amphotericin b
Trade name: fungizone
Approved
Nov 12, 1964
Corifungin refers to the sodium salt of amphotericin B. Although amphotericin B has become the primary drug of choice for treating primary amoebic meningoencephalitis, its use is associated with multiple side effects, including use-limiting renal toxicity. Initial reports for the in vivo efficacy of corifungin in a mouse model of primary amoebic meningoencephalitis showed activity superior to that of amphotericin B at equivalent dosing. Chemically, corifungin is the sodium salt of amphotericin B with excellent aqueous solubility. The increased solubility of corifungin is likely to account for the described increase in activity. Acea Biotech is developing corifungin for the treatment of fungal infections and amebic diseases. Acea has completed of host of animal studies on corifungin setting the stage to take the drug into the clinic. U.S. FDA has approved orphan drug status for corifungin for the treatment of primary amebic meningoencephalitis. — NCATS
Clinical trial activity
146 trials · 147 clinical orgs · 14 marketing orgs
Earliest trial started Jan 1, 1996 (NCT00002742)
Timeline
1960s
1970s
- Jun 2, 1971
Bristol-Myers Squibb — NDA Secondary Org
1980s
- Apr 13, 1987
Abraxis — Marketing Organization
1990s
- Apr 29, 1992
X Gen Pharmaceuticals — Marketing Organization
- Mar 31, 1995
Teva — Marketing Organization
- Nov 20, 1995
Leadiant Biosciences, Inc. — NDA Secondary Org
- Jan 1, 1996
Earliest Phase 3 Sponsor(trial)
- Nov 22, 1996
Alkopharma Usa — NDA Secondary Org
- Dec 23, 1996
Abbott — Marketing Organization
- Aug 11, 1997
Astellas — NDA Secondary Org
- Jan 1, 1999
Earliest Phase 1 Sponsor(trial)
- Jan 1, 1999
Earliest Phase 2 Sponsor(trial)
2020s
- Dec 14, 2021
Sun Pharmaceuticals — Marketing Organization
- Nov 17, 2022
Eugia Pharma — Marketing Organization
- Jun 2, 2025
Avet Lifesciences — Marketing Organization
- Jun 30, 2025
Mylan — Marketing Organization
Indications
Approved for
Studied for
- Acquired Immunodeficiency Syndrome · Phase 3
- Allogeneic Cells · Phase 2
- Antifungal Agents · Phase 4
- Aspergillosis, Allergic Bronchopulmonary · Phase 2/Phase 3
- Blastomycosis · Phase 4
- Burns · Phase 4
- Candida · Phase 4
- Candidemia · Phase 4
- Candidiasis · Phase 4
- Candidiasis, Chronic Mucocutaneous · Phase 2
- Candidiasis, Invasive · Phase 4
- Candidiasis, Oral · Phase 2
- Candidiasis, Vulvovaginal · Phase 3
- Colorectal Neoplasms · Phase 4
- Cryptococcosis · Phase 4
- Cryptococcus · Phase 1/Phase 2
- Cystic Fibrosis · Phase 1
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Esophageal Neoplasms · Phase 3
- Febrile Neutropenia · Phase 4
- Fever · Phase 3
- Fuchs' Endothelial Dystrophy · Phase 2/Phase 3
- Healthy Volunteers · Phase 1
- Hematologic Neoplasms · Phase 3
- Hematopoietic Stem Cell Transplantation · Phase 2
- Histoplasmosis · Phase 3
- HIV · Phase 2
- HIV Infections · Phase 3
- Immunologic Deficiency Syndromes · Phase 3
- Immunosuppression Therapy · Phase 3
- Invasive Fungal Infections · Phase 4
