A multi-center, open label, longitudinal, observational, 12-week study of Flexilev treatment with the dosing device OraFID and accompanying digital app in Parkinson patients.

Start Date26 May 2026

Sponsor / Collaborator

Navamedic AB

CTIS2024-514852-34-01

/ RecruitingPhase 2IIT

Prospective pilot study of L-dopa treatment in patients with a neurodevelopmental disorder linked to a pathogenic variant of the CTNNB1 gene

Start Date08 Apr 2026

Sponsor / Collaborator

Centre Hospitalier Universitaire de Montpellier

ChiCTR2500103252

/ Not yet recruitingPhase 1/2IIT

A prospective, single-arm, multicenter Phase Ib/II clinical study of liposomal irinotecan combined with capecitabine and bevacizumab for the first-line treatment of advanced colorectal cancer

Start Date31 May 2025

Sponsor / Collaborator

Zhejiang Cancer Hospital

100 Clinical Results associated with Carbidopa

100 Translational Medicine associated with Carbidopa

100 Patents (Medical) associated with Carbidopa

3,266

Literatures (Medical) associated with Carbidopa

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Subcutaneous foslevodopa/foscarbidopa (LDp/CDp) in advanced Parkinson’s disease (aPD): societal cost impact analysis for the UK, France, Germany, Spain, and Canada

Article

Author: Parra, Juan Carlos ; Boodhna, Trishal ; Belsey, Jonathan ; Ray Chaudhuri, K.

BACKGROUND:

The costs associated with advanced Parkinson's disease (aPD) extend beyond direct medical expenditure. As symptoms become more severe, professional and informal personal care costs are likely to exceed those incurred for medical and pharmacological treatment. The objective of this analysis is to explore the impact of treatment with subcutaneous foslevodopa/foscarbidopa (LDp/CDp) on the societal cost impact in the UK, France, Germany, Spain, and Canada.

METHODS:

A model was developed to aggregate expected costs incurred by a cohort with aPD over a 5-year time frame. Resource use for direct medical, non-medical, and informal care are estimated from a real world data source (Adelphi), mapped to the severity of disease as estimated by the extent of OFF-time experienced by patients. Indirect societal costs are estimated from published literature. Unit costs for each of the included countries are then applied to these resource use estimates. Symptom progression of individuals within the cohort are derived from a previously developed Markov model, which captures the differential effect on OFF-time of LDp/CDp versus best medical treatment (BMT).

RESULTS:

Overall costs for aDP patients were shown to rise over the 5-year time horizon, as symptom progression occurred. The use of LDp/CDp incurred greater drug costs than BMT, but, by delaying exacerbation of OFF-time, this additional cost was more than offset by other savings - principally attributable to professional and informal care. Aggregated results showed a net cumulative saving of €96,273 per patient over the 5 year time horizon. Results for the five individual countries evaluated ranged from €50,297 to €135,208 per patient saving.

CONCLUSION:

LDp/CDp has been shown to significantly improve OFF-time burden in patients with aPD, compared with BMT. Once the costs of professional and informal care are taken into account, the additional acquisition costs of LDp/CDp are more than offset, yielding a net societal saving.

01 Dec 2026·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Integrating Box–Behnken and Plackett–Burman designs for the robust impurity profiling of levodopa and carbidopa tablets

