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Carbidopa

Generic Name
Carbidopa
Brand Names
Dhivy, Duodopa, Duopa, Lodosyn, Parcopa, Rytary, Sinemet, Stalevo
Drug Type
Small Molecule
Chemical Formula
C10H14N2O4
CAS Number
28860-95-9
Unique Ingredient Identifier
KR87B45RGH
Background

Carbidopa presents a chemical denomination of N-amino-alpha-methyl-3-hydroxy-L-tyrosine monohydrate. It potently inhibits aromatic amino acid decarboxylase (DDC) and due to its chemical properties, it does not cross the blood-brain barrier. Due to its activity, carbidopa is always administered concomitantly with levodopa. An individual formulation containing solely carbidopa was generated to treat nausea in patients where the combination therapy levodopa/carbidopa is not efficient reducing nausea.

The first approved product by the FDA containing only carbidopa was developed by Amerigens Pharmaceuticals Ltd and approved on 2014. On the other hand, the combination treatment of carbidopa/levodopa was originally developed by Watson Labs but the historical information by the FDA brings back to the approval of this combination therapy developed by Mayne Pharma in 1992.

Indication

Carbidopa is indicated with levodopa for the treatment of symptoms of idiopathic Parkinson disease, postencephalitic parkinsonism and symptomatic parkinsonism followed by carbon monoxide or manganese intoxication.

The combination therapy is administered for the reduction of levodopa-driven nausea and vomiting.

The product of carbidopa should be used in patients where the combination therapy of carbidopa/levodopa provide less than the adequate daily dosage.

As well carbidopa can be used in patients where the dosages of carbidopa and levodopa require individual titration.

Associated Conditions
Parkinson's Disease (PD), Parkinsonism post encephalitic, Symptomatic Parkinson Disease, Levodopa-driven nausea and vomiting

Tavapadon Shows Promise in Phase 3 Trials for Parkinson's Disease with Improved Motor Function and Safety Profile

• The TEMPO-1 and TEMPO-2 trials demonstrated that tavapadon, a selective D1/D5 dopamine receptor agonist, significantly improved motor function in newly diagnosed Parkinson's disease patients compared to placebo. • Tavapadon's once-daily dosing regimen and targeting of D1/D5 receptors may offer advantages over traditional D2/D3 agonists, with lower incidence of impulse control disorders, somnolence, and other dopaminergic side effects. • The TEMPO-3 trial showed tavapadon's efficacy as an adjunctive therapy, increasing "on" time by 1.1 hours in patients with advanced Parkinson's disease who experience motor fluctuations while on levodopa.

Annovis Bio's Buntanetap Enters Phase 3 for Early Alzheimer's, AbbVie's Tavapadon Shows Promise in Parkinson's

• Annovis Bio initiated a Phase 3 trial of buntanetap for early Alzheimer's, aiming to assess both symptomatic and disease-modifying effects over 18 months. • The trial follows positive Phase 2/3 data and has secured initial funding, with plans to enroll over 750 participants across approximately 100 U.S. sites. • AbbVie's tavapadon met its primary endpoint in a Phase 3 trial for early Parkinson's disease, demonstrating significant motor function improvement. • AbbVie plans to submit a New Drug Application to the FDA in 2025, potentially offering a novel treatment option for Parkinson's patients.

TrueBinding's TB006 Receives FDA IND Clearance for Parkinson's Phase 2A Trial

• TrueBinding's TB006, a monoclonal antibody targeting Galectin-3, has received FDA IND clearance for a Phase 2A trial in Parkinson's Disease. • The Phase 2A trial will assess the safety and efficacy of TB006 in early to mild Parkinson's patients aged 50-80 over a multi-center, placebo-controlled study. • TB006 aims to neutralize Galectin-3, potentially dissociating neurotoxic oligomers and reducing neuroinflammation associated with Parkinson's Disease. • The trial plans to enroll 62 patients with an estimated primary completion date in Q1 2026, marking a significant step for a novel therapeutic approach.

TrueBinding's TB006 Receives FDA IND Clearance for Phase 2a Parkinson's Disease Trial

• TrueBinding's TB006, a monoclonal antibody targeting Galectin-3, has received FDA IND clearance for a Phase 2a trial in Parkinson's Disease, marking a significant milestone. • The Phase 2a trial will assess the safety and efficacy of TB006 in early to mild Parkinson's patients aged 50-80, with an estimated enrollment of 62 participants. • TB006, administered via monthly intravenous infusion, aims to neutralize Galectin-3, potentially reducing neurotoxic oligomers and pro-inflammatory responses in Parkinson's Disease. • This first-in-class therapy offers a promising new option for Parkinson's patients, addressing an unmet need for disease-modifying treatments, with primary completion expected in Q1 2026.

Parkinson's Disease Research Focuses on Disease-Modifying Therapies

• The Parkinson's disease (PD) therapeutic market faces unmet needs, notably the absence of neuroprotective/disease-modifying therapies (DMTs) and treatments for non-motor symptoms. • A significant portion of the PD drug development pipeline is dedicated to neuroprotective and disease-modifying agents, targeting mechanisms like alpha-synuclein aggregation and neuroinflammation. • Clinical trials are underway for therapies addressing postural instability, PD-dementia, and cognitive/emotional impairments, reflecting a comprehensive approach to managing PD's complexities.

FDA Approves Supernus' ONAPGO for Motor Fluctuations in Advanced Parkinson's Disease

• The FDA has approved ONAPGO (apomorphine hydrochloride) as the first subcutaneous apomorphine infusion device for treating motor fluctuations in advanced Parkinson's disease. • ONAPGO, a wearable device, provides continuous subcutaneous apomorphine infusion, offering more consistent control of OFF time for Parkinson's patients. • Clinical trials demonstrated that ONAPGO significantly reduced daily OFF time by 2.6 hours compared to placebo, with improvements seen as early as week 1. • Supernus plans to launch ONAPGO in the U.S. in the second quarter of 2025, supported by a dedicated nurse education program and access support.

Evecxia Therapeutics Gains FDA Support for EVX-101 Depression Trial

• Evecxia Therapeutics received positive feedback from the FDA regarding its EVX-101 development program for depression. • The FDA raised no concerns about the non-clinical or clinical safety data presented for EVX-101. • This pre-IND meeting outcome provides a clear path forward for Evecxia to file an IND for a Phase 2 trial in depression patients with inadequate response to standard treatments. • EVX-101 is a novel adjunctive antidepressant candidate designed to enhance serotonin activity in the brain.

FDA Approves AbbVie's Vyalev for Advanced Parkinson's Disease

• The FDA has approved AbbVie's Vyalev (foscarbidopa and foslevodopa) as a 24-hour subcutaneous infusion for motor fluctuations in advanced Parkinson's disease. • Vyalev is the first and only levodopa-based therapy delivered as a continuous 24-hour infusion, offering a non-surgical treatment option for patients. • Clinical trials showed Vyalev significantly increased "on" time without troublesome dyskinesia and decreased "off" time compared to oral carbidopa/levodopa. • The most common adverse reactions were infusion site events, hallucinations, and dyskinesia, with Medicare coverage expected in the second half of 2025.
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