Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate quinine hydrochloride across diverse indications, including malaria, COVID-19, aspiration pneumonia, obesity, renal impairment, and taste physiology. Supported by academic medical centers, government entities such as the National Institute of Allergy and Infectious Diseases, and pharmaceutical sponsors like Mutual Pharmaceutical Company, Inc., these protocols represent completed, actively recruiting, terminated, and unknown statuses. Research ranges from early-phase studies on gastrointestinal hormone release to late-phase evaluations of antimalarial susceptibility.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07572396 RECRUITING
High-risk HPV (Any Strain); LSIL, Low Grade Squamous Intraepithelial Lesion; ASC-US; HPV Infection; Cervical Abnormalities; Uterine Cervical Dysplasia
Amplexd Therapeutics, Inc.
 2026-04-30 PHASE2
NCT02902198 RECRUITING
Obesity
University Hospital, Basel, Switzerland
 2014-12
NCT04873011 UNKNOWN
Obesity
Universitaire Ziekenhuizen KU Leuven
 2020-10-29 PHASE1
NCT05682339 COMPLETED
Healthy
University of Adelaide
 2023-06-19
NCT05720390 COMPLETED
Healthy
University of Adelaide
 2023-02-02
NCT06472258 COMPLETED
Malaria
RESnTEC, Institute of Research
 2023-03-01
NCT05808231 UNKNOWN
COVID-19
Universitas Padjadjaran
 2021-04-26
NCT04553705 COMPLETED
Covid19; Immunodeficiency
Beni-Suef University
 2020-09-20 PHASE2; PHASE3
NCT04873011 Unknown status
Obesity
Universitaire Ziekenhuizen KU Leuven
 2020-10-29 Phase 1
NCT03565133 COMPLETED
Obesity
Maastricht University Medical Center
 2018-08-17
NCT03985865 COMPLETED
Obesity
Universitaire Ziekenhuizen KU Leuven
 2017-03-02 PHASE4
NCT02630472 TERMINATED
Rhinitis; Sinusitis
University of Pennsylvania
 2015-10 PHASE1; PHASE2
NCT02817919 Completed
Malaria
African Collaborating Centre for Pharmacovigilance|Kintampo Health Research Centre Ghana|University of Health and Allied Sciences
 2016-05 --
NCT02946970 COMPLETED
Healthy
Universitaire Ziekenhuizen KU Leuven
 2015-09
NCT02276989 WITHDRAWN
Compliance; Chronic Pain
Georgetown University
 2014-12 PHASE2
NCT02598713 Recruiting
Pneumonia|Aspiration
Massachusetts General Hospital
 2015-12 Phase 1
NCT02759926 UNKNOWN
Healthy; Obesity
Universitaire Ziekenhuizen KU Leuven
 2011-08
NCT01851473 COMPLETED
Cocaine Use; Pharmacokinetics
National Institute on Drug Abuse (NIDA)
 2012-10-24 PHASE1
NCT02492178 COMPLETED
Malaria
University of Oxford
 2015-07 PHASE2
NCT02092766 COMPLETED
Anaemia
University of Oxford
 2014-06 PHASE4
NCT01374581 COMPLETED
Malaria
Universiteit Antwerpen
 2012-05 PHASE3
NCT02563704 COMPLETED
Malaria
University of Yaounde 1
 2013-09 PHASE3
NCT02255812 COMPLETED
Exploratory Behavior
University Hospital, Basel, Switzerland
 2013-03
NCT02974348 COMPLETED
Drug Resistant Malaria Due to Plasmodium Falciparum
University of Bamenda
 2013-01 PHASE3
NCT01805232 UNKNOWN
Malaria
University of Khartoum
 2013-03 PHASE4
NCT01258049 COMPLETED
Plasmodium Falciparum Malaria
Proto Pharma Ltd
 2010-12 PHASE3
NCT00785551 TERMINATED
Healthy; Renal Impairment
Mutual Pharmaceutical Company, Inc.
 2007-11 PHASE1
NCT01047436 COMPLETED
Falciparum Malaria
Proto Pharma Ltd
 2009-12 PHASE2
NCT00639873 COMPLETED
Malaria
Medical University of Vienna
 2008-06
NCT00495508 COMPLETED
Malaria
Epicentre
 2006-10 PHASE4
NCT00785980 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2008-09 PHASE1
NCT00785213 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2008-09 PHASE1
NCT00779259 COMPLETED
Pharmacokinetics
Mutual Pharmaceutical Company, Inc.
 2007-08 PHASE1
NCT00806078 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2007-07 PHASE1
NCT00329134 COMPLETED
Malaria
University Ghent
 2006-07 PHASE2
NCT00785486 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2007-03 PHASE1
NCT00726414 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2005-12 PHASE1
NCT00299208 COMPLETED
Plasmodium Falciparum Malaria
National Institute of Allergy and Infectious Diseases (NIAID)
 PHASE2
NCT00726895 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2004-05 PHASE1
NCT00727272 COMPLETED
Healthy
Mutual Pharmaceutical Company, Inc.
 2004-02 PHASE1
NCT00322907 TERMINATED
Clinical Malaria
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland
 2000-04 PHASE2
NCT00451139 COMPLETED
Malaria
Jimma University
 PHASE4
NCT00124267 UNKNOWN
Cerebral Malaria
Makerere University
 2003-09 PHASE3
NCT00540202 UNKNOWN
Uncomplicated Malaria
Makerere University
 2007-09 PHASE4
NCT00000706 COMPLETED
HIV Infections
National Institute of Allergy and Infectious Diseases (NIAID)
NCT00167739 COMPLETED
Malaria
Albert Schweitzer Hospital
 2003-04 PHASE4

(data from https://clinicaltrials.gov, updated on 2026-05-14)

Check the Quinine HCl Dihydrate product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Quinine HCl Dihydrate acts as a potassium channel blocker and antimalarial agent that binds cellular K+ channels and inhibits parasite heme biocrystallization within infected erythrocytes. This blockade disrupts membrane potential homeostasis and causes cytotoxic accumulation of unpolymerized heme, resulting in parasite elimination and clinical therapeutic efficacy in Plasmodium falciparum malaria.

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.