Acetazolamide has been evaluated across numerous clinical trials spanning Early Phase 1 through Phase 4, targeting conditions such as acute mountain sickness, heart failure with persistent congestion, retinoschisis, PMM2-CDG, and obstructive sleep apnea. Led by university hospitals, academic centers, and research entities including Stanford University, Mayo Clinic, and the United States Army Research Institute of Environmental Medicine, these studies encompass completed, terminated, and actively recruiting statuses. Active research continues to assess specific outcomes, including retinal fluid collections and diuretic response in acute heart failure.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT00262470 | ACTIVE_NOT_RECRUITING | Tachycardia; Chronic Orthostatic Intolerance |
Satish R. Raj |
1997-04 | PHASE1; PHASE2 |
| NCT06945848 | RECRUITING | Idiopathic Intracranial Hypertension (IIH) |
University Hospital, Montpellier |
2026-01-05 | |
| NCT07737964 | NOT_YET_RECRUITING | Heart Failure |
University Hospital, Montpellier |
2026-10 | PHASE3 |
| NCT05953610 | RECRUITING | Obstructive Sleep Apnea |
University of California, Los Angeles |
2024-01-07 | PHASE2 |
| NCT06521476 | RECRUITING | Central Sleep Apnea Comorbid With Opioid Use |
Sanjay R Patel |
2025-09-30 | PHASE2 |
| NCT07469722 | NOT_YET_RECRUITING | Acute Heart Failure (AHF); Congestive Heart Failure Acute; Diuretic Effect; Lung Ultrasonography Score; Ultrasonography, Doppler; Point-of-care Ultrasound (POCUS) |
Hospital de Clinicas de Porto Alegre |
2026-03-23 | PHASE2; PHASE3 |
| NCT06166654 | RECRUITING | Acute Heart Failure |
Johannes Grand |
2024-09-05 | PHASE4 |
| NCT04887792 | RECRUITING | Schizophrenia; Schizo Affective Disorder |
Vishwajit Nimgaonkar, MD PhD |
2022-02-01 | PHASE1; PHASE2 |
| NCT06091085 | RECRUITING | OSA |
Brigham and Women's Hospital |
2024-01-31 | PHASE1; PHASE2 |
| NCT02703220 | RECRUITING | Sleep Apnea; Elderly Adults |
VA Office of Research and Development |
2015-07-03 | PHASE4 |
| NCT06584747 | ACTIVE_NOT_RECRUITING | Cerebrovascular Circulation |
Centre Antoine Lacassagne |
2025-01-09 | |
| NCT05470283 | ACTIVE_NOT_RECRUITING | Tumor; Metastatic Melanoma; Melanoma |
M.D. Anderson Cancer Center |
2022-09-07 | PHASE1 |
| NCT07635563 | RECRUITING | Obstructive Sleep Apnea (OSA) |
Incannex Healthcare Ltd |
2026-07-21 | PHASE2 |
| NCT06273397 | NOT_YET_RECRUITING | Heart Failure Acute; Decompensated Heart Failure |
Clinica Alemana de Santiago |
2024-05-01 | |
| NCT07372040 | RECRUITING | Acute Decompensated Heart Failure |
Tanta University |
2026-02-01 | PHASE2 |
| NCT03806751 | WITHDRAWN | Validation of a New Noninvasive Method to Obtain the Arterial Input Function (AIF) Directly by PET Imaging |
University of Alabama at Birmingham |
2025-02-01 | EARLY_PHASE1 |
| NCT07593612 | NOT_YET_RECRUITING | Acute Heart Failure (AHF) |
Lucrecia Maria Burgos |
2026-06-15 | PHASE4 |
| NCT05707442 | RECRUITING | Idiopathic Intracranial Hypotension; Venous Sinus Stenosis |
Beijing Tiantan Hospital |
2023-02-16 | PHASE3 |
| NCT06776432 | ACTIVE_NOT_RECRUITING | Sleep Apnea |
Shionogi |
2025-04-02 | PHASE2 |
| NCT04118387 | RECRUITING | Sleep Disordered Breathing; Able Bodied |
VA Office of Research and Development |
2021-01-07 | PHASE4 |
