Drugs / Carbidopa
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed Parkinson disease 2 milestones | |||||
| Filed | US (FDA) | Vadova | Parkinson disease | 2007-01-18 | “In April, based on the favourable results received from the FIRST STEP -study Orion applied for an expanded indication for Stalevo® (levodopa, carbidopa and entacapone) in the USA” orionpharma.com ↗ “today announced that it has filed an amendment to its new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for its Vadova(TM) (carbidopa/levodopa) tablets” amneal.com ↗ “Marketing authorisation applications for the triple tablet combining entacapone with levodopa and carbidopa were filed by Orion Pharma with the US regulatory authority FDA” orionpharma.com ↗ |
| Rejected (CRL) | US (FDA) | Vadova | Parkinson disease | 2006-03-07 | “today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) concerning its new drug application for Vadova(R)...” amneal.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Stalevo | — | 2003-10-17 | europa.eu ↗ |
| Approved | US (FDA) | SINEMET | — | 1975-05-02 | fda.gov ↗ |
Trials 71 · started per year
today
US approved 1975
EU approved 2003
1
2
1
2
5
2
1
2
4
2
1
4
1
4
6
4
4
2
2
4
5
1
5
2
3
1
1974197519761977197819791980198119821983198419851986198719881989199019911992199319941995199619971998199920002001200220032004200520062007200820092010201120122013201420152016201720182019202020212022202320242025202620272028
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT05471609 | Jun → Aug 2025 | — | University of Minnesota | Completed | No outcome recorded |
| Phase 122 trials · 1 met primary | ||||||
| Phase 1 | NCT07442591 | Mar → Apr 2026 | — | Shanghai WD Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06161220 | Oct → Dec 2023 | — | Impax Laboratories, LLC | Completed | No outcome recorded |
| Phase 1 | NCT05708274 | Jan 2023 → Oct 2025 | spinal cord injury | Bronx VA Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT05250141 | Feb 2022 | — | Laboratorios Andromaco S.A. | Completed | No outcome recorded |
| Phase 1 | NCT05128175 | Oct 2021 → Jan 2022 | Parkinson disease | Shanghai WD Pharmaceutical Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04591535 | Sep 2020 → Mar 2021 | Parkinson disease | Hong Kong WD Pharmaceutical Co., Limited | Unknown | No outcome recorded |
| Phase 1 | NCT04553978 | Sep 2020 → Mar 2021 | Parkinson disease | Hong Kong WD Pharmaceutical Co., Limited | Unknown | No outcome recorded |
| Phase 1 | NCT04513340 | Aug → Sep 2020 | Parkinson disease | Hong Kong WD Pharmaceutical Co., Limited | Unknown | No outcome recorded |
| Phase 1 | NCT03140956 | Apr → Jul 2017 | Parkinson disease | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 1 | NCT03055936 | Feb → Jun 2017 | — | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02706977 | Jan 2016 → Aug 2019 | type 2 diabetes mellitus | Emory University | Completed | No outcome recorded |
| Phase 1 | NCT02554734 | Aug → Nov 2015 | Parkinson disease | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02448914 | May → Jul 2015 | Parkinson disease | LobSor Pharmaceuticals AB | Completed | Met primary |
| Phase 1 | NCT02486432 | Apr 2015 | Parkinson disease | NeuroDerm Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT02312232 | Nov 2014 → Feb 2015 | Parkinson disease | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02096601 | Aug 2014 → Mar 2015 | Parkinson disease | NeuroDerm Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01437293 | Aug 2010 → Apr 2012 | cocaine abuse | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 1 | NCT01484990 | Apr → Sep 2010 | Parkinson disease | AbbVie | Completed | No outcome recorded |
| Phase 1 | NCT00693862 | Dec 2006 → Apr 2008 | — | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 1 | NCT00223691 | Mar 2002 → Jan 2017 | autonomic nervous system disorder, orthostatic hypotension | Vanderbilt University | Completed | Mixed |
