Numerous clinical trials evaluate caspofungin across Phase 1 through Phase 4, alongside observational and pharmacokinetic studies, for indications including candidiasis, aspergillosis, septic shock, peritonitis, and fungal prophylaxis in liver transplantation or hematological malignancies. Conducted by industry sponsors such as Merck Sharp & Dohme LLC and academic institutions like the European Organisation for Research and Treatment of Cancer and European university hospitals, these studies encompass completed, recruiting, terminated, withdrawn, and not yet recruiting statuses.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07788586 | NOT_YET_RECRUITING | Candidemia; Invasive Candidiasis |
Oliver Cornely, MD |
2026-09 | PHASE4 |
| NCT05421858 | RECRUITING | Candidemia; Candidiasis, Invasive |
Basilea Pharmaceutica |
2024-12-11 | PHASE3 |
| NCT06194201 | UNKNOWN | Patients With Candidemia and/or Invasive Candidiasis |
Fujian Shengdi Pharmaceutical Co., Ltd. |
2024-04-27 | PHASE2 |
| NCT06892951 | NOT_YET_RECRUITING | Pneumocystis Pneumonia; Pneumocystis Jirovecii Infection; Pneumocystis Infections |
University Hospital, Tours |
2025-06 | PHASE1; PHASE2 |
| NCT04728971 | UNKNOWN | Liver Transplantation |
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine |
2022-10-01 | PHASE4 |
| NCT03580733 | UNKNOWN | ICU Yeast Intra-abdominal Infection |
Centre Hospitalier Universitaire, Amiens |
2019-01-01 | PHASE3 |
| NCT03978559 | UNKNOWN | Pneumocystis Pneumonia |
Bin Du |
2019-08-14 | PHASE4 |
| NCT03667690 | COMPLETED | Candidemia; Mycoses; Fungal Infection; Invasive Candidiases |
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
2018-10-07 | PHASE3 |
| NCT02603575 | UNKNOWN | Pneumocystis Pneumonia |
Beijing Chao Yang Hospital |
2015-11 | |
| NCT03857399 | COMPLETED | Fungal Infection |
Cttq |
2018-09-17 | PHASE2 |
| NCT01503515 | COMPLETED | Fungal Infection; Hematopoietic and Lymphoid Cell Neoplasm |
Children's Oncology Group |
2013-03-21 | PHASE3 |
| NCT02734862 | COMPLETED | Candidemia; Mycoses; Fungal Infection; Fungemia; Invasive Candidiasis |
Cidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) |
2016-07-26 | PHASE2 |
| NCT01288378 | COMPLETED | Fungal Infection; Leukemia; Myelodysplastic Syndromes |
European Organisation for Research and Treatment of Cancer - EORTC |
2012-03 | PHASE3 |
| NCT04674657 | Unknown status | Critical Illness|Extracorporeal Membrane Oxygenation Complication|Infection |
Royal Brompton & Harefield NHS Foundation Trust |
2018-09-03 | -- |
| NCT01307579 | COMPLETED | Acute Myeloid Leukemia; Adult Acute Monoblastic Leukemia; Adult Acute Monocytic Leukemia; Adult Acute Myeloid Leukemia in Remission; Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With Maturation; Adult Acute Myeloid Leukemia With Minimal Differentiation; Adult Acute Myeloid Leukemia With t(16;16)(p13.1;q22); CBFB-MYH11; Adult Acute Myeloid Leukemia With t(8;21); (q22; q22.1); RUNX1-RUNX1T1; Adult Acute Myeloid Leukemia With t(9;11)(p22.3;q23.3); MLLT3-KMT2A; Adult Acute Myeloid Leukemia Without Maturation; Adult Acute Myelomonocytic Leukemia; Alkylating Agent-Related Acute Myeloid Leukemia; Childhood Acute Monoblastic Leukemia; Childhood Acute Monocytic Leukemia; Childhood Acute Myeloid Leukemia in Remission; Childhood Acute Myeloid Leukemia With Maturation; Childhood Acute Myeloid Leukemia With Minimal Differentiation; Childhood Acute Myeloid Leukemia Without Maturation; Childhood Acute Myelomonocytic Leukemia; Fungal Infection; Myeloid Neoplasm; Neutropenia; Recurrent Adult Acute Myeloid Leukemia; Recurrent Childhood Acute Myeloid Leukemia; Secondary Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia; Untreated Childhood Myeloid Neoplasm |