- Invasive Pulmonary Aspergillosis · Phase 4
- Leishmania · Phase 2
- Leishmaniasis · Phase 2/Phase 3
- Leishmaniasis, Cutaneous · Phase 4
- Leishmaniasis, Mucocutaneous · Phase 2/Phase 3
- Leukemia · Phase 4
- Leukemia, Myeloid, Acute · Phase 2
- Liver Diseases · Phase 4
- Liver Transplantation · Phase 4
- Lung Diseases · Phase 3
- Lung Transplantation · Phase 3
- Lymphoma · Phase 3
- Lymphoma, Large-Cell, Immunoblastic · Phase 2
- Meningitis · Phase 2
- Meningoencephalitis · Phase 2
- Multiple Myeloma · Phase 3
- Mycoses · Phase 4
- Mycosis Fungoides · Phase 4
- Myelodysplastic Syndromes · Phase 3
- Myeloproliferative Disorders · Phase 3
- Neoplasm Metastasis · Phase 4
- Neoplasms · Phase 3
- Neutropenia · Phase 3
- Obesity, Morbid · Phase 4
- Onychomycosis · Phase 4
- Precursor Cell Lymphoblastic Leukemia-Lymphoma · Phase 2
- Sepsis · Phase 4
- Sinusitis · Phase 3
- Therapeutic Equivalency · Phase 1
- Tinea Capitis · Phase 2/Phase 3
- Vaginosis, Bacterial · Phase 3
- Vulvovaginitis · Phase 2
- Zygomycosis · Phase 2
Mechanism of action
- ErgosterolSEQUESTERING AGENT
Ergosterol sequestering agent
forms pore in membrane by binding ergosterol
Approval history
- approvedNov 12, 1964
Chemistry & pharmacology
SMILES
C[C@H]1O[C@@H](O[C@@H]2C[C@@H]3O[C@@](O)(C[C@H](O)[C@H]3C(O)=O)C[C@@H](O)C[C@@H](O)[C@H](O)CC[C@@H](O)C[C@@H](O)CC(=O)O[C@@H](C)[C@H](C)[C@H](O)[C@@H](C)\C=C\C=C\C=C\C=C\C=C\C=C\C=C\2)[C@@H](O)[C@@H](N)[C@@H]1O- Mol. weight
- 924.079 g/mol
- Lipinski Ro5
- 3 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral, Parenteral, Topical
- Availability
- Prescription Only
Oral
Yes
Parenteral
Yes
Topical
Yes
Sources
- WikipediaAmphotericin B ↗
- NCATS7XU7A7DROE ↗
- ChEMBLCHEMBL267345 ↗
Also known as
- abelcet
- abelcet
- abelcet
- abelcet
- abelecet
- ambisome
- ambisome
- ambisome
- ambisome
- amfotericina b
- amfotericina b
- amophotericin b
- amophotericin b
- amph-b
- amph-b
- amphocin
- ampho-moronal
- ampho-moronal
- amphotec
- amphotec
- amphoteracin b
- amphotercin b
- amphotericin
- amphotericin
- amphotericin
- amphotericin b
- amphotericin b
- amphotericin b
- amphotericin b
- amphotericin b
- amphotericin b
- amphotericin b
- amphotericin b
- amphotericin b
- amphotericin b
- amphotericin b
- amphotericin b deoxycholate
- amphotericin b deoxycholate
- amphotericin b deoxycholate
- amphotericin b - deoxycholate
- amphotericin b-deoxycholate
- amphotericin b, deoxycholate drug combination
- amphotericin b lipid complex
- amphotericin b liposome
- amphotericine b
- amphotericine b
- amphotéricine b
- amphotéricine b
- amphotericinum b
- amphotericinum b
- amphotericitin b
- amphotreicin b
- amphozone
- ampotericin b
- apothecon
- c-amb
- c-amb
- d-amb cpd
- fungilin
- fungilin
- fungilin
- fungilin in orabase
- fungizone
- fungizone
- fungizone
- hamb-doc
- l-amb
- liposomal amphotericin b
- liposomal amphotericin b
- liposomal amphotericin b
- liposomal amphotericin b
- nsc527017
- nsc-527017
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07261150 | Phase 3 | Feb 1, 2026 | Federal University of Health Science of Porto Alegre, University of Minnesota |
