Drugs / Amantadine
Amantadine
also known as
Amantadine Hydrochloride · amantadine sulfate · amantadine sulphate · AMT · PK-Merz · ADS-5102 · AMA · Amantadine HCl · +5 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | GOCOVRI | — | 2021-02-01 | fda.gov ↗ |
| Label expansions (2) | US (FDA) | SYMMETREL | — | 1987-01-16 – 1993-04-19 | fda.gov ↗ |
| Approved | US (FDA) | SYMMETREL | — | 1968-02-14 | fda.gov ↗ |
Trials 62 · started per year
today
US approved 1968
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04244058 | Sep 2020 → May 2023 | cognitive disorder, traumatic brain injury | Weill Medical College of Cornell University | Suspended | No outcome recorded Stop: Enrollment |
| Phase 11 trial | ||||||
| Phase 1 | NCT00416962 | Aug → Dec 2006 | — | Novartis | Completed | No outcome recorded |
| Phase 1/23 trials | ||||||
| Phase 1/2 | NCT02696512 | Mar 2016 → Mar 2017 | brain injury | International Brain Research Foundation | Unknown | No outcome recorded |
| Phase 1/2 | NCT00867139 | Mar → Aug 2009 | influenza | Fred Hutchinson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00188383 | Jan 2004 → Dec 2006 | prostate cancer | University Health Network, Toronto | Unknown | No outcome recorded |
| Phase 219 trials · 1 met primary · 1 missed | ||||||
| Phase 2 | NCT07125222 | Sep 2025 → Aug 2028 expected | — | Weill Medical College of Cornell University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06234462 | Jun → Sep 2025 | long COVID-19 | University of Texas Southwestern Medical Center | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT06817200 | May 2025 overdue | Parkinson disease | University Hospital, Toulouse | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06055244 | Dec 2023 → Dec 2025 | long COVID-19 | Ohio State University | Completed | No outcome recorded |
| Phase 2 | NCT05479032 | Mar 2023 → Oct 2024 | — | University Hospital Tuebingen | Unknown | No outcome recorded |
| Phase 2 | NCT05667077 | Dec 2022 | post-COVID-19 disorder | Shahid Beheshti University of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT06443827 | Sep 2018 → Jan 2024 | cognitive disorder | Azienda Sanitaria dell'Alto Adige | Unknown | No outcome recorded |
| Phase 2 | NCT02486211 | Sep 2015 → Jun 2018 | cardiac arrest | Jon Rittenberger, MD | Completed | No outcome recorded |
| Phase 2 | NCT02471222 | May 2015 → Jun 2016 | gait apraxia, multiple sclerosis | Adamas Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT01538329 | Mar 2012 → Feb 2018 | Parkinson disease | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 2 | NCT01441986 | Sep 2011 → May 2012 | type 2 diabetes mellitus | Profil Institute for Metabolic Research GmbH | Completed | No outcome recorded |
| Phase 2 | NCT01227967 | Sep 2010 → May 2016 | influenza | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | Met primary |
| Phase 2 | NCT01099059 | Apr 2010 | attention deficit-hyperactivity disorder | Tehran University of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT00979251 | Sep 2009 → May 2010 | influenza | Adamas Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00830323 | Jan → Aug 2009 | influenza | Hospices Civils de Lyon | Terminated | No outcome recorded |
| Phase 2 | NCT00600093 | Jan 2008 → Jul 2011 | Parkinson disease | Rabin Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT00158132 | Sep 1999 → Mar 2005 | cocaine dependence | University of Pennsylvania | Completed | Missed primary |
| Phase 2 | NCT00001930 | Apr 1999 → Feb 2001 | Huntington disease | National Institute of Neurological Disorders and Stroke (NINDS) | Completed | No outcome recorded |
| Phase 2 | NCT00000301 | Mar 1996 → Jun 1998 | substance-related disorder | University of California, Los Angeles | Completed | No outcome recorded |
| Phase 2/32 trials · 1 met primary · 1 missed | ||||||
| Phase 2/3 | NCT04302870 | Feb 2020 → Dec 2030 expected | amyotrophic lateral sclerosis | University of Edinburgh | Recruiting | Missed primary |
| Phase 2/3 | NCT00970944 | Feb 2003 → Mar 2010 | traumatic brain injury | JFK Medical Center | Completed | Met primary |
| Phase 313 trials · 2 met primary · 4 missed | ||||||
| Phase 3 | NCT06052787 | Sep 2023 → May 2025 | traumatic brain injury | Ain Shams University | Completed | No outcome recorded |
