Clinical Trials

Amphotericin B has been evaluated across numerous clinical trials ranging from Phase 1 through Phase 4, focusing on dosage regimens and combination therapies for fungal and parasitic conditions such as primary visceral leishmaniasis, aspergillosis, candidiasis, histoplasmosis, blastomycosis, and febrile neutropenia. Sponsored by pharmaceutical companies—including Novartis, Astellas Pharma, Janssen, and CSPC ZhongQi—alongside research institutes like the Medical Research Council, these trials encompass completed, actively recruiting, terminated, and unknown recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05814432 RECRUITING
Disseminated Histoplasma Capsulatum Infection; AIDS and Infections; Immunosuppression; Fungal Infection
Federal University of Health Science of Porto Alegre
 2025-01-16 PHASE3
NCT06525389 NOT_YET_RECRUITING
Talaromycosis
Duke University
 2026-09-01 PHASE3
NCT07463040 NOT_YET_RECRUITING
Cutaneous Leihmaniasis
Institute of Tropical Medicine, Belgium
 2027-01-01 PHASE3
NCT07559032 NOT_YET_RECRUITING
Invasive Fungal Disease
Peking University People's Hospital
 2026-04
NCT07725874 NOT_YET_RECRUITING
Invasive Mold Diseases
Beijing Friendship Hospital
 2026-08-08
NCT07530263 NOT_YET_RECRUITING
Chronic Pulmonary Aspergillosis
Radboud University Medical Center
 2026-10-01 PHASE1
NCT07337720 NOT_YET_RECRUITING
Aspergillosis Invasive
Southeast University, China
 2025-12-20
NCT07215273 RECRUITING
Invasive Mould Infection
Elion Therapeutics, Inc.
 2026-02-13 PHASE2
NCT07300553 RECRUITING
IBD; Crohn Disease; Ulcerative Colitis (UC)
Assistance Publique - Hôpitaux de Paris
 2026-01-02 PHASE2
NCT06616168 ACTIVE_NOT_RECRUITING
Bacterial Vaginosis
Danylo Halytsky Lviv National Medical University
 2023-09-01 PHASE1
NCT06447402 UNKNOWN
Chronic Pulmonary Aspergillosis; CPA; Aspergilloma
Post Graduate Institute of Medical Education and Research, Chandigarh
 2024-06-03 PHASE3
NCT05468372 COMPLETED
Mucormycosis; Pulmonary (Etiology)
Post Graduate Institute of Medical Education and Research, Chandigarh
 2022-07-01 PHASE2
NCT06926569 NOT_YET_RECRUITING
HIV/AIDS-associated Talaromycosis
Shanghai Public Health Clinical Center
 2025-05-01
NCT06983665 COMPLETED
Invasive Fungal Infections; Neutropenic Fever; Visceral Leishmaniasis
Sichuan Huiyu Pharmaceutical Co., Ltd
 2025-05-25
NCT06977490 COMPLETED
Invasive Fungal Infections; Neutropenic Fever; Visceral Leishmaniasis
Sichuan Huiyu Pharmaceutical Co., Ltd
 2025-05-13
NCT06178627 UNKNOWN
Cryptococcal Meningitis; Antifungal Agents
Huashan Hospital
 2023-08-13 PHASE4
NCT06495905 UNKNOWN
Pulmonary Mucormycosis
Beijing Tsinghua Chang Gung Hospital
 2024-07-30
NCT06756191 NOT_YET_RECRUITING
Pulmonary Mucormycosis
Bin Cao
 2025-01-10 PHASE4
NCT06980493 ACTIVE_NOT_RECRUITING
Tinea Capitis
Sohag University
 2025-04-01 PHASE2; PHASE3
NCT06376201 UNKNOWN
Invasive Fungal Disease
Nanfang Hospital, Southern Medical University
 2024-04 PHASE4
NCT05541107 UNKNOWN
Cryptococcal Meningitis
Matinas BioPharma Nanotechnologies, Inc.
 2023-01 PHASE3
NCT05707832 COMPLETED
Invasive Candidiasis; Invasive Aspergillosis
CSPC Ouyi Pharmaceutical Co., Ltd.
