Crexont (levodopa/carbidopa extended-release capsule) / Amneal, Knight Therap, Zambon - LARVOL DELTA

ELEVATE-PD: Advancing Parkinson's Disease Management Through Optimized Levodopa Delivery (MDS Congress 2026) - "This Innovation Showcase will present emerging real-world evidence on the impact of IPX203 on both motor and non-motor symptoms. The session will explore how optimized levodopa delivery may address unmet needs in Parkinson's disease management and provide insights into the clinical benefits observed following conversion from existing levodopa regimens."

CNS Disorders • Movement Disorders • Parkinson's Disease

Switching to IPX203 Significantly Increases the Duration of “Good On” Intervals: Interim Real-World Results from the First 111 Patients in ELEVATE-PD (MDS Congress 2026) - "The longer duration of continuous “Good On” intervals and reduction of motor fluctuations after switching to IPX203 provide greater time and predictability for patients with PD “Off” fluctuations to perform their daily activities."

Clinical • Real-world • Real-world evidence • CNS Disorders • COMT

Switching to IPX203 from IPX066 Significantly Improves “Good On” Time and Reduces Motor Fluctuations Under Real-World Conditions (MDS Congress 2026) - "These data highlight IPX203’s ability to deliver more consistent and predictable symptom control when switching from IPX066, reinforcing its value as an effective treatment option for patients seeking improved management of motor fluctuations."

Clinical • Real-world • Real-world evidence • CNS Disorders • COMT

Improved “Good On” Time and Reduced Motor Fluctuations After Switching to IPX203: Interim Real-World Results from the First 111 Patients in ELEVATE PD (MDS Congress 2026) - " ELEVATE-PD is an ongoing, open-label phase 4 study where PD patients are converted from IR CD/LD, IR + COMT inhibitors, or IPX066 to IPX203. Switching from other levodopa-based therapies to IPX203 significantly improved daily symptom control by increasing “Good On” time, decreasing “Off” time, and enhancing motor function across all treatment groups."

Clinical • Real-world • Real-world evidence • CNS Disorders • Movement Disorders • COMT

IPX203 Achieves High Responder Rates Independent of Fluctuation Severity: Insights From RISE‑PD (MDS Congress 2026) - "Following conversion to IPX203 after IR optimization, more than half of patients achieved sustained, clinically meaningful improvement in Good ON time or OFF time, regardless of baseline fluctuation severity. Patients with severe fluctuations demonstrated greater response during IR optimization, but response rates after conversion to IPX203 were similarly high across severity groups. These results demonstrate the robust clinical effectiveness of IPX203 across fluctuation severity levels."

CNS Disorders

Evaluating the Conversion of Immediate-Release and/or Extended-Release Levodopa to IPX203 in Patients with Parkinson’s Disease (MDS Congress 2026) - "Objective: This quality improvement (QI) project was conducted to evaluate the impact of the conversion from immediate-release (IR) and/or extended-release (ER) levodopa (LD) to mucoadhesive polymer ER carbidopa/LD (IPX203). In this small QI cohort, IPX203 conversion in PD patients was generally well-tolerated and resulted in improved wearing off and decreased pill burden. Further evaluation in larger studies is warranted."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

Early clinical experience with IPX203 in Parkinson's disease with motor fluctuations. (PubMed, J Neural Transm (Vienna)) - "Phase 2 studies demonstrated rapid levodopa absorption and prolonged plasma exposure, while the phase 3 RISE-PD trial showed significantly greater Good ON time with fewer daily doses compared with optimized immediate-release levodopa/carbidopa. Three representative patient vignettes illustrate common clinical scenarios and practical approaches to treatment optimization. IPX203 provides a novel oral levodopa/carbidopa delivery strategy that combines rapid onset with prolonged duration of benefit. Clinical trial data and early clinical experience support its use as an effective option for patients with PD experiencing motor fluctuations and highlight the importance of individualized treatment optimization to maximize therapeutic benefit."

