A double blind, placebo controlled, randomized control trial studying the safety and efficacy of pyridostigmine as a rescue therapy for postoperative ileus. Patients who undergo elective colorectal resection with or without creation of an ostomy, and subsequently develop postoperative ileus will be eligible for enrollment. Patients will be randomized to receive either pyridostigmine or placebo in addition to the current elements of standard of care. Patients will also complete the pyridostigmine bromide side effects scale (PBSES) upon enrollment and following each administration of either intervention or placebo to monitor treatment safety and evaluate for the development of side effects.

开始日期2024-09-03

申办/合作机构

The Cleveland Clinic Foundation

NCT06366724

/ Not yet recruiting临床2期IIT

LIFT: Life Improvement Trial

The LIFT will be conducted at Brigham and Women's Hospital (BWH) of Harvard Medical School, focusing on the effect of Pyridostigmine (Mestinon) and Low-Dose Naltrexone (LDN) in subjects aged 18-65 meeting the Canadian consensus criteria (CCC) for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS) as well as having specifically Orthostatic Intolerance.
This double-blind, placebo-controlled study will involve 160 participants randomized into one of four possible groups: Pyridostigmine/LDN (40), Pyridostigmine/Placebo (40), LDN/Placebo (40), Placebo/Placebo (40). The dose of Pyridostigmine will be carefully titrated from 30mg to 60mg three times a day, and the dose of LDN will be titrated from 1.5 mg to 4.5 mg once daily.
The trial includes a scale-back plan, allowing participants to reduce their dosage if they experience intolerance symptoms, with adjustments made during weekly visits. This plan provides a personalized approach to medication tolerance, ensuring participant's safety and comfort throughout the trial.
The time commitment for the participant is approximately three (3) months, and during this time, there will be three (3) in-person visits to BWH and four (4) virtual visits. Study procedures will include two (2) submaximum cardiopulmonary exercise tests, questionnaires (virtually completed), and blood and urine collection. We will be recruiting from the BWH Dyspnea Clinic as well as the Open Medicine Foundation (OMF) StudyME Registry and anticipate the entire trial will take two (2) years to complete.
The LIFT represents a significant endeavor to improve treatment options for ME/CFS patients and contribute to the broader understanding of this debilitating condition.

开始日期2024-08-01

申办/合作机构

The Brigham & Women's Hospital, Inc.

[+1]

NCT06035757

/ Recruiting临床4期IIT

The Effect of Administration of Sugammadex on the Occurrence of Emergence Agitation in Pediatric Strabismus Surgery-prospective Randomized Controlled Trial

The present trial conducted to demonstrate the administration of sugammadex as reversal of neuromuscular blockade agent reduces the incidence of emergence agitation (EA) comparing to neostigmine

开始日期2023-12-01

申办/合作机构

Konkuk University Medical Center

100 项与溴吡斯的明相关的临床结果

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100 项与溴吡斯的明相关的转化医学

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100 项与溴吡斯的明相关的专利（医药）

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项与溴吡斯的明相关的文献（医药）

2025-03-01·CURRENT PROBLEMS IN CARDIOLOGY

Pathophysiology and management of postural orthostatic tachycardia syndrome (POTS): A literature review

Review

作者: Akkawi, Abdul Rahman ; Tanzeem, Hammad ; Briasoulis, Alexandros ; Sajjad, Laiba ; Fancher, Andrew ; Oundo, Emmanuel ; Ghazal, Mohamad

Postural Orthostatic Tachycardia Syndrome (POTS) is a form of cardiovascular autonomic disorders characterized by orthostatic intolerance and a symptomatic increase in heart rate upon standing, which can significantly impair patients' quality of life. Its pathophysiology is complex, multifactorial; thus, a variety of treatment approaches have been investigated. Recent studies have identified three primary POTS phenotypes-hyperadrenergic, neuropathic, and hypovolemic-each requiring tailored management strategies. First-line treatment for all patients focuses on lifestyle modifications, including increased fluid and salt intake, compression garment use, physical reconditioning, and postural training. Currently, there are no medications approved by the United States Food and Drug Administration (FDA)for POTS. Pharmacologic therapies are primarily used to manage specific symptoms, though the evidence supporting their efficacy is limited. In hyperadrenergic POTS, excessive norepinephrine production or impaired reuptake leads to sympathetic overactivity, making beta-blockers an effective option. Neuropathic POTS, resulting from impaired vasoconstriction during orthostatic stress, responds to agents that enhance vascular tone, such as pyridostigmine and midodrine. Hypovolemic POTS, often triggered by dehydration and physical deconditioning, respond primarily to volume expansion and exercise. This review article provides a comprehensive overview of the pathophysiology and management strategies for POTS, with a focus on phenotype-based approaches to guide tailored treatment and improve patient outcomes.

2025-01-14·NEUROLOGY

Changes in Myasthenia Gravis Incidence in Denmark From 1985 to 2021

Article

作者: Andersen, Henning ; Jul Jarbæk Nielsen, Josefine ; Levison, Lotte

BACKGROUND AND OBJECTIVES:

Previous studies on incident myasthenia gravis (MG) have shown inconsistent results. In this study, we determined the MG incidence rates (IRs) over a 36-year period to detect potential trends in MG incidence over time and for different age groups.

METHODS:

In this nationwide population-based study from 1985 to 2021, we identified patients aged 18 and older with a primary MG diagnosis in the Danish National Patient Registry. The patients were categorized into 3 distinct groups defined by age at onset: early-onset (≤50 years of age), late-onset (>50 and ≤65 years of age), and very late-onset (>65 years of age). MG IRs were calculated and stratified by sex and time periods in the specified age groups. To increase the validity of the MG IRs, we performed sensitivity analyses from 1995 until 2021, adding ≥2 prescriptions of pyridostigmine and/or acetylcholine receptor seropositivity.

