COMT inhibitors(Catechol-O-methyl transferase inhibitors), DDC inhibitors(DOPA decarboxylase inhibitors), DRDs antagonists(Dopamine receptors antagonists)

Therapeutic Areas

Nervous System DiseasesEndocrinology and Metabolic Disease

Active Indication

Parkinson Disease

Inactive Indication-

Originator Organization

Orion Pharma Ltd.

Active Organization

Orion Oyj

Orion Pharma Ltd.

Inactive Organization-

License Organization

Lotus Pharmaceutical Co., Ltd.

Drug Highest PhaseApproved

First Approval Date

United States (11 Jun 2003),

Parkinson Disease

Regulation-

Structure/Sequence

Molecular FormulaC33H40N6O13

InChIKeyOTVUCEMFRGJEMR-FTXVUGNJSA-N

CAS Registry745835-09-0

Clinical Trials associated with Carbidopa/Entacapone/Levodopa

NCT07151378

/ RecruitingPhase 3IIT

Intestinal Levodopa + Entacapone Therapy (Lecigon®) to Counteract Dopaminergic Desensitization and Neuropsychiatric Complications in Parkinson's Disease

This study is a Phase III multicentric randomized controlled trial with parallel group design and waiting list in patients that have an indication to undergo intestinal L-Dopa + entacapone (Lecigon®) under the existing indication criteria (according to SmPC (Fachinformation) Lecigon®). As primary endpoint, we will analyze the difference of the pre-interventional baseline and 6-month follow-up on the "hyperdopaminergic symptoms" corresponding to section 3 of the "Ardouin Behavioural Scale" hypothesizing on the superiority of LECIG therapy compared to best medical treatment.

Start Date27 Oct 2025

Sponsor / Collaborator-

CTR20253460

/ CompletedNot Applicable

恩他卡朋双多巴片（Ⅱ）在中国健康受试者中餐后给药条件下随机、开放、单剂量、两序列、四周期、完全重复交叉生物等效性试验

[Translation] A randomized, open-label, single-dose, two-sequence, four-period, fully repeated crossover bioequivalence study of entacapone dopaminergic tablets (II) in healthy Chinese volunteers after meal administration

主要研究目的：按有关生物等效性试验的规定，选择Orion Corporation持证的恩他卡朋双多巴片（Ⅱ）（商品名：达灵复®，Stalevo®；规格：左旋多巴100mg、卡比多巴25mg和恩他卡朋200mg）为参比制剂，对山东京卫制药有限公司生产并提供的受试制剂恩他卡朋双多巴片（Ⅱ）（规格：左旋多巴100mg、卡比多巴25mg和恩他卡朋200mg）进行餐后给药人体生物等效性试验，比较受试制剂中药物的吸收速度和吸收程度与参比制剂的差异是否在可接受的范围内，评价两种制剂在餐后给药条件下的生物等效性。次要研究目的：观察健康受试者口服受试制剂恩他卡朋双多巴片（Ⅱ）（规格：左旋多巴100mg、卡比多巴25mg和恩他卡朋200mg）和参比制剂恩他卡朋双多巴片（Ⅱ）（商品名：达灵复®，Stalevo®；规格：左旋多巴100mg、卡比多巴25mg和恩他卡朋200mg）的安全性。

[Translation]

The main purpose of this study was to conduct a postprandial bioequivalence study on the entacapone bidopa tablets (II) (trade name: Stalevo®; strength: levodopa 100 mg, carbidopa 25 mg, and entacapone 200 mg) produced and provided by Shandong Jingwei Pharmaceutical Co., Ltd. in accordance with the relevant bioequivalence test regulations. The study aimed to compare the absorption rate and extent of the drug in the test preparation with those of the reference preparation to determine whether they were within an acceptable range, and to evaluate the bioequivalence of the two preparations under postprandial administration conditions. Secondary study objective: To observe the safety of oral administration of the test preparation Entacapone Bidopa Tablets (II) (specifications: levodopa 100 mg, carbidopa 25 mg and entacapone 200 mg) and the reference preparation Entacapone Bidopa Tablets (II) (trade name: Stalevo®; specifications: levodopa 100 mg, carbidopa 25 mg and entacapone 200 mg) in healthy subjects.

