Clinical Trials

Numerous clinical trials evaluate levodopa and related therapeutic regimens across Phase 1 through Phase 4, focusing predominantly on Parkinson's disease, levodopa-induced dyskinesias, and central nervous system movement disorders. These investigations are sponsored by diverse entities ranging from pharmaceutical companies—such as AbbVie, NeuroDerm Ltd., and PharmaTher Inc.—to academic institutions like Stanford University. Across this global clinical portfolio, study statuses encompass completed, active non-recruiting, suspended, and upcoming protocols that are not yet recruiting.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07151378 RECRUITING
PARKINSON DISEASE (Disorder)
University Hospital Tuebingen
2025-10-27 PHASE3
NCT07793461 NOT_YET_RECRUITING
Parkinson's Disease
Beth Israel Deaconess Medical Center
2027-07 PHASE4
NCT06891781 NOT_YET_RECRUITING
Parkinson Disease, Idiopathic
Newronika
2026-08
NCT07781696 NOT_YET_RECRUITING
Freezing of Gait Symptoms in Parkinson Disease
Iahn Cajigas
2026-09
NCT06013956 RECRUITING
Parkinson Disease
David Escobar
2023-08-29 PHASE4
NCT05285683 RECRUITING
Chronic Pain
University of Rochester
2024-01-31 PHASE2
NCT04735627 RECRUITING
Parkinson Disease
University of California, San Diego
2021-12-07
NCT07725562 RECRUITING
Parkinson Disease (PD)
Zhejiang Vimgreen Pharmaceuticals, Ltd.
2026-07-17 PHASE2; PHASE3
NCT07647913 NOT_YET_RECRUITING
Parkinson Disease(PD)
McMaster University
2026-09-01
NCT07432958 RECRUITING
Parkinson Disease
Appello Pharmaceuticals, Inc.
2026-02-25 PHASE2
NCT06234995 RECRUITING
Parkinson Disease
Emory University
2021-08-09 PHASE4
NCT06570824 RECRUITING
Dyskinesia, Drug-Induced; Parkinson Disease
Danish Research Centre for Magnetic Resonance
2024-08-22
NCT06075771 RECRUITING
Anhedonia; Depression
Emory University
2023-11-21 PHASE4
NCT06316232 RECRUITING
Freezing of Gait; Parkinson Disease
IRCCS Istituto delle Scienze Neurologiche di Bologna
2023-10-10 PHASE4
NCT06785298 RECRUITING
Parkinson Disease
Tanta University
2024-12-10 PHASE2; PHASE3
NCT07229664 RECRUITING
Parkinson Disease
Tanta University
2025-11-10 PHASE2; PHASE3
NCT07229651 RECRUITING
Parkinson Disease
Tanta University
2025-11-10 PHASE2; PHASE3
NCT07246278 RECRUITING
Parkinson Disease
Tanta University
2025-11-20 PHASE1; PHASE2
NCT06113640 RECRUITING
Parkinson Disease
Mostafa Bahaa
2023-11-05 PHASE2; PHASE3
NCT06831500 RECRUITING
Multi-system Atrophy - Parkinsonian Type; Orthostatic Hypotension, Dysautonomic; Parkinson Disease
Julien Bally
2025-07-18 PHASE1; PHASE2
NCT07375693 ENROLLING_BY_INVITATION
Parkinson Disease
Bangladesh Medical University
2026-02-17 PHASE2
NCT07442591 RECRUITING
Healhty
Shanghai WD Pharmaceutical Co., Ltd.
2026-03-24 PHASE1
NCT07001150 RECRUITING
Parkinson Disease
Tanta University
2025-05-10 PHASE2
NCT06722729 ACTIVE_NOT_RECRUITING
Parkinson Disease
Kissei Pharmaceutical Co., Ltd.
2024-12-16 PHASE2
NCT06772220 RECRUITING
Parkinson&Amp;#39;s Disease
Oregon Health and Science University
2024-03-05
NCT06365515 UNKNOWN
Hormonal Changes; Menstrual Cycle
University Hospital Tuebingen
2024-05
NCT07444892 COMPLETED
Diabetic Retinopathy
Emory University
2022-04-18 PHASE2
NCT06765668 RECRUITING
Parkinson Disease
Impax Laboratories, LLC
2025-02-12 PHASE4
NCT06596876 COMPLETED
Parkinson's Disease
Jiangsu HengRui Medicine Co., Ltd.
2024-11-06 PHASE3
NCT05471609 COMPLETED
Healthy Volunteers
University of Minnesota
2025-06-12 EARLY_PHASE1
NCT06954662 COMPLETED
Parkinson Disease, Idiopathic
UConn Health
2025-05-22 EARLY_PHASE1
NCT07055958 ACTIVE_NOT_RECRUITING
Parkinson Disease
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
2024-12-29 PHASE3
NCT05463367 ACTIVE_NOT_RECRUITING
Opioid Use; Opioid Dependence; Opioid-use Disorder; Narcotic Use; Back Pain; Back Injuries; Chronic Pain; Chronic Low-back Pain; Pain, Chronic; Pain;Back Low;Chronic; Pain, Back
Northwestern University
2021-01-01 PHASE2
NCT06587217 COMPLETED
Parkinsonian Signs in Older Persons
University of Michigan
2024-10-29 PHASE1; PHASE2
NCT05094011 Not yet recruiting
Idiopathic Parkinson''s Disease
Taiwan Mitochondrion Applied Technology Co. Ltd.
