A Single Dose, Randomized, Open-label, Four-period, Replicate Crossover Bioequivalence Study of Generic Entacapone 200 mg Film-coated Tablets and Reference Product (Comtan) in Healthy Thai Volunteers under Fasting Conditions

Start Date02 Nov 2025

Sponsor / Collaborator

International Bio Research

CTR20253873

/ CompletedNot Applicable

恩他卡朋片在中国健康研究参与者中空腹和餐后状态下随机、开放、单剂量、两序列、四周期、重复交叉生物等效性研究

[Translation] A randomized, open-label, single-dose, two-sequence, four-period, repeated crossover bioequivalence study of entacapone tablets in participants of the China Health Study under fasting and fed conditions

主要目的：健康研究参与者在空腹和餐后状态下，单次口服恩他卡朋片受试制剂（规格：0.2g，河北龙海药业有限公司）与参比制剂[规格：0.2g，珂丹®，Orion Corporation持证]后，比较两制剂在体内血药浓度及主要药代动力学参数，评价两制剂的生物等效性。次要目的：评价两制剂在健康研究参与者中空腹和餐后状态下的安全性。

[Translation]

Primary Objective: To evaluate the bioequivalence of the two formulations after a single oral dose of the test formulation of entacapone tablets (0.2g, Hebei Longhai Pharmaceutical Co., Ltd.) and the reference formulation (0.2g, Kedan®, licensed by Orion Corporation) in healthy study participants under fasting and fed conditions. Secondary Objective: To evaluate the safety of the two formulations in healthy study participants under fasting and fed conditions.

Start Date07 Oct 2025

Sponsor / Collaborator

Hebei Longhai Pharmaceutical Co. Ltd.

ChiCTR2500104562

/ RecruitingNot ApplicableIIT

Exploratory Clinical Study ofEntacapone Combined with PD-1/1Antibody andTargeted Therapy in Advanced Hepatocellular Carcinoma Refractory to StandardTreatment

Start Date14 Jun 2025

Sponsor / Collaborator

Zhongshan Hospital Fudan University

100 Clinical Results associated with Entacapone

100 Translational Medicine associated with Entacapone

100 Patents (Medical) associated with Entacapone

1,061

Literatures (Medical) associated with Entacapone

01 Jun 2026·Drug Metabolism and Pharmacokinetics

N6-methyladenosine modification of MRP7 mRNA modulates its expression and paclitaxel sensitivity in lung cancer-derived A549 cells

Article

Author: Nakajima, Miki ; Inamoto, Takuto ; Fukami, Tatsuki ; Nakano, Masataka

Methylation of adenosine at the N⁶ position (m⁶A modification) is the most prevalent epitranscriptomic modification in mammals, regulating RNA stability, splicing, translation, and decay. Growing evidence has revealed that m⁶A modification is intricately linked to cancer progression. This study aimed to investigate the effects of m⁶A modification on the sensitivity of lung cancer-derived A549 cells to paclitaxel (PTX). Knockdown of methyltransferase like (METTL) 3/14, the m⁶A writer complex, increased A549 cell viability under PTX, indicating m⁶A modification enhances PTX sensitivity. METTL3/14 knockdown increased the expression of multidrug resistance-associated protein (MRP) 7, but not multiple drug resistance (MDR) 1 or MRP1, promoting PTX efflux. RNA immunoprecipitation showed that MRP7 mRNA is highly methylated at the 5'-untranslated region (UTR), coding region, and 3'-UTR. METTL3/14 knockdown stabilized MRP7 mRNA, while depletion of m⁶A readers YTHDC2 or YTHDF2 also elevated MRP7 mRNA, suggesting these readers mediate its degradation. Moreover, knockdown of the erasers fat mass and obesity-associated protein (FTO) or AlkB homolog 5 as well as treatment with entacapone, an FTO inhibitor, increased PTX sensitivity in PTX-resistant A549 cells. These results suggest that the m⁶A-dependent regulation of MRP7 expression contributes to PTX resistance, highlighting a potential therapeutic avenue in lung cancer.

01 Jun 2026·BASIC & CLINICAL PHARMACOLOGY & TOXICOLOGY

The Cardiovascular Safety of Antiparkinsonian Drugs—Analysis of Signals in the FDA Adverse Event Report System Database

Article

Author: Mu, Xin ; Ning, Pingping ; Wang, Yanfeng ; Wei, Peiyao ; Ren, Junwei

ABSTRACT:

Objective:

This study aimed to investigate the characteristics and spectrum of cardiotoxicity induced by various antiparkinsonian drugs based on the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database.

Methods:

Data from the FAERS database from the first quarter of 2004 to the third quarter of 2025 were downloaded for disproportionality analysis. We employed validated disproportionality metrics including the reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN) and multi‐item gamma Poisson shrinker (MGPS) to detect significant drug‐event associations.