Start Date08 Sep 2025

Sponsor / Collaborator

Jewim Pharmaceutical (Shandong) Co., Ltd

CTR20252368

/ CompletedNot Applicable

恩他卡朋双多巴片（Ⅱ）人体生物等效性研究

[Translation] Study on the bioequivalence of Entacapone Bidopa Tablets (Ⅱ) in human body

本试验旨在研究单次空腹和餐后口服宁波美诺华天康药业有限公司研制、生产的恩他卡朋双多巴片（Ⅱ）（100 mg/25 mg/200 mg）的药代动力学特征；以Orion Corporation生产的恩他卡朋双多巴片（Ⅱ）（达灵复®，100 mg/25 mg/200 mg）为参比制剂，比较两制剂中药动学参数Cmax、AUC0-t、AUC0-∞，评价两制剂的人体生物等效性。

[Translation]

The purpose of this study was to study the pharmacokinetic characteristics of entacapone bidopa tablets (II) (100 mg/25 mg/200 mg) developed and produced by Ningbo Minova Tiankang Pharmaceutical Co., Ltd. after single oral administration on an empty stomach or after a meal; using entacapone bidopa tablets (II) (DaLingFu®, 100 mg/25 mg/200 mg) produced by Orion Corporation as the reference preparation, the pharmacokinetic parameters Cmax, AUC0-t, and AUC0-∞ of the two preparations were compared, and the bioequivalence of the two preparations in humans was evaluated.

Start Date30 Jul 2025

Sponsor / Collaborator

Ningbo Menovo TianKang Pharmaceutical Co., Ltd.

100 Clinical Results associated with Carbidopa/Entacapone/Levodopa

100 Translational Medicine associated with Carbidopa/Entacapone/Levodopa

100 Patents (Medical) associated with Carbidopa/Entacapone/Levodopa

Literatures (Medical) associated with Carbidopa/Entacapone/Levodopa

01 Aug 2026·DRUGS

Recent Developments in the Drug Treatment of Parkinson’s Disease

Review

Author: Leiter, Simon ; Mahlknecht, Philipp ; Poewe, Werner

Parkinson's disease (PD) is a common neurodegenerative disorder caused by a spread of misfolded α-synuclein and ascending neuronal degeneration mainly in dopaminergic neurons, leading to progressive nigrostriatal dysfunction and disruption of other pathways. It is clinically defined by its cardinal motor features of bradykinesia, rest tremor and rigidity, which are usually accompanied by a variety of non-motor symptoms. Here we provide a review on recent developments in the pharmacological treatment of PD with a focus on recently approved drugs, new modes of delivery and agents that are in advanced stages of clinical development. Pharmacological dopamine substitution remains the mainstay of symptomatic treatment approaches to control PD motor symptoms. While levodopa is still considered the gold-standard of symptomatic efficacy, its chronic use is associated with the development of response oscillations and drug-induced dyskinesias in a majority of patients. Thus, much effort has been put into developing more continuous ways of levodopa delivery. 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). Additionally, different preparations for subcutaneous and sublingual administration of apomorphine, a dopamine agonist with equivalent efficacy to levodopa, are available for the treatment of PD motor fluctuations. 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. Beyond the approval of different botulinum toxin preparations for the treatment of sialorrhea, efforts to address the plethora of non-motor symptoms of the disease have not translated to novel PD-specific approvals over the last few years. PD symptoms can usually be satisfactorily controlled in the early to mid-stages, but the progressive course of the disease inevitably leads to increasing functional disability underlining the yet unmet need for disease-modifying therapies. While there is currently no conclusive evidence for disease-modifying efficacy on any of the numerous efforts, we summarize recent late-stage clinical trial evidence focusing on glucagon-like peptide 1 (GLP1) agonists, approaches targeting the glucocerebrosidase (GBA) pathway and inhibition of the leucine-rich repeat kinase 2 (LRRK2), as well as α-synuclein based treatments.

