Gocovri

(amantadine)

ApprovedSmall molecule

GGrupo Espanol de Tumores Neuroendocrinos

Gocovri is a small molecule that works as a Matrix Protein 2 Inhibitor; Glutamate [NMDA] Receptor Antagonist.[2] It is being used across 12 indications, with its most advanced program in Approved.[1]

Gocovri is one of 247 small molecule programs targeting Frontotemporal Dementia. It is currently in Approved.

Indications

Total Trials

Active Trials

246

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Frontotemporal DementiaWithdrawn

TremorActive, not recruiting

Parkinson DiseaseActive, not recruiting

Brain InjuryCompleted

Cerebral InfarctionApproved

IrritabilityActive, not recruiting

Breast CancerNot yet recruiting

InfluenzaActive, not recruiting

Maintenance TherapyUnknown status

Post Operative Cognitive DysfunctionUnknown status

Frontotemporal DementiaApproved

Withdrawn

TremorPreclinical

Active, not recruiting

Parkinson DiseaseApproved

Active, not recruiting

Brain InjuryApproved

Completed

Cerebral InfarctionApproved

Approved

IrritabilityPreclinical

Active, not recruiting

Breast CancerPhase 2

Not yet recruiting

InfluenzaApproved

Active, not recruiting

Maintenance TherapyPreclinical

Unknown status

Post Operative Cognitive DysfunctionPreclinical

Unknown status

Showing 10 of 12 indications

Competition

Competitive Landscape

702 competitors in Breast Cancer

#DrugCompanyPhaseTrials

Gocovri

GGrupo Espanol de Tumores Neuroendocrinos

Approved

1 2

Lexiscan

Astellas

Preclinical

1 3

Blenoxane

Bristol-Myers Squibb

Preclinical

1 4

Methylthioninium Chloride

PProvepharm SAS

Preclinical

3 5

Spravato

WWim Janssens

Preclinical

2 6

Nubain

AAultman Health Foundation

Preclinical

1 7

Systemic Therapy

Bristol-Myers Squibb

Preclinical

1 8

Beta Blocker

WWeill Medical College of Cornell University

Preclinical

1 9

Ablavar

LLantheus Medical Imaging

Preclinical

2 10

Tc99m Sestamibi

MM.D. Anderson Cancer Center

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2028

Phase 2Not yet recruiting

Breast Cancer

NCT07889115

Recruiting

SARS Cov 2 Infection

NCT05504057

Recruiting

Influenza

NCT04367883

Clinical

Trials by Indication[1]

Amantadine6 trials

Acetylamantadine Excretion by Cancer Patients

Unknown status·UUniversity of Manitoba··NCT02277938·120 enrolled

Treatment of Huntington's Chorea With Amantadine

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 2·NCT00001930·25 enrolled

Amantadine + rTMS as a Neurotherapeutic for Disordered Consciousness

Completed·—·N/A·NCT02025439·4 enrolled

Show 3 more trials

Perioperative Treatment of Parkinsonian Patients With Parenteral Amantadine

Terminated·RRabin Medical Center·Phase 2·NCT00600093·20 enrolled

Amantadine for Neuroenhancement in Acute Patients Study

Unknown status·UUniversity Hospital Tuebingen·Phase 2·NCT05479032·50 enrolled

Urinary Excretion of Acetylamantadine by Normal Healthy Volunteers

Completed·UUniversity of Manitoba·N/A·NCT01467258·20 enrolled

Parkinson's Disease4 trials

Topiramate as an Adjunct to Amantadine in the Treatment of Dyskinesia in Parkinson's Disease

Terminated·RRush University Medical Center·Phase 2·NCT01789047·42 enrolled

Efficacy Study of Amantadine to Treat Gait Dysfunction and Freezing in Parkinson's Disease

Terminated·NNorthwestern University·Phase 3·NCT01652534·3 enrolled

Amantadine and L-DOPA-induced Dyskinesia in Early Parkinson's Disease

Completed·UUniversity Hospital, Toulouse·Phase 2·NCT01538329·210 enrolled

Show 1 more trial

Quantification of the Antidyskinetic Effect of Amantadine and Topiramate in Parkinson's Disease

Terminated·OOregon Health and Science University·N/A·NCT00794313·3 enrolled

Hepatitis C2 trials

Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous Hepatitis C Virus (HCV) Non Responders

Terminated·FFrench National Agency for Research on AIDS and Viral Hepatitis·Phase 3·NCT00122629·405 enrolled

Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients

Completed·UUniversity Hospital, Bordeaux·Phase 3·NCT00221624·131 enrolled

COVID-192 trials

Efficacy of Amantadine Treatment in COVID-19 Patients

Terminated·NNoblewell·Phase 3·NCT04952519·193 enrolled

Amantadine for COVID-19

Unknown status·—·Phase 3·NCT04894617·226 enrolled

Brain Injury2 trials

Citicholine-Amantadine Trial in Traumatic Brain Injury

Completed·—·Phase 4·NCT03430817·45 enrolled

Amantadine and Temporal Discrimination in Patients With Traumatic Brain Injury (TBI)

Withdrawn·WWake Forest University Health Sciences·N/A·NCT00800514

25 more indications

Cocaine Dependence2 trials

Effectiveness of Amantadine and Propranolol for Treating Cocaine Dependence - 2

Completed·UUniversity of Pennsylvania·Phase 2·NCT00158132·199 enrolled

Prepulse Inhibition of Startle in Cocaine Dependence - 7

Completed·NNational Institute on Drug Abuse (NIDA)·Phase 1·NCT00015249

Post Operative Cognitive Dysfunction1 trial

Effects of Amantadine on Postoperative Cognitive Dysfunction

Unknown status·ZZhiyi Zuo·N/A·NCT03527134·390 enrolled

Schizophrenia1 trial

Amantadine as Adjunctive Therapy to Antipsychotics in Schizophrenia

Unknown status·HHospital de Clinicas de Porto Alegre·Phase 3·NCT00999505·40 enrolled

SARS CoV 2 Infection1 trial

Antihistamines, Amantadine and Evolution of the SARS-CoV-2 Infection

Recruiting·CConsorci Sanitari de Terrassa··NCT05504057·140,660 enrolled

Safety and Efficacy1 trial

Assessment of Safety and Efficacy of Therapy for the Prevention of Weight Gain Associated With Olanzapine

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00401973·199 enrolled

Stroke1 trial

Promoting Recovery After STroke With Amantadine

Recruiting·UUniversity of Pennsylvania·Phase 2·NCT05140148·60 enrolled

Cardiac Arrest1 trial

Amantadine to Speed Awakening After Cardiac Arrest

Completed·—·Phase 2·NCT02486211·14 enrolled

Influenza1 trial

Influenza Vaccination, ACEI and ARB in the Evolution of SARS-CoV2 Infection

Recruiting·CConsorci Sanitari de Terrassa··NCT04367883·3,000 enrolled

Irritability1 trial

Utility of Amantadine Hydrochloride in the Treatment of Post-traumatic Irritability

Completed·WWake Forest University Health Sciences·N/A·NCT00627250·76 enrolled

Tremor1 trial

A Study Comparing Propranolol and Amantadine for Reducing Tremors in People With Parkinson's Disease

Completed·MMultan Medical And Dental College·N/A·NCT07113015·220 enrolled

Homeostasis1 trial

Dextromethorphan, Amantadine and Glucose Homeostasis in Diabetes Subjects

Completed·PProfil Institut für Stoffwechselforschung GmbH·Phase 2·NCT01441986·20 enrolled

Pilot Study1 trial

Amantadine and Functional Improvement Following ABI Measured by MRI Tractography; A Pilot Study

Unknown status·HHamilton Health Sciences Corporation·N/A·NCT02566720·10 enrolled

Treatment Resistant Depression1 trial

Comparison of Antidepressant Augmentation With Amantadine vs Pramipexole vs Quetiapine in Treatment Resistant Depression

Unknown status·—·Phase 4·NCT04936126·150 enrolled

Frontotemporal Dementia1 trial

Amantadine for the Treatment of Behavioral Disturbance in Frontotemporal Dementia (FTD)

Withdrawn·JJohns Hopkins University·Phase 4·NCT00127114

Attention Deficit Hyperactivity Disorder1 trial

Amantadine Versus Ritalin in the Treatment of Attention Deficit Hyperactivity Disorder (ADHD)

Unknown status·TTehran University of Medical Sciences·Phase 2·NCT01099059·40 enrolled

Prostatectomy1 trial

Effects of N-Methyl-D-Aspartate (NMDA)-Receptor Antagonism on Hyperalgesia, Opioid Use, and Pain After Radical Prostatectomy

Unknown status·UUniversity Health Network, Toronto·Phase 1/2·NCT00188383·132 enrolled