| Phase 1 | NCT02763839 | Apr → Jul 2001 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT00223717 | Jan 2001 → Jan 2017 | hypertensive disorder | Vanderbilt University | Completed | No outcome recorded |
| Phase 1/27 trials | ||||||
| Phase 1/2 | NCT06831500 | Jul 2025 → Nov 2026 expected | Parkinson disease, multiple system atrophy, parkinsonian type, orthostatic hypotension | Julien Bally | Recruiting | No outcome recorded |
| Phase 1/2 | NCT06587217 | Oct 2024 → Apr 2025 | parkinsonian disorder | University of Michigan | Completed | No outcome recorded |
| Phase 1/2 | NCT06219915 | Mar → May 2024 | parkinsonian disorder | University of Michigan | Completed | No outcome recorded |
| Phase 1/2 | NCT04325503 | Feb 2021 → Jun 2022 | parkinsonian disorder | University of Michigan | Completed | No outcome recorded |
| Phase 1/2 | NCT02696512 | Mar 2016 → Mar 2017 | brain injury | International Brain Research Foundation | Unknown | No outcome recorded |
| Phase 1/2 | NCT00547911 | Oct 2007 → Apr 2013 | Parkinson disease, autonomic nervous system disorder, multiple system atrophy | National Institute of Neurological Disorders and Stroke (NINDS) | Terminated | No outcome recorded |
| Phase 1/2 | NCT00239564 | Oct 2005 → Dec 2007 | Parkinson disease | Impax Laboratories, LLC | Completed | No outcome recorded |
| Phase 221 trials · 1 met primary | ||||||
| Phase 2 | NCT05036473 | Nov 2021 → Dec 2022 | Parkinson disease | Shanghai WD Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT04778176 | Jun 2021 → Jul 2022 | Parkinson disease | SynAgile Corporation | Completed | No outcome recorded |
| Phase 2 | NCT02873351 | Sep 2019 → Dec 2020 | age-related macular degeneration | Snyder, Robert W., M.D., Ph.D., P.C. | Withdrawn | No outcome recorded |
| Phase 2 | NCT03541356 | May 2018 → Jun 2019 | Parkinson disease | Impel Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03197493 | Aug 2017 → Jul 2020 | age-related macular degeneration | Snyder, Robert W., M.D., Ph.D., P.C. | Completed | No outcome recorded |
| Phase 2 | NCT02577523 | Dec 2015 → Dec 2016 | Parkinson disease | NeuroDerm Ltd. | Completed | Met primary |
| Phase 2 | NCT02271503 | Nov 2015 → Aug 2016 | Parkinson disease | Impax Laboratories, LLC | Completed | No outcome recorded |
| Phase 2 | NCT02553265 | Sep 2015 → May 2019 | Riley-Day syndrome, baroreflex failure | NYU Langone Health | Completed | No outcome recorded |
| Phase 2 | NCT02080819 | Feb 2014 → Jan 2017 | cocaine dependence | Virginia Commonwealth University | Completed | No outcome recorded |
| Phase 2 | NCT01663935 | Oct 2012 → Apr 2018 | albinism, oculocutaneous albinism | University of Wisconsin, Madison | Terminated | No outcome recorded Stop: Business |
| Phase 2 | NCT00947037 | Aug 2012 | Parkinson disease | Intec Pharma Ltd. | Withdrawn | No outcome recorded |
| Phase 2 | NCT01515410 | Jan → Sep 2012 | Parkinson disease | Depomed | Completed | No outcome recorded |
| Phase 2 | NCT01296464 | Feb → Jul 2011 | Parkinson disease | Orion Corporation, Orion Pharma | Completed | No outcome recorded |
| Phase 2 | NCT00983814 | Oct 2009 → May 2011 | attention deficit-hyperactivity disorder | Chelsea Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00918177 | Jul 2009 → Oct 2012 | Parkinson disease | Intec Pharma Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT01399905 | Mar 2009 → Apr 2011 | Parkinson disease | Oregon Health and Science University | Completed | No outcome recorded |
| Phase 2 | NCT00562198 | Jan → Feb 2008 | Parkinson disease | Orion Corporation, Orion Pharma | Terminated | No outcome recorded |
| Phase 2 | NCT00218023 | Mar 2006 → Apr 2012 | cocaine abuse | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 2 | NCT00253084 | Nov 2005 → Dec 2007 | Parkinson disease | Impax Laboratories, LLC | Completed | No outcome recorded |
| Phase 2 | NCT00200447 | Mar → Sep 2004 | Parkinson disease | Molecular NeuroImaging | Completed | No outcome recorded |