 2023-03-30 PHASE3
NCT06040489 UNKNOWN
Leishmaniasis; Brazilian; Leishmaniasis, Mucocutaneous
University of Brasilia
 2022-06-22 PHASE2; PHASE3
NCT04799236 UNKNOWN
Mucosal Leishmaniasis
Fundacion Nacional de Dermatologia
 2021-04-01 PHASE3
NCT07239765 COMPLETED
Invasive Mold Disease
CSPC Ouyi Pharmaceutical Co., Ltd.
 2021-07-09 PHASE3
NCT05913921 COMPLETED
Bioequivalence
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
 2023-06-02 PHASE1
NCT06413056 COMPLETED
Neonatal Infection; Invasive Fungal Infections
Ain Shams University
 2022-10-20 PHASE4
NCT05471063 UNKNOWN
Cryptococcal Meningitis
Peking Union Medical College Hospital
 2022-08-22
NCT05593666 Recruiting
Primary Visceral Leishmaniasis
Drugs for Neglected Diseases|Novartis Pharmaceuticals
 2022-12-27 Phase 2
NCT04031833 COMPLETED
Cryptococcal Meningitis
Matinas BioPharma Nanotechnologies, Inc.
 2019-10-24 PHASE1; PHASE2
NCT04267497 COMPLETED
Invasive Pulmonary Aspergillosis
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
 2019-10-18 PHASE1
NCT04072640 UNKNOWN
Cryptococcal Meningitis; HIV/AIDS
First Affiliated Hospital of Zhejiang University
 2021-01-25 EARLY_PHASE1
NCT05108545 UNKNOWN
Neutropenia and Fever
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2021-12-15 PHASE3
NCT04225195 UNKNOWN
Invasive Candidiasis; Invasive Aspergillosis
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2020-01 PHASE2
NCT04140461 UNKNOWN
Cryptococcal Meningitis; HIV Infections
Shanghai Public Health Clinical Center
 2020-01-02 PHASE3
NCT04059770 COMPLETED
Histoplasmosis; AIDS
Alessandro Pasqualotto
 2020-02-14 PHASE2
NCT03827278 UNKNOWN
Talaromyces in Human Immunodeficiency Virus Negative; To Compare Voriconazole and Amphotericin Sequential Itraconazole Therapy; To Dynamically Monitor the Anti-Interferon-γ Autoantibodies
Guangxi Medical University
 2018-12-30
NCT05108545 Unknown status
Neutropenia and Fever
CSPC ZhongQi Pharmaceutical Technology Co. Ltd.
 2021-12-15 Phase 3
NCT02629419 COMPLETED
Candidiasis, Chronic Mucocutaneous
Matinas BioPharma Nanotechnologies, Inc.
 2016-09-27 PHASE2
NCT04502381 COMPLETED
Pulmonary Mucormycosis
Post Graduate Institute of Medical Education and Research, Chandigarh
 2020-07-01 PHASE2
NCT06449040 COMPLETED
Cutaneous Leishmaniasis, American
Hospital Universitário Professor Edgard Santos
 2019-03-01 PHASE1; PHASE2
NCT02656797 COMPLETED
Leishmaniasis
Soroka University Medical Center
 2018-01-30 PHASE2
NCT03187691 WITHDRAWN
Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia
Matinas BioPharma Nanotechnologies, Inc.
 2019-08 PHASE2
NCT03167957 WITHDRAWN
Vulvovaginal Candidiases; Yeast Infection; Vulvovaginitis; Yeast Infection Vaginal; Candidiasis, Vulvovaginal
Matinas BioPharma Nanotechnologies, Inc.
 2019-12 PHASE2
NCT03814343 COMPLETED
Fungal Infection; Onychomycosis; Fungus, Nail
Mahidol University
 2019-01-15 PHASE4
NCT02283905 TERMINATED
Blastomycosis
University of Manitoba
 2015-06 PHASE4
NCT04993222 COMPLETED
Bioequivalence
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co., Ltd.
 2020-06-04 PHASE1
NCT04993222 Completed
Bioequivalence
CSPC Zhongnuo Pharmaceutical (Shijiazhuang) Co. Ltd.
 2020-06-04 Phase 1
NCT03196921 WITHDRAWN
Cryptococcal Infections
Matinas BioPharma Nanotechnologies, Inc.