| Phase 3 | NCT05809414 | Nov 2022 → Jul 2024 | multiple sclerosis | Hospital San Carlos, Madrid | Unknown | No outcome recorded |
| Phase 3 | NCT04952519 | Mar 2021 → Mar 2022 | — | Noblewell | Terminated | Missed primary |
| Phase 3 | NCT04854759 | Mar 2021 → Mar 2022 | COVID-19 | Independent Public Clinical Hospital No. 4 in Lublin | Unknown | No outcome recorded |
| Phase 3 | NCT03436199 | Mar 2018 → Dec 2019 | multiple sclerosis | Adamas Pharmaceuticals, Inc. | Completed | Met primary |
| Phase 3 | NCT03185065 | Oct 2017 → Nov 2019 | myalgic encephalomeyelitis/chronic fatigue syndrome | Johns Hopkins University | Completed | Missed primary |
| Phase 3 | NCT02153645 | Aug 2014 → May 2016 | Parkinson disease, drug-induced dyskinesia | Adamas Pharmaceuticals, Inc. | Terminated | Missed primary |
| Phase 3 | NCT02153632 | Jul 2014 → May 2016 | Parkinson disease, drug-induced dyskinesia | Adamas Pharmaceuticals, Inc. | Terminated | Met primary |
| Phase 3 | NCT00401973 | Nov 2006 → Sep 2008 | schizoaffective disorder, schizophrenia | Eli Lilly and Company | Completed | Missed primary |
| Phase 3 | NCT00299923 | Nov 2005 → ? | chronic hepatitis C virus infection | University of Hamburg-Eppendorf | Unknown | No outcome recorded |
| Phase 3 | NCT00221624 | Nov 2001 → Apr 2004 | chronic hepatitis C virus infection | University Hospital, Bordeaux | Completed | No outcome recorded |
| Phase 3 | NCT00122629 | Oct 2000 → May 2003 | chronic hepatitis C virus infection | French National Agency for Research on AIDS and Viral Hepatitis | Terminated | No outcome recorded |
| Phase 3 | NCT00146016 | Feb 2000 → Jan 2007 | chronic hepatitis C virus infection | UMC Utrecht | Completed | No outcome recorded |
| Phase 411 trials | ||||||
| Phase 4 | NCT04936126 | Aug 2021 → Jul 2024 | — | All India Institute of Medical Sciences, Bhubaneswar | Unknown | No outcome recorded |
| Phase 4 | NCT04387773 | Nov 2020 → Sep 2022 | Parkinson disease | Oregon Health and Science University | Completed | Mixed |
| Phase 4 | NCT04527289 | Sep 2020 → Oct 2021 | traumatic brain injury | Damanhour University | Completed | No outcome recorded |
| Phase 4 | NCT04273737 | Feb 2020 → Feb 2022 | cerebral palsy | Columbia University | Terminated | No outcome recorded |
| Phase 4 | NCT03988010 | May → Dec 2019 | — | TC Erciyes University | Unknown | No outcome recorded |
| Phase 4 | NCT03430817 | Dec 2017 → Mar 2024 | — | Ain Shams University | Completed | No outcome recorded |
| Phase 4 | NCT02321761 | Jun 2014 → Dec 2018 | traumatic brain injury | Loewenstein Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01071395 | Jan 2010 → Apr 2012 | Parkinson disease | Rush University Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00950196 | Nov 2008 → Nov 2009 | cerebellar ataxia, choreatic disease, dystonic disorder, parkinsonian disorder | Sheba Medical Center | Completed | No outcome recorded |
| Phase 4 | NCT00127114 | Sep 2005 → Jul 2007 | dementia | Johns Hopkins University | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT00127777 | Jul 2002 → Dec 2006 | chronic hepatitis C virus infection | University Hospital, Saarland | Unknown | No outcome recorded |
| Phase not applicable12 trials · 1 missed | ||||||
| — | NCT07421427 | Feb 2026 → Jan 2027 expected | chronic pain syndrome | Cairo University | Recruiting | No outcome recorded |
| — | NCT06833203 | Dec 2023 → May 2025 | — | Cairo University | Completed | No outcome recorded |
| — | NCT04260581 | Mar 2020 → Feb 2021 | Parkinson disease | Seoul National University Hospital | Unknown | No outcome recorded |
| — | NCT03527134 | Apr 2019 → Jul 2021 | — | Zhiyi Zuo | Unknown | No outcome recorded |
| — | NCT02566720 | Jan → Dec 2016 | traumatic brain injury | Hamilton Health Sciences Corporation | Unknown | No outcome recorded |
| — | NCT02025439 | Feb 2014 → Jul 2016 | traumatic brain injury | Edward Hines Jr. VA Hospital | Completed | No outcome recorded |
| — | NCT01467258 | Nov 2011 → Apr 2012 | — | University of Manitoba | Completed | No outcome recorded |
| — | NCT01190553 | Nov 2010 → Dec 2011 | Parkinson disease | Rabin Medical Center | Unknown | No outcome recorded |
| — | NCT00794313 | Sep 2009 → Jun 2010 | Parkinson disease | Oregon Health and Science University | Terminated | No outcome recorded Stop: Business |