RESULTS:

We identified 2,110 patients with MG (1,060 women), with a median age of 57.1 (interquartile range [IQR] 40.2-74.0) years for women and 63.6 (IQR 56.4-74.3) years for men. In the study period, the MG IR was 1.4 (95% CI 1.3-1.4) per 100,000 person-years, which persisted in our sensitivity analyses, with no significant differences between the sexes. Overall, 579 patients (27.4%) were classified as early-onset, 490 (23.2%) as late-onset, and 1,040 (49.3%) as very late-onset. For early-onset MG, the IR was 0.7 (95% CI 0.6-0.7) and remained stable throughout the study period. Inversely, the IRs for late-onset and very late-onset MG increased over time, with corresponding incidence rate ratios (IRRs) of 1.9 (95% CI 1.3-2.6) and 2.2 (95% CI 1.7-2.9), from the first 5 years from 1985 to 1990 until the last 6 years of the study period from 2015 to 2021.

DISCUSSION:

The overall IR of MG increased from 1985 to 2021, aligning with recent reports from neighboring European countries. The most significant rise occurred during the last 6 years of the study period compared with the first 5 years, with an IRR reaching 1.9 (95% CI 1.6-2.3). This increase in IRs was observed only in the late-onset and very late-onset age groups.

2025-01-01·NEUROMUSCULAR DISORDERS

CHRNE-related congenital myasthenic syndrome in Iran: Clinical and molecular insights

Article

作者: Nafissi, Shahriar ; Ziaadini, Bentolhoda ; Karimi, Narges ; Ghasemi, Aida ; Panahi, Akram

Variants in the CHRNE gene can lead to a condition called congenital myasthenic syndrome (CMS), which affects the neuromuscular junction (NMJ). CHRNE mutations are the most common cause of CMS. Seventy-seven patients with a possible diagnosis of CMS were referred to the neuromuscular clinic of Shariati Hospital affiliated with the Tehran University of Medical Sciences. We performed whole-exome sequencing (WES) to determine the underlying defect in a group of individuals with a possible diagnosis of CMS. Clinical features and morphological and molecular data on 33 patients with mutations in CHRNE were described. Age of onset, age at diagnosis, consanguinity, family history, motor milestone delay, ophthalmoparesis, generalized fatigue, dysphagia, neurophysiologic findings, and response to treatment of the patients were assessed. Nineteen CHRNE variants including 10 novel ones were identified. The most common mutations were c.1327del; (p.Glu443LysfsTer64) in four different families and c.1252-1267dup; (p.Cys423SerfsTer38) in three families. Clinical onset was mostly at birth or under one year with bilateral fatigable ptosis, ophthalmoplegia, bulbar weakness, and proximal muscle weakness. All patients were treated with pyridostigmine ± salbutamol, which resulted in improvement of motor function, dysphagia, and breathing.

项与溴吡斯的明相关的新闻（医药）

2024-10-21

·BioSpace

Amneal Receives U.S. FDA Approval of New Drug Application for Pyridostigmine Bromide Extended-Release Tablets

Pyridostigmine Bromide Extended Release is a once-daily soman nerve agent pretreatment pyridostigmine product for the U.S. Armed Services and U.S. allies developed utilizing Amneal’s GRANDE ® drug delivery technology Developed with the support of Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) BRIDGEWATER, N.J.--(BUSINESS WIRE)--Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) (“Amneal” or the “Company”), a global pharmaceutical company based in the U.S., today announced that it has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for Pyridostigmine Bromide Extended-Release (PB ER) Tablets USP 105 mg. PB ER 105 mg tablets are a once-daily, orally administered product indicated for pretreatment against the lethal effects of soman nerve agent poisoning in adults developed for the U.S. Armed Services and U.S. allies. This product offers potential for improved compliance and steady 24-hour release of the drug’s therapeutic benefit, which is intended to provide an alternative to the current PB product that is administered every eight hours and avoiding the need for service members to self-administer three times a day. This product was not previously disclosed and was developed with Amneal’s GRANDE ® drug delivery technology, which is an advanced gastric retention system that allows for sustained delivery drug release. This project was funded in part by the U.S. government under Agreement W911QY-21-9-0018. “Amneal is proud to receive our second NDA approval this year, after the recent approval of CREXONT for Parkinson’s disease. This new pyridostigmine therapy speaks to Amneal’s expertise in developing new innovative product formulations and our ongoing work with the U.S. government on new solutions. With the approval of pyridostigmine bromide extended-release tablets, we are proudly supporting the U.S. military,” said Chirag and Chintu Patel, Co-Chief Executive Officers of Amneal. The most frequently reported serious adverse reactions were breathing difficulties, dizziness, and loss of consciousness. Other reported adverse reactions observed included dysmenorrhea, nosebleeds, reduced vision in one eye, and decreased tactile sensitivity. Disclaimer: The views and opinions of authors expressed herein do not necessarily state or reflect those of the U.S. government and shall not be used for advertising or product endorsement purposes. About Amneal Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global pharmaceuticals company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 generic and specialty pharmaceuticals, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit . Disclaimer The views expressed herein are those of Amneal and may not reflect the official policy or position of the Department of Defense (DoD) or the U.S. Government. Reference herein to any specific commercial products, process or service by trade name, trademark, manufacturer, or otherwise, does not constitute or imply its endorsement, recommendation, or favoring by the U.S. government and shall not be used for advertising or product endorsement purposes. Cautionary Statement on Forward-Looking Statements Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof. Contacts Investor Contact Anthony DiMeo VP, Investor Relations anthony.dimeo@amneal.com

申请上市上市批准

2024-10-15

·GlobeNewswire-Health Care

argenx Highlights Data Showing Patient Impact Across Multiple Immunology Programs at 2024 American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting and Myasthenia Gravis Foundation of America Scientific Sessions