| NCT07300553 | Phase 2 | Dec 31, 2025 | Assistance Publique - Hôpitaux de Paris |
| NCT06983665 | N/A | May 25, 2025 | Government of China, Jinan University |
| NCT06977490 | N/A | May 13, 2025 | Government of China, Jinan University |
| NCT06926569 | N/A | May 1, 2025 | Fudan University |
| NCT06980493 | Phase 2/Phase 3 (Phase 3) | Apr 1, 2025 | Sohag University |
| NCT06756191 | Phase 4 | Jan 10, 2025 | Capital Medical University |
| NCT06525389 | Phase 3 | Jan 6, 2025 | Bach Mai Hospital, Chiangmai University, Duke University, Gilead Sciences, Guangzhou Medical University, Maharat Nakhon Ratchasima Hospital, National Hospital for Tropical Diseases, Hanoi, Vietnam, National Institute of Allergy and Infectious Diseases (NIAID), Pham Ngoc Thach University of Medicine, Shenzhen Third People's Hospital, Tropical Diseases Hospital, Ho Chi Minh City, Viatris |
| NCT06447402 | Phase 3 | Jun 3, 2024 | Postgraduate Institute of Medical Education and Research |
| NCT05865743 | Phase 3 | Sep 30, 2023 | Katholieke Universiteit Leuven, Radboud University, ZonMw: The Netherlands Organisation for Health Research and Development |
| NCT05814432 | Phase 3 | Sep 1, 2023 | Federal University of Health Science of Porto Alegre, Gilead Sciences |
| NCT06616168 | Phase 1 | Sep 1, 2023 | Lviv National Medical University |
| NCT06178627 | Phase 4 | Aug 13, 2023 | Fudan University |
| NCT05913921 | Phase 1 | Jun 2, 2023 | CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd., Haikou People's Hospital |
| NCT05802264 | Phase 1 | Mar 21, 2023 | Cystetic Medicines, Inc., DevPro Biopharma |
| NCT05541107 | Phase 3 | Jan 31, 2023 | Makerere University, Matinas Biopharma, Inc, University of Minnesota |
| NCT05593666 | Phase 2 | Nov 7, 2022 | Drugs for Neglected Diseases Initiative, Novartis |
| NCT06413056 | Phase 4 | Oct 20, 2022 | Ain Shams University |
| NCT05471063 | N/A | Aug 22, 2022 | Chinese Academy of Medical Sciences |
| NCT05468372 | Phase 2 | Jul 1, 2022 | Postgraduate Institute of Medical Education and Research |
Organizations
Research & Development (147)
Marketing (16)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Abbott | For profit | MKTG | Dec 23, 1996 |
| Abraxis | For profit | MKTG | Apr 13, 1987 |
| Alkopharma Usa | For profit | NDA2 | Nov 22, 1996 |
| Apothecon | For profit | NDA2 | Nov 12, 1964 |
| Apothecon | For profit | MKTG | Nov 12, 1964 |
| Astellas | For profit | NDA2 | Aug 11, 1997 |
| Avet Lifesciences | For profit | MKTG | Jun 2, 2025 |
| Bristol-Myers Squibb | For profit | NDA2 | Jun 2, 1971 |
| Eugia Pharma | For profit | MKTG | Nov 17, 2022 |
| Leadiant Biosciences, Inc. | For profit | NDA2 | Nov 20, 1995 |
| Mylan | For profit | MKTG | Jun 30, 2025 |
| Squibb | For profit | NDA | — |
| Sun Pharmaceuticals | For profit | MKTG | Dec 14, 2021 |
| Teva | For profit | MKTG | Mar 31, 1995 |
| X Gen Pharmaceuticals | For profit | SYN | Apr 29, 1992 |
| X Gen Pharmaceuticals | For profit | MKTG | Apr 29, 1992 |