| — | NCT00779324 | Aug 2009 → Apr 2013 | traumatic brain injury | Wake Forest University Health Sciences | Completed | Missed primary |
| — | NCT00800514 | Jan 2009 → Nov 2010 | traumatic brain injury | Wake Forest University Health Sciences | Withdrawn | No outcome recorded Stop: Enrollment |
| — | NCT00627250 | Mar 2003 → Nov 2007 | mood disorder, traumatic brain injury | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Comparator or background therapy19 trials | ||||||
| Phase 1 | NCT00287352 Comparator | May 2005 → Sep 2009 | mood disorder, schizoaffective disorder, schizophrenia, schizophreniform disorder | University of North Carolina, Chapel Hill | Completed | No outcome recorded |
| Phase 1 | NCT00015249 Background | Feb 1997 → Apr 1998 | cocaine dependence | National Institute on Drug Abuse (NIDA) | Completed | No outcome recorded |
| Phase 2 | NCT06253923 Comparator | Jun 2024 → Jul 2025 overdue | traumatic brain injury | SHINKEI Therapeutics, Inc | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05140148 Comparator | Feb 2022 → Dec 2027 expected | hemorrhagic stroke, ischemic stroke | University of Pennsylvania | Recruiting | No outcome recorded |
| Phase 2 | NCT03612921 Comparator | Aug 2018 → Mar 2022 | — | Assiut University | Unknown | No outcome recorded |
| Phase 2 | NCT01789047 Comparator | Mar 2013 → Jul 2016 | Parkinson disease, drug-induced dyskinesia | Rush University Medical Center | Terminated | No outcome recorded |
| Phase 2 | NCT00755898 Comparator | Dec 2003 → Jun 2008 | cancer | University of Manitoba | Completed | No outcome recorded |
| Phase 2/3 | NCT03178708 Comparator | Aug 2017 → Dec 2019 | scoliosis | Assiut University | Completed | No outcome recorded |
| Phase 2/3 | NCT00538811 Comparator | — | hepatitis C virus infection | Aga Khan University | Completed | No outcome recorded |
| Phase 3 | NCT04894617 Comparator | Jun 2021 → Jan 2022 | COVID-19 | Copenhagen University Hospital, Hvidovre | Unknown | No outcome recorded |
| Phase 3 | NCT01652534 Comparator | Jun 2011 → May 2015 | Parkinson disease | Northwestern University | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00999505 Comparator | May 2010 → Sep 2011 | schizophrenia | Hospital de Clinicas de Porto Alegre | Unknown | No outcome recorded |
| Phase 4 | NCT01313819 Comparator | Apr → Dec 2011 | Parkinson disease, primary progressive freezing gait | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01313845 Comparator | Feb 2011 → Jun 2012 | Parkinson disease | Jee-Young Lee | Completed | No outcome recorded |
| Phase 4 | NCT00975611 Comparator | Oct 2009 → Jan 2012 | schizoaffective disorder, schizophrenia | David C. Henderson, MD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00632762 Comparator | Nov 2007 → Jan 2011 | Parkinson disease | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 4 | NCT00693121 Comparator | Apr 2003 → Nov 2007 | delirium, traumatic brain injury, traumatic encephalopathy | Methodist Rehabilitation Center | Completed | No outcome recorded |
| — | NCT07113015 Comparator | Jul → Dec 2024 | Parkinson disease, movement disorder | Multan Medical And Dental College | Completed | No outcome recorded |
| — | NCT04173832 Background | Jan → Dec 2020 | drug-induced dyskinesia | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Unknown | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-08-28 | Zydus Lifesciences Limited | Regulatory Zydus receives final approval from USFDA for Amantadine extended-release capsules 68.5 mg and tentative approval for 137 mg zyduslife.com ↗
Zydus receives final approval from USFDA for Amantadine extended-release capsules 68.5 mg and tentative approval for 137 mg |
| 2022-10-04 | Zydus Lifesciences Limited | Regulatory Zydus receives tentative approval from the USFDA for Amantadine Extended-Release Capsules zyduslife.com ↗
Zydus Lifesciences Limited’s (formerly known as Cadila Healthcare Limited) U.S. subsidiary Zydus Pharmaceuticals (USA) Inc. has received tentative approval from the United States Food and Drug Administration (USFDA) to market Amantadine Extended-Release Capsules USP 68.5 mg and 137 mg (USRLD: Gocovri®). |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-08-28 | Zydus Lifesciences Limited | Zydus receives final approval from USFDA for Amantadine extended-release capsules 68.5 mg and tentative approval for 137 mg zyduslife.com ↗ |
