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Mycamine

(Micafungin)

ApprovedSmall molecule

BBaxter Healthcare Corporation

Micafungin is used to treat serious fungal infections, particularly those caused by Candida species. It works by stopping the growth of fungal cells and is often used in patients with weakened immune systems or those undergoing certain medical procedures.[2] Mycamine is currently approved and in use across 9 indications[4].[1]

Mycamine is one of 198 small molecule programs targeting Neutropenia. It is currently in Approved.

9

Indications

48

Total Trials

0

Active Trials

197

Competitors

4

FDA Applications

NDA/BLA/ANDA regulatory filings

1

Patents

Pipeline

Status by Indication[4][1]

Indication

NeutropeniaActive, not recruiting

Candidiasis, InvasiveApproved

AspergillosisApproved

Liver TransplantActive, not recruiting

LeukemiaApproved

CandidiasisActive, not recruiting

Fungal Infectious DiseaseApproved

Myelodysplastic SyndromeActive, not recruiting

Acute LeukemiaActive, not recruiting

NeutropeniaApproved

Active, not recruiting

Candidiasis, InvasiveApproved

Approved

AspergillosisApproved

Approved

Liver TransplantPhase 3

Active, not recruiting

LeukemiaApproved

Approved

CandidiasisApproved

Active, not recruiting

Fungal Infectious DiseaseApproved

Approved

Myelodysplastic SyndromeApproved

Active, not recruiting

Acute LeukemiaPhase 2

Active, not recruiting

Competition

Competitive Landscape

508 competitors in Leukemia

#DrugCompanyPhaseTrials

Mycamine

BBaxter Healthcare Corporation

Cytosar

Trexall

Alnylam Pharmaceuticals

Fludara

Cytoxan

BBaxter Healthcare Corporation

Rituxan

Vepesid

Oncovin

Decadron

AAspen Global Incorporated

Cellcept

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Candidiasis12 trials

Micafungin Versus AmBisome in Invasive Candidiasis and Candidemia

Completed· Astellas logo

Astellas·Phase 3·NCT00106288·637 enrolled

A Study to Evaluate the Efficacy and Safety of Micafungin Against Invasive Candidiasis or Candidemia

Terminated· Astellas logo

Astellas·Phase 4·NCT01982071·59 enrolled

Comparative Trial of Micafungin Versus Fluconazole for Treating Esophageal Candidiasis

Completed· Astellas logo

Astellas·Phase 3·NCT00666185·523 enrolled

Show 9 more trials

Oral Ibrexafungerp (SCY-078) vs Standard-of-Care Following IV Echinocandin in the Treatment of Invasive Candidiasis

Completed·SScynexis, Inc.·Phase 2·NCT02244606·27 enrolled

Determination of Levels of Micafungin in Neonates Suffering From Systemic Candidiasis and/or Candida Meningitis

Completed· Astellas logo

Astellas·Phase 2·NCT03421002·35 enrolled

Trial of Two Dosing Regimens of Micafungin Versus Caspofungin for the Treatment of Esophageal Candidiasis

Completed· Astellas logo

Astellas·Phase 3·NCT00665639·454 enrolled

Fluconazole Versus Micafungin in Neonates With Candidiasis

Completed·IInstitut National de la Santé Et de la Recherche Médicale, France·Phase 2/3·NCT02145832·100 enrolled

Comparison of Two Diagnostic Tests in Patients With Suspected Invasive Candidiasis in Internal Medicine Wards and Who Are Currently Timely Treated With Micafungin

Terminated·FFadoi Foundation, Italy·Phase 4·NCT03906916·14 enrolled

A Study to Evaluate Pre-emptive Treatment for Invasive Candidiasis in High Risk Surgical Subjects

Completed· Astellas logo

Astellas·Phase 2·NCT01122368·252 enrolled

Study of Micafungin in Patients With Invasive Candidiasis or Candidemia

Completed· Astellas logo

Astellas·Phase 3·NCT00105144·611 enrolled

Micafungin Versus Fluconazole in the Treatment of Invasive Candidiasis and Candidemia

Completed· Astellas logo

Astellas·Phase 3·NCT00189709·24 enrolled

Study to Compare the Efficacy and Safety of Micafungin Versus Conventional Amphotericin B for the Treatment of Neonatal Candidiasis