Journal • Review • CNS Disorders • Movement Disorders • Parkinson's Disease

Efficacy and safety of extended-release carbidopa-levodopa (IPX203) versus immediate-release carbidopa-levodopa for Parkinson's disease: A systematic review. (PubMed, J Int Med Res) - "Compared with immediate-release carbidopa-levodopa, IPX203 increased total "Good On-time" and reduced "Off-time." Scores on Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale demonstrated greater improvement in motor function with IPX203. The incidence of adverse events was comparable between the two groups, although treatment-emergent adverse events and treatment discontinuations were more frequent in the IPX203 group.ConclusionCompared with immediate-release carbidopa-levodopa, IPX203 increased "Good On-time," reduced "Off-time," improved motor function as measured by Part III of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale, and demonstrated a comparable safety profile."

Journal • Review • CNS Disorders • Movement Disorders • Parkinson's Disease

Zambon Announces European Commission Approval of Hopledo for Adults with Parkinson's Disease and Moderate to Severe Motor Fluctuations (Businesswire) - "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."

EMA approval • Launch Europe • Parkinson's Disease

Population pharmacokinetic analyses comparing immediate-release levodopa/carbidopa, controlled-release levodopa/carbidopa, and IPX203. Findings from a phase 1 study in healthy volunteers. (PubMed, J Neural Transm (Vienna)) - "Model-based simulations of commonly used dosing regimens suggested that IPX203 administered every 6 h achieved the most stable levodopa concentrations. These findings indicate that IPX203 provides a distinct exposure profile characterized by rapid onset and sustained levodopa exposure driven by controlled absorption."

Journal • P1 data • PK/PD data • CNS Disorders • Movement Disorders • Parkinson's Disease

CREXONT® (IPX203) Significantly Increases the Duration of “Good On” Intervals: Interim Real-World Results from the First 100 Patients in ELEVATE-PD (EAN 2026) - "Background and aims: CREXONT is a novel extended-release carbidopa-levodopa formulation containing a mucoadhesive polymer, designed to improve levodopa delivery and absorption.We evaluated the impact of CREXONT on the duration of “Good On” intervals and daily motor fluctuations in patients with PD after switching from other levodopa-based therapies. The longer duration of continuous “Good On” intervals and reduction of motor fluctuations after switching to CREXONT provide greater time and predictability for patients with PD “Off” fluctuations to perform their daily activities."

Clinical • Real-world • Real-world evidence • Movement Disorders • COMT

Switching to CREXONT/IPX203 improves good on time and reduces motor fluctuations: Interim real-world results from the first 100 patients in ELEVATE-PD (EAN 2026) - " ELEVATE-PD is an ongoing, open-label phase 4 study where PD patients are converted from prior levodopa-based therapies (IR CD/LD, IR+COMTinhibitors, Rytary) to CREXONT. Switching from other levodopa-based therapies to CREXONT significantly improved daily symptom control by increasing “Good On” time, decreasing “Off” time, and enhancing motor function across all treatment groups."

Clinical • Real-world • Real-world evidence • Movement Disorders

On 25 June 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Hopledo, intended for the treatment of adults with Parkinson’s disease and moderate to severe motor fluctuations. (European Medicines Agency) - "Hopledo will be available as 140 mg / 35 mg, 210 mg / 52.5 mg, 280 mg / 70 mg and 350 mg / 87.5 mg modified-release hard capsules. The active substances of Hopledo are levodopa and carbidopa, dopaminergic agents (ATC code: N04BA02)."

CHMP • Parkinson's Disease

BOOST-PD A Naturalistic Study on IPX-203 for Parkinson's Disease (clinicaltrials.gov) - P4 | N=22 | Recruiting | Sponsor: The Cleveland Clinic | Trial primary completion date: May 2026 ➔ Dec 2026

Trial primary completion date • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT

Amneal Pharmaceuticals...announced new positive interim results from its ongoing Phase 4 ELEVATE-PD study, which are being presented at the Advanced Therapeutics in Movement & Related Disorders (ATRMD) 2026 Congress on June 5, 2026. (GlobeNewswire) - "After patients switched from prior therapies, treatment with CREXONT delivered meaningful increases in 'Good On' time, reductions in 'Off' time, and improved motor symptom control. Patients switching from RYTARY achieved consistent gains in continuous 'Good On' intervals, the length of uninterrupted time patients experience 'Good On.'...Improvements of –14.6, –9.9, and –10.0 points when switching from IR CD/LD, IR CD/LD + COMT inhibitor, and RYTARY, respectively — reductions of this magnitude reflect clinically meaningful gains in overall motor function...Mean daily motor fluctuations were meaningfully reduced, decreasing from 5.28 at baseline to 2.98 at Week 6, a 2.26 (42.80%) reduction in the average number of daily motor fluctuations....With enrollment in ELEVATE-PD now complete and patients continuing through the 12-month follow-up period, Amneal will present longer-term outcomes and patient-reported results throughout 2026..."

P4 data • Parkinson's Disease

Effect of CREXONT® (IPX203, ER CD-LD) on sleep in patients with Parkinson’s disease and associated sleep disturbances (WPC 2026) - "These findings suggest that in PD patients with clinically relevant sleep disturbances, IR CD-LD optimization followed by conversion to CREXONT improves patient-reported sleep quality. CREXONT may also enhance nighttime and early morning motor control."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease • Sleep Disorder

Switching to CREXONT® improves “Good On” time and reduces motor fluctuations in Parkinson’s disease: interim results from the real-world ELEVATE-PD phase 4 study (WPC 2026) - "BACKGROUND: CREXONT, a novel extended-release carbidopa-levodopa formulation containing a mucoadhesive polymer, is designed to improve levodopa delivery and absorption, enhancing therapeutic benefit...At baseline, mean daily “Good On” time was 9.58±2.36 hours, “Off” time was 5.94±2.02 hours: • CREXONT treatment increased daily “Good On” time: +3.13 hours for patients switching from IR CD-LD (n=36), +2.31 hours from IR CD-LD+COMT inhibitor (n=6), +1.80 hours from Rytary (n=11)... CREXONT substantially increased “Good On” time, reduced “Off” time, and improved motor function in PD patients across all therapy groups, confirming that switching patients from other levodopa-based therapies to CREXONT offers meaningful improvements in symptom control through the day."

Clinical • P4 data • Real-world • Real-world evidence • CNS Disorders • Infectious Disease • Movement Disorders • Nephrology • Parkinson's Disease • COMT

Recent Developments in the Drug Treatment of Parkinson's Disease. (PubMed, Drugs) - "Novel formulations and modes of application include extended-release (ER) oral levodopa (IPX203), levodopa powder for inhalation, and levodopa infusion therapies through subcutaneous (foslevodopa/foscarbidopa, ND0612) or intrajejunal pumps (levodopa [entacapone] carbidopa intestinal gel)...Novel dopamine agonists have been developed and tavapadon, a selective dopamine D1/D5 receptor partial agonist, was shown to be efficacious as monotherapy in early PD and adjunct to levodopa in patients with motor fluctuations. In addition, new data on the early use of the COMT-inhibitor opicapone have emerged. This expanding drug armamentarium is complemented by an increasing number of drugs targeting non-dopaminergic pathways with increasing evidence for amantadine's symptomatic efficacy in treating levodopa-induced dyskinesia and motor fluctuations...PD symptoms can usually be satisfactorily controlled in the early to mid-stages, but the progressive course of the disease..."

Journal • Review • CNS Disorders • Movement Disorders • Parkinson's Disease • COMT • LRRK2

In brief: New warnings for carbidopa/levodopa products. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • CNS Disorders • Movement Disorders • Parkinson's Disease

Efficacy and Safety of Extended-release Carbidopa Levodopa (IPX203) versus Immediate-release Carbidopa Levodopa in the Management of Parkinson’s Disease: A Systematic Review (AAN 2026) - "Conclusions IPX203 increased “Good On-time” and reduced “Off-time” more than immediate-release carbidopa-levodopa, with improved motor function (MDS-UPDRS III) and a comparable safety profile. Findings suggest its potential use in managing motor fluctuations in advanced Parkinson’s disease."

