Bendopa

(levodopa)

ApprovedSmall molecule

Bendopa is a small molecule that works as a Dopamine D3 Receptor Agonist.[2] It is being used across 21 indications, with its most advanced program in Approved.[1]

Bendopa is one of 456 small molecule programs targeting Nicotine Dependence. It is currently in Approved.

Indications

Total Trials

Active Trials

455

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Nicotine DependenceApproved

Depressive DisorderActive, not recruiting

Cognitive ImpairmentUnknown status

Retinitis PigmentosaApproved

Restless Legs SyndromeApproved

Parkinson DiseaseRecruiting

Oculocutaneous AlbinismApproved

Chronic PainApproved

Post-Traumatic Stress DisorderApproved

Tourette SyndromeApproved

Nicotine DependenceApproved

Approved

Depressive DisorderPreclinical

Active, not recruiting

Cognitive ImpairmentApproved

Unknown status

Retinitis PigmentosaApproved

Approved

Restless Legs SyndromeApproved

Approved

Parkinson DiseaseApproved

Recruiting

Oculocutaneous AlbinismApproved

Approved

Chronic PainApproved

Approved

Post-Traumatic Stress DisorderApproved

Approved

Tourette SyndromeApproved

Approved

Showing 10 of 20 indications

Competition

Competitive Landscape

174 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Bendopa

MMerz North America, Inc.

Approved

47 2

Inapsine

Jazz Pharmaceuticals

Preclinical

1 3

Ozempic

Novo Nordisk

Preclinical

1 4

Resotran

Takeda

Preclinical

1 5

Depakote

Ibrance

Lunesta

3 8

Persantine

Boehringer Ingelheim

Preclinical

1 9

Luvox

SSolvay Pharmaceuticals

Preclinical

1 10

Catapres

Boehringer Ingelheim

Preclinical

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

Timeline

Expected Milestones

Q3 2027

ApprovedRecruiting

Parkinson Disease

NCT06234995

Q4 2030

ApprovedNot yet recruiting

Parkinson's Disease

NCT07793461

Clinical

Trials by Indication[1]

Parkinson's Disease13 trials

Timing of Levodopa Treatment in Parkinson's Disease

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 3·NCT00004733

Study of the Effects of Dopaminergic Medications on Dopamine Transporter Imaging in Parkinson's Disease

Completed·IInstitute for Neurodegenerative Disorders·Phase 2·NCT00096720·112 enrolled

Dopamine Turnover Rate as Surrogate Parameter for Diagnosis of Early Parkinson's Disease

Completed·TTechnische Universität Dresden·Phase 4·NCT00153972·39 enrolled

Show 10 more trials

Safety and Efficacy Study of Human ESC-derived Neural Precursor Cells in the Treatment of Parkinson's Disease

Unknown status·CChinese Academy of Sciences·Phase 1/2·NCT03119636·50 enrolled

Use of Zolpidem in Parkinson's Disease

Withdrawn·RRush University Medical Center·Phase 2·NCT01351168

A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease

Completed· Biogen logo

Biogen·Phase 2·NCT03000569·29 enrolled

Lisuride Patch to Treat Parkinson's Disease

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 2·NCT00089622·40 enrolled

SLV308 for Treatment of Patients With Parkinson's Disease Experiencing Motor Fluctuations

Completed·SSolvay Pharmaceuticals·Phase 3·NCT00406588·295 enrolled

ACP-103 to Treat Parkinson's Disease

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 2·NCT00086294·40 enrolled

A Trial of tPCS on Parkinson's Disease OFF State

Unknown status·WWestern University, Canada·N/A·NCT04054960·15 enrolled

Measuring Parkinson's Disease Progression

Completed·—·Phase 1·NCT03205956·31 enrolled

Efficacy Phase IIa Study of CVXL-0107 in Advanced Parkinson's Disease

Completed·CCleveXel Pharma·Phase 2·NCT02641054·21 enrolled

Gastrointestinal Dopamine Decarboxylase and Levodopa Pharmacokinetics

Not yet recruiting·BBeth Israel Deaconess Medical Center·Approved·NCT07793461·40 enrolled