| NCT05589753 | RECRUITING | Sleep Apnea; Opioid Use; Sleep Disordered Breathing |
VA Office of Research and Development |
2019-05-02 | PHASE1; PHASE2 |
| NCT07707544 | ACTIVE_NOT_RECRUITING | Idiopathic Intracranial Hypertension |
Sohag University |
2026-06-01 | |
| NCT03011671 | ACTIVE_NOT_RECRUITING | Malignant Glioma of Brain |
University of Chicago |
2018-10-03 | PHASE1 |
| NCT06981234 | RECRUITING | Type 1 Diabetes |
University of California, San Diego |
2024-08-14 | PHASE2 |
| NCT05804084 | RECRUITING | Obstructive Sleep Apnea |
University of California, San Diego |
2023-05-16 | PHASE2 |
| NCT05293600 | RECRUITING | Obstructive Sleep Apnea |
Brigham and Women's Hospital |
2023-07-01 | PHASE1; PHASE2 |
| NCT03467360 | RECRUITING | Small Cell Lung Cancer |
Centre Antoine Lacassagne |
2019-08-02 | PHASE1 |
| NCT07199088 | RECRUITING | Acute Decompensated Heart Failure; Heart Failure, Diastolic; Heart Failure, Systolic |
University of Health Sciences Lahore |
2025-10-11 | |
| NCT07101250 | RECRUITING | Post Operative Pain; Laparoscopic Hysterectomy; Referred Pain |
Prisma Health-Upstate |
2025-10-30 | PHASE4 |
| NCT07517068 | ACTIVE_NOT_RECRUITING | Hypoxemia; Acute Mountain Sickness (AMS); Inflammation; Immune Response |
University of California, Riverside |
2025-09-17 | EARLY_PHASE1 |
| NCT07118462 | RECRUITING | High Altitude Effects; High Altitude Hypoxia; Acute Mountain Sickness (AMS); Plasma Volume; Women |
Centre d'Expertise sur l'Altitude EXALT |
2024-07-15 | PHASE4 |
| NCT06043830 | COMPLETED | Sleep-Disordered Breathing; Obstructive Sleep Apnea; Central Sleep Apnea; Chronic Pain; Opioid Use |
University of California, San Diego |
2023-10-18 | PHASE2 |
| NCT05589792 | COMPLETED | Obstructive Sleep Apnea |
Brigham and Women's Hospital |
2023-01-30 | PHASE1; PHASE2 |
| NCT06499727 | COMPLETED | Acute Mountain Sickness |
University of Zurich |
2024-07-15 | PHASE4 |
| NCT06498531 | COMPLETED | Sleep-Disordered Breathing |
University of Zurich |
2024-07-15 | PHASE4 |
| NCT06498505 | COMPLETED | High Altitude |
University of Zurich |
2024-07-15 | PHASE4 |
| NCT05802849 | RECRUITING | Chronic Heart Failure |
Samara State Medical University |
2023-05-01 | PHASE4 |
| NCT06535529 | UNKNOWN | Acute Decompensated Heart Failure |
Helwan University |
2024-08-24 | PHASE3 |
| NCT06783166 | RECRUITING | Acute Heart Failure |
Mansoura University |
2024-08-15 | PHASE2; PHASE3 |
| NCT05940220 | UNKNOWN | Heart Failure |
Tehran University of Medical Sciences |
2023-12-30 | PHASE3 |
| NCT06146101 | COMPLETED | Obstructive Sleep Apnea |
Incannex Healthcare Ltd |
2024-05-02 | PHASE2; PHASE3 |
| NCT05616260 | COMPLETED | Obstructive Sleep Apnea |
University of California, San Diego |
2022-12-02 | PHASE2 |
| NCT05986773 | TERMINATED | Acute Heart Failure; Diuretic Resistance |
Stadtspital Zürich |
2023-10-10 | PHASE4 |
| NCT03540914 | UNKNOWN | Altitude Hypoxia |
University of Zurich |
2018-06-01 | PHASE4 |
| NCT06414759 | UNKNOWN | Acute Decompensated Heart Failure; Volume Overload; Edema |
Cairo University |
2024-07-01 | PHASE4 |
| NCT06475105 | RECRUITING | Acute Decompensated Heart Failure |
Universitas Diponegoro |
2024-04-20 | PHASE4 |
| NCT04975269 | COMPLETED | Idiopathic Normal Pressure Hydrocephalus (INPH) |
Uppsala University Hospital |
2022-02-17 | PHASE2 |