Long-term and real-world data of VYVGART® (efgartigimod alfa-fcab) and VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) demonstrate speed of onset, depth of response, and durability of response VYVGART demonstrates consistent, favorable safety profile from follow-up safety data that totals >8,000 patient years; no vaccinations required and no impact on human serum albumin levels Real-world data show more than 50 percent of gMG patients demonstrate substantial and sustained reduction in steroid use following VYVGART initiation argenx continues to expand its reach in neurology through pipeline programs, including empasiprubart advancing in MMN and ARGX-119 in ALS and CMS October 15, 2024 – 7:00am CET Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, today announced the presentation of clinical and real-world data across its growing immunology pipeline at the 2024 American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting and Myasthenia Gravis Foundation of America (MGFA) Scientific Sessions in Savannah, GA from October 15-18, 2024. “VYVGART continues to deliver impactful benefits to patients in terms of safety, speed of onset, depth of response, and durability of response,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer, argenx. “The robust data we are showing at AANEM and MGFA continue to confirm VYVGART as the leading innovative biologic with an established ability to reduce steroid usage, drive minimal symptom expression for gMG patients, and reduce CIDP symptoms quickly. In addition to VYVGART, we are excited to highlight our growing neurology pipeline, including empasiprubart and ARGX-119, through which we can advance our mission of delivering transformative outcomes for even more patients.” VYVGART and VYVGART Hytrulo Demonstrate Rapid, Deep and Sustained Responses in gMG and CIDP The data presented at AANEM continue to demonstrate the significant impact of VYVGART (including VYVGART Hytrulo), the first-in-class neonatal Fc receptor (FcRn) blocker for people living with generalized myasthenia gravis (gMG) and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART is setting a new treatment standard in gMG and has shown rapid, deep and sustained responses, enabling a majority of patients to achieve minimal symptom expression (MSE) with a consistent and favorable safety profile and more than 8,000 patient years of safety data. Based on real-world data, more than half of patients can reduce steroid use by >5mg/day following VYVGART initiation. In CIDP, a majority of patients in the ADHERE trial responded to VYVGART Hytrulo and experienced reduced risk of relapse versus placebo and improvements in motor function and muscle strength, regardless of prior CIDP treatment. Highlights from VYVGART data presented at AANEM and MGFA: Early Line Use and Meaningful Steroid Reduction: VYVGART demonstrates consistent improvement across gMG patient subtypes, including those on mestinon alone, indicating its efficacy in early line use. Real-world gMG data show that at one-year post VYVGART initiation, 55% of patients reduced corticosteroid use by ≥5 mg/day and 42% of patients had achieved steroid doses of ≤5mg/day.Expansion to Seronegative and Ocular MG: argenx is honoring its long-term commitment to the broader MG community with two Phase 3 studies ongoing in additional MG patient populations, including seronegative (ADAPT-SERON) and ocular MG (ADAPT-OCULUS). Seronegative (AChR-) gMG patients evaluated in VYVGART clinical studies experienced consistent and clinically meaningful MG-ADL improvements, including patients achieving MSE.Sustained Functional Benefit in CIDP: VYVGART Hytrulo showed sustained functional benefit in motor function and muscle strength, regardless of prior treatment, which was maintained through ADHERE and the open-label extension study (through week 24).Consistent, Favorable Safety Profile: VYVGART’s consistent and favorable safety profile has been established across multiple autoimmune diseases with no increase in the incidence of adverse events with increased exposure. The unique safety profile of VYVGART is further supported by no black box warnings, no labs or immunoglobulin (Ig) monitoring, and no vaccination requirements. Advancing Immunology Pipeline Across Two First-in-Class Opportunities to Reach New Patients argenx will also highlight two additional pipeline candidates, including Phase 2 ARDA data of empasiprubart (anti-C2 inhibitor) for the treatment of multifocal motor neuropathy (MMN), and clinical trial designs of ARGX-119 (muscle-specific kinase (MuSK) agonist) for the treatment of congenital myasthenic syndromes (CMS) and amyotrophic lateral sclerosis (ALS). Cohort 1 data from the Phase 2 ARDA study will be presented in a poster, showing treatment with empasiprubart for MMN reduced the risk of IVIg retreatment by 91% (HR: 0.09 [95% CI: 0.02–0.44]) and demonstrated significant improvement in grip strength in both hands as compared to placebo. Data from a Patient Global Impression of Change scale show 94.4% of patients said they improved on empasiprubart from the start of the study, compared to 11.1% of placebo patients. As part of its commitment to the MMN community, argenx initiated the iMMersioN longitudinal study of ~150 patients to collect data on the impact of disease and burden of current treatment options on clinical outcomes and quality of life measures. A Phase 3 study of empasiprubart in MMN will start by the end of 2024. argenx posters included in MGFA Scientific Sessions All MGFA posters to be presented on Tuesday, October 15, 12:00 – 12:45pm ETPosters with an asterisk (*) will also be presented in AANEM scientific program Full TitlePresentation DetailsPatterns of Efgartigimod Dosing in Clinical Practice in the United StatesPoster # MG9Real-World Reduction in Oral Glucocorticoid Utilization at 1-Year Following Efgartigimod Initiation*Poster # MG31 / AANEM Poster # 262Efficacy, Safety, and Pharmacodynamics of Efgartigimod PH20 SC Across Bodyweight Quartiles: A Post hoc Analysis of the ADAPT-SC+ TrialPoster # MG32Fixed Cycle and Every-Other-Week Dosing of Intravenous Efgartigimod for Generalized Myasthenia Gravis: Part A of ADAPT NXT*Poster # MG33 /AANEM Poster # 182Design of a Phase 3 Randomized, Double-Blinded, Placebo-Controlled Study Evaluating the Efficacy and Safety of Subcutaneous Efgartigimod PH20 Administered by Prefilled Syringe in Adults with Ocular Myasthenia GravisPoster # MG38Phase 3 Trial Investigating Impact of Intravenous Efgartigimod in Anti-Acetylcholine Receptor Antibody Negative Generalized Myasthenia Gravis*Poster # MG39 / AANEM Poster # 178Observed Efficacy of Efgartigimod in Generalized Myasthenia Gravis Across Patient Subgroups in the ADAPT-SC+ StudyPoster # MG68Exploring the Impact of Non-Steroidal Immunosuppressive Drugs and Steroids on the Development of Comorbidities in Patients with Myasthenia Gravis in the National Veterans Affairs Health NetworkPoster # MG86Quality of Life of Patients with Symptomatic Ocular MG: Comparison with the General PopulationPoster # MG87Steroid Use, Toxicity, and Monitoring in Patients With Generalized Myasthenia Gravis: A Survey Of Neurologists In The United States*Poster # MG89 / AANEM Poster # 235Comparative Risk-Benefit Profiles of Immunomodulatory