Children's Oncology Group |
2011-04-04 | PHASE3 |
| NCT02895529 | TERMINATED | Hematologic Neoplasms |
Xian-Janssen Pharmaceutical Ltd. |
2016-11-30 | PHASE4 |
| NCT02596984 | COMPLETED | Shock |
Centre Hospitalier Universitaire de Saint Etienne |
2015-03-16 | |
| NCT03399032 | Completed | Septic Shock|Fungal Infection|Critical Illness |
Medical University of Lublin |
2018-02-05 | -- |
| NCT01945281 | TERMINATED | Candidiasis, Invasive |
Merck Sharp & Dohme LLC |
2014-01-15 | PHASE2 |
| NCT01501708 | UNKNOWN | Leukemia; Transplantation, Hematopoietic Stem Cell |
Shanghai Jiao Tong University School of Medicine |
2011-12 | PHASE2 |
| NCT02856178 | WITHDRAWN | Pulmonary Aspergillosis - Invasive; Acute Myeloid Leukemia |
F2G Ltd |
2017-04-20 | PHASE1; PHASE2 |
| NCT02805049 | Completed | Septic Shock|Peritonitis |
Centre Hospitalier Universitaire de Nīmes |
2017-01-28 | Phase 4 |
| NCT02941068 | COMPLETED | Intra-abdominal Perforation |
Nanjing PLA General Hospital |
2012-03 | PHASE2 |
| NCT02510053 | UNKNOWN | Invasive Fungal Infection |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University |
2014-07 | |
| NCT03798600 | Completed | Critical Illness|Infection |
Careggi Hospital |
2016-01-01 | -- |
| NCT01994096 | COMPLETED | Critically Ill; Suspected Invasive Candidiasis |
University Medical Center Groningen |
2013-11 | PHASE4 |
| NCT00413218 | COMPLETED | Candidiasis, Invasive; Candidemia; Mycoses |
Astellas Pharma Inc |
2007-03-08 | PHASE3 |
| NCT02596984 | Completed | Shock |
Centre Hospitalier Universitaire de Saint Etienne|Merck Sharp & Dohme LLC |
2015-03-16 | Not Applicable |
| NCT01499433 | UNKNOWN | Invasive Pulmonary Aspergillosis; Chronic Obstructive Pulmonary Disease |
The First Affiliated Hospital of Guangzhou Medical University |
2012-01 | PHASE4 |
| NCT01968395 | COMPLETED | Bacterial Infections and Mycoses; Liver Disease |
Erasme University Hospital |
2013-09 | PHASE4 |
| NCT00982540 | TERMINATED | Invasive Fungal Infections; Invasive Aspergillosis; Invasive Fusariosis |
Universidade Federal do Rio de Janeiro |
2010-02 | |
| NCT01165320 | COMPLETED | Candidiasis, Esophageal; Candidiasis, Invasive; Aspergillosis |
Merck Sharp & Dohme LLC |
2010-07-06 | PHASE2 |
| NCT01318148 | COMPLETED | Fungal Infection |
Werner J. Heinz |
2011-04 | PHASE2 |
| NCT01260974 | UNKNOWN | Fungemia; Mycoses |
Azienda Ospedaliera di Padova |
2009-05 | PHASE2 |
| NCT00805740 | TERMINATED | Candidiasis; Fungemia |
Pfizer |
2009-04 | PHASE3 |
| NCT01058174 | COMPLETED | Liver Transplantation; Mycoses |
Astellas Pharma Inc |
2009-12-15 | PHASE3 |
| NCT01045798 | TERMINATED | Invasive Candidiasis |
Merck Sharp & Dohme LLC |
2010-12 | PHASE2 |
| NCT00806351 | TERMINATED | Fungemia; Neutropenia; Candidiasis |
Pfizer |
2009-08 | PHASE3 |
| NCT00635648 | COMPLETED | Fungal Infection |
Merck Sharp & Dohme LLC |
2008-01 | PHASE3 |
| NCT01062165 | COMPLETED | Obesity; Fungal Infection |
Texas Tech University Health Sciences Center |
2010-02 | PHASE4 |