Levodopa4 trials

Improved Language Acquisition With Levodopa

Completed·UUniversity Hospital Muenster·Phase 4·NCT00103805·20 enrolled

Natural History of Levodopa-Induced Dyskinesia (LID)

Withdrawn·OOregon Health and Science University··NCT01003002

Developing Objective Measures of Levodopa Induced Dyskinesia: (Study 1)

Completed·UUS Department of Veterans Affairs··NCT00467597·36 enrolled

Show 1 more trial

Effect of Levodopa on Human Multifocal Electroretinogram

Completed·MMedical University of Vienna·Phase 4·NCT00812760·20 enrolled

Cocaine Dependence2 trials

Behavioral Therapy Combined With Carbidopa/Levodopa for the Treatment of Cocaine Dependence

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT00218075·200 enrolled

Carbidopa/Levodopa Combined With Behavioral Therapy for the Treatment of Cocaine Dependence

Completed·TThe University of Texas Health Science Center, Houston·Phase 2·NCT00713583·85 enrolled

Idiopathic Parkinson's Disease2 trials

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients.

Completed·BBial - Portela C S.A.·Phase 3·NCT01227655·427 enrolled

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon

Completed·BBial - Portela C S.A.·Phase 3·NCT01568073·600 enrolled

Aphasia1 trial

Dopaminergic Enhancement of Learning and Memory in Aphasia

Completed·UUniversity Hospital Muenster·Phase 4·NCT00102869·12 enrolled

23 more indications

Neuromodulation1 trial

Neuromodulation and Language Acquisition (Project Stage Ia)

Terminated·UUniversity Hospital Muenster·Phase 4·NCT00102284·100 enrolled

Albinism1 trial

Trial of L-DOPA as a Treatment to Improve Vision in Albinism

Completed·UUniversity of Minnesota·Phase 2·NCT01176435·45 enrolled

Cognitive impairment1 trial

Dopaminergic Enhancement of Learning and Memory in Healthy Adults and Patients With Dementia/Mild Cognitive Impairment

Unknown status·UUniversity Hospital Muenster·Phase 4·NCT00306124·120 enrolled

Neuropathic Pain1 trial

Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's Disease

Completed·UUniversity Hospital, Toulouse·Phase 2/3·NCT02601586·67 enrolled

Efficacy1 trial

Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ON

Completed·SSeoul National University Hospital·Phase 4·NCT02769793·40 enrolled

Depression1 trial

A Study of L-DOPA for Depression and Slowing in Older Adults

Completed·NNew York State Psychiatric Institute·Phase 4·NCT02744391·47 enrolled

Efficacy and Safety1 trial

A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS

Completed· Pfizer logo

Pfizer·Phase 3·NCT00625547·361 enrolled

Parkinsonism1 trial

Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550)

Completed· Merck & Co. logo

Merck & Co.·Phase 1·NCT00845000·12 enrolled

Deep Brain Stimulation1 trial

The Correlation of Reduction of Levodopa and Non-motor Symptoms of Parkinson's Disease After Deep Brain Stimulation

Completed·QQilu Hospital of Shandong University·N/A·NCT05901350·338 enrolled

Angelman syndrome1 trial

A Trial of Levodopa in Angelman Syndrome

Completed·WWen-Hann Tan·Phase 2/3·NCT01281475·67 enrolled

Cardiovascular Events1 trial

Cardiovascular Events in Parkinson's Disease Patients

Completed· GSK logo

GSK··NCT01545856·1 enrolled

Clinical Trial1 trial

Clinical Trial of Levodopa/Carbidopa ( Sinemet) Therapy in Angel Man Syndrome

Completed·BBennett Lavenstein·N/A·NCT03235037·10 enrolled

Stroke1 trial

Combinational Rehabilitative Therapy and Functional Brain Imaging for Patients Recovering From Motor Stroke