Therapies for Patients with Generalized Myasthenia GravisPoster # MG98 argenx posters included in AANEM Scientific Program * Session Times: Session I: Wednesday, October 16, 6:15 - 6:45pm ETSession II: Thursday, October 17, 9:30 - 10am ETSession III: Thursday, October 17, 2:45 - 3:15pm ET Full TitlePresentation Details*Long-Term Safety and Efficacy of Efgartigimod PH20 SC in Generalized Myasthenia Gravis: Interim Analysis of Anti-Acetylcholine Receptor Antibody Seronegative Participants in ADAPT-SC+Poster # 144Session I & Session IICombined Analyses of Participants With Anti-Acetylcholine Receptor Seronegative Generalized Myasthenia Gravis Treated With Efgartigimod Across Clinical StudiesPoster # 146Session I & Session IISafety, Tolerability, Pharmacokinetics, Immunogenicity, and Efficacy of ARGX-119 in Participants With DOK7 Congenital Myasthenic Syndromes: Phase 1b Study in ProgressPoster # 165Session I & Session IIIEfficacy and Safety of Subcutaneous Efgartigimod PH20SC in Chronic Inflammatory Demyelinating Polyneuropathy: ADHERE Trial Subgroup AnalysisPoster # 176Session I & Session IIEfficacy and Safety of Subcutaneous Efgartigimod PH20 in Chronic Inflammatory Demyelinating Polyneuropathy: ADHERE/ADHERE+ TrialPoster # 177Session I & Session IIISafety Profile of Intravenous Efgartigimod From Clinical Trials in Immunoglobulin G–Mediated Autoimmune DiseasesPoster # 180Session I & Session IISafety Profile of Subcutaneous Efgartigimod PH20 From Clinical Trials in Immunoglobulin G–Mediated Autoimmune DiseasesPoster # 181Session I & Session IIIEmpasiprubart (ARGX-117) in Multifocal Motor Neuropathy: Initial Safety and Efficacy Data of the Phase 2 ARDA StudyPoster # 198Session I & Session IILong-Term Safety, Tolerability, and Efficacy of Subcutaneous Efgartigimod PH20 in Participants With Generalized Myasthenia Gravis: Interim Results of the ADAPT-SC+ StudyPoster # 212Session I & Session IIISafety, Tolerability, Efficacy, Pharmacokinetics, and Immunogenicity of ARGX-119 in Patients with Amyotrophic Lateral Sclerosis: A Phase 2a Study in ProgressPoster # 237Session I & Session IIRisk of Serious Infections and Malignancies in Adult Myasthenia Gravis Patients: A US Claims Database StudyPoster # 251Session I & Session IIChronic Steroid Toxicity in Adults With Myasthenia Gravis in the United States Based on Electronic Health RecordsPoster # 263Session I & Session IISubcutaneous Efgartigimod PH20 in Chronic Inflammatory Demyelinating Polyneuropathy: Key Secondary Outcomes from the ADHERE TrialPoster # 280Session I & Session IIIEmpasiprubart (ARGX-117) in Multifocal Motor Neuropathy: Baseline Characteristics and MMN Confirmation Committee Outcome of the Phase ARDA Study Cohort 1Poster # 293Session I & Session IICOVID-19 Vaccination Response in Participants Receiving Efgartigimod IV or Efgartigimod PH20 SC in ADAPT+ or ADAPT-SC+Poster # 298Session I & Session IIISteroid Use, Toxicity, and Monitoring in Patients with Chronic Inflammatory Demyelinating Polyneuropathy: A Survey of Neurologists in The United StatesPoster # 306Session I & Session IIIClinical Outcomes, Disease Course, and Quality of Life in Patients With Multifocal Motor Neuropathy: iMMersioN, Study in ProgressPoster # 307Session I & Session II More information on the data presented at the 2024 AANEM Annual Meeting can be found here. See FDA-approved Important Safety Information below, full Prescribing Information for VYVGART and full Prescribing Information for VYVGART Hytrulo for additional information. Important Safety Information What is VYVGART® (efgartigimod alfa-fcab)?VYVGART is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive). IMPORTANT SAFETY INFORMATIONDo not use VYVGART if you have a serious allergy to efgartigimod alfa or any of the other ingredients in VYVGART. VYVGART can cause serious allergic reactions and a decrease in blood pressure leading to fainting. VYVGART may cause serious side effects, including: Infection. VYVGART may increase the risk of infection. The most common infections were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.Allergic Reactions (hypersensitivity reactions). VYVGART can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with VYVGART.Infusion-Related Reactions. VYVGART can cause infusion-related reactions. The most frequent symptoms and signs reported with VYVGART were high blood pressure, chills, shivering, and chest, abdominal, and back pain. Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction. Before taking VYVGART, tell your doctor if you: take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,have received or are scheduled to receive a vaccine (immunization), orhave any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding. What are the common side effects of VYVGART?The most common side effects of VYVGART are respiratory tract infection, headache, and urinary tract infection. These are not all the possible side effects of VYVGART. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088. Please see the full Prescribing Information for VYVGART and talk to your doctor. What is VYVGART® HYTRULO (efgartigimod alfa and hyaluronidase-qvfc)?VYVGART HYTRULO is a prescription medicine used to treat a condition called generalized myasthenia gravis, which causes muscles to tire and weaken easily throughout the body, in adults who are positive for antibodies directed toward a protein called acetylcholine receptor (anti-AChR antibody positive).VYVGART HYTRULO is a prescription medicine used for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) IMPORTANT SAFETY INFORMATIONDo not use VYVGART HYTRULO if you have a serious allergy to efgartigimod alfa, hyaluronidase, or any of the other ingredients in VYVGART HYTRULO. VYVGART HYTRULO can cause serious allergic reactions and a decrease in blood pressure leading to fainting. VYVGART HYTRULO may cause serious side effects, including: Infection. VYVGART HYTRULO may increase the risk of infection. The most common infections for efgartigimod alfa-fcab-treated patients were urinary tract and respiratory tract infections. Signs or symptoms of an infection may include fever, chills, frequent and/or painful urination, cough, pain and blockage of nasal passages/sinus, wheezing, shortness of breath, fatigue, sore throat, excess phlegm, nasal discharge, back pain, and/or chest pain.Allergic Reactions (hypersensitivity reactions). VYVGART HYTRULO can cause allergic reactions such as rashes, swelling under the skin, and shortness of breath. Hives were also observed in patients treated with VYVGART HYTRULO. Serious allergic reactions, such as trouble breathing and decrease in blood pressure leading to fainting have been reported with efgartigimod alfa-fcab.Infusion-Related Reactions. VYVGART HYTRULO can cause infusion-related reactions. The most frequent symptoms and signs reported with efgartigimod alfa-fcab were high blood pressure, chills, shivering, and chest, abdominal, and back pain. Tell your doctor if you have signs or symptoms of an infection, allergic reaction, or infusion-related reaction. These can happen while you are receiving your VYVGART HYTRULO treatment or afterward. Your doctor may need to pause or stop your treatment. Contact your doctor immediately if you have signs or symptoms of a serious allergic reaction. Before