| Phase 2 | NCT00218075 | Mar 2000 → Oct 2007 | cocaine abuse | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT01468012 | Jul 2014 | cocaine dependence | New York State Psychiatric Institute | Completed | No outcome recorded |
| Phase 2/3 | NCT00685919 | May 2008 → Jul 2020 | postural orthostatic tachycardia syndrome | Vanderbilt University | Completed | No outcome recorded |
| Phase 38 trials · 1 met primary | ||||||
| Phase 3 | NCT04379050 | Jun 2020 → Apr 2026 | Parkinson disease | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT03462043 | Apr → Nov 2018 | Parkinson disease | NeuroDerm Ltd. | Withdrawn | No outcome recorded |
| Phase 3 | NCT02615873 | Jul 2016 → Dec 2019 | Parkinson disease | Intec Pharma Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT02605434 | Mar 2016 → Jul 2019 | Parkinson disease | Intec Pharma Ltd. | Unknown | No outcome recorded |
| Phase 3 | NCT01736176 | Mar 2013 → Mar 2015 | Parkinson disease | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT01212484 | Dec 2009 → Feb 2012 | Riley-Day syndrome | NYU Langone Health | Completed | No outcome recorded |
| Phase 3 | NCT00134966 | Aug 2005 → Sep 2007 | Parkinson disease | Novartis | Completed | Met primary |
| Phase 3 | NCT00139880 | Jun → Aug 2005 | Parkinson disease | UCB Pharma | Completed | No outcome recorded |
| Phase 48 trials | ||||||
| Phase 4 | NCT06765668 | Feb → Nov 2025 overdue | Parkinson disease | Impax Laboratories, LLC | Recruiting | No outcome recorded |
| Phase 4 | NCT06236230 | Nov 2023 → Jun 2024 | Parkinson disease | Second Affiliated Hospital of Soochow University | Unknown | No outcome recorded |
| Phase 4 | NCT04742348 | Feb → Aug 2023 | alcohol-related disorders | University of Washington | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT04723147 | Jan 2021 → Oct 2023 | atypical depressive disorder, depressive disorder | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT03761030 | Jan 2019 → Sep 2021 | dysthymic disorder, major depressive disorder | New York State Psychiatric Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT03111485 | May 2017 → Oct 2022 | Parkinson disease, obstructive sleep apnea syndrome | McGill University Health Centre/Research Institute of the McGill University Health Centre | Completed | No outcome recorded |
| Phase 4 | NCT01683253 | Nov 2012 → Dec 2014 | impulse control disorder | Sandoz | Completed | No outcome recorded |
| Phase 4 | NCT00174239 | Jul 2004 → Sep 2005 | Parkinson disease | Pfizer | Terminated | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT05909267 | Jul 2023 → Jul 2026 overdue | major depressive disorder | Charite University, Berlin, Germany | Recruiting | No outcome recorded |
| — | NCT00129181 | Jan 2005 → Dec 2006 | Parkinson disease | Institute for Neurodegenerative Disorders | Completed | No outcome recorded |
| Comparator or background therapy70 trials | ||||||
| Phase 0 | NCT05132660 Background | Jul 2022 → Dec 2027 expected | diabetic retinopathy | VA Office of Research and Development | Enrolling by invitation | No outcome recorded |
| Phase 0 | NCT04244058 Background | Sep 2020 → May 2023 | cognitive disorder, traumatic brain injury | Weill Medical College of Cornell University | Suspended | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04052776 Comparator | Sep 2020 → Oct 2023 | spinal cord injury | Centre Hospitalier Universitaire Vaudois | Completed | No outcome recorded |
| Phase 1 | NCT04246437 Background | Feb 2020 → Feb 2027 expected | Lewy body dementia, Parkinson disease, pure autonomic failure | Daniel Claassen | Recruiting | No outcome recorded |
| Phase 1 | NCT03929068 Comparator | May 2019 → Jul 2022 | amyotrophic lateral sclerosis | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT03887884 Background | Mar → Jun 2019 | Parkinson disease | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03266965 Background | Mar 2018 → Aug 2020 | multiple sclerosis | University of Miami | Completed | No outcome recorded |