Article

Author: Arabacı, Burak ; Gençer, Pelin ; Korkmaz, Daria Angelika

Pharmacopeial methods are essential for pharmaceutical quality control, yet impurity profiling of levodopa/carbidopa fixed-dose combination tablets remains challenging because both actives are chemically labile and several structurally related impurities exhibit closely spaced retention behavior. During verification of the compendial procedure, a process-related impurity (1 R,3S)-6,7-Dihydroxy-1-methyl-1,2,3,4-tetrahydroisoquinoline-1,3-dicarboxylic acid (IP2) was found to co-elute with levodopa, compromising selective quantification and peak-purity assessment; moreover, small univariate adjustments (e.g., mobile-phase composition and pH) improved the levodopa/IP2 separation but created new critical overlaps among carbidopa, catechol, and levodopa related compound C, indicating limited robustness. To systematically resolve these deficiencies, a Design of Experiment (DoE) strategy was applied using a Box-Behnken response surface design to model and optimize three critical method parameters-ethanol content 11.5 - 31.5%, v/v, mobile-phase pH 2.20 - 2.50 and column temperature 26°C - 32°C with chromatographic resolutions between the most critical pairs as the primary responses; quadratic (second-order) regression models were generated and used with desirability-based numerical optimization to define operating conditions that maximize separation while maintaining suitable chromatographic performance. Under the optimized conditions mobile-phase pH, column (temperature 26°C, flow rate 0.9 mL/min, UV 280 nm, gradient runtime 75min), baseline separation of the critical impurity pairs was achieved, and system suitability confirmed adequate selectivity, including a resolution between levodopa related compound C and carbidopa in the System Suitability Test (SST) solution. Method robustness was further assessed using a Plackett-Burman design to identify parameters most sensitive to deliberate variation, supporting reliable performance under routine analytical conditions and across potential raw-material/formulation variability.

01 Nov 2026·NEUROPHARMACOLOGY

Exploring the therapeutic potential of hesperidin nanoparticles, carbidopa-levodopa, or their combined administration in a rat model of reserpine-induced Parkinsonism

Article

Author: Katreen Amin, E H ; Khadrawy, Yasser A ; Mohammed, Haitham S ; Ibrahim, I H

In the pursuit of novel and effective therapeutic strategies, this study investigates the effects of hesperidin nanoparticles (HSP NPs), either alone or in combination with Carbidopa-levodopa (CLD), in a reserpine-induced Parkinson's disease (PD) rat model. Rats were randomly assigned to five experimental groups: control, PD model, PD model + HSP NPs, PD model + CLD, and PD model + HSP NPs + CLD. Behavior was assessed by the open field and grip strength tests. Monoamine levels, oxidative stress, enzyme activity, tumor necrosis factor-α (TNF-α), and brain-derived neurotrophic factor (BDNF) were analyzed in two brain areas; midbrain and striatum. Untreated rats exhibited motor deficits, a significant decrease in dopamine, norepinephrine, and serotonin levels, along with an increase in oxidative stress markers, monoamine oxidase, and acetylcholinesterase activities in both the midbrain and striatum compared to control values. Treatment with CLD or HSP NPs resulted in elevated levels of monoamines, restoring enzyme activity, and mitigating oxidative stress with partial improvement in motor activity. The combination of HSP NPs and CLD significantly restored Biochemical parameters in the midbrain and striatum, and decreased midbrain AChE activity. These findings underscore the potential of HSP NPs in mitigating neurochemical and behavioral alterations induced by reserpine in the rat PD model. According to the present promising preclinical data, HSP NPs could be investigated on other models of PD to ensure their antiparkinsonian effects. These preclinical results may represent a primary step toward using HSP NPs in human investigation.

257

News (Medical) associated with Carbidopa

31 Aug 2026

·www.biospace.com

BioVie Announces Completion of Treatment Phase of ADDRESS-LC Trial of Bezisterim for the Treatment of Neurological Symptoms Associated with Long COVID