2025-03-01 Phase 1
NCT05781711 COMPLETED
Parkinson Disease
Tanta University
2023-01-06 PHASE2
NCT05297201 COMPLETED
Parkinson Disease; Dyskinesia, Medication-Induced
Celon Pharma SA
2021-11-02 PHASE2
NCT06115538 UNKNOWN
Parkinson Disease; Treatment Adherence
Ankara Ataturk Sanatorium Training and Research Hospital
2023-10-01 PHASE4
NCT05962957 COMPLETED
Parkinson Disease
Mostafa Bahaa
2023-08-07 PHASE2
NCT04218526 COMPLETED
Parkinson Disease
Jonathan Jagid
2020-04-27
NCT06284629 Not yet recruiting
Parkinson Disease
Rigshospitalet Denmark|Odense University Hospital|Zealand University Hospital
2024-09-01 Not Applicable
NCT05262348 WITHDRAWN
Parkinson Disease
Newronika
2022-08
NCT03735901 ACTIVE_NOT_RECRUITING
Acute Stroke; Stroke Rehabilitation
University Hospital, Basel, Switzerland
2019-06-14 PHASE3
NCT05558189 Not yet recruiting
Parkinson Disease
Stanford University
2024-08-20 Not Applicable
NCT05959044 UNKNOWN
Parkinson Disease
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
2023-04-16 PHASE2
NCT06236230 UNKNOWN
Parkinson Disease
Second Affiliated Hospital of Soochow University
2023-11-15 PHASE4
NCT06339034 Not yet recruiting
Parkinson Disease
State University of New York at Buffalo|The Cure Parkinson''s Trust
2024-06 Phase 1|Phase 2
NCT06219915 COMPLETED
Parkinsonian Signs in Older Persons
University of Michigan
2024-03-15 PHASE1; PHASE2
NCT04821830 COMPLETED
Parkinson Disease
University of Michigan
2020-02-12 PHASE4
NCT05119075 COMPLETED
Parkinson Disease
Insel Gruppe AG, University Hospital Bern
2021-11-10
NCT06614153 COMPLETED
Parkinson's Disease
Jiangsu HengRui Medicine Co., Ltd.
2023-05-16 PHASE2
NCT04542499 COMPLETED
Parkinson Disease
AbbVie
2020-09-23 PHASE3
NCT06180720 UNKNOWN
Healthy
The Affiliated Hospital of Qingdao University
2023-12-20 PHASE1
NCT06432309 COMPLETED
Parkinson Disease; Effect of Drug
University Hospital of Ferrara
2022-07-01
NCT04952194 UNKNOWN
Parkinson Disease
Second Affiliated Hospital, Zhejiang University, School of Medicine
2022-01-01 PHASE4
NCT05752240 UNKNOWN
Parkinson Disease
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
2022-03-10
NCT04912115 SUSPENDED
Dyskinesias; Movement Disorders; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations
PharmaTher Inc.
2021-10-05 PHASE2
NCT05087914 WITHDRAWN
Acute Pain; Bunionectomy; Toe Fusion
Northwestern University
2021-11-01 PHASE2
NCT05795088 UNKNOWN
Parkinson Disease
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
2022-06-16
NCT04147949 UNKNOWN
Parkinson Disease; Dyskinesia, Medication-Induced; L-Dopa Causing Adverse Effects in Therapeutic Use
VistaGen Therapeutics, Inc.
2022-08 PHASE2
NCT06037590 COMPLETED
Parkinson; Parkinson Disease; Parkinson's Disease and Parkinsonism
PureIMS B.V.
2023-09-25 PHASE1
NCT04723147 COMPLETED
Depression; Anhedonia
Emory University
2021-01-29 PHASE4
NCT04052776 COMPLETED
Spinal Cord Injuries; Drug Effect
Centre Hospitalier Universitaire Vaudois
2020-09-11 PHASE1
NCT05976737 UNKNOWN
Healthy
The Affiliated Hospital of Qingdao University
2023-08-17 PHASE1
NCT04742348 WITHDRAWN
Alcohol Drinking
University of Washington
2023-02 PHASE4
NCT05312632 COMPLETED
Parkinson Disease
Eisai Korea Inc.
2022-04-05 PHASE4
NCT05487300 COMPLETED
Parkinson Disease; Orthostatic Hypotension
University of Utah
2022-05-11 PHASE2; PHASE3
NCT04990284 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
2021-11-29 PHASE4
NCT05094050 COMPLETED
Parkinson's Disease
AbbVie
2022-01-18 PHASE1
NCT05683925 COMPLETED
Parkinson Disease; Gait Disorders, Neurologic
University Medical Centre Ljubljana
2022-09-01
NCT05148884 COMPLETED
Medication-Induced Dyskinesia
Neurolixis SAS
2021-11-09 PHASE2
NCT04978597 COMPLETED
Parkinson
Bial - Portela C S.A.
2021-05-31 PHASE3
NCT05492019 UNKNOWN
Parkinson Disease
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
2022-07-01 PHASE2
NCT05036473 COMPLETED
Parkinson Disease
Shanghai WD Pharmaceutical Co., Ltd.
2021-11-11 PHASE2
NCT04082715 WITHDRAWN
Chronic Back Pain
Second Affiliated Hospital of Wenzhou Medical University
2019-10 PHASE2
NCT05435729 COMPLETED
Levodopa-induced Dyskinesia; Parkinson's Disease
Sumitomo Pharma Co., Ltd.
2022-05-31 PHASE1
NCT05083260 COMPLETED
Parkinson Disease
BioVie Inc.
2022-01-04 PHASE1; PHASE2
NCT02542696 COMPLETED
Parkinson Disease
Sumitomo Pharma America, Inc.
2015-08-31 PHASE3
NCT03111485 COMPLETED
Parkinson's Disease; Obstructive Sleep Apnea
McGill University Health Centre/Research Institute of the McGill University Health Centre
2017-05-24 PHASE4
NCT06021756 UNKNOWN
Levodopa-Induced Dyskinesia; Parkinson's Disease
University of Arizona
2019-07-28 PHASE1
NCT04821687 COMPLETED
Parkinson Disease
SK Chemicals Co., Ltd.
2021-06-17 PHASE4
NCT04778176 COMPLETED
Parkinson's Disease
SynAgile Corporation
2021-06-16 PHASE2
NCT03929068 COMPLETED
Amyotrophic Lateral Sclerosis; Motor Neuron Disease
Washington University School of Medicine
2019-05-13 PHASE1
NCT05523791 COMPLETED
Parkinson Disease
Ospedale Generale Di Zona Moriggia-Pelascini
2022-01-01
NCT05116813 TERMINATED
Parkinson Disease; Dyskinesia, Drug-Induced; Dyskinesias
Addex Pharma S.A.