| NCT00717860 | COMPLETED | Fungal Infection |
Merck Sharp & Dohme LLC |
2008-08 | PHASE3 |
| NCT00839540 | COMPLETED | Candidemia |
Gary E. Stein, Pharm.D. |
2008-12 | PHASE4 |
| NCT00520234 | COMPLETED | Invasive Candidiasis |
Mycoses Study Group |
2007-08 | PHASE4 |
| NCT00748345 | COMPLETED | Thermal Injury |
Assistance Publique - Hôpitaux de Paris |
2009-02 | PHASE2; PHASE3 |
| NCT00404092 | COMPLETED | Invasive Aspergillosis |
University of Cologne |
2006-10 | PHASE2 |
| NCT00501098 | COMPLETED | Invasive Pulmonary Aspergillosis |
Northern Italy Leukemia Group |
2007-01 | PHASE2 |
| NCT00238355 | TERMINATED | Infection; Unspecified Adult Solid Tumor, Protocol Specific |
OHSU Knight Cancer Institute |
2003-08 | PHASE2 |
| NCT00110045 | COMPLETED | Cancer |
European Organisation for Research and Treatment of Cancer - EORTC |
2005-02 | PHASE2 |
| NCT00250432 | COMPLETED | Invasive Candidiasis |
Merck Sharp & Dohme LLC |
2006-01 | PHASE3 |
| NCT00082524 | COMPLETED | Aspergillosis; Candidiasis |
Merck Sharp & Dohme LLC |
2004-04 | PHASE2 |
| NCT00548080 | COMPLETED | Fungal Infection |
Merck Sharp & Dohme LLC |
2006-03 | PHASE3 |
| NCT00082537 | COMPLETED | Neutropenia; Fever |
Merck Sharp & Dohme LLC |
2004-04 | PHASE2 |
| NCT00330395 | COMPLETED | Candidiasis |
Merck Sharp & Dohme LLC |
2006-05 | PHASE2 |
| NCT00292071 | COMPLETED | Fungal Infection |
Merck Sharp & Dohme LLC |
2004-05 | PHASE2 |
| NCT00379964 | COMPLETED | Fungal Infection |
Merck Sharp & Dohme LLC |
2005-06 | PHASE3 |
| NCT00105144 | COMPLETED | Candidiasis; Candidemia |
Astellas Pharma Inc |
2004-09 | PHASE3 |
| NCT00083343 | COMPLETED | Candidiasis |
Merck Sharp & Dohme LLC |
2004-05 | PHASE2 |
| NCT00665639 | COMPLETED | Candidiasis, Oral |
Astellas Pharma Inc |
2004-06 | PHASE3 |
| NCT00076869 | COMPLETED | Aspergillosis |
Merck Sharp & Dohme LLC |
2003-01 | PHASE2 |
| NCT00008359 | COMPLETED | Cancer |
Memorial Sloan Kettering Cancer Center |
2000-08 | PHASE3 |
| NCT00333645 | UNKNOWN | Liver Transplantation; Fungal Infection |
Grupo de Estudio de Infecciones en Transplantados |
2003-10 | PHASE2 |
| NCT00099775 | COMPLETED | Candidiasis |
National Cancer Institute (NCI) |
2004-12 | PHASE3 |
| NCT00334412 | COMPLETED | Invasive Aspergillosis |
Gilead Sciences |
2004-03 | PHASE4 |
| NCT00148148 | COMPLETED | Hematopoietic Stem Cell Transplantation; Fungus Diseases |
University Hospital Muenster |
2004-05 | PHASE2 |
| NCT00095316 | TERMINATED | Candidiasis |
National Institute of Allergy and Infectious Diseases (NIAID) |
2004-10 | PHASE3 |
| NCT00020527 | COMPLETED | Fever, Sweats, and Hot Flashes; Infection; Kidney Cancer; Leukemia; Lymphoma; Neuroblastoma; Neutropenia; Sarcoma |
National Cancer Institute (NCI) |
2001-03 |
(data from https://clinicaltrials.gov, updated on 2026-09-01)
Check the
Caspofungin (MK-0991) Acetate
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
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>).
- Caspofungin (MK-0991) Acetate Solubility in DMSO
- Caspofungin (MK-0991) Acetate Storage
- Caspofungin (MK-0991) Acetate Stability
- Caspofungin (MK-0991) Acetate Molecular Weight
- Caspofungin (MK-0991) Acetate SMILES
- Caspofungin (MK-0991) Acetate CAS Number
- Caspofungin (MK-0991) Acetate Chemical Structure (2D and 3D)
- Caspofungin (MK-0991) Acetate SDS｜MSDS
Note: Technical data last updated: Sep 1, 2026.