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Abelcet (AMPHOTERICIN B)
Abelcet (Amphotericin B) is a lipid-based polyene antifungal drug, originally developed by Apothecan and currently owned by Astellas. It is a small molecule modality that has been FDA-approved since 1964 for various fungal infections, including aspergillosis, blastomycosis, and bronchitis. Abelcet is off-patent, with 9 generic manufacturers available. Key safety considerations include its low bioavailability (3%) and long half-life (40 hours). It is used to treat a range of fungal infections.
At a glance
| Generic name | AMPHOTERICIN B |
|---|---|
| Sponsor | Astellas Pharma |
| Drug class | Lipid-based Polyene Antifungal [EPC] |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 1964 |
Approved indications
- Acne vulgaris
- Actinomycotic infection
- Acute gonococcal cervicitis
- Acute gonococcal urethritis
- Anthrax
- Aspergillosis
- Blastomycosis
- Bronchitis
- Brucellosis
- Candida Peritonitis
- Candidal endocarditis
- Candidal meningitis
- Candidal septicemia
- Candidemia
- Candidiasis
- Candidiasis of mouth
- Candidiasis of skin
- Candidiasis of the esophagus
- Chlamydia trachomatis infection of genital structure
- Coccidioidomycosis
Common side effects
- Sepsis
- Hypotension
- Pain
- Chills
- Dyspnea
- Abdominal pain
- Diarrhea
- Vomiting
- Nausea
- Hypertension
- Tachycardia
- Hypoxia
Drug interactions
- Antineoplastic Agents
- Corticosteroids and Corticotropin (ACTH)
- Digitalis Glycosides
- Flucytosine
- Azoles (e.g., ketoconazole, miconazole, clotrimazole, fluconazole, etc.)
- Leukocyte Transfusions
- Other Nephrotoxic Medications
- Skeletal Muscle Relaxants
Key clinical trials
- Human Bioequivalence Study of Liposomal Amphotericin B for Injection (NA)
- Impact Of The Gut Microbiota On Host Cells Energy Metabolism in Health And In Inflammatory Bowel Disease (PHASE2)
- Study Comparing Several Drugs to Understand Which Work Against Cutaneous Leishmaniasis (CL) (PHASE3)
- Pilot Study of High Dose Liposomal Amphotericin B Efficacy in Initial Zygomycosis Treatment (PHASE2)
- Histoplasmosis Induction and Consolidation Therapy Factorial Randomized Clinical Trial (Histo-FACT) (PHASE3)
- Study of EL219 vs Standard of Care for Early Antifungal Therapy of Suspected Invasive Mould Infections (PHASE2)
- A Study of the Efficacy and Safety of Bronchoscopic Airway Clearance and Amphotericin B Spraying in Patients With ABPA
- A Real-world Prospective Observational Study on the Efficacy and Safety of L-AmB(Liposomal Amphotericin B) for br- IFD(Breakthrough Invasive Fungal Disease) in Children and Adolescent Patients With Hematological Malignancies Receiving Triazoles or Echinocandins Prophylaxis
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Abelcet CI brief — competitive landscape report
- Abelcet updates RSS · CI watch RSS
- Astellas Pharma portfolio CI