2021-10-25 PHASE2; PHASE3
NCT04857359 TERMINATED
Parkinson Disease; Dyskinesia, Drug-Induced; Dyskinesias
Addex Pharma S.A.
2021-08-06 PHASE2; PHASE3
NCT05901350 COMPLETED
Parkinson Disease; Visual Impairment
Qilu Hospital of Shandong University
2019-06-01
NCT05250141 COMPLETED
Bioequivalence
Laboratorios Andromaco S.A.
2022-02-14 PHASE1
NCT04590612 UNKNOWN
Parkinson Disease; Depression
Western University, Canada
2021-01
NCT04650217 TERMINATED
Depressive Disorder
New York State Psychiatric Institute
2021-10-07 PHASE4
NCT05128175 COMPLETED
Parkinson Disease
Shanghai WD Pharmaceutical Co., Ltd.
2021-10-29 PHASE1
NCT02480803 COMPLETED
Parkinson's Disease
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
2014-12-19 PHASE4
NCT06275633 COMPLETED
Parkinson Disease; Medication; UPDRS; Motor Function; Cognitive Impairment; Depression; Impulsive; Levodopa
University Hospital Bispebjerg and Frederiksberg
2019-03-19
NCT00660673 COMPLETED
Advanced Parkinson's Disease
AbbVie
2009-11-13 PHASE3
NCT04493320 TERMINATED
Depression; Cognitive Impairment; Gait Impairment
New York State Psychiatric Institute
2021-02-10 PHASE4
NCT04380142 COMPLETED
Parkinson's Disease (PD)
AbbVie
2020-10-19 PHASE3
NCT04054960 UNKNOWN
Parkinson Disease
Western University, Canada
2019-09
NCT03881371 COMPLETED
Parkinson Disease
Zambon SpA
2019-08-01 PHASE3
NCT03391882 COMPLETED
Motor OFF Episodes Associated With Parkinson's Disease
Sumitomo Pharma America, Inc.
2018-12-19 PHASE3
NCT03065192 COMPLETED
Idiopathic Parkinson's Disease; Parkinson's Disease; Basal Ganglia Disease; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Nervous System Diseases; Neurodegenerative Diseases; Parkinsonian Disorders
Neurocrine Biosciences
2017-05-11 PHASE1
NCT03670953 COMPLETED
Parkinson's Disease (Disorder)
Impax Laboratories, LLC
2018-11-06 PHASE3
NCT04591535 UNKNOWN
Parkinson Disease
Hong Kong WD Pharmaceutical Co., Limited
2020-09-28 PHASE1
NCT02589340 TERMINATED
Parkinson's Disease; Dyskinesias; Movement Disorders
Oregon Health and Science University
2016-01 PHASE1
NCT04173845 UNKNOWN
Levodopa-Induced Dyskinesia
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
2019-09-01
NCT02873351 WITHDRAWN
Age-related Macular Degeneration
Snyder, Robert W., M.D., Ph.D., P.C.
2019-09 PHASE2
NCT02601586 COMPLETED
Parkinson Disease
University Hospital, Toulouse
2016-09 PHASE2; PHASE3
NCT04513340 UNKNOWN
Parkinson Disease
Hong Kong WD Pharmaceutical Co., Limited
2020-08-13 PHASE1
NCT03922711 TERMINATED
Parkinson Disease
Prilenia
2019-05-22 PHASE2
NCT03197493 COMPLETED
Macula; Degeneration; Retina
Snyder, Robert W., M.D., Ph.D., P.C.
2017-08-01 PHASE2
NCT02549092 COMPLETED
Advanced Parkinson's Disease
AbbVie
2015-10-26 PHASE3
NCT03703570 COMPLETED
Parkinson's Disease
Kyowa Kirin Co., Ltd.
2018-09-29 PHASE2
NCT03419806 COMPLETED
Parkinson Disease
Vastra Gotaland Region
2018-02-16 PHASE1
NCT03023059 COMPLETED
Age-related Macular Degeneration
Snyder, Robert W., M.D., Ph.D., P.C.
2017-05-02 PHASE2
NCT02513485 COMPLETED
Depression
Emory University
2015-10-09 PHASE4
NCT03162874 COMPLETED
Parkinson Disease
Prexton Therapeutics
2017-07-04 PHASE2
NCT01973543 COMPLETED
Parkinson's Disease
Neurocrine Biosciences
2013-10 PHASE1
NCT03022318 COMPLETED
Age-related Macular Degeneration
Snyder, Robert W., M.D., Ph.D., P.C.
2017-05-02 PHASE2
NCT02615873 UNKNOWN
Parkinson's Disease
Intec Pharma Ltd.
2016-07 PHASE3
NCT03451500 TERMINATED
Age Related Macular Degeneration
Snyder, Robert W., M.D., Ph.D., P.C.
2018-07-01 PHASE2
NCT03205956 COMPLETED
Parkinson's Disease
Kevin J. Black, MD
2017-10-19 PHASE1
NCT02799381 COMPLETED
Parkinson's Disease (PD)
AbbVie
2017-02-09 PHASE3
NCT04236921 COMPLETED
Other
Riverside Pharmacueticals Corporation
2019-07-15 PHASE1
NCT02726386 ACTIVE_NOT_RECRUITING
Parkinson's Disease
NeuroDerm Ltd.
2016-05-04 PHASE2
NCT03761004 COMPLETED
Healthy Volunteers
Hong Kong WD Pharmaceutical Co., Limited
2019-01-14 PHASE1
NCT02605434 UNKNOWN
Parkinson's Disease
Intec Pharma Ltd.
2016-03 PHASE3
NCT03887884 COMPLETED
Parkinson's Disease
Acorda Therapeutics
2019-03-05 PHASE1
NCT03599726 COMPLETED
Parkinson Disease
Oregon Health and Science University
2018-07-30 EARLY_PHASE1
NCT03331848 WITHDRAWN
Parkinson Disease
Prexton Therapeutics
2018-01-15 PHASE2
NCT03235037 COMPLETED
Angelman Syndrome
Bennett Lavenstein
2013-11-26
NCT03576638 UNKNOWN
Parkinson Disease
Intec Pharma Ltd.
