INBRIJA (levodopa)
INBRIJA is an aromatic amino acid indicated for the intermittent treatment of OFF episodes in patients with Parkinson's disease. This medication is specifically for patients who are already receiving treatment with carbidopa/levodopa. It serves as a supplemental therapy to address the return of symptoms that occurs between scheduled doses of maintenance medication.
How INBRIJA Works
Levodopa functions as a metabolic precursor to dopamine, a chemical messenger in the brain. The drug crosses the blood-brain barrier and is presumably converted into dopamine within the central nervous system. This process is thought to be the mechanism by which the medication relieves the symptoms associated with Parkinson's disease.
Details
- Status
- Prescription
- First Approved
- 2018-12-21
- Patent Cliff
- 2033
- Routes
- INHALATION
- Dosage Forms
- POWDER
INBRIJA Approval History
What INBRIJA Treats
1 indicationsINBRIJA is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Parkinson's Disease
INBRIJA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to INBRIJA
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
17 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02601586 OXYDOPA | 14 7440 01 | Ph 2, Ph 3 | completed | Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's Disease |
| NCT06234995 | STUDY00007291 P50NS123103, 2025P008808 | Ph 4 | recruiting | Cortical Electrophysiology of Response Inhibition in Parkinson's Disease |
| NCT07444892 | STUDY00002995 2025P013031 | Ph 2 | completed | Levodopa for Diabetic Retinopathy |
| NCT03000569 results posted | 217-PRK-201 | Ph 2 | completed | A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease |
| NCT02744391 results posted | 7270 | Ph 4 | completed | A Study of L-DOPA for Depression and Slowing in Older Adults |
| NCT03205956 MPDP | 009 | Ph 1 | completed | Measuring Parkinson's Disease Progression |
| NCT03055936 COMDOS1 results posted | 3112005 | Ph 1 | completed | Dose-finding Pharmacokinetic Study in Healthy Males |
| NCT02769793 | 16-2015-52 | Ph 4 | completed | Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ON |
| NCT01281475 results posted | 09-12-0610 3523 | Ph 2, Ph 3 | completed | A Trial of Levodopa in Angelman Syndrome |
| NCT02560389 results posted | 204583 | Ph 4 | completed | Dopamine Enhancement of Fear Extinction Learning in PTSD (1R21MH108753) |
| NCT00845000 results posted | P05550 MK-3814-023 | Ph 1 | completed | Acute Effects of Preladenant (SCH 420814) on Dyskinesia and Parkinsonism in Levodopa Treated Participants (P05550) |
| NCT01176435 results posted | 0912M75653 | Ph 2 | completed | Trial of L-DOPA as a Treatment to Improve Vision in Albinism |
| NCT00713583 results posted | 1R01DA023608-01 1R01DA023608-01, R01DA023608-01 | Ph 2 | completed | Carbidopa/Levodopa Combined With Behavioral Therapy for the Treatment of Cocaine Dependence |
| NCT02641054 | CT-CVXL-0107-01 | Ph 2 | completed | Efficacy Phase IIa Study of CVXL-0107 in Advanced Parkinson's Disease |
| NCT02073773 | CIRB 2013/323/D | Ph 3 | completed | Combinational Rehabilitative Therapy and Functional Brain Imaging for Patients Recovering From Motor Stroke |
| NCT01227655 BIPARKII results posted | BIA-91067-302 2010-022366-27, BIA-91067-302 | Ph 3 | completed | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients. |
| NCT01568073 results posted | BIA-91067-301 2010-021860-13 | Ph 3 | completed | Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
INBRIJA FDA Label Details
Indications & Usage
FDA Label (PDF)INBRIJA is indicated for the treatment of Parkinson's Disease.
Pro Intelligence Preview
Deep insights for INBRIJA
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2033
- • 6 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.