 2018-10-01 PHASE1; PHASE2
NCT03905447 Terminated
Aspergillosis|Lung Transplant Infection
Pulmocide Ltd
 2019-09-17 Phase 2
NCT04018417 WITHDRAWN
Fuchs' Endothelial Dystrophy
Cornea Research Foundation of America
 2019-07-03 PHASE2; PHASE3
NCT02273661 COMPLETED
Allergic Bronchopulmonary Aspergillosis
Poitiers University Hospital
 2014-11-19 PHASE2
NCT03636659 COMPLETED
Visceral Leishmaniasis
Aurobindo Pharma Ltd
 2018-05-02 PHASE1
NCT03828773 Recruiting
Candidiasis|Fungal Infection|Acute Myeloid Leukemia|Genetic Predisposition|Aspergillosis
Bochud Pierre-Yves|Swiss National Science Foundation|Centre Hospitalier Universitaire Vaudois
 2019-02-11 Not Applicable
NCT03327727 TERMINATED
Invasive Aspergillosis; Invasive Pulmonary Aspergillosis
Vical
 2018-02-20 PHASE2
NCT02320604 COMPLETED
Morbid Obesity
Radboud University Medical Center
 2018-03-22 PHASE4
NCT03577509 COMPLETED
Invasive Fungal Disease
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
 2018-07-02 PHASE1
NCT03112031 COMPLETED
Meningitis Streptococcal; Hiv; Meningitis; Meningoencephalitis
Oxford University Clinical Research Unit, Vietnam
 2017-10-10 PHASE2
NCT01945281 TERMINATED
Candidiasis, Invasive
Merck Sharp & Dohme LLC
 2014-01-15 PHASE2
NCT02686853 UNKNOWN
Cryptococcal Meningitis
Hui Bu
 2016-01 PHASE4
NCT02971007 COMPLETED
Vulvovaginitis; Yeast Infection; Yeast Infection Vaginal; Candidiasis, Vulvovaginal
Matinas BioPharma Nanotechnologies, Inc.
 2016-11 PHASE2
NCT01740947 TERMINATED
Colorectal Cancer
H. Jaap Bonjer, PhD
 2013-01 PHASE4
NCT00885703 COMPLETED
Cryptococcal Meningitis; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 2010-04-16 PHASE1; PHASE2
NCT01566552 UNKNOWN
Visceral Leishmaniasis
Banaras Hindu University
 2014-06 PHASE4
NCT02011958 COMPLETED
Visceral Leishmaniasis
Drugs for Neglected Diseases
 2014-07 PHASE3
NCT01845727 COMPLETED
Cutaneous Leishmaniasis
Drugs for Neglected Diseases
 2014-02 PHASE1; PHASE2
NCT02136030 UNKNOWN
Cryptococcal Meningitis
TTY Biopharm
 2011-02
NCT01857479 COMPLETED
Allergic Bronchopulmonary Aspergillosis
Post Graduate Institute of Medical Education and Research, Chandigarh
 2013-05 PHASE2; PHASE3
NCT01843309 TERMINATED
Patients With Fungic Infections
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
 2013-05 PHASE4
NCT00815516 TERMINATED
Candidiasis
Astellas Pharma Global Development, Inc.