Multiple Sclerosis1 trial

Treatment of Fatigue With Methylphenidate, Modafinil and Amantadine in Multiple Sclerosis

Completed·JJohns Hopkins University·Phase 3·NCT03185065·141 enrolled

Chronic Hepatitis1 trial

Study on Chronic Hepatitis C Treatment With Interferon Alpha, Ribavirin and Amantadine in Naive Patients

Completed·UUMC Utrecht·Phase 3·NCT00146016·390 enrolled

Cocaine Abuse1 trial

Rapid Evaluation of Amantadine for Treatment of Cocaine Abuse/Dependence - 4

Completed·UUniversity of California, Los Angeles·Phase 2·NCT00000301

Cognitive impairment1 trial

Amantadine Therapy for Cognitive Impairment in Long COVID

Completed·OOhio State University·Phase 2·NCT06055244·64 enrolled

Cognitive Dysfunction1 trial

A Study of Amantadine for Cognitive Dysfunction in Patients With Long-Covid

Withdrawn·UUniversity of Texas Southwestern Medical Center·Phase 2·NCT06234462

Maintenance Therapy1 trial

Pilot Study of Maintenance Therapy With Intravenous AMANTADINE

Unknown status·RRabin Medical Center·N/A·NCT01190553·20 enrolled

Skin1 trial

Validation of Dyskinesia Rating Scales

Completed·RRush University Medical Center·Phase 4·NCT01071395·68 enrolled

Fatigue1 trial

The Effect of Amantadine on Post-COVD-19 Fatigue

Unknown status·SShahid Beheshti University of Medical Sciences·Phase 2·NCT05667077·83 enrolled

Breast Cancer1 trial

Evaluation of the Effect of Amantadine in the Prevention of Paclitaxel-Induced Peripheral Neuropathy in Breast Cancer Patients

Not yet recruiting·AAl-Azhar University·Phase 2·NCT07889115·80 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

SYMMETREL

NDA NDA016020

Jan 1, 1982

SYMMETREL

NDA NDA016023

Jan 1, 1982

SYMMETREL

NDA NDA018101

Aug 24, 2017

GOCOVRI

NDA NDA208944

Feb 16, 2018

OSMOLEX ER

NDA NDA209410

Sources

References

[1]
ClinicalTrials.gov — 42 trial records for amantadine. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — amantadine compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for amantadine. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209410). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Gocovri. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Grupo Espanol de Tumores Neuroendocrinos company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Matrix Protein 2 Inhibitor; Glutamate [NMDA] Receptor Antagonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: GGrupo Espanol de Tumores Neuroendocrinos

Patent Landscape[5]

Patent Cliff

Jan 22, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8389578Jan 22, 2028

8252331Mar 13, 2030

11197835Dec 2, 2030

9877933Dec 2, 2030

9867791Dec 2, 2030

16 more patents

9867793Dec 2, 2030

8741343Dec 2, 2030

9867792Dec 2, 2030

10646456Jun 17, 2034

11903908Jun 17, 2034

10154971Dec 4, 2034

10500170Feb 15, 2038

10213393Feb 15, 2038

10213394Feb 15, 2038

10500171Feb 15, 2038

10500172Feb 15, 2038

10512617Feb 15, 2038

11890261Feb 15, 2038

11077073Aug 23, 2038

12233033Aug 23, 2038

11065213Aug 23, 2038

Gocovri

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2028

Trials by Indication[1]

Amantadine6 trials

Parkinson's Disease4 trials

Hepatitis C2 trials

COVID-192 trials

Brain Injury2 trials

Cocaine Dependence2 trials

Post Operative Cognitive Dysfunction1 trial

Schizophrenia1 trial

SARS CoV 2 Infection1 trial

Safety and Efficacy1 trial

Stroke1 trial

Cardiac Arrest1 trial

Influenza1 trial

Irritability1 trial

Tremor1 trial

Homeostasis1 trial

Pilot Study1 trial

Treatment Resistant Depression1 trial

Frontotemporal Dementia1 trial

Attention Deficit Hyperactivity Disorder1 trial

Prostatectomy1 trial

Multiple Sclerosis1 trial

Chronic Hepatitis1 trial

Cocaine Abuse1 trial

Cognitive impairment1 trial

Cognitive Dysfunction1 trial

Maintenance Therapy1 trial

Skin1 trial

Fatigue1 trial

Breast Cancer1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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