01 Jun 2026·Clinical Pharmacology in Drug Development

Pharmacokinetics and Tolerability of Entacapone, Levodopa, and Carbidopa Tablets in Healthy Chinese Subjects: A Randomized, Open‐Label, Four‐Period Crossover Study Under Fasting and Fed Conditions

Article

Author: Ma, Xuewei ; Xu, Yuan ; Wang, Jingyan ; Yang, Zhen ; Tao, Ye ; Zou, Yang ; Lan, Yi

Abstract:

This study aimed to assess the pharmacokinetics, bioequivalence, and safety of a generic entacapone/levodopa/carbidopa (100/25/200 mg) tablet formulation compared to its reference listed drug (RLD, Stalevo) in healthy Chinese adults. A randomized, open‐label, single‐dose, four‐period crossover study was conducted under fasting and fed conditions, with a 5‐day washout. A total of 68 subjects were enrolled and randomly assigned (1:1) to receive a single oral dose of either the test or reference formulation. Plasma concentrations of analytes were quantified using liquid chromatography‐tandem mass spectrometry (LC‐MS/MS), and key pharmacokinetic parameters (C max , AUC 0–t , AUC 0–∞ ) were calculated. Under both fasting and fed conditions, bioequivalence was assessed under both fasting and fed conditions using the reference‐scaled average bioequivalence (RSABE) or average bioequivalence (ABE) approach. For the key pharmacokinetic parameters (C max , AUC 0–t , and AUC 0–∞ ), the geometric mean ratios (GMRs) and their 90% confidence intervals (CIs) all fell within the 80.00%–125.00% range, or the one‐sided 95% upper confidence bound for the scaled difference was ≤0 and the point estimate of the GMR between the test and reference formulations fell within the 80.00%–125.00% range, thus confirming bioequivalence. Concomitant high‐fat food intake had a certain impact on the pharmacokinetics of each active ingredient. Adverse events (AEs) were mild, with no serious AEs reported, indicating comparable safety profiles. In conclusion, the generic formulation is bioequivalent to the RLD and demonstrates an acceptable safety profile in healthy Chinese subjects.

01 Mar 2026·JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Voltammetric analysis of entacapone, levodopa, and carbidopa in tablets: A chemometric approach

Article

Author: Budak, Fatma ; Cetinkaya, Ahmet ; Safarnejad, Azam ; Dogan-Topal, Burcu ; Ozkan, Sibel A

The objective of the present work is to develop a voltammetric method for the determination of entacapone (ENT) in the presence of levodopa (LEV) and carbidopa (CAR) in synthetic mixtures and pharmaceutical formulations, using a multivariate approach. ENT is an inhibitor of Catechol-O-methyltransferase (COMT), used in the treatment of Parkinson's disease as an adjunct for the combination therapy with LEV and CAR. With the optimized parameters in a pH 3.0 Britton-Robinson buffer, the quantitative analyses were assessed by the root mean square error in prediction (RMSEP), as well as the root mean square error of calibration (RMSEC) and the relative error of prediction (REP). The Radial Basis Function Artificial Neural Network (RBF-ANN) and Partial Least Squares regression (PLS) were applied for the determination of ENT in the presence of LEV and CAR. In the RBF-ANN model, the REP of 0.87 and RMSEP of 2.14×10^-7 are obtained for the test data when quantifying the ENT. The RBF model, as a nonlinear calibration method, was successful for predicting ENT concentration. To evaluate the validity of the recommended method, a commercial pharmaceutical tablet (Stalevo ® 200 mg) was analyzed. RBF model has the ability to overcome difficulties such as non-linearity and overlaps in the voltammograms.

News (Medical) associated with Carbidopa/Entacapone/Levodopa

23 Mar 2026

·www.fiercepharma.com

FDA mandates label updates to common Parkinson's meds based on seizure risk finding