 2013-02 PHASE3
NCT01310738 TERMINATED
Visceral Leishmaniasis
University of Brasilia
 2011-02 PHASE4
NCT01303549 COMPLETED
Liver Disease; Fungal Infection
Fundacion SEIMC-GESIDA
 2011-11 PHASE4
NCT01122771 COMPLETED
Visceral Leishmaniasis
Drugs for Neglected Diseases
 2010-05 PHASE3
NCT01259713 COMPLETED
Invasive Fungal Disease
Gilead Sciences
 2011-04 PHASE3
NCT01615809 COMPLETED
Invasive Pulmonary Aspergillosis; Lymphoblastic Leukaemia; Myeloblastic Leukaemia; Lymphoblastic Leukemia; Myeloblastic Leukemia
Fundació Sant Joan de Déu
 2011-10 PHASE2
NCT02025491 COMPLETED
Disseminated Leishmaniasis
Hospital Universitário Professor Edgard Santos
 2011-04 PHASE3
NCT01652859 COMPLETED
Normal Healthy Subjects
Taiwan Liposome Company
 2012-02 PHASE1
NCT00750737 COMPLETED
Invasive Fungal Infections; Hematologic Malignancies
M.D. Anderson Cancer Center
 2008-06 PHASE3
NCT01058174 COMPLETED
Liver Transplantation; Mycoses
Astellas Pharma Inc
 2009-12-15 PHASE3
NCT00467883 COMPLETED
Zygomycosis
Assistance Publique - Hôpitaux de Paris
 2007-06 PHASE2
NCT01067443 COMPLETED
Primary Visceral Leishmaniasis
Drugs for Neglected Diseases
 2010-03 PHASE2
NCT01293643 COMPLETED
Vaginosis, Bacterial; Candidiasis, Vulvovaginal
Merck Sharp & Dohme LLC
 2010-05 PHASE3
NCT00876824 COMPLETED
Leishmaniasis, Visceral
Bharat Serums and Vaccines Limited
 2009-07 PHASE3
NCT00986713 UNKNOWN
Invasive Pulmonary Aspergillosis
Capital Medical University
 2008-06 PHASE4
NCT00832208 TERMINATED
Visceral Leishmaniasis
Drugs for Neglected Diseases
 2009-04 PHASE2
NCT00936910 COMPLETED
Central Line Fungal Infections
Bill McGhee
 2006-09 PHASE4
NCT00889356 UNKNOWN
Candidiasis; Bacterial Vaginosis
Zodiac Produtos Farmaceuticos S.A.
 2009-09 PHASE3
NCT01032187 COMPLETED
Visceral Leishmaniasis
University of Brasilia
 2007-10 PHASE4
NCT00696969 COMPLETED
Visceral Leishmaniasis
Drugs for Neglected Diseases
 2008-06 PHASE3
NCT01656382 WITHDRAWN
Invasive Cryptococcosis
Medstar Health Research Institute
 2007-01 PHASE4
NCT00419770 COMPLETED
Mucormycosis
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
 2007-10 PHASE2
NCT00624143 UNKNOWN
Pediatric Acute Leukemia Induction
All India Institute of Medical Sciences
 2008-02 PHASE3
NCT00418951 COMPLETED
Acute Myelogenous Leukemia; Myelodysplastic Syndrome
M.D. Anderson Cancer Center
 2006-11 PHASE2
NCT00371995 COMPLETED
Visceral Leishmaniasis
Banaras Hindu University
 2007-10 PHASE2
NCT00523965 COMPLETED
Leishmaniasis, Visceral
Banaras Hindu University
 2007-09 PHASE3
NCT00391014 COMPLETED
Acute Myeloid Leukemia; Allogeneic Haematopoietic Progenitor Cell Transplant
PETHEMA Foundation
 2006-01 PHASE2
NCT00670657 COMPLETED
Candidemia; Invasive Candidiasis
Gilead Sciences
 2007-05 PHASE4
NCT00628719 COMPLETED
Visceral Leishmaniasis
Banaras Hindu University
 2008-02 PHASE3
NCT00497601 COMPLETED
Visceral Leishmaniasis
Banaras Hindu University
 2007-02 PHASE2
NCT00421187 TERMINATED
Febrile Neutropenia
Gilead Sciences
 2007-03 PHASE4
NCT00145249 COMPLETED
Cryptococcal Meningitis
National Institute of Allergy and Infectious Diseases (NIAID)
 2005-05 PHASE2
NCT00847678 TERMINATED
Cryptococcal Meningitis
Novartis Pharmaceuticals
 2006-08 PHASE2
NCT00361517 COMPLETED
Aspergillosis
Singapore General Hospital
 2006-06-01 PHASE3
NCT00381394 COMPLETED
Leishmaniasis, Visceral
GlaxoSmithKline
 2006-08-04 PHASE2
NCT00082537 COMPLETED
Neutropenia; Fever
Merck Sharp & Dohme LLC
 2004-04 PHASE2
NCT00106288 COMPLETED
Candidiasis
Astellas Pharma Inc
 2003-01 PHASE3
NCT00076869 COMPLETED
Aspergillosis
Merck Sharp & Dohme LLC
 2003-01 PHASE2
NCT00003938 COMPLETED
Cancer
European Organisation for Research and Treatment of Cancer - EORTC
 1999-06 PHASE3
NCT00008359 COMPLETED
Cancer
Memorial Sloan Kettering Cancer Center
 2000-08 PHASE3
NCT00047827 TERMINATED
Aspergillosis
Astellas Pharma Inc
 2002-12 PHASE2
NCT00003031 COMPLETED
Infection; Pulmonary Complications
European Organisation for Research and Treatment of Cancer - EORTC
 1997-06 PHASE3
NCT00000708 COMPLETED
Meningitis, Cryptococcal; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00001017 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
 PHASE3
NCT00216346 COMPLETED
Visceral Leishmaniasis
PATH
 2003-06 PHASE3
NCT00163111 COMPLETED
Candidiasis
Pfizer
 1998-09 PHASE3
NCT00001065 COMPLETED
Candidiasis, Oral; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002316 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Alkermes, Inc.