Last Patient Last On-Site Visit Completed with Topline Data Release Targeted September 2026 CARSON CITY, Nev., Aug. 31, 2026 (GLOBE NEWSWIRE) -- BioVie Inc. (NASDAQ: BIVI) (“BioVie” or the “Company”), a clinical-stage company developing innovative drug therapies for neurological and neurodegenerative diseases, today announced that the last on-treatment visit of its ADDRESS-LC Phase 2 trial evaluating bezisterim for the treatment of neurological symptoms of Long COVID has been completed. The Phase 2 study is fully funded by a grant from the U.S. Department of War (DoW, formerly the U.S. Department of Defense). “With the last patient’s treatment visit completed, and the one-month virtual follow-up nearly complete, we anticipate announcing topline results for ADDRESS-LC before the end of September 2026,” said Cuong Do, President and CEO of BioVie. “The growing body of research surrounding Long COVID continues to reinforce the rationale for bezisterim’s proposed mechanism, particularly its modulation of inflammatory pathways associated with symptoms relating to fatigue and ‘brain fog.’” “We thank the trial participants, clinical investigators, site staff and the broader Long COVID community for their strong interest in and commitment to the ADDRESS-LC trial,” said Penelope Markham, PhD, Senior Vice President of Liver Disease and Long COVID Programs at BioVie. “We are especially grateful to our advisors living with Long COVID, as well as advocacy partners SolveME and the Patient-Led Research Collaborative (PLRC), whose efforts to raise awareness and educate communities helped support enrollment and participation in the study.” An estimated 17-20 million U.S. adults reported to be living with Long COVID, 1 with 3.8 million experiencing significant limitation to their daily lives. 2 Almost 50 percent of those with Long COVID develop persistent or intermittent symptoms. 3 The neurological and neuropsychiatric symptoms are among the most common and disabling manifestations of the condition and include fatigue, post-exertional malaise, sleep disturbance, and persistent sense of difficulty with thinking and memory. 4 Chronic innate inflammation accompanied by ongoing immune dysregulation is among the leading hypotheses proposed to explain the symptoms in Long COVID, with numerous investigators describing findings in Long COVID that appear to be supportive of the intended biological targets of bezisterim. Currently, there are no FDA-approved treatment options for Long-COVID. About the ADDRESS-LC trial The Phase 2 ADDRESS-LC study, which is fully funded by a grant from the U.S. Department of War (DoW), is a randomized (1:1), placebo-controlled, proof-of-concept, multicenter trial evaluating the efficacy, safety and tolerability of bezisterim in adult participants with Long COVID who have cognitive impairment sequelae and fatigue. The study is comparing bezisterim, administered as a 20 mg oral capsule twice daily, with a matching placebo to assess its effects on neurocognitive and fatigue-related symptoms. End points include assessing changes in overall clinical benefit, subjective and objective cognitive function, fatigue, sleep disturbance, Quality of Life and post-exertional malaise. About Bezisterim Bezisterim (NE3107) is an investigational oral drug that crosses the blood-brain barrier and works to reduce inflammation and improve insulin sensitivity without suppressing the immune system and with a low risk of drug-drug interactions. By modulating key pathways involved in neuroinflammation (ERK, NFκB, TNF-α), bezisterim may have therapeutic potential in several disease indications, including Parkinson’s disease, Long COVID, and Alzheimer’s disease. In PD, BioVie completed the SUNRISE-PD trial, which enrolled 57 patients to establish proof of mechanism and proof of concept in individuals with early-stage disease who had not previously been treated with carbidopa/levodopa. Topline results showed that patients treated with bezisterim experienced improvements with blood-based markers of inflammation, as well as a broad range of biomarkers associated with cellular health and neuronal integrity. Clinically, patients treated with bezisterim demonstrated