In its safety review, the FDA found 14 causes of seizures linked to vitamin B6 deficiency in patients taking the common Parkinson’s disease drugs. A common drug combo for Parkinson’s disease will require a new FDA warning after the agency flagged 14 cases of seizures in patients using the medications. The agency is mandating (PDF) that drugmakers marketing products incorporating levodopa and carbidopa update their prescribing information to note that the drugs can cause vitamin B6 deficiency and vitamin B6 deficiency-associated seizures. Healthcare providers should evaluate patients’ baseline vitamin B6 levels prior to and during treatment and supplement patients with the vitamin as necessary, the warning says.The label update affects Amneal’s Crexont and Rytary; Avion Pharmaceuticals’ Dhivy; Merck’s Sinemet and controlled-release Sinemet CR; Novartis’ Stalevo; and AbbVie’s Duopa. Also affected is AbbVie’s newer Vyalev, a subcutaneous treatment that delivers prodrugs of carbidopa and levodopa via an infusion pump system. Vyalev’s ingredients of foscarbidopa and foslevodopa are drug derivatives of carbidopa and levodopa that become active after entering the body. Parkinson’s disease has been linked to dopamine deficiency, making levodopa, a metabolic precursor to dopamine, a favored treatment approach dating back to the 1960s. However, the drug must be taken with another medication to prevent it from breaking down in the bloodstream before crossing the blood-brain barrier, making the combo of carbidopa and levodopa the reigning standard-of-care in Parkinson’s disease treatment.But as levodopa converts to dopamine, crucial vitamin B6 levels can be impacted, the FDA pointed out in its warning. Carbidopa also binds to the active form of the vitamin, which can further drive down vitamin B6 levels. In its safety review, the FDA identified 14 causes of seizures linked to vitamin B6 deficiency in patients taking the common Parkinson’s disease drugs, including 13 instances that were submitted to the FDA’s adverse events reporting system and 1 reported in medical literature. There are “likely additional cases about which we were unaware,” the agency notes. Each of the reviewed cases involved levodopa doses greater than 1,000 mg daily and the seizures were split across oral formulations of the drugs and an enteral suspension. AbbVie makes the enteral suspension version with its Duopa, a gel medication that’s delivered directly into the small intestine through a tube. Some of the cases progressed to status epilepticus, a longer-lasting seizure that can cause brain damage or death, the FDA added. Several of the seizure reports showed “clinical evidence supportive of vitamin B6 deficiency,” and nine seizures were resolved when treated with supplemental vitamin B6. Two deaths occurred in patients with “documented low vitamin B6 levels and poorly controlled seizures,” according to the agency. “Based on the available data, FDA concluded there is reasonable evidence of a causal association between drug products containing carbidopa/levodopa and vitamin B6 deficiency-associated seizures,” the FDA said.Although no seizures were confirmed to result from products containing carbidopa/levodopa and entacapone (Novartis’ Stalevo) and injectable versions of carbidopa/levodopa (AbbVie’s Vyalev), the FDA is slapping the same warning on those meds, considering a likely risk based on “biological plausibility” and clinical trial data from the meds. Vyalev was the most recently approved carbidopa/levodopa med, scoring its FDA nod in 2024. The drug is a follow-up to AbbVie’s landmark 2015 Duopa, which sparked a trend of delivery system innovation in the Parkinson’s space as manufacturers looked to avoid the short half-life associated with oral versions of the meds. The FDA safety sweep of carbidopa and levodopa meds could lend credence to Supernus Pharmaceuticals’ novel Parkinson’s disease approach with Onapgo, a wearable pump that delivers a continuous subcutaneous infusion of Supernus’ dopamine agonist apomorphine (Apokyn). After winning approval in 2025 following three FDA rejections, the drug made so much of a splash in the disease space that the company had to pause delivery to new patients in November based on “stronger than expected demand,” Supernus said.Onapgo’s shipments has since resumed and the drug collected $17.3 million in 2025 sales, while AbbVie’s Vyalev took home $482 million and its older Duopa garnered sales of $381 million.