2018-07 PHASE2
NCT03462043 WITHDRAWN
Parkinson
NeuroDerm Ltd.
2018-04-10 PHASE3
NCT03119636 UNKNOWN
Parkinson's Disease
Chinese Academy of Sciences
2017-05 PHASE1; PHASE2
NCT02782481 WITHDRAWN
Parkinson's Disease
NeuroDerm Ltd.
2016-08 PHASE3
NCT03354455 COMPLETED
Dyskinesia, Drug-Induced; Parkinson Disease
Danish Research Centre for Magnetic Resonance
2017-08-01
NCT02744391 COMPLETED
Major Depressive Disorder; Dysthymia; Depression Not Otherwise Specified; Decreased Processing Speed; Decreased Gait Speed
New York State Psychiatric Institute
2016-08-24 PHASE4
NCT02657681 COMPLETED
Dyskinesia, Medication-Induced; Parkinson's Disease
Fundación de investigación HM
2015-10 PHASE2
NCT02769793 COMPLETED
Parkinson Disease
Seoul National University Hospital
2015-06 PHASE4
NCT02847442 COMPLETED
Parkinson's Disease With Wearing-off Motor Fluctuations
Bial - Portela C S.A.
2016-11-23 PHASE4
NCT03496870 COMPLETED
Parkinson Disease
Neurocrine Biosciences
2018-02-08 PHASE1
NCT02560389 COMPLETED
Stress Disorder, Post Traumatic
University of Wisconsin, Madison
2016-03 PHASE4
NCT02242487 COMPLETED
Idiopathic Parkinson's Disease
Acorda Therapeutics
2015-03 PHASE3
NCT01663935 TERMINATED
Albinism; Oculocutaneous Albinism
University of Wisconsin, Madison
2012-10-17 PHASE2
NCT02764125 COMPLETED
Parkinson's Disease
Orion Corporation, Orion Pharma
2016-04-08 PHASE2
NCT02202551 COMPLETED
Dyskinesia; Levodopa Induced Dyskinesia (LID); Parkinson's Disease (PD)
Adamas Pharmaceuticals, Inc.
2014-07 PHASE3
NCT03051607 TERMINATED
Idiopathic Parkinson Disease
Biotie Therapies Inc.
2017-04-10 PHASE3
NCT02453386 TERMINATED
Idiopathic Parkinson's Disease
Biotie Therapies Inc.
2015-07 PHASE3
NCT02469090 COMPLETED
Parkinson Disease, Off Episodes
Sumitomo Pharma America, Inc.
2015-06-18 PHASE3
NCT01951105 COMPLETED
Sub-acute Back Pain
Northwestern University
2015-02-24 PHASE4
NCT03000569 COMPLETED
Parkinson Disease
Biogen
2016-11-30 PHASE2
NCT03140956 COMPLETED
Parkinson Disease
Orion Corporation, Orion Pharma
2017-04-19 PHASE1
NCT03055936 COMPLETED
Healthy Volunteers
Orion Corporation, Orion Pharma
2017-02-21 PHASE1
NCT02837640 UNKNOWN
Retinitis Pigmentosa
Beirut Eye Specialist Hospital
2016-06 PHASE2
NCT02439125 UNKNOWN
Parkinson's Disease; Dyskinesia
Amarantus BioScience Holdings, Inc.
2015-05 PHASE2
NCT02641054 COMPLETED
Idiopathic Parkinson Disease
CleveXel Pharma
2016-02 PHASE2
NCT02785978 COMPLETED
Parkinson Disease; Healthy Volunteers
Institut de Myologie, France
2016-06
NCT02452606 UNKNOWN
Parkinson Disease; Sleep Disorders
Asan Medical Center
2015-03
NCT02352363 COMPLETED
Idiopathic Parkinson's Disease
Acorda Therapeutics
2015-03 PHASE3
NCT03531060 COMPLETED
Parkinson Disease
Integrative Research Laboratories AB
2016-11-08 PHASE1; PHASE2
NCT02337751 COMPLETED
Parkinson's Disease
Takeda
2015-07-10 PHASE3
NCT02386475 COMPLETED
Stroke
Hospital de Granollers
2015-01 PHASE4
NCT02346630 WITHDRAWN
Stroke
Ross D. Zafonte, MD
2015-03 PHASE4
NCT01393457 COMPLETED
Cocaine Dependence
The University of Texas Health Science Center, Houston
2011-06 PHASE2
NCT02080819 COMPLETED
Cocaine Dependence
Virginia Commonwealth University
2014-02 PHASE2
NCT00223691 COMPLETED
Autonomic Failure; Orthostatic Hypotension
Vanderbilt University
2002-03 PHASE1
NCT02577523 COMPLETED
Parkinson's Disease
NeuroDerm Ltd.
2015-12-29 PHASE2
NCT02240030 COMPLETED
Idiopathic Parkinson's Disease
Acorda Therapeutics
2014-11 PHASE3
NCT02807675 COMPLETED
Parkinson's Disease
Acorda Therapeutics
2016-06 PHASE1
NCT02337764 COMPLETED
Parkinson's Disease
Takeda
2015-02-03 PHASE3
NCT02337738 COMPLETED
Parkinson's Disease
Takeda
2015-01-27 PHASE2; PHASE3
NCT02337725 COMPLETED
Parkinson's Disease
Takeda
2015-02-07 PHASE3
NCT00715520 COMPLETED
Stroke
Emory University
2007-04
NCT00607451 TERMINATED
Levodopa-induced Dyskinesia
Neurim Pharmaceuticals Ltd.
2008-03 PHASE1; PHASE2
NCT02812394 COMPLETED
Parkinson Disease
Acorda Therapeutics
2016-06 PHASE1
NCT02153645 TERMINATED
Parkinson's Disease; Levodopa Induced Dyskinesias (LID)
Adamas Pharmaceuticals, Inc.
2014-08-18 PHASE3
NCT02153632 TERMINATED
Parkinson's Disease; Levodopa Induced Dyskinesia (LID)
Adamas Pharmaceuticals, Inc.