| NCT02390284 | TERMINATED | Glaucoma |
University of Miami |
2015-09 | PHASE3 |
| NCT06362668 | COMPLETED | Acute Decompensated Heart Failure |
Reprieve Cardiovascular, Inc |
2024-05-17 | |
| NCT06114537 | COMPLETED | Retinoschisis |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
2023-01-20 | PHASE2 |
| NCT05857384 | COMPLETED | Obstructive Sleep Apnea |
Incannex Healthcare Ltd |
2023-09-08 | PHASE1 |
| NCT05411991 | COMPLETED | Acute Heart Failure; Diuretics Drug Reactions |
Vrije Universiteit Brussel |
2022-06-12 | PHASE4 |
| NCT06110078 | UNKNOWN | Obesity |
University of Arizona |
2024-01-18 | EARLY_PHASE1 |
| NCT04726982 | COMPLETED | Obstructive Sleep Apnea |
University Hospital, Antwerp |
2021-04-20 | PHASE4 |
| NCT06285760 | Not yet recruiting | Heart Failure|Persistent Congestion |
Puerta de Hierro University Hospital|Hospital Clinic of Barcelona|Hospital Central de la Defensa Gómez Ulla|Hospital Vall d''Hebron|Hospital Universitario Ramon y Cajal|University Hospital of Girona Dr.Josep Trueta|Fundación de Investigación Biomédica - Hospital Universitario de La Princesa |
2024-03 | -- |
| NCT05473364 | COMPLETED | Type 1 Diabetes |
University of California, San Diego |
2023-03-20 | PHASE1; PHASE2 |
| NCT05575180 | COMPLETED | High Altitude Effects |
University of Waterloo |
2023-08-11 | PHASE4 |
| NCT04679389 | TERMINATED | Pmm2-CDG; CDG1A |
Mayo Clinic |
2021-03-17 | PHASE2; PHASE3 |
| NCT05300477 | ACTIVE_NOT_RECRUITING | Hypobaric Hypoxia |
United States Army Research Institute of Environmental Medicine |
2022-05-27 | PHASE4 |
| NCT05904808 | COMPLETED | Chronic Heart Failure; Diuretics Drug Reactions; Congestive Heart Failure |
Rambam Health Care Campus |
2023-04-19 | PHASE4 |
| NCT06039475 | Recruiting | Acute Mountain Sickness|High Altitude Pulmonary Edema|High Altitude Cerebral Edema |
B.P. Koirala Institute of Health Sciences |
2023-07-01 | -- |
| NCT04227093 | UNKNOWN | Obstructive Sleep Apnea |
University Hospital, Antwerp |
2020-01-22 | PHASE4 |
| NCT06114537 | Recruiting | Retinoschisis |
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
2023-01-20 | Phase 2 |
| NCT04915365 | UNKNOWN | Right Heart Function; Chronic Obstructive Pulmonary Disease; Altitude Sickness |
University of Zurich |
2021-05-01 | PHASE3 |
| NCT03539367 | UNKNOWN | Altitude Hypoxia |
University of Zurich |
2018-06-01 | PHASE4 |
| NCT03537924 | UNKNOWN | Altitude Hypoxia |
University of Zurich |
2018-06-01 | PHASE4 |
| NCT05023941 | COMPLETED | Acute Mountain Sickness |
Ji Xunming,MD,PhD |
2021-12-01 | PHASE4 |
| NCT04913389 | UNKNOWN | Chronic Obstructive Pulmonary Disease; Altitude Sickness; Altitude Hypoxia |
University of Zurich |
2021-06-01 | PHASE3 |
| NCT03377049 | COMPLETED | Subarachnoid Hemorrhage, Aneurysmal; Vasospasm, Cerebral |
University of Wisconsin, Madison |
2019-07-28 | PHASE4 |
| NCT05290948 | UNKNOWN | Macular Edema |
Shahid Beheshti University of Medical Sciences |
2022-03-12 | PHASE2 |
| NCT02466074 | TERMINATED | Multiple Sclerosis |
The University of Texas Health Science Center, Houston |
2016-08-17 | PHASE2 |
| NCT04639193 | COMPLETED | OSA; Obstructive Sleep Apnea |
University of California, San Diego |
2020-12-01 | PHASE2 |
| NCT03505788 | COMPLETED | Acute Decompensated Heart Failure; Volume Overload |
Ziekenhuis Oost-Limburg |