Drug ApprovalClinical Result

23 Mar 2026

·www.biospace.com

FDA Warns of Seizure Risk With Some Parkinson’s Drugs

iStock, undefined undefined The FDA detected 14 cases of vitamin B6 deficiency–linked seizures and two deaths in patients with Parkinson’s disease taking carbidopa/levodopa drugs. Both AbbVie and Novartis market levodopa-based products. Products containing levodopa and carbidopa, a common drug combination for treating Parkinson’s disease, could trigger seizures, the FDA has found. The agency conducted a safety review of drugs carrying these compounds and found 14 cases of seizures linked to vitamin B6 deficiency, according to a safety alert on Friday. In all of these cases, levodopa doses exceeded 1,000 mg per day. Seizures were typically focal-onset, meaning they started in a limited region of the brain. They then spread to include both hemispheres, leading to convulsions and causing emergencies in some cases. Two patients died, both of whom had had low vitamin B6 levels and poorly controlled seizures, the FDA said. Nine patients were given vitamin B6 supplementation, which in all cases led to the resolution of their seizures. All 14 cases of carbidopa/levodopa-linked seizures were detected through post-marketing surveillance or found in the medical literature, “so there are likely additional cases about which we are unaware,” the FDA said. While the safety signals arose in those taking oral formulations and enteral suspensions of carbidopa/levodopa, the regulator did not dismiss the possibility that other products—such as injectables or those that use additional compounds to enhance the original drug combo—could carry the same risk. “Biological plausibility suggests there may be a similar risk across all drug products containing carbidopa/levodopa,” the FDA wrote. The agency has already notified all manufacturers of drugs carrying carbidopa/levodopa, asking them to update the labels of their respective products to carry warnings for vitamin B6 deficiency-associated seizures. In the meantime, healthcare professionals should assess their patients’ vitamin B6 levels at baseline and throughout treatment, and consider supplementation as needed, the FDA recommended. Levodopa is a synthetic drug that, once it reaches the brain, is converted into dopamine, a neurotransmitter that is deficient in patients with Parkinson’s disease. Levodopa’s therapeutic benefits for Parkinson’s were first established in the 1960s, and the first drug that combined it with the decarboxylase inhibitor carbidopa—which improved its efficacy and safety—entered the market in 1975 . The combo remains in use today. In October 2024, the FDA approved AbbVie’s Vyalev , a levodopa-based therapy for advanced Parkinson’s disease. The product contains foscarbidopa and foslevodopa, prodrugs that can be given continuously over 24 hours as a subcutaneous infusion. Novartis also owns a carbidopa/levodopa product in Stalevo , which additionally uses entacapone to sustain heightened levels of the drug in the bloodstream. The industry is now opening up new therapeutic avenues for Parkinson’s disease, however. Eli Lilly in January scooped up Ventyx Biosciences for $1.2 billion, gaining access to a pipeline of drugs that target the NLRP3 inflammatory cascade, an underlying pathway driving the condition. Also looking at an immune-centered approach to Parkinson’s is AC Immune, which in December 2025 demonstrated slower disease progression in patients treated with its anti-alpha-synuclein therapy. Parkinson’s disease 5 Investigational Therapies That Could Change the Parkinson’s Landscape From opening new therapeutic mechanisms to repairing neuronal damage, investigational molecules from Ventyx Therapeutics, AC Immune, Gain Therapeutics and more could shape the future of Parkinson’s disease treatment. January 26, 2026 · 9 min read · Tristan Manalac Read more