Results:

After removing duplicates, a total of 42 583 cases of patients treated with antiparkinsonian drugs were included in the FAERS database. Dopamine receptor agonists exhibited the most extensive range of cardiac adverse events. Monoamine oxidase B inhibitors displayed the second broadest range of toxicity. As for catechol‐O‐methyltransferase inhibitors, a total of six signals were detected in entacapone. Four signals were detected for amantadine, while no signals were identified for levodopa.

Conclusion:

This study highlights the cardiovascular adverse reactions associated with Parkinson's treatment drugs. These findings underscore the importance of monitoring and evaluating the cardiovascular safety of antiparkinsonian medications.

01 May 2026·JOURNAL OF NEUROLOGY

Patient-reported outcomes and experiences with COMT inhibitors in the management of motor fluctuations in Parkinson’s disease: a UK-based nested cross-sectional study

Article

Author: Noyce, Alastair J ; Maio, Raquel ; Periñan, Maria Teresa ; Efthymiadou, Olina ; Harrison-Jones, Glynn ; Akindele, Lara ; Ippolito, Mario ; Shelton, Emma-Louise

BACKGROUND:

Motor fluctuations are a common complication in Parkinson's disease (PD), often managed with catechol-O-methyltransferase (COMT) inhibitors. We aimed to explore patient perspectives on their COMT inhibitor treatment and to evaluate and compare patient-reported outcomes and experiences with the COMT inhibitors opicapone and entacapone.

METHODS:

This UK-based cross-sectional study utilised anonymised, real-world data from the AccessPD registry. A convenience sample of 102 registry participants who had received either opicapone or entacapone. completed validated patient-reported outcome measures (PDQ-39 and, EQ-5D-5L) and an online survey assessing treatment experiences, preferences, and communication with healthcare providers.

RESULTS:

Survey responses highlighted that increased ON time and reduced OFF time were the most valued treatment attributes for COMT inhibitors, while hallucinations and dyskinesia were the least acceptable side effects. Only 25% of respondents recalled being informed about alternative treatment options prior to starting COMT inhibitor therapy. Communication from clinicians about the role of these drugs was inconsistent, with 27.5% of participants only rating it as 'fair/poor' and 58% reporting no follow-up after initiation. Patients' overall quality of life was generally reported as mild to moderately affected in both treatment groups.

CONCLUSIONS:

Survey findings underscore the heterogeneity of patient preferences and the need for improved clinician-patient communication and personalised care. Both COMT inhibitors should be considered in shared decision-making to optimise motor fluctuation management and quality of life in PD.

News (Medical) associated with Entacapone

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

22 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 Entacapone

External Link

KEGG	Wiki	ATC	Drug Bank
D00781	Entacapone	N04BX02	DB00494

R&D Status

10 top approved records.

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Indication	Country/Location	Organization	Date
Parkinson Disease	European Union	Orion Oyj	16 Sep 1998
Parkinson Disease	Iceland	Orion Oyj	16 Sep 1998
Parkinson Disease	Liechtenstein	Orion Oyj	16 Sep 1998
Parkinson Disease	Norway	Orion Oyj	16 Sep 1998

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed \| J Neural Transm (Vienna)	Phase 3	-	551	Levodopa/carbidopa	rbeffokrsl(oqqrmppyhh) = xdnstxuwtx cbyfoqkhdf (ogizfofpjr ) View more	-	01 Dec 2015
				Levodopa/benserazide	rbeffokrsl(oqqrmppyhh) = arlbchooux cbyfoqkhdf (ogizfofpjr ) View more
NCT00547911 (CTgov)	Phase 1/2	Dopamine Beta Hydroxylase Deficiency \| Multiple System Atrophy \| Parkinson Disease	14	Carbidopa+Droxidopa+Entacapone (LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT)	uvhofxvqcz(fzmxfiaiki) = ddwnfbtalh fruznzgnxs (hmsfzoevig, ymjywnfnov - kejfucyugq) View more	-	17 Jul 2014
				Carbidopa+Droxidopa+Entacapone (LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR)	uvhofxvqcz(fzmxfiaiki) = xdrhuhsiqm fruznzgnxs (hmsfzoevig, izywhnuoyn - jzhedvcihx) View more
Pubmed \| Int J Neurosci	Not Applicable	Parkinson Disease	-	Immediate Switch to Levodopa/Carbidopa/Entacapone	uocweuebwh(igxslztfub) = xlincsulip cgthunfxpl (okufdcmixy ) View more	Positive	13 Oct 2011
				Delayed Switch to Levodopa/Carbidopa/Entacapone	uocweuebwh(igxslztfub) = rpcgmzmzvz cgthunfxpl (okufdcmixy )

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