare systems and clinicians, micafungin's established approval status and multiple sourcing options provide treatment certainty and supply chain flexibility. The commercial significance is substantial given the chronic nature of aspergillosis management and the large patient populations at risk for invasive fungal infections across global healthcare settings.
Drug Class: Echinocandin antifungal
Modality: Small-molecule
Route of Administration: Intravenous injection
Mechanism of Action: Not yet disclosed in available facts
Target: Not yet disclosed in available facts
Indication: Aspergillosis
Related Therapies: Liposomal amphotericin B (AmBisome) represents an alternative antifungal agent; emerging investigational agents including olorofim are in clinical development for aspergillosis and related invasive fungal infections.
Regulatory Status: Approved in the United States with multiple manufacturers holding active approvals.
Patent Status: Not yet disclosed in available facts
Aspergillosis is an infection, growth, or allergic response caused by the Aspergillus fungus. There are several different kinds of aspergillosis. One kind is allergic bronchopulmonary aspergillosis (also called ABPA), a condition where the fungus causes allergic respiratory symptoms similar to asthma, such as wheezing and coughing, but does not actually invade and destroy tissue. Another kind of aspergillosis is invasive aspergillosis. This infection usually affects people with weakened immune systems due to cancer, AIDS, leukemia, organ transplantation, chemotherapy, or other conditions or events that reduce the number of normal white blood cells. In this condition, the fungus invades and damages tissues in the body. Invasive aspergillosis most commonly affects the lungs, but can also cause infection in many other organs and can spread throughout the body (commonly affecting the kidneys and brain). Aspergilloma, a growth (fungus ball) that develops in an area of previous lung disease such as tuberculosis or lung abscess, is a third kind of aspergillosis. This type of aspergillosis is composed of a tangled mass of fungus fibers, blood clots, and white blood cells. The fungus ball gradually enlarges, destroying lung tissue in the process, but usually does not spread to other areas.
ClinicalTrials.gov lists 51 registered studies for Aspergillosis (AACT aggregate).
Phase breakdown: NA (20), PHASE2 (11), PHASE3 (10), PHASE2/PHASE3 (4), PHASE4 (4), PHASE1 (2)
Common investigational therapies:
Disease data sourced from MONDO Disease Ontology (MONDO:0005657), Orphanet — aspergillosis, NCT00001646, NCT00001810, NCT00001937, NCT00005668, NCT00005912, AACT (ClinicalTrials.gov aggregate), ClinicalTrials.gov, Open Targets Platform (CC BY 4.0).
US regulatory approval achieved
Micafungin sodium approved in the United States through multiple NDA and ANDA applications across multiple manufacturers.
Latest milestone recorded
Program milestone recorded; specific details not yet disclosed.
The aspergillosis treatment landscape includes both established and emerging therapies. Micafungin sodium represents an approved standard-of-care option with multiple manufacturers, providing treatment accessibility and supply chain diversity. Olorofim (Biotech Pharmaceutical Co.) is in phase 3 development and represents a potential future alternative with a novel mechanism. AmBisome liposomal amphotericin B (Disc Medicine) is listed in phase 1 status in the competitive data, though this likely reflects a data classification artifact given the well-established approval of liposomal amphotericin B. Dupilumab (Regeneron UK Limited) is noted in phase 2 status for aspergillosis, representing an immunomodulatory approach distinct from direct antifungal mechanisms. REZZAYO 200 mg (Mundipharma Pty Limited) is in phase 2 development. The presence of multiple competitors at various development stages suggests continued innovation in antifungal therapy, though micafungin's established approval and multiple sourcing options provide immediate clinical availability and cost-effectiveness advantages.
| Therapy | Company | Mechanism | Status |
|---|---|---|---|
| Olorofim | Biotech Pharmaceutical Co., | small_molecule | phase_3 |
| dupilumab | Regeneron UK Limited | small_molecule | phase_2 |
| DEFEROXAMINE , GALLIUM (68GA) CHLORIDE | Disc Medicine | small_molecule | phase_2 |
| REZZAYO 200 mg powder for concentrate for solution for infusion | Mundipharma Pty Limited | small_molecule | phase_2 |
| AmBisome liposomale amfotericine B 50 mg, poeder voor oplossing voor infusie, TECHNETIUM (99MTC) PERTECHNETATE | Disc Medicine | small_molecule | phase_1 |
| PREDNISOLONE | — | Glucocorticoid receptor agonist | Phase 3 |
| INTERFERON GAMMA-1B | — | Interferon gamma receptor agonist | Phase 2 |
| DEFLAZACORT | — | Glucocorticoid receptor agonist | Phase 2 |
| BUDESONIDE | — | Glucocorticoid receptor agonist | Phase 2 |
| TACROLIMUS ANHYDROUS | — | FK506-binding protein 1A inhibitor | Phase 1 |
| PANTOPRAZOLE | — | Potassium-transporting ATPase inhibitor | Phase 1 |
| MIDAZOLAM | — | GABA-A receptor; anion channel positive allosteric modulator | Phase 1 |
| CYCLOSPORINE | — | Cyclophilin A modulator | Phase 1 |
Additional associated therapies sourced from Open Targets Platform (CC0), linked to NovaPharmaNews drug profiles where matched.