| Phase 1 | NCT03496870 Background | Feb → Jul 2018 | Parkinson disease | Neurocrine Biosciences | Completed | No outcome recorded |
| Phase 1 | NCT02633839 Background | Dec 2015 → Apr 2016 | — | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02633007 Background | Dec 2015 → Mar 2016 | asthma | Acorda Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02116465 Comparator | Mar 2014 | — | Desitin Arzneimittel GmbH | Completed | No outcome recorded |
| Phase 1 | NCT01486628 Comparator | Apr → Nov 2012 | Parkinson disease | NeuroDerm Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01519284 Background | Nov 2009 → Feb 2010 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT00845000 Background | Apr 2009 → Apr 2010 | Parkinson disease | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 1 | NCT00505843 Background | May 2007 → Feb 2008 | Parkinson disease | Merck Sharp & Dohme LLC | Completed | Missed primary |
| Phase 1 | NCT02774564 Background | Sep → Nov 2005 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1/2 | NCT07709741 Comparator | Apr → Jun 2027 expected | — | University of Minnesota | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT07246278 Comparator | Nov 2025 → Nov 2026 expected | Parkinson disease | Tanta University | Recruiting | No outcome recorded |
| Phase 1/2 | NCT01229332 Comparator | Jan → Nov 2011 | Parkinson disease | NeuroDerm Ltd. | Completed | No outcome recorded |
| Phase 1/2 | NCT01026428 Background | Sep 2009 → Jul 2010 | Parkinson disease | Newron Pharmaceuticals SPA | Completed | No outcome recorded |
| Phase 1/2 | NCT00914602 Comparator | May 2009 → Jan 2010 | Parkinson disease | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT07001150 Comparator | May 2025 → May 2026 overdue | Parkinson disease | Tanta University | Recruiting | No outcome recorded |
| Phase 2 | NCT06626152 Background | Aug 2024 → May 2026 overdue | major depressive disorder | University of British Columbia | Recruiting | No outcome recorded |
| Phase 2 | NCT06614153 Comparator | May 2023 → Jan 2024 | Parkinson disease | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT05781711 Background | Jan 2023 → Jan 2025 | Parkinson disease | Tanta University | Completed | No outcome recorded |
| Phase 2 | NCT07444892 Background | Apr 2022 → Nov 2025 | diabetic retinopathy | Emory University | Completed | No outcome recorded |
| Phase 2 | NCT04558112 Background | Feb 2021 → Dec 2023 overdue | post-traumatic stress disorder | University of Wisconsin, Madison | Recruiting | No outcome recorded |
| Phase 2 | NCT03022318 Background | May 2017 → Dec 2019 | age-related macular degeneration | Snyder, Robert W., M.D., Ph.D., P.C. | Completed | No outcome recorded |
| Phase 2 | NCT02764125 Background | Apr 2016 → Mar 2018 | Parkinson disease | Orion Corporation, Orion Pharma | Completed | Met primary |
| Phase 2 | NCT02763137 Comparator | Jul 2014 → Oct 2015 | Parkinson disease | IRCCS San Raffaele Roma | Completed | No outcome recorded |
| Phase 2 | NCT01479127 Background | Oct 2011 → Jul 2012 | Parkinson disease | AbbVie | Completed | No outcome recorded |
| Phase 2 | NCT01171313 Background | Jul 2010 → Oct 2011 | Parkinson disease | XenoPort, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01568047 Background | Feb → Jun 2010 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 2 | NCT01568034 Background | Apr 2009 → Feb 2010 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 2 | NCT00789672 Comparator | Jan → Sep 2009 | amblyopia | Jaeb Center for Health Research | Completed | No outcome recorded |
| Phase 2 | NCT01323374 Comparator | Jan 2009 → Oct 2011 | fibromyalgia | Chelsea Therapeutics | Completed | No outcome recorded |
| Phase 2 | NCT00713583 Background | Jan 2008 → Dec 2011 | cocaine dependence | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 2 | NCT00558337 Comparator | Nov 2007 → Dec 2008 | Parkinson disease | Osmotica Pharmaceutical US LLC | Completed | No outcome recorded |