greater improvements than those receiving placebo across multiple measures of daily functioning, motor symptoms, and non-motor symptoms. For Long COVID, the ADDRESS-LC trial enrolled approximately 200 patients to evaluate whether bezisterim may help reduce brain fog, fatigue, and other lingering neurological symptoms associated with Long COVID. The hypothesis being studied is that these symptoms may be triggered by persistent circulation of spike protein fragments that trigger inflammation via NFκB activation (which bezisterim has been shown to modulate). In Alzheimer’s disease, BioVie has conducted Phase 2 and Phase 3 trials. Preliminary data from these trials suggest improvements in cognition and biomarkers, supporting further trials to evaluate its potential as a therapy for the six million Americans living with Alzheimer’s. Terms of the U.S. Department of War (DoW) Award The work is supported by the Assistant Secretary of War for Health Affairs and endorsed by the DoW by a fully funded award in the amount of $13.13 million through the Peer-Reviewed Medical Research Program (PRMRP) under Award No. HT9425-24-1-0113. Opinions, interpretations, conclusions, and recommendations in this press release are those of the author and are not necessarily endorsed by the Assistant Secretary of Defense for Health Affairs or the DoW. About BioVie Inc. BioVie Inc. (NASDAQ: BIVI) is a clinical-stage biopharmaceutical company focused on developing therapies for neurological disorders and advanced liver disease. Its lead investigational drug candidate, bezisterim (NE3107), targets neuroinflammation and insulin resistance, which are believed to be key drivers of Alzheimer’s and Parkinson’s disease. Bezisterim is also being studied for Long COVID, where persistent TLR-4 driven neuroinflammation is thought to underlie symptoms such as brain fog and fatigue. In liver disease, BioVie is advancing BIV201, a continuous infusion of terlipressin treatment that has received FDA Orphan and Fast Track designations. The active agent is approved in the U.S. and in about 40 countries for related complications of advanced liver cirrhosis, and the Company plans to study BIV201 in a Phase 3 trial for the reduction of further decompensation in patients with cirrhosis and ascites. For more information, visit . Forward-Looking Statements This press release contains forward-looking statements, which may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project," “potential,” “may,” or words of similar meaning. Although BioVie Inc. believes such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Actual results may vary materially from those expressed or implied by the statements herein due to risk related to the early stage of development of bezisterim and other product candidates, the Company's ability to successfully raise sufficient capital on reasonable terms or at all, available cash on hand and contractual and statutory limitations that could impair our ability to pay future dividends, our ability to complete our pre-clinical or clinical studies and to obtain approval for our product candidates, the possibility that clinical trial results may not be indicative of results in subsequent or larger trials, our ability to successfully defend potential future litigation, changes in local or national economic conditions as well as various additional risks, many of which are now unknown and generally out of the Company's control, and which are detailed from time to time in reports filed by the Company with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K. BioVie Inc. does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law. For Investor Relations Inquiries: Contact: Chuck Padala Managing Director, LifeSci Advisors, LLC chuck@lifesciadvisors.com For Media Inquiries: Contact: Melyssa Weible Managing Partner, Elixir Health Public Relations mweible@elixirhealthpr.com ___________________________ 1 U.S. Department of Health and Human Services ( ) 2 Bonuck et al. Commun Med. 2026;6:177. doi:10.1038/s43856-026-01516-7. 3 Thaweethai et al. Nat Commun. 2025;16(1):9557. doi:10.1038/s41467-025-65239-4. 4 Geng et al. JAMA. 2025 Feb 25;333(8):694-700. doi: 10.1001/jama.2024.24184.

