TheraRadar
Data updated: May 26, 2026

CREXONT (carbidopa)

DOPA Decarboxylase Inhibitors
CNS Approved 2024-08-07

CREXONT is indicated for the treatment of Parkinson's Disease; Post-Encephalitic Parkinsonism; Parkinsonism.

Source: FDA Label • IMPAX • Aromatic Amino Acid Decarboxylation Inhibitor

How CREXONT Works

Levodopa serves as a metabolic precursor to dopamine that crosses the blood-brain barrier to be converted into dopamine within the brain. Because levodopa is typically converted to dopamine in peripheral tissues before reaching the central nervous system, carbidopa is included to inhibit this peripheral decarboxylation. By blocking this extracerebral conversion, carbidopa increases the amount of unchanged levodopa available for transport to the brain. This mechanism ensures that the precursor reaches the brain to be converted into the neurotransmitter dopamine.

1
Indication
--
Phase 3 Trials
1
Years on Market

Details

Status
Prescription
First Approved
2024-08-07
Patent Cliff
2041

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE

Companies

Active Ingredient: CARBIDOPA , LEVODOPA

CREXONT Approval History

2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2024 to 2026
Mar 2026 SUPPL
Label · Labeling
Aug 2024 ORIGINAL
New Form · Type 3 - New Dosage Form

What CREXONT Treats

3 indications

CREXONT is approved for 3 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Parkinson's Disease
  • Post-Encephalitic Parkinsonism
  • Parkinsonism
Source: FDA Label

CREXONT Competitive Set

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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 CREXONT

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FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

DHIVY
CARBIDOPA
3 shared
AVION PHARMS
Shared indications:
Parkinson's DiseasePost-Encephalitic ParkinsonismParkinsonism
RYTARY
CARBIDOPA
3 shared
IMPAX
Shared indications:
Parkinson's DiseasePost-Encephalitic ParkinsonismParkinsonism
SINEMET
CARBIDOPA
3 shared
Merck
Shared indications:
Parkinson's DiseasePost-Encephalitic ParkinsonismParkinsonism
📋

Clinical Trial Registry

17 trials
Trial Sponsor ID Phase Status Title
NCT04520178 5-HTP only Pro00119483/00125176 Ph 2, Ph 3 recruiting Effects of 5HTP on the Injured Human Spinal Cord
NCT04325503 RES results posted HUM00156490 5U01AG061393-05 Ph 1, Ph 2 completed Neurobiological Drivers of Mobility Resilience: The Dopaminergic System
NCT01323374 FMS201 Droxidopa FMS201 Ph 2 completed Study To Assess The Clinical Benefit Of Droxidopa And Droxidopa/Carbidopa In Subjects With Fibromyalgia
NCT04000919 18.1268 Ph 2, Ph 3 suspended Effects of 5HTP and LDOPA on CNS Excitability After SCI
NCT00685919 results posted 101499 HL071784-05A1 Ph 2, Ph 3 completed Peripheral Dopamine in Postural Tachycardia Syndrome
NCT03055936 COMDOS1 results posted 3112005 Ph 1 completed Dose-finding Pharmacokinetic Study in Healthy Males
NCT03266965 20161186 W81XWH-16-1-0462 Ph 1 completed Histaminergic Basis of Central Fatigue in Multiple Sclerosis - A Novel Approach
NCT03115827 results posted VUMC54580 Ph 4 completed Norepinephrine-targeted Therapy for Action Control in Parkinson Disease
NCT01399905 results posted IRB00004133 Ph 2 completed High and Low Dose Carbidopa Treatment of Parkinson's Disease
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)
NCT02633839 CVT-301-007 Ph 1 completed A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults
NCT02633007 CVT-301-008 Ph 1 completed A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma
NCT01212484 results posted 09-0011 Ph 3 completed Carbidopa for the Treatment of Nausea and Vomiting in Familial Dysautonomia
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
NCT01229332 ND0611/002 Ph 1, Ph 2 completed A Safety, Tolerability and Pharmacokinetic Study of ND0611 on the Top of Different Oral Dosage Forms of Levodopa/Carbidopa in Parkinson's Disease Patients
NCT01296464 PARTEST 2939136 Ph 2 completed Comparing Different Levodopa/Carbidopa/Entacapone Treatment Regimens
🔬

Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.

CREXONT FDA Label Details

Indications & Usage

FDA Label (PDF)

CREXONT is indicated for the treatment of Parkinson's Disease; Post-Encephalitic Parkinsonism; Parkinsonism.

View full patent landscape →
29 OB patents · 4 families · 100 international docs across 14 countries

CREXONT Patents & Exclusivity

Latest Patent: Dec 2041
Exclusivity: Aug 2027

Patents (29 active)

US12303482 Expires Dec 21, 2041
US12295931 Expires Dec 21, 2041
US12303481 Expires Dec 21, 2041
US11986449 Expires Dec 21, 2041
US12201596 Expires Dec 21, 2041
US12109185 Expires Dec 21, 2041
US12458616 Expires Dec 21, 2041
US12453710 Expires Dec 21, 2041
US12263148 Expires Dec 21, 2041
US12263149 Expires Dec 21, 2041
US12447139 Expires Dec 21, 2041
US12194150 Expires Dec 21, 2041
US12370163 Expires Dec 21, 2041
US11666538 Expires Oct 7, 2034
US10987313 Expires Oct 7, 2034
US10973769 Expires Oct 7, 2034
US10688058 Expires Oct 7, 2034
US10292935 Expires Oct 7, 2034
US10098845 Expires Oct 7, 2034
US12178919 Expires Oct 7, 2034
US12128141 Expires Oct 7, 2034
US12491164 Expires Oct 7, 2034
US12274793 Expires Oct 7, 2034
US11622941 Expires Oct 7, 2034
US12303605 Expires Oct 7, 2034
US12403099 Expires Oct 7, 2034
US12064521 Expires Oct 7, 2034
US12178918 Expires Oct 7, 2034
US11357733 Expires Oct 7, 2034

Exclusivity

NP Until Aug 2027
NP Until Aug 2027
NP Until Aug 2027
NP Until Aug 2027
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NP Until Aug 2027
NP Until Aug 2027
NP Until Aug 2027
NP Until Aug 2027
NP Until Aug 2027
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NP Until Aug 2027
NP Until Aug 2027
NP Until Aug 2027
NP Until Aug 2027
NP Until Aug 2027
Source: FDA Orange Book

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Revenue Insights

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  • Historical trend analysis

Patent Timeline

  • Cliff: 2041
  • 976 active patents

Trial Analysis

  • Clinical trial tracking
  • Development stage analysis

Competitive Landscape

  • 20 similar drugs
  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.