taking VYVGART HYTRULO, tell your doctor if you: take any medicines, including prescription and non-prescription medicines, supplements, or herbal medicines,have received or are scheduled to receive a vaccine (immunization), orhave any allergies or medical conditions, including if you are pregnant or planning to become pregnant, or are breastfeeding. What are the common side effects of VYVGART HYTRULO?The most common side effects in efgartigimod-alfa-fcab-treated patients were respiratory tract infection, headache, and urinary tract infection. Additional common side effects with VYVGART HYTRULO are injection site reactions, including rash, redness of the skin, itching sensation, bruising, pain, and hives. These are not all the possible side effects of VYVGART HYTRULO. Call your doctor for medical advice about side effects. You may report side effects to the US Food and Drug Administration at 1-800-FDA-1088. Please see the full Prescribing Information for VYVGART HYTRULO and talk to your doctor. About VYVGARTVYVGART is a human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. It is the first approved FcRn blocker in the United States, EU, China and Canada for the treatment of adults with generalized myasthenia gravis (gMG) who are anti- acetylcholine receptor (AChR) antibody positive and in Japan for the treatment of adults with gMG who do not have sufficient response to steroids or non-steroidal immunosuppressive therapies (ISTs). About VYVGART® HytruloVYVGART Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as VYVGART®, and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), VYVGART Hytrulo results in the reduction of circulating IgG. It is the first-and-only approved FcRn blocker administered by subcutaneous injection. VYVGART Hytrulo is the proprietary name in the U.S. for subcutaneous efgartigimod alfa and recombinant human hyaluronidase PH20. It may be marketed under different proprietary names following approval in other regions. About Generalized Myasthenia Gravis (gMG)Generalized myasthenia gravis (gMG) is a rare and chronic autoimmune disease where IgG autoantibodies disrupt communication between nerves and muscles, causing debilitating and potentially life-threatening muscle weakness. Approximately 85% of people with MG progress to gMG within 24 months,1 where muscles throughout the body may be affected. Patients with confirmed AChR antibodies account for approximately 85% of the total gMG population. About Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare and serious autoimmune disease of the peripheral nervous system. Although confirmation of disease pathophysiology is still emerging, there is increasing evidence that IgG antibodies play a key role in the damage to the peripheral nerves. People with CIDP experience fatigue, muscle weakness and a loss of feeling in their arms and legs that can get worse over time or may come and go. These symptoms can significantly impair a person's ability to function in their daily lives. Without treatment, one-third of people living with CIDP will need a wheelchair. About EmpasiprubartEmpasiprubart (ARGX-117) is a first-in-class humanized monoclonal antibody that binds C2 and blocks activation of both the classical and lectin pathways of the complement cascade, leaving the alternative pathway intact for its antimicrobial properties. By blocking complement activity upstream of C3 and C5, empasiprubart has the potential to reduce tissue inflammation and cellular damage, representing a broad pipeline opportunity across multiple severe autoimmune indications. In addition to multifocal motor neuropathy, argenx is evaluating empasiprubart in delayed graft function following kidney transplant, dermatomyositis and chronic inflammatory demyelinating polyneuropathy. About Multifocal Motor NeuropathyMultifocal motor neuropathy (MMN) is a rare, severe, chronic autoimmune disease of the peripheral nervous system. The disease is characterized by slowly progressive, asymmetric muscle weakness mainly of the hands, forearms and lower legs. MMN is often associated with the presence of anti-GM1 IgM autoantibodies, leading to activation of the classical complement pathway, driving subsequent axon damage. High-dose IVIg is the only approved treatment for MMN and patients typically experience disease progression despite therapy, indicating an unmet need for efficacious and better tolerated therapeutic options. About ARGX-119ARGX-119 is a humanized agonistic monoclonal antibody (mAb) that targets and activates muscle-specific kinase (MuSK) to promote maturation and stabilization of the neuromuscular junction (NMJ). MuSK is a receptor kinase that has a critical role in the structure and function of the NMJ. ARGX-119 is being developed as a potential therapy for patients with neuromuscular disease. About Congenital Myasthenic Syndromes (CMS) Congenital Myasthenic Syndromes (CMS) are a heterogenous group of rare genetic disorders of the neuromuscular junction (NMJ) that lead to muscle weakness. CMS cases are classified into subtypes depending on the underlying genetic mutation. While clinical features vary widely across and within subtypes, the predominant manifestation of CMS is fatigable weakness. Age of onset varies widely; while many patients are diagnosed in infancy or early childhood, patients with milder phenotypes may not present or be diagnosed until adulthood. About Amyotrophic Lateral Sclerosis (ALS) ALS is a neurodegenerative disorder of the brain and spinal cord leading to deteriorating muscle function, weakness and atrophy. The multisystemic nature can have impacts throughout the body with specific signs and symptoms associated with lower motor neuron and upper motor neuron loss. Life expectancy is typically 2.5-5 years from diagnosis. About argenxargenx is a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker in the U.S., Japan, Israel, the EU, the UK, Canada and China. The Company is evaluating efgartigimod in multiple serious autoimmune diseases and advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit www.argenx.com and follow us on LinkedIn, X/Twitter, Instagram, Facebook, and YouTube. ContactsMedia:Ben Petokbpetok@argenx.com Investors:Alexandra Roy (US)aroy@argenx.com Lynn Elton (EU)lelton@argenx.com Forward-Looking Statements The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “aim,” and “will,” and include statements argenx makes regarding the anticipated timing of the initiation of the Phase 3 clinical trial for empasiprubart in MMN and its goal of translating immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including the results of argenx's clinical trials; expectations regarding the inherent uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development activities and regulatory approval requirements in products and product candidates; the acceptance of argenx's products and product candidates by patients as safe, effective and cost-effective; the impact of governmental laws and regulations on our business; disruptions caused on our reliance of third-party suppliers, service providers and manufacturers; inflation and deflation and the corresponding fluctuations in interest rates; and regional instability and conflicts. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law. ###