Phase 2Clinical ResultFast TrackPhase 3

28 Aug 2026

·www.businesswire.com

Zambon Announces European Commission Approval of Hopledo® for Adults with Parkinson's Disease and Moderate to Severe Motor Fluctuations

Hopledo® is a first-in-class, oral, modified-release formulation of levodopa/carbidopa (LD/CD) approved for the treatment of motor fluctuations of Parkinson’s disease Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026 The approval is based on data from the Phase 3 RISE-PD trial where Hopledo® demonstrated a significant increase in Good ON time compared with immediate-release LD/CD with fewer daily doses and a comparable safety profile MILAN, Italy--(BUSINESS WIRE)--Zambon today announced that the European Commission (EC) has granted marketing authorization for Hopledo® (modified-release levodopa/carbidopa) for the treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatment regimens. Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026. The company is working closely with healthcare authorities and other stakeholders to support timely access for people with Parkinson’s disease who continue to experience moderate to severe motor fluctuations despite current oral therapies. The approval of Hopledo® marks an important step in Zambon’s long-standing commitment to the Parkinson’s disease community. Hopledo® is a first-in-class, oral, modified-release formulation of levodopa/carbidopa (LD/CD) approved for the treatment of motor fluctuations of Parkinson’s disease, the fastest growing neurological condition in the world according to the World Health Organization1. Despite available oral treatments, there is a substantial need for new therapeutic options; during the course of the disease, more than 80% of patients with Parkinson’s disease experience motor fluctuations 10 years after condition onset2. Hopledo® contains a unique formulation combining immediate-release granules and extended-release beads in a single hard capsule, designed to provide both a rapid onset of action and prolonged therapeutic benefit, helping maintain more stable levodopa plasma concentrations and extending duration of symptom control. The EC approval follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is based on data from the Phase 3 RISE-PD trial, which compared Hopledo® with an immediate-release LD/CD formulation in patients with Parkinson’s disease and moderate to severe motor fluctuations. In the study, Hopledo® demonstrated a significant increase in Good ON time per day and in Good ON time per dose compared with immediate-release LD/CD, with fewer daily doses and a comparable safety profile3. “For people living with Parkinson’s disease, as well as their caregivers and healthcare professionals, the need for additional therapeutic options to help manage motor fluctuations remains significant. The approval of Hopledo® marks an important step in Zambon’s long-standing commitment to the Parkinson’s disease community. It reflects our focus on advancing meaningful innovation in both cure and care, with the aim of supporting patients facing the daily challenges of the disease and opening new life possibilities”, said Giovanni Magnaghi, Chief Executive Officer of Zambon. “Motor fluctuations shape the daily lives of people with Parkinson's, often forcing them to plan their days around the timing of their medication. They decide whether someone can share a meal with family, keep a commitment, or simply move through the day with confidence. So, any advance that gives people more good hours in their day and more control over when those hours come is meaningful for our community. We welcome new options that give people with Parkinson's and their clinicians more ways to tailor treatment to individual lives, and we will keep advocating for timely and equitable access across Europe, so that everyone who could benefit is able to," commented Josefa Domingos, President of Parkinson's Europe. “A major therapeutic challenge in Parkinson’s disease is maintaining stable motor control throughout the day. Many patients experience fluctuations in symptom control and often have to plan their daily activities around the timing and duration of levodopa’s effect”, said Prof. Günter Höglinger, MD, FEAN, Director of the Department of Neurology with Friedrich Baur Institute, LMU University Hospital Munich. “Thanks to its unique modified‑release formulation, Hopledo provides substantially more Good ON time per dose while maintaining a safety profile comparable to immediate‑release levodopa/carbidopa. This combination of extended benefit and reduced dosing frequency represents an important advancement in levodopa therapy in People with PD and motor fluctuations”. In 2024, Zambon entered into an exclusive licensing agreement with Amneal Pharmaceuticals for the commercialization of Hopledo® in the European Union, United Kingdom and Switzerland. Hopledo®, formerly known as IPX203, is already approved and marketed in the United States under the brand name CREXONT®, providing established regulatory and commercial experience as the therapy advances toward European launch. About Hopledo® Hopledo® is a modified-release oral formulation of levodopa/carbidopa developed for the treatment of adults with Parkinson's disease and moderate to severe motor fluctuations. It contains a unique formulation combining immediate-release granules and extended-release beads in a single hard capsule, designed to provide both a rapid onset of action and prolonged therapeutic benefit, helping maintain more stable levodopa plasma concentrations and extending duration of symptom control. About Parkinson's Disease Parkinson's disease is a chronic, progressive neurodegenerative disorder characterized by the loss of dopamine-producing neurons in the brain. Symptoms include tremors, rigidity, slowness of movement, and postural instability. As the disease progresses, many patients experience motor fluctuations, with periods during which symptoms are not adequately controlled despite treatment. More than one million people live with Parkinson's disease in the European Union. About the RISE-PD Phase 3 Trial The multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group RISE-PD trial evaluated the efficacy and safety of Hopledo® compared with IR LD/CD in the treatment of patients with PD with motor fluctuations. The primary endpoint of the trial assessed the change from baseline in “Good On” time in hours per day at the end of the double-blind treatment period (Week 20 or early termination). Secondary endpoints assessed the change from baseline in “Off” time in hours per day, proportion of patients who were either “much improved” or “very much improved” in Patients' Global Impression of Change (PGI-C) scores, change from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score, and the change from baseline in sum of MDS-UPDRS Parts II and III scores. The study included 506 patients who had received a PD diagnosis at age 40 or older. About Zambon For further information on Zambon please visit www.zambon.com References 1. https://www.who.int/publications/i/item/9789240050983 2. Fabbri M, et al. Off-time Treatment Options for Parkinson’s Disease. Neurol Ther. 2023;12(2):391-424; Demailly A, et al. Effectiveness of Continuous Dopaminergic Therapies in Parkinson’s Disease: A Review of L-DOPA Pharmacokinetics/ Pharmacodynamics. J Parkinsons Dis. 2024;14(5):925-939. 3. Hauser RA, et al. JAMA Neurol. 2023;80(10):1062-1069 and Supplementary materials

