Atovaquone is currently evaluated in numerous clinical trials spanning Early Phase 1 through Phase 4. These studies focus on infectious indications—such as Pneumocystis jirovecii pneumonia, falciparum malaria, and cerebral toxoplasmosis—as well as oncology targets including non-small-cell lung carcinoma and high-grade glioma. Sponsored by academic, government, and pharmaceutical organizations, the trials exhibit varied recruitment statuses ranging from completed and actively recruiting to terminated and withdrawn.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07357103 | NOT_YET_RECRUITING | Pneumocystis; Pneumocystis Infection; Pneumocystis Carinii Infection; Pneumocystis Carinii; Infection, Resulting From HIV Disease; Pneumocystis Jirovecii Pneumonia; Pneumocystis Jirovecii Infection; Pneumocystosis Associated With AIDS; Pneumocystosis; Pneumonia (Etiology) |
McGill University Health Centre/Research Institute of the McGill University Health Centre |
2026-03 | PHASE4 |
| NCT06624371 | RECRUITING | High-grade Glioma; Medulloblastoma; Diffuse Intrinsic Pontine Glioma; Diffuse Midline Glioma, H3 K27M-Mutant |
Emory University |
2025-03-28 | PHASE1 |
| NCT05998135 | RECRUITING | Ovarian High Grade Serous Adenocarcinoma; Platinum-Resistant Ovarian Carcinoma |
Emory University |
2023-11-09 | PHASE2 |
| NCT06294912 | COMPLETED | Malaria |
Merck Sharp & Dohme LLC |
2024-04-18 | PHASE1 |
| NCT05974267 | COMPLETED | Malaria Infection |
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany |
2023-11-28 | PHASE2 |
| NCT04648033 | COMPLETED | Locally Advanced Non-Small Cell Lung Cancer |
University of Oxford |
2020-12-07 | PHASE1 |
| NCT03726593 | UNKNOWN | Plasmodium Falciparum Malaria (Drug Resistant) |
Armed Forces Research Institute of Medical Sciences, Thailand |
2018-10-04 | PHASE4 |
| NCT04339426 | TERMINATED | Covid19 |
HonorHealth Research Institute |
2020-04-20 | PHASE2 |
| NCT04568772 | COMPLETED | Gastroesophageal Reflux Disease |
Seoul National University Hospital |
2020-11-25 | PHASE1 |
| NCT04203186 | WITHDRAWN | Plasmodium Falciparum |
U.S. Army Medical Research and Development Command |
2020-03 | |
| NCT03813108 | TERMINATED | Malaria,Falciparum; Controlled Human Malaria Infection; Immunization; Infection |
Radboud University Medical Center |
2019-04-01 | |
| NCT04456153 | COMPLETED | COVID-19 |
University of Texas Southwestern Medical Center |
2020-07-22 | PHASE2 |
| NCT03568994 | COMPLETED | Acute Myeloid Leukemia |
Baylor College of Medicine |
2018-07-10 | EARLY_PHASE1 |
| NCT05458752 | Completed | Pneumocystis Jirovecii Infection |
Central Hospital Nancy France |
2020-04-01 | -- |
| NCT03278808 | WITHDRAWN | Malaria |
U.S. Army Medical Research and Development Command |
2018-09-17 | PHASE2 |
| NCT04002687 | COMPLETED | Malaria |
Medicines for Malaria Venture |
2019-04-04 | PHASE1 |
| NCT04002687 | Completed | Malaria |
Medicines for Malaria Venture|Richmond Pharmacology Limited |
2019-04-04 | Phase 1 |
| NCT03454048 | COMPLETED | Malaria,Falciparum; Gametocytes; Controlled Human Malaria Infection; Transmission |
Radboud University Medical Center |
2018-05-07 | |
| NCT02628080 | COMPLETED | Carcinoma, Non-Small-Cell Lung |
University of Oxford |
2016-05 | EARLY_PHASE1 |
| NCT02564471 | COMPLETED | Rabies |
State University of New York - Upstate Medical University |
2016-11-11 | PHASE4 |
| NCT02858817 | COMPLETED | Malaria |
University Hospital Tuebingen |
2016-11-28 | PHASE1 |
| NCT02836002 | COMPLETED | Malaria |
Radboud University Medical Center |
2016-06 | PHASE1; PHASE2 |
| NCT02628080 | Completed | Carcinoma Non-Small-Cell Lung |
University of Oxford |
2016-05 | Early Phase 1 |
| NCT02297477 | UNKNOWN | Malaria |
Armed Forces Research Institute of Medical Sciences, Thailand |
2014-12 | PHASE4 |
| NCT02098590 | COMPLETED | Malaria |
Radboud University Medical Center |
2014-10 | |
| NCT02080026 | COMPLETED | Malaria |
Radboud University Medical Center |
2014-06 | |
| NCT01150344 | COMPLETED | Malaria |
Assistance Publique - Hôpitaux de Paris |
2010-07 | PHASE4 |
| NCT01479361 | COMPLETED | HIV; PCP; Toxoplasmosis |
National Institutes of Health Clinical Center (CC) |
2011-10-31 | PHASE1 |
| NCT01442168 | TERMINATED | Malaria, Falciparum |
Modus Therapeutics AB |
2011-09 | PHASE1; PHASE2 |
| NCT01858831 | COMPLETED | Malaria |
GlaxoSmithKline |
2012-04 | PHASE1 |
| NCT01858831 | Completed | Malaria |
GlaxoSmithKline |
2012-04 | Phase 1 |
| NCT00984256 | COMPLETED | Malaria |
U.S. Army Medical Research and Development Command |
2009-09 | PHASE2 |
| NCT00379821 | COMPLETED | Plasmodium Falciparum Infection |
National Institute of Allergy and Infectious Diseases (NIAID) |
2007-02 | PHASE3 |
| NCT00421473 | COMPLETED | HIV Infections; Malaria |
Radboud University Medical Center |
2007-03 | PHASE4 |
| NCT00444106 | COMPLETED | Malaria; Falciparum |
Novartis |
2007-05 | PHASE4 |
| NCT00386750 | TERMINATED | Malaria; Falciparum |
Novartis Pharmaceuticals |
2005-06 | PHASE4 |
| NCT00000655 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00000802 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE3 | |
| NCT00001994 | COMPLETED | Toxoplasmosis, Cerebral; HIV Infections |
Glaxo Wellcome |
||
| NCT00001991 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
Glaxo Wellcome |
||
| NCT00451139 | COMPLETED | Malaria |
Jimma University |
PHASE4 | |
| NCT00001990 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
Glaxo Wellcome |
||
| NCT00084227 | COMPLETED | Malaria, Falciparum |
Pfizer |
2004-07 | PHASE2; PHASE3 |
| NCT00001996 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
Glaxo Wellcome |
PHASE2 | |
| NCT00000811 | COMPLETED | Bacterial Infections; Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00000773 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE1 | |
| NCT00000794 | COMPLETED | Toxoplasmosis, Cerebral; HIV Infections |
National Institute of Allergy and Infectious Diseases (NIAID) |
PHASE2 | |
| NCT00002340 | COMPLETED | Pneumonia, Pneumocystis Carinii; HIV Infections |
Glaxo Wellcome |
PHASE3 |
(data from https://clinicaltrials.gov, updated on 2026-01-21)
Check the
Atovaquone
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>).
Note: Technical data last updated: Sep 1, 2026.