Drug ApprovalClinical Result

30 Sep 2025

·www.einpresswire.com

April - June 2025 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

Acetaminophen-containing products Anaphylactic reaction FDA is evaluating the need for regulatory action. Aptryxol (desvenlafaxine) DaTscan (ioflupane I 123 injection) Desvenlafaxine extended-release tablets Effexor XR (venlafaxine extended-release) capsules Pristiq (desvenlafaxine) extended-release tablets Venlafaxine (venlafaxine hydrochloride) extended-release tablets False positive radioisotope investigation test result potentially secondary to a drug interaction with venlafaxine FDA is evaluating the need for regulatory action. Barium sulfate-containing products Entero Vu 24% (barium sulfate) oral suspension E-Z-Disk (barium sulfate) tablets Liquid E-Z-Paque (barium sulfate) oral suspension Readi-Cat 2 (barium sulfate) oral suspension Readi-Cat 2 Smoothie (barium sulfate) oral suspension Taglitol V (barium sulfate) oral suspension Varibar Honey (barium sulfate) oral suspension Varibar Nectar (barium sulfate) oral suspension Varibar Pudding (barium sulfate) oral paste Varibar Thin Honey (barium sulfate) oral suspension Varibar Thin Liquid (barium sulfate) oral suspension Anaphylactic reaction FDA is evaluating the need for regulatory action. Blincyto (blinatumomab) for injection Columvi (glofitamab-gxbm) injection Elrexfio (elranatamab-bcmm) injection Epkinly (epcoritamab-bysp) injection Imdelltra (tarlatamab-dlle) for injection Kimmtrak (tebentafusp-tebn) injection Lunsumio (mosunetuzumab-axgb) injection Talvey (talquetamab-tgvs) injection Tecvayli (teclistamab-cqyv) injection Progressive multifocal leukoencephalopathy FDA is evaluating the need for regulatory action. BRAF kinase inhibitors Braftovi (encorafenib) capsules Ojemda (tovorafenib) for oral suspension; tablets Tafinlar (dabrafenib) capsules; tablets Zelboraf (vemurafenib) tablets Gingival hypertrophy FDA is evaluating the need for regulatory action. Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Acute hepatic failure The "Warnings and Precautions" section of the labeling was updated in August 2025 to include information about liver injury. Example: Briumvi labeling Briumvi (ublituximab-xiiy) injection Kesimpta (ofatumumab) injection Ocrevus (ocrelizumab) injection Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) injection Central nervous system infection FDA is evaluating the need for regulatory action. Crexont (carbidopa and levodopa) extended-release capsules Dhivy (carbidopa and levodopa) tablets Duopa (carbidopa and levodopa) enteral suspension Rytary (carbidopa and levodopa) extended-release capsules Sinemet (carbidopa and levodopa) tablets Sinemet CR (carbidopa and levodopa) sustained-release tablets Stalevo (carbidopa, levodopa and entacapone) tablets Vyalev (foscarbidopa and foslevodopa) injection Seizure FDA is evaluating the need for regulatory action. Crysvita (burosumab-twza) injection Hypercalcemia The "Dosage and Administration", "Warnings and Precautions" and "Adverse Reactions" sections of the labeling were updated in August 2025 to include information about hypercalcemia. Crysvita labeling Dexmedetomidine-containing products Dexmedetomidine injection Precedex (dexmedetomidine hydrochloride) injection Igalmi (dexmedetomidine) sublingual film Diabetes insipidus FDA is evaluating the need for regulatory action. Dupixent (dupilumab) injection Ocular infections, irritations, and inflammation FDA is evaluating the need for regulatory action. Eprontia (topiramate) oral solution Qudexy XR (topiramate) extended-release capsules Qsymia (phentermine and topiramate) extended-release capsules Topamax (topiramate) tablets Topamax Sprinkle (topiramate) capsules Trokendi XR (topiramate) extended-release capsules Hypersensitivity FDA is evaluating the need for regulatory action. Gavreto (pralsetinib) capsules Chylothorax FDA is evaluating the need for regulatory action. Glucagon-like peptide-1 (GLP-1) receptor agonists Adlyxin (lixisenatide) injection Bydureon (exenatide) for extended-release injectable suspension Bydureon BCise (exenatide extended-release) injectable suspension Byetta (exenatide) injection Mounjaro (tirzepatide) injection Ozempic (semaglutide) injection Rybelsus (semaglutide) tablets Saxenda (liraglutide) injection Soliqua 100/33 (insulin glargine and lixisenatide) injection Trulicity (dulaglutide) injection Victoza (liraglutide) injection Wegovy (semaglutide) injection Xultophy 100/3.6 (insulin degludec and liraglutide) injection Zepbound (tirzepatide) injection Intestinal obstruction and fecal impaction FDA is evaluating the need for regulatory action. Imbruvica (ibrutinib) capsules; tablets; oral suspension Nail and nail bed conditions (excluding infections and infestations) FDA is evaluating the need for regulatory action. MEK inhibitors Avmapki Fakzynja Co-pack (avutometinib capsules; defactinib tablets) Cotellic (cobimetinib) tablets Mekinist (trametinib) tablets; oral solution Mektovi (binimetinib) tablets Koselugo (selumetinib) capsules Gingival hypertrophy FDA is evaluating the need for regulatory action. Neffy (epinephrine nasal spray) Product storage error FDA is evaluating the need for regulatory action. Nurtec ODT (rimegepant) orally disintegrating tablets Zavzpret (zavegepant) nasal spray Anaphylactic reaction The "Contraindications" and "Warnings and Precautions" sections of the labeling were updated in August 2025 to include information about hypersensitivity reactions, including anaphylaxis. Example: Nurtec ODT labeling Rozlytrek (entrectinib) capsules; oral pellets Brugada syndrome FDA is evaluating the need for regulatory action. Sodium-glucose cotransporter-2 (SGLT2) inhibitors Fournier's gangrene FDA is evaluating the need for regulatory action. Teriparatide injection (a particular generic product) Device malfunction FDA is evaluating the need for regulatory action. Vizamyl (flutemetamol F18 injection) Anaphylactic reaction The "Warnings and Precautions" section of the labeling was updated in June 2025 to include information about anaphylaxis and other serious hypersensitivity reactions. Vizamyl labeling Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Drug ApprovalBiosimilar