Phase 3Drug ApprovalClinical ResultLicense out/in

28 Aug 2026

·www.biospace.com

Zambon Announces European Commission Approval of Hopledo® for Adults with Parkinson’s Disease and Moderate to Severe Motor Fluctuations

Hopledo® is a first-in-class, oral, modified-release formulation of levodopa/carbidopa (LD/CD) approved for the treatment of motor fluctuations of Parkinson’s disease Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026 The approval is based on data from the Phase 3 RISE-PD trial where Hopledo® demonstrated a significant increase in Good ON time compared with immediate-release LD/CD with fewer daily doses and a comparable safety profile MILAN, Italy--(BUSINESS WIRE)-- #ParkinsonsDisease --Zambon today announced that the European Commission (EC) has granted marketing authorization for Hopledo® (modified-release levodopa/carbidopa) for the treatment of adult patients with Parkinson’s disease and moderate to severe motor fluctuations who have not been sufficiently stabilized with oral levodopa/dopa decarboxylase (DDC) inhibitor-based treatment regimens. Zambon expects to begin the phased introduction of Hopledo® across European markets starting October 2026. The company is working closely with healthcare authorities and other stakeholders to support timely access for people with Parkinson’s disease who continue to experience moderate to severe motor fluctuations despite current oral therapies. Hopledo® is a first-in-class, oral, modified-release formulation of levodopa/carbidopa (LD/CD) approved for the treatment of motor fluctuations of Parkinson’s disease, the fastest growing neurological condition in the world according to the World Health Organization 1 . Despite available oral treatments, there is a substantial need for new therapeutic options; during the course of the disease, more than 80% of patients with Parkinson’s disease experience motor fluctuations 10 years after condition onset 2 . Hopledo® contains a unique formulation combining immediate-release granules and extended-release beads in a single hard capsule, designed to provide both a rapid onset of action and prolonged therapeutic benefit, helping maintain more stable levodopa plasma concentrations and extending duration of symptom control. The EC approval follows the positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) and is based on data from the Phase 3 RISE-PD trial, which compared Hopledo® with an immediate-release LD/CD formulation in patients with Parkinson’s disease and moderate to severe motor fluctuations. In the study, Hopledo® demonstrated a significant increase in Good ON time per day and in Good ON time per dose compared with immediate-release LD/CD, with fewer daily doses and a comparable safety profile 3 . “For people living with Parkinson’s disease, as well as their caregivers and healthcare professionals, the need for additional therapeutic options to help manage motor fluctuations remains significant. The approval of Hopledo® marks an important step in Zambon’s long-standing commitment to the Parkinson’s disease community. It reflects our focus on advancing meaningful innovation in both cure and care, with the aim of supporting patients facing the daily challenges of the disease and opening new life possibilities”, said Giovanni Magnaghi, Chief Executive Officer of Zambon . “Motor fluctuations shape the daily lives of people with Parkinson's, often forcing them to plan their days around the timing of their medication. They decide whether someone can share a meal with family, keep a commitment, or simply move through the day with confidence. So, any advance that gives people more good hours in their day and more control over when those hours come is meaningful for our community. We welcome new options that give people with Parkinson's and their clinicians more ways to tailor treatment to individual lives, and we will keep advocating for timely and equitable access across Europe, so that everyone who could benefit is able to," commented Josefa Domingos, President of Parkinson's Europe. “A