2014-07-30 PHASE3
NCT02633839 COMPLETED
Smoking
Acorda Therapeutics
2015-12 PHASE1
NCT02274766 COMPLETED
Dyskinesia; Levodopa-Induced Dyskinesia (LID); Parkinson's Disease (PD)
Adamas Pharmaceuticals, Inc.
2014-10 PHASE3
NCT02633007 COMPLETED
Asthma
Acorda Therapeutics
2015-12 PHASE1
NCT01937169 UNKNOWN
Restless Legs Syndrome
Tel-Aviv Sourasky Medical Center
2014-01
NCT02439203 COMPLETED
Parkinson's Disease; Levodopa Induced Dyskinesia (LID)
Bukwang Pharmaceutical
2015-05 PHASE2
NCT02741947 COMPLETED
Parkinson Disease
IRCCS San Raffaele Roma
2014-04 PHASE4
NCT01636037 COMPLETED
Schizophrenia
Centre for Addiction and Mental Health
2012-09 PHASE2
NCT02136914 COMPLETED
Dyskinesia; Levodopa Induced Dyskinesia (LID); Parkinson's Disease
Adamas Pharmaceuticals, Inc.
2014-05 PHASE3
NCT02073773 COMPLETED
Ischaemic Stroke
Singapore General Hospital
2014-01 PHASE3
NCT02554734 COMPLETED
Parkinson's Disease
Orion Corporation, Orion Pharma
2015-08 PHASE1
NCT02763137 COMPLETED
Parkinson Disease
IRCCS San Raffaele Roma
2014-07-30 PHASE2
NCT03333369 COMPLETED
Healthy; Schizotypal Personality
University of Zurich
2014-05-15 EARLY_PHASE1
NCT01484184 COMPLETED
Spinal Cord Injury
Nordic Life Science Pipeline Inc.
2013-07 PHASE1; PHASE2
NCT01281475 COMPLETED
Angelman Syndrome
Wen-Hann Tan
2011-01 PHASE2; PHASE3
NCT02448914 COMPLETED
Parkinson's Disease
LobSor Pharmaceuticals AB
2015-05 PHASE1
NCT02005029 COMPLETED
Parkinson's Disease; Levodopa
Virginia Commonwealth University
2013-04
NCT01883505 COMPLETED
Parkinson's Disease
NeuroDerm Ltd.
2014-01-06 PHASE2
NCT02486432 COMPLETED
Parkinson's Disease
NeuroDerm Ltd.
2015-04 PHASE1
NCT02096601 COMPLETED
Parkinson's Disease
NeuroDerm Ltd.
2014-08-11 PHASE1
NCT01960842 COMPLETED
Advanced Parkinson's Disease
AbbVie
2013-10 PHASE3
NCT01736176 COMPLETED
Advanced Parkinson's Disease
AbbVie (prior sponsor, Abbott)
2013-03 PHASE3
NCT01767129 COMPLETED
Dyskinesia; Parkinson's Disease
Avanir Pharmaceuticals
2013-10-16 PHASE2
NCT02312232 COMPLETED
Parkinson's Disease
Orion Corporation, Orion Pharma
2014-11 PHASE1
NCT01840423 COMPLETED
Healthy
Orion Corporation, Orion Pharma
2013-05 PHASE1
NCT01683253 COMPLETED
Impulse Control Disorder
Sandoz
2012-11 PHASE4
NCT01176435 COMPLETED
Albinism
University of Minnesota
2010-09 PHASE2
NCT01646255 COMPLETED
Idiopathic Parkinson's Disease
UCB Pharma
2012-07 PHASE3
NCT01688089 COMPLETED
Healthy
Orion Corporation, Orion Pharma
2012-09 PHASE1
NCT01470859 COMPLETED
Idiopathic Parkinson's Disease
Huashan Hospital
2011-12
NCT01468012 COMPLETED
Cocaine Dependence
New York State Psychiatric Institute
2014-07 PHASE2; PHASE3
NCT01937078 COMPLETED
Dyskinesia
University Health Network, Toronto
2011-04 PHASE2
NCT02116465 COMPLETED
Fasted State
Desitin Arzneimittel GmbH
2014-03 PHASE1
NCT01777555 COMPLETED
Idiopathic Parkinson's Disease
Acorda Therapeutics
2013-04 PHASE2
NCT01190813 COMPLETED
Amblyopia
Jaeb Center for Health Research
2010-09 PHASE3
NCT01556165 COMPLETED
Parkinson's Disease
H. Lundbeck A/S
2012-04 PHASE3
NCT01568073 COMPLETED
Parkinson's Disease
Bial - Portela C S.A.
2011-03 PHASE3
NCT01577992 COMPLETED
Pain Threshold; Multiple System Atrophy
University Hospital, Toulouse
2011-12-01
NCT01479530 COMPLETED
Parkinson's Disease
H. Lundbeck A/S
2011-12 PHASE3
NCT01736891 COMPLETED
Parkinson´s Disease
Chongqing Fortune Pharmaceutical Co., Ltd.
2011-11 PHASE3
NCT01397422 COMPLETED
Dyskinesia; Levodopa Induced Dyskinesia; Parkinson's Disease
Adamas Pharmaceuticals, Inc.
2011-07 PHASE2; PHASE3
NCT01411137 COMPLETED
Parkinson's Disease
Impax Laboratories, LLC
2011-08 PHASE3
NCT01725802 COMPLETED
Parkinson's Disease
NeuroDerm Ltd.
2012-12-16 PHASE1
NCT01486628 COMPLETED
Parkinson's Disease
NeuroDerm Ltd.
2012-04-30 PHASE1
NCT01617135 COMPLETED
Idiopathic Parkinson's Disease
Acorda Therapeutics
2012-05 PHASE2
NCT01283594 COMPLETED
Parkinson's Disease
Biotie Therapies Inc.
2011-03 PHASE2; PHASE3
NCT00918177 COMPLETED
Parkinson's Disease
Intec Pharma Ltd.