| 2022-10-04 | Zydus Lifesciences Limited | Zydus receives tentative approval from the USFDA for Amantadine Extended-Release Capsules zyduslife.com ↗ |
| 2019-08-27 | SHINKEI Therapeutics, Inc | FDA ACCEPTS SHINKEI THERAPEUTICS INVESTIGATIONAL NEW DRUG APPLICATION FOR MR-301 FOR TRAUMATIC BRAIN INJURY shinkeitherapeutics.com ↗ |
Evidence & citations 16 cited values
Every value below carries the sentence it was read from. 82 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Amantadine | “This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study of ADS-5102 extended release (ER) capsules, an investigational formulation of...” NCT02471222 ↗76“Battery of medications provided through a 12-week schedule including: Minocycline, Lamotrigine, Flumazenil, Modafinil, Bromocriptine, Donepezil, Methylphenidate, Methyl B12,...” NCT02696512 ↗ “This was a multicenter, 3-arm, randomized, placebo-controlled, double-blind, parallel-group study of ADS-5102 (amantadine) extended release capsules in MS subjects with walking...” NCT03436199 ↗ “A triple-combination antiviral drug (TCAD) regimen consisting of amantadine (AMT), oseltamivir (OSL) and ribavirin (RBV) demonstrated good efficacy in an animal model.” PMID 23264438 ↗ Dec 2012 “with Amantadine (prescribed as an antidyskinetic) in patients suffering from Parkinson disease” NCT00632762 ↗ “Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h” NCT00979251 ↗ “GOCOVRI (Amantadine, Extended Release Capsules)” NCT04387773 ↗ |
| Known as | ADS-5102 | “This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study of ADS-5102 extended release (ER) capsules, an investigational formulation of...” NCT02471222 ↗ |
| Known as | AMA | “standard dose Peg-Interferon alfa-2a (PEG-IFN alfa-2a), Ribavirin (RBV) and Amantadine (AMA)” NCT00299923 ↗ |
| Known as | Amantadine HCl | “Amantadine HCl ER Tablets 240mg daily for 12 weeks post two week titration phase.” NCT02153645 ↗ |
| Known as | Amantadine Hydrochloride | “Amantadine hydrochloride 100 mg; tablets; single, oral dose.” NCT01441986 ↗5“one of them is Amantadine (Amantadine Hydrochloride) 100 mg” NCT06833203 ↗ “Amantadine Hydrochloride 100 mg (milligrams) Oral Capsule” NCT05809414 ↗ |
| Known as | amantadine sulfate | “participants received intravenous amantadine sulfate 200 mg after induction of anesthesia and 24 hours later.” PMID 24045608 ↗ Sep 20131“Drug: Amantadine Sulfate” NCT06443827 ↗ |
| Known as | amantadine sulphate | “Patients will receive 200 mg of amantadine sulphate in a 500 ml solution every 12 hours by slow intravenous infusion over a period of 4 hours for 7 days then oral form will be used.” NCT03430817 ↗1“Amantadine Sulphate on Disorders of Consciousness” NCT06443827 ↗ |
| Known as | Amantadine, STADA Arzneimittel AG. | “Amantadine, STADA Arzneimittel AG.” NCT01441986 ↗ |
| Known as | amantidine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07125222 ↗ |
| Known as | AMT | “A triple-combination antiviral drug (TCAD) regimen consisting of amantadine (AMT), oseltamivir (OSL) and ribavirin (RBV) demonstrated good efficacy in an animal model.” PMID 23264438 ↗ Dec 20121“a single dose of amantadine (AMT), a compound that blocks NMDA-R and increases glutamate levels at the synaptic cleft” NCT04244058 ↗ |
| Known as | GOCOVRI | “The purpose of the study is to learn about the effect of GOCOVRI (Amantadine extended release) on activity levels and measures of gait and balance quality in people with...” NCT04387773 ↗ |
| Known as | MANTADIX | “Amantadine MANTADIX” NCT00632762 ↗ |
| Known as | MR-301 | “MR-301 is an I.V. formulation for the treatment of TBI.” NCT06253923 ↗ |
| Known as | PK-Merz | “PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj” NCT01313819 ↗1“one tablet of Amantadine 100 mg (PK-Merz 100 mg, MERZ Pharma)” NCT07421427 ↗ |
| Action | Inhibit | “Amantadine works by attaching to special sites called NMDA (N-methyl-D-aspartate) receptors and blocking the normal activity of glutamate there.” NCT00001930 ↗ |
| Route | Oral | “oral administration of an NMDA-receptor antagonist (amantadine)” NCT00188383 ↗ |