2018-11-11 | PHASE4 |
| NCT04351061 | WITHDRAWN | Cerebrospinal Fluid Leak |
University of Miami |
2020-05-07 | PHASE2 |
| NCT04251364 | COMPLETED | Hypoxia, Altitude |
Centre d'Expertise sur l'Altitude EXALT |
2020-02-15 | |
| NCT02902133 | WITHDRAWN | Cerebrospinal Fluid Leak |
University of Miami |
2016-09-01 | PHASE2 |
| NCT04470843 | COMPLETED | Prostate Cancer; Men |
Medical College of Wisconsin |
2018-08-22 | PHASE1 |
| NCT04679389 | Terminated | Pmm2-CDG|CDG1A |
Mayo Clinic|Seattle Children''s Hospital|Children''s Hospital of Philadelphia |
2021-03-17 | Phase 2|Phase 3 |
| NCT04611373 | UNKNOWN | HCC |
The First Affiliated Hospital of Zhengzhou University |
2020-05-01 | PHASE3 |
| NCT02755298 | COMPLETED | Hypertension, Pulmonary |
University of Zurich |
2016-10 | PHASE2; PHASE3 |
| NCT03779594 | UNKNOWN | Normal Pressure Hydrocephalus |
Rabin Medical Center |
2018-12 | PHASE2 |
| NCT03720288 | UNKNOWN | Heart Failure; Acute Heart Failure |
University of Sao Paulo General Hospital |
2018-10-01 | PHASE3 |
| NCT03828474 | COMPLETED | Acute Mountain Sickness |
Stanford University |
2019-08-09 | PHASE1 |
| NCT03561675 | COMPLETED | Acute Mountain Sickness |
University of Zurich |
2018-05-15 | PHASE4 |
| NCT03501966 | TERMINATED | Idiopathic Intracranial Hypertension |
Jaeb Center for Health Research |
2019-02-06 | PHASE3 |
| NCT02904265 | TERMINATED | Landau-Kleffner Syndrome; Status Epilepticus, Electrographic |
Mayo Clinic |
2016-09 | PHASE2; PHASE3 |
| NCT03525561 | COMPLETED | Hypoxia; Exercise Performance; Cognitive Function; Dexterity |
United States Army Research Institute of Environmental Medicine |
2018-10-10 | EARLY_PHASE1 |
| NCT02755259 | COMPLETED | Hypertension, Pulmonary |
University of Zurich |
2017-01-01 | PHASE2; PHASE3 |
| NCT02945527 | TERMINATED | Neurocysticercosis |
Universidad Peruana Cayetano Heredia |
2015-12-04 | PHASE2; PHASE3 |
| NCT03424226 | COMPLETED | Acute Mountain Sickness |
Stanford University |
2018-08-04 | PHASE1 |
| NCT02992938 | COMPLETED | Hyperalgesia; Opioid-Related Disorders |
University of Chile |
2016-12 | PHASE4 |
| NCT03156231 | COMPLETED | Chronic Obstructive Pulmonary Disease (COPD) |
University of Zurich |
2017-05-24 | PHASE4 |
| NCT03177811 | COMPLETED | Chronic Obstructive Pulmonary Disease |
University of Zurich |
2017-05-24 | PHASE4 |
| NCT03536520 | COMPLETED | Altitude Hypoxia |
University of Zurich |
2018-05-15 | PHASE4 |
| NCT03536455 | COMPLETED | Altitude Hypoxia |
University of Zurich |
2018-05-15 | PHASE4 |
| NCT03536507 | COMPLETED | Altitude Hypoxia |
University of Zurich |
2018-05-15 | PHASE4 |
| NCT03540901 | COMPLETED | Chronic Obstructive Pulmonary Disease |
University of Zurich |
2018-05-22 | PHASE4 |
| NCT03536429 | COMPLETED | Altitude Hypoxia |
University of Zurich |
2018-05-15 | PHASE4 |
| NCT03167034 | COMPLETED | Chronic Obstructive Pulmonary Disease |
University of Zurich |
2017-05-24 | PHASE4 |
| NCT03173508 | COMPLETED | Chronic Obstructive Pulmonary Disease |
University of Zurich |
2017-05-24 | PHASE4 |
| NCT03177837 | COMPLETED | Chronic Obstructive Pulmonary Disease |
University of Zurich |
2017-05-24 | PHASE4 |
| NCT03177850 | COMPLETED | Chronic Obstructive Pulmonary Disease |
University of Zurich |
2017-05-24 | PHASE4 |