临床结果临床2期临床3期临床1期

2024-07-19

·凯莱英药闻

和铂医药“稳步增长”--2024H1正面盈利，抗FcRn单抗巴托利单抗国内上市申请获受理！

欢迎关注凯莱英药闻今日，和铂医药发布截至2024年6月30日止（报告期）上半年正面盈利预告。未经审核综合管理帐目的初步审阅，预期上半年盈利约100至150万美元；与2023年上半年相比，报告期内的服务类业务收入在总收入中占比增加。此外，根据国家药品监督管理局药品审评中心（CDE）公示，公司重新递交的巴托利单抗注射液上市申请获受理，用于治疗全身性重症肌无力（gMG）成人患者。巴托利单抗是一款靶向FcRn的全人源单克隆抗体，最早曾于2023年6月向CDE提交过上市申请，但未获得批准。目前，公司已顺利完成三期临床试验的扩展研究，在未招募新患者的情况下收集了更多长期安全性数据。关于巴托利单抗巴托利单抗（HBM9161，batoclimab）可阻断FcRn-IgG相互结合，加速体内IgG的清除，从而达到有效治疗致病性IgG介导的自身免疫性疾病的效果。早期研究表明，巴托利单抗具有良好耐受性，可迅速降低多种自身免疫疾病患者体内IgG水平。该药物于2021年初获得中国国家药品监督管理局授予的“突破性治疗认证”，并于同年8月完成针对中国全身型重症肌无力患者的概念验证研究。 2017年9月，和铂与HanAll签署战略合作协议，获得了巴托利单抗在大中华地区，包括中国大陆、香港、澳门和台湾开发的授权。 2022年10月，和铂医药与石药集团全资子公司恩必普药业达成协议，在大中华区共同开发巴托利单抗。恩必普药业获得在大中华区（包括中国大陆、香港、澳门及台湾）开发、生产与商业化巴托利单抗的独家授权；和铂医药负责巴托利单抗在中国针对全身型重症肌无力的全完整临床实验的设计与执行, 并根据产品年度净销售额获得分层销售提成。 2024年3月，公司在国际顶级医学期刊JAMA Neurology刊登了巴托利单抗的一项III期临床研究结果。这项由中国27家研究中心共同参与开展的随机、双盲、安慰剂对照平行研究，共纳入132例全身型重症肌无力成人患者，其中131例AChR/MuSK抗体阳性患者。患者随机分配至巴托利单抗治疗组和安慰剂组，进行以6周为一个周期的皮下注射治疗，以患者重症肌无力日常生活量表（MG-ADL）得分较基线的变化情况，评估巴托利单抗治疗对疾病症状的持续改善效果。结果显示：在治疗开始的第二周，巴托利单抗治疗组患者MG-ADL评分改善率曲线就与对照组产生了明显的分离，说明药物能够快速起效，发挥症状改善效果。在第43天，结束了第一个治疗周期后，巴托利单抗治疗组的ADL评分持续改善率（ADL评分较基线改善3分且连续持续4周的比例）达58.2%（39/67），显著高于对照组（31.1%，20/64）。在第一个治疗周期中，巴托利单抗治疗组患者达到最轻微症状表现（MSE，定义为ADL评分为0或1）的比例为25.4%（17/67），远高于对照组4.7%（3/64）。在MG定量评分（QMGs）、MG复合评分（MGC）、15项重症肌无力生活质量评分（MG-QOL15r）分析中，巴托利单抗治疗组与对照组也呈现了相似的趋势。在安全性上，与对照组治疗后出现的不良事件（TEAEs）发生率相近，总体耐受性和安全性数据良好。关于FcRn药物 FcRn 又称Brambell受体，是一种由Fcgrt 基因编码的非典型的Fcγ 受体（FcγRs）。FcγRs 对IgG 的识别代表了一种重要的免疫调节方式，即能够不IgG 上保守的Fc 结构域相结合，再以IgG免疫复合物（IgG IC）的形式递送独特的抗原决定簇。这些抗原决定簇被装载到I 类和II 类MHC 分子上，随后刺激相关CD8+和CD4+ T 细胞。IgG主要由脾脏以及淋巴结中的浆细胞合成和分泌，常以单体形式存在，是血清中最主要的抗体成分。在大多数体液免疫过程中，无论是针对病毒还是细胞病原体的保护作用也都涉及IgG 所介导的效应子功能。IgG能够清除侵入人体的外源异物，FcRn则在人体内用于维持IgG水平，增长IgG抗体半衰期，减缓IgG在溶酶体中的降解速度。研究表明，FcRn 广泛表达于各个组织的细胞中，其中包括与血管壁对齐的内皮细胞，肠上皮细胞、气道上皮细胞、胎盘合胞体滋养细胞、肝细胞、内皮细胞、髓样细胞以及支气管导管细胞等；此外，在造血细胞如B 细胞、巨噬细胞以及树突状细胞中也収现了高水平表达的FcRn，理论上可导致七八十种自身免疫性疾病。由FcRn 介导的抗原递呈过程不能影响各个部位的稳态免疫激活，是内源抗肿瘤活性及肿瘤免疫监视系统中的重要组成部分，该过程已被广泛认可的CD8+ T 细胞能够抗肿瘤方面的重要性相一致，因此FcRn 介导的交叉递呈也能够启动肿瘤保护的机制。