Clinical • Review • CNS Disorders • Movement Disorders • Parkinson's Disease

Protein-induced Motor Fluctuations Despite Continuous Subcutaneous Foslevodopa/Foscarbidopa Infusion: A Case Report (AAN 2026) - "Results A 41-year-old right-handed male with young-onset Parkinson’s disease diagnosed at age 35 was switched over to fCD/fLD pump due to increasing wearing off fluctuations after failing best medical treatment with immediate-release carbidopa/levodopa (IR CD/LD) and extended-release carbidopa/levodopa (Rytary and Crexont). Conclusions Even though fCD/fLD pump is a subcutaneous levodopa infusion, it seems that oral protein interferes with its central effect. We propose that amino acids, the products of protein breakdown, may compete with levodopa for transport into the central nervous system at the L-type amino-acid transporter 1 (LAT1) protein located in the blood-brain barrier."

Case report • Clinical • CNS Disorders • Gastrointestinal Disorder • Movement Disorders • Parkinson's Disease

Effect of CREXONT® (IPX203, ER CD-LD) on Sleep in Patients with Parkinson’s Disease and Associated Sleep Disturbances (AAN 2026) - "Conclusions These findings suggest that in PD patients with clinically relevant sleep disturbances, IR CD-LD optimization followed by conversion to CREXONT improves patient-reported sleep quality. CREXONT may also enhance nighttime and early morning motor control."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease • Sleep Disorder

Simplified Twice-daily CREXONT® Regimen Delivers Significant Gain in “Good On” Time in Parkinson’s Patients with Lower Levodopa Needs (AAN 2026) - "Conclusions In patients with motor fluctuations with lower levodopa needs, CREXONT BID provided a robust and clinically meaningful increase in “Good On” time. These findings support a simplified regimen with CREXONT that may reduce pill burden while maintaining strong efficacy in these PD patients."

Clinical • CNS Disorders • Movement Disorders • Parkinson's Disease

CREXONT® (IPX203, ER CD-LD) Super-responders: Enhanced Symptom Control in Parkinson’s Disease (AAN 2026) - "On average, after using the predefined IR CD-LD to CREXONT conversion algorithm, SR needed reductions from their CREXONT starting dose (-213mg of TDD), while MP needed an increase (+144mg of TDD, p=1.1x10-6). Conclusions Patients with short response durations on high doses of IR CD-LD are most likely to have enhanced response to CREXONT and may require lower doses than suggested by the dosing algorithm."

CNS Disorders • Movement Disorders • Parkinson's Disease

Switching to CREXONT® Improves “Good On” Time and Reduces Motor Fluctuations in Parkinson’s Disease: Interim Results from the Real-world ELEVATE-PD Phase Four Study (AAN 2026) - "Background CREXONT, a novel extended-release carbidopa-levodopa formulation containing a mucoadhesive polymer, is designed to improve levodopa delivery and absorption, enhancing therapeutic benefit. At baseline, mean daily “Good On” time was 9.58±2.36 hours, “Off” time was 5.94±2.02 hours:- CREXONT treatment increased daily “Good On” time:+3.13 hours for patients switching from IR CD-LD (n=36), +2.31 hours from IR CD-LD+COMT inhibitor (n=6), +1.80 hours from Rytary (n=11).- Corresponding reductions in “Off” time were –2.82, –2.36, –2.47 hours, respectively.- CREXONT increased “Good On” time per dose by 1.81, 0.77, 0.78 hours, respectively.- CREXONT improved MDS-UPDRS total scores by –14.1, –4.2, –10.8 points, respectively.- TEAEs were mild to moderate; most common (≥3%) were nausea (5.5%), falls (3.6%), dizziness (3.6%), urinary tract infection (3.6%). Conclusions CREXONT substantially increased “Good On” time, reduced “Off” time, and improved motor function in..."

Clinical • Real-world • Real-world evidence • CNS Disorders • Infectious Disease • Movement Disorders • Nephrology • Parkinson's Disease • COMT