100 Deals associated with Carbidopa/Entacapone/Levodopa

External Link

KEGG	Wiki	ATC	Drug Bank
D10293	Carbidopa/Entacapone/Levodopa	N04BA03	-

R&D Status

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Parkinson Disease	United States	Orion Pharma Ltd.	11 Jun 2003

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NEWS Manual	Not Applicable	Primary Parkinson's disease	154	恩他卡朋双多巴片+多巴丝肼	cfaxhgpxqu(tdpswilzxy) = dpgqbmsmlt lxxvuemwzp (pzzxcrjakz ) View more	Positive	21 May 2025
				多巴丝肼	cfaxhgpxqu(tdpswilzxy) = geuatnnkjd lxxvuemwzp (pzzxcrjakz ) View more
MDS2023	Not Applicable	Parkinson Disease	9	Levodopa-entacapone-carbidopa intestinal gel (LECIG)	mbscptpceg(gocpmiksel) = in 4/9 patients (44.4%) vgahmpmglf (zxshdzqrua ) View more	-	27 Aug 2023
NCT02448914 (CTgov)	Phase 1	Parkinson Disease	11	carbidopa monohydrate+entacapone+levodopa+Duodopa+TRIGEL (TRIGEL)	opdusuuiou(hwmwaiihuh) = yyiwxdlucu qgkujhxhky (lnwegxbspz, ccubrbplqp - plvzabfexc) View more	-	23 May 2016
				carbidopa monohydrate+levodopa+Duodopa+TRIGEL (Duodopa)	opdusuuiou(hwmwaiihuh) = wclndxaqzd qgkujhxhky (lnwegxbspz, tlhyfiiajk - jqlnffyhcp) View more
Phase IV study (Pubmed \| J Neural Transm (Vienna))	Phase 4	Parkinson Disease	-	Levodopa/carbidopa/entacapone (LCE)	uglmgnifgx(vcktsmaznn) = afzmfgggrr jxktfbsbwv (lnfhtyxayd )	Positive	01 Apr 2014
AAN2013	Phase 2	Parkinson Disease	117	ODM-101/65mg	hyroepywzn(ufmtmtxdxx) = Dyskinesias reported as spontaneous adverse events were more commonly reported for ODM-101/105 mg vs other treatments. tbargghpqr (ilonrlophd )	-	12 Feb 2013
				ODM-101/105mg
NCT00219284 (CTgov)	Phase 4	Parkinson Disease	359	Carbidopa/levodopa/entacapone (Immediate Switch)	ebohsooiwm(xalxdeusnj) = jafclquaxf zgbwszpaug (deevkwvpos, 0.66) View more	-	15 Mar 2011
				Carbidopa/levodopa/entacapone (Delayed Switch)	ebohsooiwm(xalxdeusnj) = thdntixcqm zgbwszpaug (deevkwvpos, 0.58) View more
NCT00391898 (CTgov)	Phase 4	Parkinson Disease	95	Levodopa/carbidopa/entacapone (Levodopa/Carbidopa/Entacapone)	xcmyidgtou(lswwnfhzeh) = dgtaefcdej qzvhorlfml (kpxhokipon, 2.8) View more	-	15 Mar 2011
				Levodopa/carbidopa (Levodopa/Carbidopa)	xcmyidgtou(lswwnfhzeh) = witdlmxpjy qzvhorlfml (kpxhokipon, 3.0) View more
NCT00099268 (STRIDE-PD, CTgov)	Phase 3	Parkinson Disease	747	Carbidopa/levodopa/entacapone	qetluhliwz = twyvbekong ssixdlhzog (vnbpkmedth, lpduqzevjt - qdzlmjecrn) View more	-	08 Mar 2011
NCT00642356 (CTgov)	Phase 4	Parkinson Disease	14	Carbidopa/levodopa/entacapone (Carbidopa/Levodopa/Entacapone)	qfzjkvtifo(blifzvomhl) = phiwcskaub hxdjklxygj (vzumjxruqq, 0.90) View more	-	11 Jan 2011
				Immediate release carbidopa/levodopa (Immediate Release Carbidopa/Levodopa)	qfzjkvtifo(blifzvomhl) = ztlcenljjh hxdjklxygj (vzumjxruqq, 2.49) View more

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