major therapeutic challenge in Parkinson’s disease is maintaining stable motor control throughout the day. Many patients experience fluctuations in symptom control and often have to plan their daily activities around the timing and duration of levodopa’s effect”, said Prof. Günter Höglinger, MD, FEAN, Director of the Department of Neurology with Friedrich Baur Institute, LMU University Hospital Munich. “Thanks to its unique modified‑release formulation, Hopledo provides substantially more Good ON time per dose while maintaining a safety pro to immediate‑release levodopa/carbidopa. This combination of extended benefit and reduced dosing frequency represents an important advancement in levodopa therapy in People with PD and motor fluctuations”. In 2024, Zambon entered into an exclusive licensing agreement with Amneal Pharmaceuticals for the commercialization of Hopledo® in the European Union, United Kingdom and Switzerland. Hopledo®, formerly known as IPX203, is already approved and marketed in the United States under the brand name CREXONT®, providing established regulatory and commercial experience as the therapy advances toward European launch. About Hopledo® Hopledo® is a modified-release oral formulation of levodopa/carbidopa developed for the treatment of adults with Parkinson's disease and moderate to severe motor fluctuations. It contains a unique formulation combining immediate-release granules and extended-release beads in a single hard capsule, designed to provide both a rapid onset of action and prolonged therapeutic benefit, helping maintain more stable levodopa plasma concentrations and extending duration of symptom control. About Parkinson's Disease Parkinson's disease is a chronic, progressive neurodegenerative disorder characterized by the loss of dopamine-producing neurons in the brain. Symptoms include tremors, rigidity, slowness of movement, and postural instability. As the disease progresses, many patients experience motor fluctuations, with periods during which symptoms are not adequately controlled despite treatment. More than one million people live with Parkinson's disease in the European Union. About the RISE-PD Phase 3 Trial The multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group RISE-PD trial evaluated the efficacy and safety of Hopledo ® compared with IR LD/CD in the treatment of patients with PD with motor fluctuations. The primary endpoint of the trial assessed the change from baseline in “Good On” time in hours per day at the end of the double-blind treatment period (Week 20 or early termination). Secondary endpoints assessed the change from baseline in “Off” time in hours per day, proportion of patients who were either “much improved” or “very much improved” in Patients' Global Impression of Change (PGI-C) scores, change from baseline in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score, and the change from baseline in sum of MDS-UPDRS Parts II and III scores. The study included 506 patients who had received a PD diagnosis at age 40 or older. About Zambon For further information on Zambon please visit References 1. 2. Fabbri M, et al. Off-time Treatment Options for Parkinson’s Disease. Neurol Ther. 2023;12(2):391-424; Demailly A, et al. Effectiveness of Continuous Dopaminergic Therapies in Parkinson’s Disease: A Review of L-DOPA Pharmacokinetics/ Pharmacodynamics. J Parkinsons Dis. 2024;14(5):925-939. 3. Hauser RA, et al. JAMA Neurol . 2023;80(10):1062-1069 and Supplementary materials Contacts Zambon media@zambongroup.com

Phase 3Drug ApprovalClinical ResultLicense out/in

100 Deals associated with Carbidopa

External Link

KEGG	Wiki	ATC	Drug Bank
D00558	Carbidopa	N04BA03	DB00190

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Nausea	United States	Aton Pharma, Inc.	25 Apr 1977
Parkinson Disease	United States	Aton Pharma, Inc.	25 Apr 1977
Parkinson Disease, Postencephalitic	United States	Aton Pharma, Inc.	25 Apr 1977
Parkinson Disease, Secondary	United States	Aton Pharma, Inc.	25 Apr 1977
Vomiting	United States	Aton Pharma, Inc.	25 Apr 1977