| Phase 2 | NCT03103399 Background | Sep 2006 → Sep 2007 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 2/3 | NCT07229651 Comparator | Nov 2025 → Nov 2026 expected | Parkinson disease | Tanta University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT07229664 Comparator | Nov 2025 → Nov 2026 expected | Parkinson disease | Tanta University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06785298 Comparator | Dec 2024 → Dec 2026 expected | Parkinson disease | Tanta University | Recruiting | No outcome recorded |
| Phase 2/3 | NCT06113640 Comparator | Nov 2023 → Aug 2026 | Parkinson disease | Mostafa Bahaa | Completed | No outcome recorded |
| Phase 2/3 | NCT04520178 Comparator | Jul 2020 → May 2026 overdue | spinal cord injury | University of Alberta | Active not recruiting | No outcome recorded |
| Phase 2/3 | NCT04000919 Comparator | Jun 2019 → Jun 2023 | spinal cord injury | Jessica M D'Amico | Suspended | No outcome recorded |
| Phase 2/3 | NCT01429077 Comparator | Oct 2007 → Mar 2012 | aphasia, stroke disorder | Shirley Ryan AbilityLab | Completed | No outcome recorded |
| Phase 3 | NCT03735901 Comparator | Jun 2019 → Aug 2024 overdue | stroke disorder | University Hospital, Basel, Switzerland | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01568073 Background | Mar 2011 → Nov 2013 | Parkinson disease | Bial - Portela C S.A. | Completed | Met primary |
| Phase 3 | NCT01227655 Background | Mar 2011 → Jul 2012 | Parkinson disease | Bial - Portela C S.A. | Completed | Met primary |
| Phase 3 | NCT01190813 Comparator | Sep 2010 → Jan 2014 | amblyopia | Jaeb Center for Health Research | Completed | No outcome recorded |
| Phase 3 | NCT00357994 Comparator | Jan 2009 → Oct 2011 | Parkinson disease | AbbVie | Completed | No outcome recorded |
| Phase 3 | NCT00099268 Comparator | Sep 2004 → Nov 2008 | Parkinson disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT06075771 Background | Nov 2023 → Jan 2027 expected | atypical depressive disorder, depressive disorder | Emory University | Recruiting | No outcome recorded |
| Phase 4 | NCT06013956 Background | Aug 2023 → Jun 2028 expected | Parkinson disease | David Escobar | Recruiting | No outcome recorded |
| Phase 4 | NCT04952194 Comparator | Jan 2022 → Dec 2023 | Parkinson disease | Second Affiliated Hospital, School of Medicine, Zhejiang University | Unknown | No outcome recorded |
| Phase 4 | NCT04990284 Background | Nov 2021 → Apr 2023 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 4 | NCT04821830 Background | Feb 2020 → Apr 2024 | Parkinson disease | University of Michigan | Completed | No outcome recorded |
| Phase 4 | NCT03115827 Background | Apr 2017 → Dec 2018 | Parkinson disease | Vanderbilt University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT02513485 Comparator | Oct 2015 → Feb 2020 | major depressive disorder | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT02346630 Comparator | Mar 2015 → Mar 2017 | stroke disorder | Ross D. Zafonte, MD | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT01951105 Comparator | Feb 2015 → Sep 2017 | subacute bursitis | Northwestern University | Completed | No outcome recorded |
| Phase 4 | NCT00642356 Background | Mar 2008 → May 2009 | Parkinson disease | Novartis | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00391898 Background | Oct 2006 → Jun 2008 | Parkinson disease | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00143026 Background | Jul 2005 → Jun 2006 | Parkinson disease | Novartis | Completed | No outcome recorded |
| Phase 4 | NCT00219284 Background | Jan 2005 → Jul 2008 | Parkinson disease | Novartis Pharmaceuticals | Completed | No outcome recorded |
| — | NCT07614126 Background | Apr → Dec 2026 expected | CTNNB1-related neurodevelopmental disorder and/or vitreoretinopathy | University Hospital, Montpellier | Recruiting | No outcome recorded |