| NCT03963336 | COMPLETED | Idiopathic Intracranial Hypertension |
Fayoum University |
2017-07-22 | EARLY_PHASE1 |
| NCT02371473 | UNKNOWN | Central Sleep Apnea, Secondary |
Shahid Beheshti University of Medical Sciences |
2014-11 | PHASE4 |
| NCT03490916 | TERMINATED | High Altitude Pulmonary Edema |
Vincent Kan |
2018-03-23 | PHASE4 |
| NCT03154645 | COMPLETED | Acute Mountain Sickness |
Grant S Lipman |
2017-08-12 | PHASE1 |
| NCT03165890 | COMPLETED | Chronic Obstructive Pulmonary Disease (COPD) |
University of Zurich |
2017-05-24 | PHASE4 |
| NCT02758470 | COMPLETED | Hypoxia |
University of British Columbia |
2016-11 | PHASE4 |
| NCT02972411 | UNKNOWN | Altitude Sickness |
Hospital del Trabajador de Santiago |
2016-10 | |
| NCT01973335 | COMPLETED | Heart Failure |
Hasselt University |
2013-11 | PHASE4 |
| NCT00223691 | COMPLETED | Autonomic Failure; Orthostatic Hypotension |
Vanderbilt University |
2002-03 | PHASE1 |
| NCT02163330 | TERMINATED | Motor Condition as Measured by Quantified Scale; Cognitive Investigation |
Rabin Medical Center |
2014-06 | PHASE3 |
| NCT01377987 | COMPLETED | Heart Failures |
David Andrew Wellman |
2011-08 | |
| NCT02670096 | WITHDRAWN | Sleep Apnea |
NYU Langone Health |
2016-01 | |
| NCT01993667 | COMPLETED | Prophylaxis of Acute Mountain Sickness |
University of Utah |
2012-03 | PHASE4 |
| NCT03005665 | COMPLETED | Intracranial Pressure Increase |
Post Graduate Institute of Medical Education and Research, Chandigarh |
2016-02 | |
| NCT02604173 | COMPLETED | Acute Mountain Sickness |
Stanford University |
2016-08 | PHASE3 |
| NCT02760121 | COMPLETED | Altitude Sickness; Hypertension, Pulmonary |
University of British Columbia |
2016-05 | PHASE4 |
| NCT02220803 | COMPLETED | Obstructive Sleep Apnea; Sleep-Disordered Breathing; Blood Pressure; Hypertension |
Göteborg University |
2014-03 | PHASE2 |
| NCT01889498 | UNKNOWN | Thoracic Aneurysm |
Liverpool Heart and Chest Hospital NHS Foundation Trust |
2014-07 | PHASE4 |
| NCT02276989 | WITHDRAWN | Compliance; Chronic Pain |
Georgetown University |
2014-12 | PHASE2 |
| NCT01851473 | COMPLETED | Cocaine Use; Pharmacokinetics |
National Institute on Drug Abuse (NIDA) |
2012-10-24 | PHASE1 |
| NCT03107429 | COMPLETED | IOP |
University of Nottingham |
2015-03-01 | |
| NCT02760901 | COMPLETED | Cisplatin Nephrotoxicity |
Ain Shams University |
2013-11 | PHASE2 |
| NCT02165644 | WITHDRAWN | Acute Cerebrovascular Accident; Vasospasm |
University of Florida |
2015-09 | PHASE2 |
| NCT02427880 | COMPLETED | Nephrotic Syndrome; Edema |
Shiraz University of Medical Sciences |
2015-04 | PHASE4 |
| NCT01867268 | UNKNOWN | Fibrolipoma of Filum Terminale; Lipomyelomeningocele; Split Cord Malformation; Dermal Sinus; Tethered Cord Syndrome; Tumor |
Tehran University of Medical Sciences |
2012-10 | PHASE2 |
| NCT01499485 | COMPLETED | Pulmonary Disease, Chronic Obstructive; Obesity Hypoventilation Syndrome; Metabolic Alkalosis |
Hospital Son Llatzer |
2011-11 | PHASE3 |
| NCT02090738 | WITHDRAWN | H. Pylori Infection |
Yonsei University |
2014-03 | PHASE2 |
| NCT01627639 | COMPLETED | Decompensated Chronic Obstructive Pulmonary Disease |
Assistance Publique - Hôpitaux de Paris |
2011-10 | PHASE4 |
| NCT01146288 | COMPLETED | Obesity-induced Hyperfiltration |
Rabin Medical Center |
2010-07 | |