2009-07 PHASE2
NCT00360568 COMPLETED
Dyskinesias; Parkinson's Disease; Severe Motor Fluctuations
AbbVie (prior sponsor, Abbott)
2009-06 PHASE3
NCT01515410 COMPLETED
Parkinson's Disease; Motor Fluctuations
Depomed
2012-01 PHASE2
NCT01479127 COMPLETED
Advanced Parkinson's Disease
AbbVie (prior sponsor, Abbott)
2011-10 PHASE2
NCT01227655 COMPLETED
Parkinson's Disease
Bial - Portela C S.A.
2011-03 PHASE3
NCT01528592 COMPLETED
Parkinson's Disease
Northwestern University
2011-06
NCT01218425 COMPLETED
Dopamine Activity; Episodic Memory Consolidation; Response Preparation
Maastricht University Medical Center
2010-11
NCT00335153 COMPLETED
Advanced Parkinson's Disease
AbbVie (prior sponsor, Abbott)
2008-01 PHASE3
NCT01268891 COMPLETED
Parkinson's Disease
H. Lundbeck A/S
2011-01 PHASE3
NCT01437293 COMPLETED
Cocaine Abuse
New York State Psychiatric Institute
2010-08 PHASE1
NCT00218023 COMPLETED
Cocaine Abuse; Cocaine-Related Disorders
The University of Texas Health Science Center, Houston
2006-03 PHASE2
NCT01429077 COMPLETED
Nonfluent Aphasia; Stroke
Shirley Ryan AbilityLab
2007-10 PHASE2; PHASE3
NCT01336088 COMPLETED
Parkinson's Disease
Addex Pharma S.A.
2011-04 PHASE2
NCT01191944 COMPLETED
Parkinson Disease
Boehringer Ingelheim
2010-08 PHASE3
NCT01130493 COMPLETED
Parkinson's Disease
Impax Laboratories, LLC
2010-05 PHASE3
NCT02170376 COMPLETED
Parkinson's Disease (PD)
Bial - Portela C S.A.
2011-09 PHASE1
NCT00627640 COMPLETED
Idiopathic Parkinson's Disease
Newron Pharmaceuticals SPA
2009-02 PHASE3
NCT00713583 COMPLETED
Cocaine Dependence
The University of Texas Health Science Center, Houston
2008-01 PHASE2
NCT01113320 COMPLETED
Parkinson's Disease
Newron Pharmaceuticals SPA
2010-04 PHASE2
NCT01229332 COMPLETED
Parkinson's Disease
NeuroDerm Ltd.
2011-01 PHASE1; PHASE2
NCT00357994 COMPLETED
Advanced Parkinson's Disease
AbbVie (prior sponsor, Abbott)
2009-01 PHASE3
NCT00660387 COMPLETED
Advanced Parkinson's Disease
AbbVie (prior sponsor, Abbott)
2009-12 PHASE3
NCT01296464 COMPLETED
Parkinson's Disease
Orion Corporation, Orion Pharma
2011-02 PHASE2
NCT00758368 WITHDRAWN
Parkinson's Disease
Oregon Health and Science University
2009-03 PHASE2
NCT01023282 COMPLETED
Parkinson's Disease; Tolerability
NeuroSearch A/S
2009-11 PHASE1
NCT00141518 COMPLETED
Advanced Idiopathic Parkinson's Disease
AbbVie (prior sponsor, Abbott)
2006-03 PHASE4
NCT00632762 COMPLETED
Parkinson's Disease
University Hospital, Toulouse
2007-11 PHASE4
NCT00914134 COMPLETED
Parkinson's Disease
University of Helsinki
2009-04 PHASE4
NCT00552474 COMPLETED
Parkinson Disease; Movement Disorders
Abbott Medical Devices
2005-10
NCT01103011 COMPLETED
Parkinson's Disease
NeuroDerm Ltd.
2010-04 PHASE1
NCT00634556 COMPLETED
Tourette Syndrome
Washington University School of Medicine
2006-02 PHASE1
NCT00957918 COMPLETED
Parkinson's Disease
Neuraltus Pharmaceuticals, Inc.
2009-10 PHASE1; PHASE2
NCT01484990 COMPLETED
Parkinson Disease
AbbVie
2010-04 PHASE1
NCT01026428 COMPLETED
Idiopathic Parkinson's Disease
Newron Pharmaceuticals SPA
2009-09 PHASE1; PHASE2
NCT02169414 COMPLETED
Parkinson's Disease (PD)
Bial - Portela C S.A.
2010-02 PHASE1
NCT01568047 COMPLETED
Parkinson's Disease
Bial - Portela C S.A.
2010-02 PHASE2
NCT00829439 COMPLETED
Angelman Syndrome
Boston Children's Hospital
2009-01 PHASE1
NCT00845000 COMPLETED
Parkinson Disease
Merck Sharp & Dohme LLC
2009-04-21 PHASE1
NCT01286935 COMPLETED
Parkinson's Disease
Newron Pharmaceuticals SPA
2007-08 PHASE3
NCT01519284 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
2009-11 PHASE1
NCT01070628 COMPLETED
Parkinson's Disease
Orion Corporation, Orion Pharma
2009-12 PHASE1
NCT01568034 COMPLETED
Parkinson's Disease
Bial - Portela C S.A.
2009-04 PHASE2
NCT00601978 WITHDRAWN
Parkinson's Disease
Novartis Pharmaceuticals
2008-08 PHASE4
NCT00906828 COMPLETED
Parkinson Disease
Uppsala University
2008-10 PHASE4
NCT01533077 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
2009-03 PHASE1
NCT01327261 COMPLETED
Healthy Volunteers
University of Buenos Aires
2009-08 PHASE4
NCT00789672 COMPLETED
Amblyopia
Jaeb Center for Health Research
2009-01 PHASE2
NCT00941265 COMPLETED
Aphasia
University Hospital, Geneva
2007-02
NCT01533116 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
2009-03 PHASE1
NCT00869791 COMPLETED
Parkinson's Disease
Impax Laboratories, LLC
2008-11 PHASE2
NCT02169466 COMPLETED
Parkinson's Disease (PD)
Bial - Portela C S.A.