| — | NCT04590612 Comparator | Jan 2021 → Jan 2022 | Parkinson disease, depressive disorder | Western University, Canada | Unknown | No outcome recorded |
| — | NCT04054960 Comparator | Sep 2019 → Sep 2021 | Parkinson disease | Western University, Canada | Unknown | No outcome recorded |
| — | NCT01470859 Comparator | Dec 2011 → Aug 2014 | Parkinson disease | Huashan Hospital | Completed | No outcome recorded |
| — | NCT01218425 Background | Nov 2010 → Jun 2012 | — | Maastricht University Medical Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 23
| Date | Issuer | Release |
|---|---|---|
| 2026-06-29 | Impax Laboratories, LLC | Regulatory Zambon and Amneal Announce Positive CHMP Opinion for Hopledo® (IPX203) for Adults with Parkinson’s Disease and Moderate to Severe Motor Fluctuations amneal.com ↗ |
| 2026-06-05 | Impax Laboratories, LLC | Results Amneal Announces Full Study Population Interim Phase 4 ELEVATE-PD Results, Reinforcing Previously Reported Benefits of CREXONT® in Parkinson's Disease amneal.com ↗
After patients switched from prior therapies, treatment with CREXONT delivered meaningful increases in “Good On” time, reductions in “Off” time, and improved motor symptom control. |
| 2025-12-05 | Impax Laboratories, LLC | Results Amneal Announces Positive Interim Phase 4 ELEVATE-PD Results With CREXONT® for Parkinson’s Disease amneal.com ↗
CREXONT delivered substantial “Off” time reductions, improved motor symptom control and provided a longer duration of benefit with each dose |
| 2025-04-07 | Impax Laboratories, LLC | Results Amneal Announces New Data from Phase 3 Study Showing Significant Improvements in Sleep Quality with CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules in Parkinson’s Disease amneal.com ↗
Analysis of RISE-PD presented at AAN 2025 showed CREXONT treatment significantly improved patients’ Parkinson’s Disease Sleep Scale-2 (PDSS-2) total and sub-scale scores |
| 2024-08-07 | Impax Laboratories, LLC | Regulatory Amneal Receives U.S. FDA Approval for IPX203 for Treatment of Parkinson’s Disease to Be Launched as CREXONT® (Carbidopa and Levodopa) Extended-Release Capsules amneal.com ↗
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved CREXONT ® (carbidopa and levodopa) extended-release capsules for the treatment of Parkinson’s disease (PD). |
| 2023-08-24 | Impax Laboratories, LLC | Results JAMA Neurology Publishes Phase 3 Study Results Comparing IPX203 to Immediate-Release Carbidopa/Levodopa for Parkinson’s Disease amneal.com ↗
Amneal Pharmaceuticals, Inc. (NYSE: AMRX) today announced that JAMA Neurology has published results from the RISE-PD clinical study assessing the efficacy and safety of IPX203 versus optimized immediate-release carbidopa/levodopa (IR CD/LD) for the treatment of Parkinson’s disease (PD). |
| 2021-10-28 | AbbVie | Results AbbVie Announces ABBV-951 (Foslevodopa/Foscarbidopa) Showed Improvement in Controlling Motor Fluctuations Compared to Oral Levodopa/Carbidopa Medication in Pivotal Phase 3 Trial in Patients with Advanced Parkinson's Disease abbvie.com ↗
The increase in "On" time at week 12 was 2.72 hours for ABBV-951 versus 0.97 hours for oral levodopa/carbidopa (LD/CD) (p= 0.0083). |
| 2020-09-17 | LobSor Pharmaceuticals AB | Regulatory Lobsor Pharmaceuticals receive approval for Lecigon in Germany, the Netherlands, Belgium, Austria, Slovenia and Romania lobsor.com ↗
Lobsor Pharmaceuticals receive approval for Lecigon in Germany, the Netherlands, Belgium, Austria, Slovenia and Romania |
| 2019-10-01 | LobSor Pharmaceuticals AB | Regulatory Lobsor Pharmaceuticals receive approval for Lecigon® in Denmark, Finland and Norway lobsor.com ↗
Lobsor Pharmaceuticals AB today announced that Lecigon has been approved, and that the Swedish Medical Products Agency (MPA) has confirmed End of Procedure according to the European Mutual Recognition Procedure (MRP) including Denmark, Finland and Norway. |
| 2016-08-09 | Impax Laboratories, LLC | Results Impax Reports Second Quarter 2016 Financial Results amneal.com ↗