| NCT01228149 | COMPLETED | Glaucoma |
Katrin Lorenz |
2010-08 | PHASE4 |
| NCT02140450 | COMPLETED | Intraocular Pressure Change in Intravitreal Injection |
Mashhad University of Medical Sciences |
2012-02 | |
| NCT01187108 | COMPLETED | Erythrocytosis; Mountain Sickness |
University of Colorado, Denver |
2013-06 | PHASE1; PHASE2 |
| NCT00780325 | TERMINATED | Healthy Volunteers |
University of Pennsylvania |
2008-10 | PHASE1 |
| NCT01003639 | COMPLETED | Idiopathic Intracranial Hypertension |
St. Luke's-Roosevelt Hospital Center |
2010-01 | PHASE2; PHASE3 |
| NCT01750723 | COMPLETED | Headache; Migraine |
Danish Headache Center |
2012-12 | |
| NCT01427192 | COMPLETED | Pulmonary Hypertension; Breathing-Related Sleep Disorder |
University of Zurich |
2010-11 | PHASE2 |
| NCT01519544 | COMPLETED | High-altitude Sleep Disturbance |
Massachusetts General Hospital |
2012-03 | |
| NCT01418157 | COMPLETED | Acute Mountain Sickness |
Oxford University Clinical Research Unit, Vietnam |
2011-08 | PHASE4 |
| NCT00746954 | TERMINATED | Central Apnea; Heart Failure |
VA Office of Research and Development |
2008-09 | PHASE3 |
| NCT01288781 | COMPLETED | High Altitude Headache |
Bangor University |
2011-07 | |
| NCT00517426 | COMPLETED | Chronic Heart Failure |
Centro Cardiologico Monzino |
2007-07 | PHASE4 |
| NCT01131377 | UNKNOWN | Ventilator Weaning; Alkalosis, Metabolic |
Asan Medical Center |
2010-05 | |
| NCT00839501 | TERMINATED | Andersen-Tawil Syndrome |
University of Rochester |
2008-12 | PHASE1 |
| NCT01060969 | COMPLETED | Pulmonary Edema; Cerebral Edema |
Sheba Medical Center |
2006-01 | |
| NCT00222534 | COMPLETED | Respiratory Insufficiency; Alkalosis |
University of Oslo School of Pharmacy |
2002-01 | PHASE4 |
| NCT00928655 | COMPLETED | Obstructive Sleep Apnea Syndrome |
University of Zurich |
2009-06 | PHASE4 |
| NCT00864838 | COMPLETED | Age Related Macular Degeneration; Diabetic Retinopathy |
University of Sao Paulo |
2008-06 | PHASE2 |
| NCT00714740 | COMPLETED | Obstructive Sleep Apnea Syndrome |
University of Zurich |
2008-06 | PHASE4 |
| NCT00634491 | COMPLETED | Contrast Induced Nephropathy |
Shiraz University of Medical Sciences |
2007-09 | PHASE2 |
| NCT01923454 | COMPLETED | Glaucoma, Angle-closure |
Siriraj Hospital |
2005-12 | |
| NCT00108602 | WITHDRAWN | Sleep Apnea, Obstructive; Stroke |
US Department of Veterans Affairs |
2007-05 | |
| NCT00000115 | COMPLETED | Macular Edema, Cystoid |
National Eye Institute (NEI) |
1990-12 | PHASE2 |
| NCT00120731 | WITHDRAWN | Kidney Calculi |
Children's Mercy Hospital Kansas City |
2005-07 | |
| NCT00804921 | COMPLETED | Macular Edema; Diabetic Retinopathy; Macular Degeneration |
University of Sao Paulo |
PHASE2 | |
| NCT00637468 | TERMINATED | Retinal Artery Occlusion; Fibrinolysis; Visual Acuity; Stroke; Hemodilution |
University Hospital Freiburg |
2002-09 | PHASE3 |
| NCT00497120 | UNKNOWN | Sleep Apnea |
University Hospital, Antwerp |
||
| NCT00424970 | COMPLETED | High Altitude Polycythemia |
Association pour la Recherche en Physiologie de l'Environnement |
2007-01 | PHASE4 |
| NCT00485238 | UNKNOWN | Glaucoma |
National University Hospital, Singapore |
2007-02 | PHASE4 |
(data from https://clinicaltrials.gov, updated on 2025-10-08)
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>).