2009-01 PHASE1
NCT00605553 COMPLETED
Parkinson's Disease
Biotie Therapies Inc.
2008-04 PHASE2
NCT00642356 TERMINATED
Parkinson's Disease
Novartis
2008-03 PHASE4
NCT00272688 COMPLETED
Parkinson Disease
University Hospital, Akershus
2006-01 PHASE4
NCT00438607 COMPLETED
Parkinson's Disease
Biogen
2007-04 PHASE2
NCT00307450 COMPLETED
Parkinson's Disease
Technische Universität Dresden
2006-03 PHASE4
NCT00125567 COMPLETED
Idiopathic Parkinson's Disease
Orion Corporation, Orion Pharma
2005-08 PHASE4
NCT02169453 COMPLETED
Parkinson's Disease (PD)
Bial - Portela C S.A.
2008-10 PHASE1
NCT02169479 COMPLETED
Parkinson's Disease (PD)
Bial - Portela C S.A.
2008-09 PHASE1
NCT00558337 COMPLETED
Parkinson's Disease
Osmotica Pharmaceutical US LLC
2007-11 PHASE2
NCT00099268 COMPLETED
Parkinson's Disease
Novartis Pharmaceuticals
2004-09 PHASE3
NCT00477802 TERMINATED
Parkinson Disease
University of Cincinnati
2007-05 PHASE4
NCT02169895 COMPLETED
Parkinson's Disease (PD)
Bial - Portela C S.A.
2008-09 PHASE1
NCT00590122 COMPLETED
Parkinson's Disease
Baylor College of Medicine
2006-10 PHASE4
NCT01187966 COMPLETED
Parkinson's Disease
Newron Pharmaceuticals SPA
2007-01 PHASE3
NCT00153972 COMPLETED
Parkinson's Disease
Technische Universität Dresden
2005-02 PHASE4
NCT00219284 COMPLETED
Parkinson's Disease With End of Dose Wearing Off
Novartis Pharmaceuticals
2005-01 PHASE4
NCT00391898 COMPLETED
Parkinson's Disease
Novartis
2006-10 PHASE4
NCT00888186 COMPLETED
Parkinson Disease; Dyskinesias
Uppsala University
2008-02 PHASE4
NCT00693862 COMPLETED
Pharmacokinetics
Orion Corporation, Orion Pharma
2006-12 PHASE1
NCT00360308 TERMINATED
Parkinson's Disease
Eisai Limited
2006-11 PHASE3
NCT00505622 TERMINATED
Parkinson's Disease
Eisai Limited
2007-07 PHASE3
NCT00360412 TERMINATED
Parkinson's Disease
Eisai Inc.
2006-10 PHASE3
NCT00406588 COMPLETED
Advanced Stage Parkinson's Disease
Solvay Pharmaceuticals
2007-03 PHASE3
NCT00505843 COMPLETED
Parkinson's Disease
Merck Sharp & Dohme LLC
2007-05 PHASE1
NCT00562198 TERMINATED
Parkinson´s Disease
Orion Corporation, Orion Pharma
2008-01 PHASE2
NCT00368108 COMPLETED
Parkinson's Disease
Eisai Inc.
2006-08 PHASE3
NCT00253084 COMPLETED
Parkinson's Disease
Impax Laboratories, LLC
2005-11 PHASE2
NCT00218075 COMPLETED
Cocaine Abuse; Cocaine-Related Disorders
The University of Texas Health Science Center, Houston
2000-03 PHASE2
NCT03103399 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
2006-09-26 PHASE2
NCT00134966 COMPLETED
Parkinson's Disease
Novartis
2005-08 PHASE3
NCT00462007 COMPLETED
Parkinson's Disease
Orion Corporation, Orion Pharma
2006-09 PHASE4
NCT00399477 COMPLETED
Parkinson's Disease
Teva Neuroscience, Inc.
2006-10 PHASE4
NCT00286897 COMPLETED
Parkinson's Disease
Eisai Limited
2006-02 PHASE3
NCT00666653 COMPLETED
Parkinson's Disease
Oregon Health and Science University
2003-07 PHASE1
NCT00134784 COMPLETED
Parkinson Disease
Institute for Neurodegenerative Disorders
2000-04 PHASE2
NCT00199368 COMPLETED
Parkinson's Disease
Kyowa Kirin, Inc.
2004-10 PHASE3
NCT00692328 COMPLETED
Parkinson's Disease
Oregon Health and Science University
2005-08
NCT00203957 COMPLETED
Parkinson's Disease
University of Chicago
2005-03 PHASE3
NCT00102869 COMPLETED
Cerebrovascular Accident; Aphasia
University Hospital Muenster
2005-01 PHASE4
NCT00129181 COMPLETED
Parkinson Disease; Parkinsonian Syndrome
Institute for Neurodegenerative Disorders
2005-01
NCT00203177 COMPLETED
Parkinson's Disease
Teva Branded Pharmaceutical Products R&D, Inc.
2001-10 PHASE3
NCT03097211 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
2006-07-17 PHASE1
NCT03094156 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
2006-04-26 PHASE1
NCT00143026 COMPLETED
Parkinson's Disease
Novartis
2005-07 PHASE4
NCT00199355 COMPLETED
Parkinson's Disease
Kyowa Kirin Co., Ltd.
2005-04 PHASE2
NCT02778594 COMPLETED
Parkinson's Disease (PD)
Bial - Portela C S.A.
2005-09 PHASE1
NCT00199407 COMPLETED
Parkinson's Disease
Kyowa Kirin, Inc.
2004-06 PHASE3
NCT00199420 COMPLETED
Parkinson's Disease
Kyowa Kirin, Inc.
2004-07 PHASE3
NCT02774564 COMPLETED
Parkinson's Disease
Bial - Portela C S.A.
2005-09 PHASE1
NCT02834507 COMPLETED
Parkinson's Disease (PD)
Bial - Portela C S.A.
2005-03 PHASE2
NCT00199394 COMPLETED
Parkinson's Disease
Kyowa Kirin Co., Ltd.