Terminated· Astellas logo

Astellas·Phase 3·NCT00815516·30 enrolled

Aspergillosis4 trials

Micafungin Salvage Mono-therapy in Invasive Aspergillosis

Terminated· Astellas logo

Astellas·Phase 2·NCT00376337·17 enrolled

Post Marketing Study to Evaluate the Efficacy and Safety of Micafungin Treatment on Invasive Aspergillosis

Terminated· Astellas logo

Astellas·Phase 4·NCT02646774·43 enrolled

Trial of Micafungin (FK463) in Combination With Liposomal Amphotericin B (AmBisome) for Aspergillosis

Terminated· Astellas logo

Astellas·Phase 2·NCT00047827·2 enrolled

Show 1 more trial

A Study to Evaluate the Effectiveness of Voriconazole + Micafungin Versus Voriconazole Alone for Invasive Aspergillosis

Withdrawn· Astellas logo

Astellas·Phase 4·NCT00423163

Fungal Infection3 trials

Study of Mycamine® in Children With Fungal Infections to Evaluate Safety and Blood Levels of the Drug

Completed· Astellas logo

Astellas·Phase 1·NCT00608335·84 enrolled

Non-interventional Study for Prevention and Treatment of Fungal Infections in Paediatric Patients in Asia/Oceania - ERADICATE Study

Completed· Astellas logo

Astellas··NCT03174457·120 enrolled

Study of Mycamine® in Infants and Toddlers With Fungal Infections to Evaluate Safety and Blood Levels of the Drug

Completed· Astellas logo

Astellas·Phase 1·NCT00607763·9 enrolled

MPA2 trials

Comparison of Candida Eradication and Serum Cidal Activity of Echinocandins

Completed·—·Phase 4·NCT00839540·21 enrolled

Comparative Study of Micafungin (FK463) Versus Placebo as Prophylactic Antifungal Therapy in the ICU

Terminated· Astellas logo

Astellas·Phase 3·NCT00048750·104 enrolled

Liver Transplant2 trials

Liver Transplant European Study Into the Prevention of Fungal Infection

Completed· Astellas logo

Astellas·Phase 3·NCT01058174·350 enrolled

Micafungin Versus Fluconazole for Prevention of Invasive Fungal Disease in Living Donor Liver Transplant Recipients

Unknown status·—·Phase 3·NCT01974375·172 enrolled

23 more indications

Tics2 trials

An Open-Label Study of the Safety and Pharmacokinetics of Repeated-Dose Micafungin in Neonates

Completed· Astellas logo

Astellas·Phase 1·NCT00818584·13 enrolled

Pharmacokinetics of Micafungin During Continuous Venovenous Hemofiltration

Completed·MMedical University of Vienna·Phase 4·NCT02651038·10 enrolled

Prophylaxis2 trials

Use of Micafungin (Mycamine®) as Antifungal Prophylaxis in Haematology and Onco-haematology

Completed· Astellas logo

Astellas··NCT02127788·150 enrolled

A Pharmacokinetic Study of Pediatric Micafungin Prophylaxis

Terminated·—·Phase 1·NCT02057289·9 enrolled

Overweight1 trial

Drug Concentration Analysis of Micafungin in Overweight, Obese, and Extremely Obese Volunteers

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT01090141·36 enrolled

Hematopoietic Stem Cell Transplant1 trial

A Study of Safety and Pharmacokinetics of Repeated Dose of Micafungin as Antifungal Prophylaxis in Children and Adolescents Who Undergo Hematopoietic Stem Cell Transplant

Completed· Astellas logo

Astellas·Phase 1·NCT00606268·42 enrolled

Allogeneic Stem Cell Transplantation1 trial

Antifungal Prophylaxis With Micafungin After Cord Blood Allogeneic Stem Cell Transplantation (MycaCOORD)

Completed·NNantes University Hospital·Phase 2·NCT01888458·21 enrolled

Graft Versus Host Disease1 trial

Evaluation of Budesonide and How It Interacts With Antifungal Drugs in People With Gastrointestinal Graft-Versus-Host Disease

Terminated·NNational Institutes of Health Clinical Center (CC)·Phase 1·NCT01950507·15 enrolled

Myelodysplastic Syndrome1 trial

Posaconazole Versus Micafungin for Prophylaxis Against Invasive Fungal Infections During Neutropenia in Patients Undergoing Chemotherapy for Acute Myelogenous Leukemia, Acute Lymphocytic Leukemia or Myelodysplastic Syndrome

Completed·MMemorial Sloan Kettering Cancer Center·Phase 4·NCT01200355·113 enrolled