据不完全统计，目前在研的FcRn药物约十余种，具体信息总结如下：关于重症肌无力重症肌无力（MG）是一种神经肌肉疾病，由针对突触后膜上乙酰胆碱受体、肌肉特异性激酶或其他乙酰胆碱受体相关蛋白的自身抗体引起。患者常有眼肌表现，约85%的患者会出现眼肌以外的症状，发展为全身型重症肌无力（gMG），甚至发生肌无力危象。作为一种罕见的、慢性自身免疫性疾病，MG由神经-肌肉接头传递功能障碍引起，病程长、难治愈、易复发，2018 年已被纳入我国《第一批罕见病目录》。据文献统计，全球重症肌无力的年发病率并不高，数值仅为0.3/10 万—2.8/10万，但由于重症肌无力是一种慢性病，真实患者群体规模需累加计算，实际上，全球重症肌无力实际患病率大约为10/10 万，基于这一数字保守测算，全球重症肌无力患者至少超70 万人。国内发病率虽然看似较低，只有0.68/10 万，女性发病率略高，但实际总患者规模大约有20 万。住院死亡率为14.69‰，主要死亡原因包括呼吸衰竭、肺部感染等。各个年龄阶段均可发病，30 岁和50 岁左右呈现发病双峰，中国儿童及青少年MG（JMG）患病高达50％，构成第3 个发病高峰；JMG 以眼肌型为主，很少向全身型转化。最新流行病学调查显示，我国70-74 岁年龄组为高发人群。并且，未来这一数字可能会持续增长。全球及中国重症肌无力治疗药物市场预计持续快速增长，根据弗若斯特沙利文测算，全球MG 治疗药物市场将从2020 年的12.6 亿美元增至2025年的30.48 亿美元，CAGR 达19.3%，中国市场则是从0.46 亿美元增至2.5 亿美元，CAGR 达40.2%。全球及中国重症肌无力药物市场规模逐年增长（百万美元）当前，重症肌无力最常见的治疗方案包括乙酰胆碱酯酶抑制剂、免疫抑制剂、靶向生物制剂、静脉注射免疫球蛋白、血浆置换以及胸腺切除等。 1）乙酰胆碱酯酶抑制剂是治疗重症肌无力的一线药物，最常用的是溴吡斯的明，不过这类药物只能缓解疾病的症状，不会改变疾病进程；且通常需要与其他药物（如免疫抑制剂）联合用于治疗重症MG。 2）免疫抑制药物包括糖皮质激素和其他口服非激素类免疫抑制剂，如硫唑嘌呤、他克莫司、环孢素、甲氨蝶呤、泼尼松及甲泼尼龙等，这类药物副作用巨大，不适合长期服用。 3）靶向生物制剂方面，在efgartigimod之前，被FDA 批准用于治疗MG 的有靶向抑制C5 补体的依库珠单抗（eculizumab），除此之外，还有适应证外用药的靶向B 细胞的利妥昔单抗（rituximab）。不过两者都是针对难治性MG，而且依库珠单抗价格昂贵，容易增加脑膜炎奈瑟菌感染风险，因此适用人群非常有限。 4）其他挽救性治疗手段如胸腺切除术、静脉注射免疫球蛋白、血浆置换等，也存在安全性、可及性等问题。重症肌无力治疗手段与限制关于和铂医药 Part.1 公司简介和铂医药是一家专注于肿瘤及免疫性疾病领域创新药研发及商业化的全球化生物制药企业。公司拥有是全人源抗体药物产生平台Harbour Mice® ，可以产生全人源的、亲和力成熟的、具有优良成药性的单克隆抗体以及新型抗体，包括双重、双轻链（H2L2）和仅重链（HCAb）形式的全人源单克隆抗体。作为技术平台型公司，其已在全球拥有50多个合作伙伴，建立了多达200+合作项目，10多条处于临床阶段。通过自研+多元化合作，和铂医药快速拓展其新药研发管线，目前已经建立了强大的研发管线，覆盖单抗、双抗、ADC等多种抗体药物形式。从免疫通路的角度，覆盖了直接杀伤型、T细胞募集型、T/NK细胞激活型、NK细胞募集型、解除肿瘤微环境免疫抑制性等等。 Part.2 财务情况截止2023年12月31日，公司2023全年总收入达8950万美元，同比增长119.9%；总盈利2276万美元，是公司首次实现年度财务盈利。公司的收入构成主要包括产品授权、研究服务和技术授权，其增长主要得益于与辉瑞、Cullinan Oncology和科伦博泰的授权合作。其中，研发总投入4508万美元，同比下降66.6%；管理费用共计1950万美元，同比下降28.6%。 Part.3 交易合作据不完全统计，公司近年来与包括阿斯利康、辉瑞、Boostimmune、Ingenia、Cullinan、Mythic、Dragonfly、亿一生物在内的公司，达成多项合作授权。参考资料 1、公司官网 2、德邦证券、东亚前海证券、中信建投、西南证券 3、公众号：征战重症肌无力、罕见病新进展感谢关注、转发，转载授权、加行业交流群，请加管理员微信号“hxsjjf1618”。 “在看”点一下