2004-11 PHASE3
NCT00103805 COMPLETED
Healthy
University Hospital Muenster
2003-03 PHASE4
NCT00203164 COMPLETED
Parkinson's Disease
Teva Branded Pharmaceutical Products R&D, Inc.
2002-05 PHASE3
NCT00244387 COMPLETED
Parkinson Disease, Idiopathic
UCB Pharma
2004-03 PHASE3
NCT01044992 COMPLETED
Multisystemic Atrophy
University Hospital, Toulouse
2002-05
NCT03091868 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
2004-11-03 PHASE1
NCT00148512 COMPLETED
Parkinson Disease
Boehringer Ingelheim
2003-03 PHASE2
NCT00144209 COMPLETED
Restless Legs Syndrome
Boehringer Ingelheim
2003-02 PHASE3
NCT00160576 COMPLETED
Idiopathic Parkinson Disease
UCB Pharma
2003-07 PHASE2
NCT03091543 COMPLETED
Parkinson Disease
Bial - Portela C S.A.
2004-05-04 PHASE1
NCT00139867 COMPLETED
Parkinson's Disease
UCB Pharma
2004-01 PHASE3
NCT00812760 COMPLETED
Retinal Diseases
Medical University of Vienna
2001-10 PHASE4
NCT00456794 COMPLETED
Parkinson's Disease
Kyowa Kirin, Inc.
2002-03 PHASE2
NCT00955045 COMPLETED
Parkinson's Disease
Kyowa Kirin, Inc.
2002-08 PHASE2; PHASE3
NCT00456586 COMPLETED
Parkinson's Disease
Kyowa Kirin, Inc.
2002-04 PHASE2
NCT00203034 COMPLETED
Parkinson's Disease
Teva Branded Pharmaceutical Products R&D, Inc.
2000-05 PHASE3
NCT02763852 COMPLETED
Parkinson's Disease
Bial - Portela C S.A.
2001-04 PHASE1
NCT02763839 COMPLETED
Parkinson's Disease
Bial - Portela C S.A.
2001-04 PHASE1
NCT00203060 COMPLETED
Parkinson's Disease
Teva Neuroscience, Inc.
1997-07 PHASE3
NCT02177357 COMPLETED
Parkinson Disease
Boehringer Ingelheim
1998-11 PHASE3
NCT00086294 COMPLETED
Parkinson's Disease; Dyskinesias
National Institute of Neurological Disorders and Stroke (NINDS)
2004-06-25 PHASE2
NCT00291733 UNKNOWN
Levodopa Induced Dyskinesia
1st Hospital of Social Security Services
2006-05 PHASE2
NCT00006077 COMPLETED
Parkinson's Disease
National Institute of Neurological Disorders and Stroke (NINDS)
2000-08 PHASE2
NCT00108667 COMPLETED
Parkinson Disease
National Institute of Neurological Disorders and Stroke (NINDS)
2005-04 PHASE2
NCT00625547 COMPLETED
Restless Legs Syndrome
Pfizer
2003-01 PHASE3
NCT00004733 COMPLETED
Parkinson's Disease
National Institute of Neurological Disorders and Stroke (NINDS)
1998-01 PHASE3
NCT00296959 TERMINATED
Parkinson's Disease
University Health Network, Toronto
2004-09 PHASE2
NCT00111371 UNKNOWN
Dyslexia
University Hospital Muenster
2005-01 PHASE4
NCT01351168 WITHDRAWN
Parkinson's Disease
Rush University Medical Center
PHASE2
NCT00247247 COMPLETED
Parkinson's Disease
Orion Corporation, Orion Pharma
2002-12 PHASE4
NCT00507715 COMPLETED
Parkinson's Disease, Idiopathic
Rottapharm Spain
2006-09 PHASE1
NCT00432393 COMPLETED
Nonarteritic Anterior Ischemic Optic Neuropathy
Shahid Beheshti University of Medical Sciences
2002-06 PHASE4
NCT00451633 WITHDRAWN
Parkinson's Disease
Eisai Inc.
2007-03 PHASE2
NCT00415922 COMPLETED
Healthy
Novartis
2006-07 PHASE1
NCT00040209 COMPLETED
Parkinson Disease
National Institute of Neurological Disorders and Stroke (NINDS)
2002-06 PHASE2
NCT00415831 COMPLETED
Healthy
Novartis
2006-06 PHASE1
NCT00102284 TERMINATED
Healthy
University Hospital Muenster
2004-03 PHASE4
NCT00096720 COMPLETED
Parkinson Disease; Parkinsonian Syndrome
Institute for Neurodegenerative Disorders
2004-02 PHASE2
NCT00076674 COMPLETED
Dyskinesias; Parkinson Disease
National Institute of Neurological Disorders and Stroke (NINDS)
2004-01 PHASE2
NCT00306124 UNKNOWN
Alzheimer's Disease; Mild Cognitive Impairment; Healthy
University Hospital Muenster
2006-01 PHASE4
NCT00415740 COMPLETED
Healthy
Novartis
2006-05 PHASE1
NCT00006337 COMPLETED
Parkinson's Disease
National Institute of Neurological Disorders and Stroke (NINDS)
2000-10 PHASE2
NCT00174239 TERMINATED
Parkinson Disease
Pfizer
2004-07 PHASE4
NCT00089622 COMPLETED
Parkinson Disease
National Institute of Neurological Disorders and Stroke (NINDS)
2004-08-04 PHASE2
NCT00415844 COMPLETED
Healthy
Novartis
2006-06 PHASE1
NCT00013624 COMPLETED
Parkinson's Disease
National Institute of Neurological Disorders and Stroke (NINDS)
2001-03 PHASE2
NCT00009048 COMPLETED
Parkinson's Disease
National Institute of Neurological Disorders and Stroke (NINDS)
2001-01 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-07-13)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Levodopa acts as an amino acid precursor that crosses the blood-brain barrier and undergoes enzymatic decarboxylation by DOPA decarboxylase to generate endogenous dopamine within central neurons. This intracellular dopamine synthesis directly restores dopaminergic receptor stimulation in the striatum, compensating for neurochemical deficits to relieve motor symptoms in patients with Parkinson's disease.

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.