Completed·SSingapore General Hospital·Phase 3·NCT02073773·9 enrolled

Diabetic Retinopathy1 trial

Levodopa for Diabetic Retinopathy

Completed·EEmory University·Phase 2·NCT07444892·230 enrolled

PTSD1 trial

Dopamine Enhancement of Fear Extinction Learning in PTSD (1R21MH108753)

Completed·UUniversity of Wisconsin, Madison·Phase 4·NCT02560389·103 enrolled

Safety and Efficacy1 trial

Safety and Efficacy Study of SYN115 in Parkinson's Patients Using Levodopa to Treat End of Dose Wearing Off

Completed·BBiotie Therapies Inc.·Phase 2/3·NCT01283594·420 enrolled

Autonomic Nervous System1 trial

Duodenal Levodopa Infusion, Quality of Life and Autonomic Nervous System in Parkinson's Disease

Completed·UUniversity of Helsinki·Phase 4·NCT00914134·12 enrolled

Unknown status·UUniversity Hospital Muenster·Phase 4·NCT00111371·100 enrolled

Multiple System Atrophy1 trial

Motor Activation in Multiple System Atrophy and Parkinson Disease: a Positron Emission Tomography (PET) Study

Completed·UUniversity Hospital, Toulouse·N/A·NCT01044992·38 enrolled

Parkinson disease1 trial

Cortical Electrophysiology of Response Inhibition in Parkinson's Disease

Recruiting·EEmory University·Approved·NCT06234995·80 enrolled

Unspecified3 trials

Targeting Dopamine Therapy in RLS

Unknown status·TTel-Aviv Sourasky Medical Center·N/A·NCT01937169·30 enrolled

Dose-finding Pharmacokinetic Study in Healthy Males

Completed· Orion Corporation, Orion Pharma logo

Orion Corporation, Orion Pharma·Phase 1·NCT03055936·56 enrolled

Sustained Release Oral Formulation for Treatment of Parkinson's Disease

Completed·UUniversity of Minnesota·Phase 1·NCT05471609·6 enrolled

Regulatory

FDA Approval Timeline[4]

Jan 1, 1982

BENDOPA

NDA NDA016948

Jan 1, 1982

DOPAR

NDA NDA016913

Jan 1, 1982

LARODOPA

NDA NDA016912

Dec 21, 2018

INBRIJA

NDA NDA209184

Sources

References

[1]
ClinicalTrials.gov — 47 trial records for levodopa. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — levodopa compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for levodopa. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA209184). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Bendopa. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Merz North America, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Dopamine D3 Receptor Agonist[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: MMerz North America, Inc.

Patent Landscape[5]

Patent Cliff

Feb 3, 2029

Earliest patent expiration — generic entry possible after this date

Patent #Expires

RE43711Feb 3, 2029

8685442Nov 16, 2032

8945612Nov 16, 2032

8545878Nov 16, 2032

9393210Nov 16, 2032

1 more patents

12458615Oct 21, 2033

Bendopa

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q4 2030

Trials by Indication[1]

Parkinson's Disease13 trials

Levodopa4 trials

Cocaine Dependence2 trials

Idiopathic Parkinson's Disease2 trials

Aphasia1 trial

Neuromodulation1 trial

Albinism1 trial

Cognitive impairment1 trial

Neuropathic Pain1 trial

Efficacy1 trial

Depression1 trial

Efficacy and Safety1 trial

Parkinsonism1 trial

Deep Brain Stimulation1 trial

Angelman syndrome1 trial

Cardiovascular Events1 trial

Clinical Trial1 trial

Stroke1 trial

Diabetic Retinopathy1 trial

PTSD1 trial

Safety and Efficacy1 trial

Autonomic Nervous System1 trial

Treatment1 trial

Impairment1 trial

Memory1 trial

Multiple System Atrophy1 trial

Parkinson disease1 trial

Unspecified3 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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