The results of the interim analysis showed that IPX203 exhibited a statistically significant improvement in the reduction of "off" time compared to both immediate-release CD-LD and Rytary. |
| 2015-11-25 | Impax Laboratories, LLC | Regulatory Impax Receives European Commission Marketing Authorization for NUMIENT™ (Levodopa and Carbidopa) Modified-Release Capsules for the Symptomatic Treatment of Adult Patients with Parkinson's Disease amneal.com ↗
Impax Laboratories, Inc. (NASDAQ: IPXL) today announced that the European Commission (EC) has granted marketing authorization for NUMIENT (Levodopa and Carbidopa), a modified-release oral capsule formulation for the symptomatic treatment of adult patients with Parkinson's disease. |
| 2015-09-25 | Impax Laboratories, LLC | Regulatory Impax Receives Positive CHMP Opinion for NUMIENT™ (Levodopa and Carbidopa) Modified-Release Capsules for the Symptomatic Treatment of Adult Patients with Parkinson's disease amneal.com ↗ |
| 2015-01-12 | AbbVie | Regulatory AbbVie Announces U.S. FDA Approval of DUOPA™ (carbidopa and levodopa) Enteral Suspension for the Treatment of Motor Fluctuations in Patients with Advanced Parkinson's Disease abbvie.com ↗
The U.S. Food and Drug Administration (FDA) has approved AbbVie's (NYSE: ABBV) DUOPA™ (carbidopa and levodopa) enteral suspension for the treatment of motor fluctuations for people with advanced Parkinson's disease. |
| 2015-01-08 | Impax Laboratories, LLC | Regulatory Impax Pharmaceuticals Announce FDA Approval of RYTARY™ (Carbidopa and Levodopa) Extended-Release Capsules for the Treatment of Parkinson's disease amneal.com ↗
Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), today announced that the U.S. Food and Drug Administration ( FDA ) approved RYTARY, an extended-release oral capsule formulation of carbidopa-levodopa, for the treatment of Parkinson's disease, post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication. |
| 2014-04-11 | Impax Laboratories, LLC | Regulatory Impax Pharmaceuticals Resubmits New Drug Application for RYTARY™ (Carbidopa and Levodopa) Extended-Release Capsules (IPX066) amneal.com ↗
Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced today the resubmission of Impax's New Drug Application (NDA) for RYTARY (IPX066) to the U.S. Food and Drug Administration ( FDA ). |
| 2013-03-19 | Impax Laboratories, LLC | Results Impax Pharmaceuticals Announces Presentation of RYTARYTM (IPX066) (Carbidopa and Levodopa) Extended-Release Capsules Phase III and Open-Label Extension Data at the American Academy of Neurology 2013 Annual Meeting amneal.com ↗
During this clinical trial, the total daily IPX066 levodopa dose was approximately double that of the levodopa IR dose received. |
| 2013-01-21 | Impax Laboratories, LLC | Regulatory FDA Issues Complete Response Letter for RYTARY™ (Carbidopa and Levodopa) Extended-Release Capsules (IPX066) New Drug Application amneal.com ↗ |
| 2008-11-03 | Orion Corporation, Orion Pharma | Regulatory Orion comments on ANDA filed by Wockhardt Limited for a generic version of Orion's proprietary drug Stalevo® in the United States orionpharma.com ↗
At this point, the ANDA review process is just beginning and the realisation of generic competition is neither certain nor imminent. |
| 2008-01-30 | Impax Laboratories, LLC | Regulatory IMPAX Receives FDA Non-Approvable Letter for Vadova(R); Company Considering Options amneal.com ↗
IMPAX Laboratories, Inc. (OTC:IPXL) today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) concerning its new drug application (NDA) and subsequent submissions for Vadova(R) (carbidopa/levodopa extended release) tablets. |
| 2007-06-08 | Impax Laboratories, LLC | Results IMPAX Presents at Movement Disorder Society's 11th International Congress of Parkinson's Disease and Movement Disorders amneal.com ↗