United States FDA Status: Approved. Micafungin sodium holds multiple approved applications including:
Approved Manufacturers: Astellas, Apotex, Aspiro, Baxter Healthcare Corp, Biocon Pharma, Fresenius Kabi USA, Fujisawa Healthcare, Hikma, Hisun Pharma Hangzhou, Jiangsu Hansoh Pharma, Meitheal, PH Health, Qilu Pharma Hainan, Teva Pharmaceuticals USA Inc, Xellia Pharma APS, Yichang Humanwell, Zydus Pharma.
EMA Status: Not yet disclosed in available facts
PMDA (Japan) Status: Not yet disclosed in available facts
NMPA (China) Status: Not yet disclosed in available facts
Micafungin sodium is an approved antifungal medication used to treat aspergillosis, a serious fungal infection that can affect the lungs and other organs, particularly in immunocompromised patients.
Yes, micafungin sodium is approved by the FDA. Multiple manufacturers hold approved applications, including both original new drug applications (NDAs) and abbreviated new drug applications (ANDAs) indicating both branded and generic formulations are available.
Micafungin sodium is administered as an intravenous injection.
Multiple manufacturers hold approved applications including Astellas, Baxter Healthcare, Teva Pharmaceuticals USA, Fresenius Kabi USA, Apotex, Aspiro, Biocon Pharma, Fujisawa Healthcare, Hikma, Hisun Pharma, Jiangsu Hansoh Pharma, Meitheal, PH Health, Qilu Pharma, Xellia Pharma, Yichang Humanwell, and Zydus Pharma.
The specific mechanism of action is not yet disclosed in available facts, though micafungin is classified as an echinocandin antifungal agent.
The program was sponsored by Xiyuan Hospital of China Academy of Chinese Medical Sciences, indicating an academic or investigator-initiated research effort.
The program is currently terminated. The latest milestone was recorded on 2024-11-07, though specific details are not yet disclosed.
NCT02646800 is the clinical trial associated with this program, though detailed information about the trial design, objectives, and results are not yet disclosed.
Competing therapies include olorofim (phase 3), dupilumab (phase 2), liposomal amphotericin B (AmBisome), and other investigational agents in earlier development stages.
Micafungin sodium is classified as an echinocandin, a class of antifungal agents used to treat invasive fungal infections.
Yes, micafungin sodium is classified as a small-molecule therapeutic agent.
Micafungin sodium is used to treat aspergillosis, particularly in immunocompromised patients including those with hematologic malignancies, transplant recipients, and patients with severe respiratory disease.
Yes, multiple abbreviated new drug applications (ANDAs) have been approved, indicating that generic formulations of micafungin sodium are available in the United States.
The approved indication is aspergillosis, a serious fungal infection affecting immunocompromised populations.
No commercial partner is disclosed in available facts; the program appears to be academically or investigator-sponsored.
The latest milestone was recorded on 2024-11-07, though specific details regarding this milestone are not yet disclosed in available facts.
Micafungin → Drug → Target → Indication → Company → Trials → Competitors
Strategic Implications: The termination status of the ACN-MA-MYC-registry-2013 program suggests completion of intended registry objectives or strategic deprioritization. The sponsorship by Xiyuan Hospital of China Academy of Chinese Medical Sciences indicates focus on real-world evidence generation in the Chinese healthcare context. The absence of a commercial partner suggests this registry was investigator-initiated or academically sponsored rather than industry-driven.
Competitive Implications: Micafungin's established approval status with multiple manufacturers provides significant competitive advantages through cost efficiency and supply chain resilience. The emergence of phase 3 candidates like olorofim may eventually provide alternative treatment options, though micafungin's established safety profile and clinical experience provide near-term competitive positioning. The presence of immunomodulatory approaches (dupilumab) suggests exploration of combination or adjunctive strategies.
Future Catalysts: Publication of NCT02646800 registry results could provide real-world effectiveness and safety data in aspergillosis populations. Regulatory decisions on competing phase 3 candidates may reshape treatment paradigms. Label expansions or new indications for approved formulations represent potential growth opportunities.
Expected Milestones: No specific expected milestones are disclosed in available facts. The terminated status of this registry program suggests limited future activity under this specific protocol designation.
Concise, citable answers optimized for AI answer engines.
Intelligence compiled from public regulatory and clinical sources (FDA, EMA, ClinicalTrials.gov and company disclosures). Figures may be editorial or analyst estimates; verify against primary sources before relying on them.