 PHASE1
NCT00002306 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
NCT00177684 COMPLETED
Lung Transplantation; Fungal Infections
University of Pittsburgh
 2004-09 PHASE3
NCT00161356 TERMINATED
Liver Transplantation
The University of Texas Health Science Center, Houston
 2005-09 PHASE4
NCT00002041 COMPLETED
Candidiasis, Esophageal; HIV Infections
Bristol-Myers Squibb
NCT00425620 COMPLETED
Chronic Sinusitis
Accentia Biopharmaceuticals
 2006-12 PHASE3
NCT00002305 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
NCT00451711 UNKNOWN
Acute Myeloid Leukemia
Bayside Health
 2007-05 PHASE2
NCT00002742 COMPLETED
Chronic Myeloproliferative Disorders; Infection; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes
Aronex Pharmaceuticals
 1996-01 PHASE3
NCT00177710 COMPLETED
Lung Transplantation; Fungal Infections
University of Pittsburgh
 2006-01 PHASE3
NCT00002074 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
NCT00235651 TERMINATED
Lung Transplantation; Lung Diseases
University of Pittsburgh
 2005-10 PHASE3
NCT00001646 COMPLETED
Acquired Immunodeficiency Syndrome; Aspergillosis; HIV Infections; Immunologic Deficiency Syndromes; Neutropenia
National Institute of Allergy and Infectious Diseases (NIAID)
 1997-08 PHASE3
NCT00002277 COMPLETED
Mycoses; HIV Infections
Pfizer
 PHASE3
NCT00148148 COMPLETED
Hematopoietic Stem Cell Transplantation; Fungus Diseases
University Hospital Muenster
 2004-05 PHASE2
NCT00310505 COMPLETED
Visceral Leishmaniasis
Banaras Hindu University
 2003-01
NCT00386997 TERMINATED
Fungal Infection
Gilead Sciences
 2006-11 PHASE4
NCT00190463 TERMINATED
Malignant Hemopathy; Duration of Neutropenia Following Chemotherapy > 10 Days
Assistance Publique - Hôpitaux de Paris
 2003-04 PHASE4
NCT00370825 COMPLETED
Visceral Leishmaniasis
Banaras Hindu University
 2006-09 PHASE2
NCT00002068 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
NCT00000639 COMPLETED
Meningitis, Cryptococcal; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00012467 COMPLETED
Meningitis, Cryptococcal; HIV Infections
InterMune
 2000-01 PHASE2
NCT00000776 COMPLETED
Meningitis, Cryptococcal; HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00002159 COMPLETED
HIV Infections; Histoplasmosis; Blastomycosis
Janssen, LP
 PHASE3
NCT00003315 COMPLETED
Infection
Medical Research Council
 1997-07 PHASE3
NCT00002019 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Liposome
NCT00037206 COMPLETED
Aspergillosis
Pfizer
 2002-05 PHASE2; PHASE3
NCT00002075 COMPLETED
Meningitis, Cryptococcal; HIV Infections
Pfizer
NCT00263315 COMPLETED
Aspergillosis
Erasmus Medical Center
 2000-01 PHASE2; PHASE3

(data from https://clinicaltrials.gov, updated on 2026-07-27)

Check the Amphotericin B product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Amphotericin B selectively binds to ergosterol within fungal cell membranes, forming transmembrane pores that disrupt membrane permeability and cause the lethal leakage of intracellular ions. This profound membrane destabilization results in rapid cell death, providing the mechanistic basis for its therapeutic use against invasive fungal infections and leishmaniasis observed in clinical trials.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.