临床3期突破性疗法申请上市ASH会议

100 项与溴吡斯的明相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00487	溴吡斯的明	N07AA02	DBSALT000190

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
中毒	美国	Amneal Pharma Germany GmbH	2024-10-04
神经中毒综合征	美国	U.S. Army War College	2003-02-05
Lambert-Eaton肌无力综合征	中国	上海中西三维药业有限公司	1995-01-01
重症肌无力	美国	Bausch Health US LLC	1955-04-06

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


DDW2024	N/A	波斯湾综合症	-	Pyridostigmine Bromide	願襯築範糧鏇鹹鹹繭顧(窪網廠夢廠夢夢衊餘窪) = 鏇願鹽鏇製廠構壓膚製鹹糧憲衊網襯遞鹽遞築 (構糧鏇觸選壓膚繭繭觸, 1.18) 更多	-	2024-05-19
NCT02941328 \| EUCTR2011-004369-34-NL (Pubmed)	临床2期	脊髓性肌萎缩	35	Pyridostigmine	鏇餘糧鑰壓獵鏇鬱艱製(壓觸構構願鏇淵構淵鏇) = 簾憲繭顧範鬱築齋範製築鬱衊艱淵積窪醖鹽衊 (繭餘遞觸壓艱鬱膚繭壓, 0.00 ~ 1.49) 更多	-	2023-01-01
NCT04343963 (Pubmed) 人工标引	临床2/3期	新型冠状病毒感染	188	SOC+Pyridostigmine Bromide	夢積範築繭願簾鏇鑰鑰(膚顧齋蓋夢窪獵選壓鏇) = 遞糧鑰窪齋衊艱膚鑰糧夢製鹽繭淵築製壓鏇獵 (鹹蓋觸鏇鑰齋膚範醖積 ) 更多	积极	2022-11-08
				SOC+Placebo	夢積範築繭願簾鏇鑰鑰(膚顧齋蓋夢窪獵選壓鏇) = 遞獵願壓淵鹹夢艱鹹襯夢製鹽繭淵築製壓鏇獵 (鹹蓋觸鏇鑰齋膚範醖積 ) 更多
NCT03674541 (CTgov)	临床2期	体位性心动过速综合征 \| 慢性疲劳综合征 \| 直立性低血压 ... 更多	45	Pyridostigmine Bromide (Study Drug - Pyridostigmine)	範製糧糧憲壓築遞積築(衊簾醖鹽鹹網鏇築齋鹽) = 襯壓壓壓鬱選觸簾鹽夢鏇鏇膚衊簾網糧艱獵選 (膚淵窪鹽憲淵觸餘淵衊, 壓膚憲鹹鑰壓簾繭積鏇 ~ 窪築鑰積醖選鏇獵製觸) 更多	-	2022-10-04
				Placebo (Placebo)	製窪鬱憲鏇繭鹽遞襯窪(齋繭範鑰餘夢齋糧壓鬱) = 齋艱膚齋醖繭憲蓋餘膚鬱獵鹹製構簾艱範鬱鏇 (鬱鏇鬱鹹築襯觸簾醖艱, 膚窪範襯鏇醖憲積醖積 ~ 襯糧製鹹願膚淵選願鹽) 更多
MDS2022	N/A	直立性低血压	-	Pyridostigmine	膚蓋壓齋夢鹽觸醖積鹽(鹹齋鏇積廠網餘廠糧餘) = 獵餘繭廠糧醖鏇蓋築鹽製願壓築願糧醖齋願廠 (膚膚鏇範膚窪鬱餘鹹簾 )	-	2022-09-15
				Midodrine	膚蓋壓齋夢鹽觸醖積鹽(鹹齋鏇積廠網餘廠糧餘) = 蓋醖艱願鏇鬱選壓襯構製願壓築願糧醖齋願廠 (膚膚鏇範膚窪鬱餘鹹簾 )
NCT03674541 (Pubmed \| Chest) 人工标引	N/A	慢性疲劳综合征	45	Pyridostigmine Bromide	願壓齋築鹹壓膚窪蓋壓(鏇壓夢遞範蓋繭鹽襯餘) = 夢餘鏇糧憲鹽網構鹹壓範憲繭齋淵製蓋鏇衊築 (壓齋醖觸壓鹹簾鑰襯範, 13.4)	积极	2022-05-05
				Placebo	願壓齋築鹹壓膚窪蓋壓(鏇壓夢遞範蓋繭鹽襯餘) = 築築製積夢鹹鹹廠範襯範憲繭齋淵製蓋鏇衊築 (壓齋醖觸壓鹹簾鑰襯範, 21.3)
NCT02850276 (ANGI, CTgov)	早期临床1期	炎症 \| HIV感染 \| 糖尿病性神经病变	76	Pyridostigmine	鏇壓蓋築淵齋夢艱鹹夢(選齋廠範鹽餘選衊淵鏇) = 鏇鹹艱窪遞膚鹹蓋壓艱構遞鏇憲膚廠網餘夢鬱 (窪糧廠廠選築願醖鑰壓, 構壓願網遞餘窪鏇製製 ~ 簾製齋膚積廠壓觸淵鑰) 更多	-	2019-05-29
ESC2017	N/A	心脏衰竭	-	Pyridostigmine	淵觸壓餘獵廠獵憲壓齋(鬱餘獵鏇網淵憲鬱願選) = 蓋醖夢襯簾襯窪憲廠醖廠網衊製襯夢鹽顧壓鏇 (夢範衊繭鹽壓製壓蓋餘 ) 更多	-	2017-08-27
				Ivabradine	淵觸壓餘獵廠獵憲壓齋(鬱餘獵鏇網淵憲鬱願選) = 獵鏇餘製襯網願醖鹽獵廠網衊製襯夢鹽顧壓鏇 (夢範衊繭鹽壓製壓蓋餘 ) 更多
NCT02308124 (CTgov)	临床4期	神经源性直立性低血压	87	pyridostigmine+Midodrine	糧廠製鏇餘糧築醖齋選(鏇遞膚鏇壓壓襯網獵網) = 蓋醖網窪鬱願鹽齋鬱鹽鏇鹽鏇網蓋遞繭遞廠觸 (鹹構範壓壓齋顧襯構蓋, 構憲餘構鏇壓積顧鑰顧 ~ 簾廠衊夢簾壓衊蓋襯積) 更多	-	2017-04-17
NCT01415921 (APP-HF, CTgov)	临床2期	心脏衰竭	33	Pyridostigmine Bromide (Pyridostigmine Bromide)	窪窪遞願窪遞鬱艱簾淵(網遞鑰齋壓襯壓餘膚糧) = 襯顧壓範夢蓋艱鑰鏇觸築夢簾糧積鹹鑰壓顧夢 (衊選艱膚廠築鬱鑰製鹹, 膚淵網選遞廠築鑰衊憲 ~ 衊範築製顧選鑰餘鑰繭) 更多	-	2016-10-25
				Pyridostigmine Bromide (Placebo)	窪窪遞願窪遞鬱艱簾淵(網遞鑰齋壓襯壓餘膚糧) = 衊齋簾鹽憲積獵範艱醖築夢簾糧積鹹鑰壓顧夢 (衊選艱膚廠築鬱鑰製鹹, 範網淵顧構顧淵廠淵齋 ~ 選糧廠壓鹹願鹽襯範鹽) 更多