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06587217 (RES, CTgov)	Phase 1/2	Parkinsonian Disorders	5	Carbidopa 25 mg+Carbidopa-Levodopa 25/100 mg	iwwpxjclbc(lwltzbcjul) = acsnsvcaze jeamygxyzx (nrbwagiwuu, 0.05) View more	-	14 Apr 2026
MDS2025	Not Applicable	Hypotension, Orthostatic	1	Mucuna pruriens 2 capsules (15% levodopa) TID + carbidopa 25mg TID	sbwsuwtshk(ksafjeiphe) = rrjqhtzuou onjwnmjyxv (ejkztowinx )	Positive	05 Oct 2025
NCT06219915 (RES, CTgov)	Phase 1/2	Parkinsonian Disorders	13	Carbidopa 25 mg+Carbidopa-Levodopa 25/100 mg (Carbidopa Monotherapy and Carbidopa-Levodopa)	slrqtoscdd(tolnbfljvf) = lxybwbmlzs zyhhpfqmpa (ayqbymfpfn, 0.14) View more	-	17 Jun 2025
				Placebo 1 (Placebo)	slrqtoscdd(tolnbfljvf) = hdtzletsgn zyhhpfqmpa (ayqbymfpfn, 0.18) View more
NCT04325503 (RES, CTgov)	Phase 1/2	Parkinsonian Disorders	14	Carbidopa+Levodopa	piqizlbomt(tgkgqjfjie) = tczdmmfaqd qyptozmauc (ivbriltjzf, 0.123) View more	-	28 Sep 2023
NCT02553265 (CarbiFD, CTgov)	Phase 2	Dysautonomia, Familial	22	Placebo (Placebo)	awwilgytcl = rzwjkugiuc mpzrabxvgh (zgxbcadllk, dxhluysxaz - zrrobzqgxa) View more	-	09 Feb 2022
				Carbidopa (Low-Dose Carbidopa)	awwilgytcl = jtiqdvwyff mpzrabxvgh (zgxbcadllk, aoujqtazoy - hljnlslsfd) View more
NCT00685919 (CTgov)	Phase 2/3	Postural Orthostatic Tachycardia Syndrome	32	Placebo (Healthy Participants Who Received Placebo as Treatment A or Treatment B)	jauaapwsgs(ycjzpfetwu) = ndbitnbuvk dylzbsojyl (rvgdvcysug, 29) View more	-	20 Sep 2021
				Carbidopa (Healthy Participants Who Received Carbidopa as Treatment A or Treatment B)	jauaapwsgs(ycjzpfetwu) = fdfeyxnzss dylzbsojyl (rvgdvcysug, 38) View more
AAN2020	Not Applicable	Parkinson Disease	23	CVT-301 84mg with CD 25mg	hoazimccdt(brrdvpjivp) = 7 (30.4%) in the CVT-301 group vs 1 (4.5%) subject administered oral CD/LD cycdljtgni (gdottntmih )	Positive	14 Apr 2020
				Oral CD/LD 25/100mg
NCT03115827 (CTgov)	Phase 4	Parkinson Disease	15	Carbidopa+Droxidopa	esutvdwego = euwtsmxiei mxzxqyjonp (hvmzzieron, sdejrucdqu - bmsrxqmuei) View more	-	27 Jan 2020
NCT01399905 (CTgov)	Phase 2	Parkinson Disease	14	Carbidopa (Low-dose Carbidopa (75 mg/Day) Day 1)	mhsjmmlwfc(bqdvesjmal) = hvyyjvswvb dqgimljcmk (hwretsceer, 103) View more	-	09 Jan 2020
				Carbidopa (Low-dose Carbidopa (75 mg/Day) Day 2)	mhsjmmlwfc(bqdvesjmal) = qfaipvhqnu dqgimljcmk (hwretsceer, 131) View more
NCT01766258 (Pubmed \| Neurology)	Phase 2	Parkinson Disease COMT genotypes Val/Met	-	ODM-101/65	ixogtjtvdw(zfiofbsxrb) = Treatment-related serious adverse events were blood creatine kinase increase (LCE) rsdirifpqk (olqrhlwqid ) View more	-	26 Mar 2019
				ODM-101/105

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