Autologous Hematopoietic Stem Cell Transplantation1 trial

Micafungin Prevention Study for Invasive Fungal Disease in Pediatric & Adolescent Patients Undergoing Autologous Hematopoietic Stem Cell Transplantation

Unknown status·SSeoul National University Hospital·Phase 2·NCT01417169·112 enrolled

Pediatric Patients1 trial

Alternate Day Micafungin: A PK Study in Pediatric Patients

Completed·—·Phase 1·NCT00842504·15 enrolled

Bloodstream Infection1 trial

Fluconazole Versus Micafungin for Candida Bloodstream Infection in Non-Neutropenic Patients

Withdrawn·KKyoto University·Phase 4·NCT00304772

Invasive Fungal Disease1 trial

Pharmacokinetics of Micafungin Given Twice Weekly Intravenously Compared to Micafungin Given Daily to Patients at Risk for Developing an Invasive Fungal Disease

Completed·RRadboud University Medical Center·Phase 2·NCT02172768·30 enrolled

Neutropenia1 trial

Antimicrobial Revision in Persistent Febrile Neutropenia

Withdrawn·WWake Forest University Health Sciences·Phase 4·NCT05784844

Safety and Efficacy1 trial

Post Marketing Study to Evaluate the Safety and Efficacy of Micafungin Against Fungal Infections Caused by Candida Spp or Aspergillus Spp

Terminated· Astellas logo

Astellas·Phase 4·NCT02646800·105 enrolled

Intensive Care Unit1 trial

Pharmacokinetics of Micafungin in Patients Intensive Care Unit

Completed·RRadboud University Medical Center··NCT01783379·20 enrolled

Extracorporeal Membrane Oxygenation1 trial

Pharmacokinetics of Micafungin in Children on Extracorporeal Membrane Oxygenation

Completed·KKevin Watt·Phase 1·NCT01666769·18 enrolled

Obese Patients1 trial

Micafungin Pharmacokinetics in Obese Patients

Completed·RRadboud University Medical Center·Phase 4·NCT03102658·24 enrolled

Treatment1 trial

Empirical Antifungal Treatment in ICUS

Completed·UUniversity Hospital, Grenoble·Phase 3·NCT01773876·260 enrolled

Invasive Fungal Infection1 trial

Micafungin Versus Amphotercine B in Treatment of Invasive Fungal Infection

Completed·—·Phase 4·NCT06413056·56 enrolled

Hematopoietic Stem Cell Transplantation1 trial

Micafungin Prevention Study for Fungal Disease in Child Receiving Allogenic Hematopoietic Stem Cell Transplantation

Unknown status·—·Phase 4·NCT01135589·145 enrolled

Acute Leukemia1 trial

Micafungin Prophylaxis During 1st Induction Chemotherapy for De Novo Acute Leukemia

Completed·SSeoul National University Hospital·Phase 2·NCT02440178·66 enrolled

Invasive Fungal Infections1 trial

A Retrospective Study Evaluating the Efficacy and Safety of Micafungin Sodium in the Treatment of Invasive Fungal Infections

Completed· Astellas logo

Astellas··NCT02678598·2,555 enrolled

Efficacy and Safety1 trial

A Study to Compare Efficacy and Safety of Mycamine® and Itraconazole for Preventing Fungal Infections

Completed· Astellas logo

Astellas·Phase 3·NCT00794703·288 enrolled

Unspecified1 trial

Evaluate Bioequivalence of Micafungin (50mg/Vial)

Completed·YYung Shin Pharm. Ind. Co., Ltd.·Phase 4·NCT05496725·14 enrolled

Regulatory

FDA Approval Timeline[5]

Mar 16, 2005

MYCAMINE

NDA NDA021506

Jun 16, 2021

MICAFUNGIN

NDA NDA212156

Jul 30, 2021

MICAFUNGIN

NDA NDA212125

Sep 29, 2023

MICAFUNGIN IN SODIUM CHLORIDE 0.9%

NDA NDA216142

Sources

References

[1]
ClinicalTrials.gov — 48 trial records for Micafungin. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Mycamine drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Micafungin compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Micafungin. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA216142). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Mycamine. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Baxter Healthcare Corporation company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: 1,3-Beta-Glucan Synthase Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BBaxter Healthcare Corporation

Patent Landscape[6]

Patent Cliff

Dec 15, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

12403173Dec 15, 2037

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