The combined immediate- and extended-release preparation may offer benefits in treating Parkinson's Disease (PD) patients with motor fluctuations. |
| 2007-01-18 | Impax Laboratories, LLC | Regulatory IMPAX Files Amendment to Vadova(TM) NDA amneal.com ↗
IMPAX Laboratories, Inc. (OTC:IPXL) today announced that it has filed an amendment to its new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for its Vadova(TM) (carbidopa/levodopa) tablets. |
| 2006-03-07 | Impax Laboratories, LLC | Regulatory IMPAX Receives FDA Non-Approvable Letter for Vadova; Company to Request Meeting With FDA amneal.com ↗
IMPAX Laboratories, Inc. (OTC:IPXL) today announced that it has received a non-approvable letter from the U.S. Food and Drug Administration (FDA) concerning its new drug application for Vadova(R) (carbidopa/levodopa) tablets. |
| 2002-09-23 | Orion Corporation, Orion Pharma | Regulatory Combination tablet for Parkinson's disease now filed also in Europe by Orion Pharma orionpharma.com ↗
The new drug application by Orion Pharma for a triple combination tablet for Parkinson's disease is under review by the European Agency for the Evaluation of Medicinal Products (EMEA), the pharmaceutical regulatory authority for the EU countries. |
All press releases naming this drug 34 releases
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 141 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Carbidopa | “Those assigned to L-DOPA will begin taking 37.5mg carbidopa/150 mg levodopa once daily (with placebo twice daily) for one week, then increase to 75mg carbidopa/300mg levodopa...” NCT03761030 ↗139“To test whether Parcopa, a new Orally Disintegrating Tablet of Carbidopa-Levodopa, has a faster onset of action, changes in the UPDRS Motor Exam score at intervals after a...” NCT00139880 ↗ “Battery of medications provided through a 12-week schedule including: Minocycline, Lamotrigine, Flumazenil, Modafinil, Bromocriptine, Donepezil, Methylphenidate, Methyl B12,...” NCT02696512 ↗ “CREXONT ER capsules will contain Carbidopa (CD)/Levodopa (LD) 35.0 milligrams (mg)/140 mg and/or CD/LD 52.5 mg/210.0 mg and/or CD/LD 70.0 mg/280 mg and/or CD/LD 87.5 mg/350 mg.” NCT06765668 ↗ “Treatment with L-dopa combined with a peripheral decarboxylase inhibitor (carbidopa) will be introduced gradually over a period of one year from the start of treatment.” NCT07614126 ↗ “A single dose of IR Carbidopa-levodopa (CD-LD) (50/200 mg) will be administered. Supplied as 2 over-encapsulated pills (25 mg carbidopa / 100 mg levodopa each).” NCT05708274 ↗ “Participants will be administered a levodopa-carbidopa challenge, at a dosage of 150mg/37.5mg once daily for one week, followed by twice daily for one week.” NCT06626152 ↗ “Treatment A: 100mg safinamide once daily administration for 6 days + immediate release levodopa formulation (100 mg levodopa + 25 mg carbidopa = Nacom®).” NCT01026428 ↗ “Intermittent Oral Administration vs. Semi-continuous Intra-oral Administration of Levodopa/Carbidopa in Fluctuating Parkinsonian Patients” NCT02763137 ↗ “Patients will receive tablets of generic 25 mg carbidopa/100 mg levodopa as the drug treatment.” NCT07444892 ↗ “Sinemet CR (25 mg carbidopa/100 mg levodopa) will be taken by mouth twice daily for two weeks.” NCT02706977 ↗ |
| Known as | Carbidopa and Levodopa Controlled Release Tablets | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04952194 ↗ |
| Known as | carbidopa monohydrate | “TRIGEL, intestinal gel (20 mg/mL levodopa, 5 mg/mL carbidopa monohydrate, and 20 mg/mL entacapone).” NCT02448914 ↗ |
| Known as | ND0611 | “Subcutaneous Continuously-delivered Carbidopa Solution (ND0611)” NCT01229332 ↗ |
| Action | Inhibit | “carbidopa belongs to a group of medicines called 'aromatic amino acid decarboxylase inhibitors'. It helps levodopa work more effectively by slowing the speed at which levodopa...” NCT00239564 ↗ |
| Route | Oral | “Orally Disintegrating Tablet” NCT00139880 ↗ |
| Target | DDC | “Carbidopa is a DOPA decarboxylase (DDC) inhibitor.” NCT01323374 ↗ |