Effects of concentrated Edaravone and Dexborneol Concentrated Solution for Injection on inflammatory factors in patients with amyotrophic lateral sclerosis

开始日期2025-03-20

申办/合作机构

宜昌市中心人民医院

[+1]

NCT06757504

/ Recruiting临床2期

A Multi-Center, Randomized, Double-Blind, Parallel Group, Placebo-controlled Phase II Trial of TTYP01 Tablets in Adolescents and Children With Autism Spectrum Disorders

This is a multi-center, randomized, double-blind, multiple dose levels, parallal group, placebo-controlled study, to evaluate the safety, PK profiles and preliminary efficacy of TTYP01 tablets in adolescents and children with ASD.

开始日期2025-01-13

申办/合作机构

上海澳宗生物科技有限公司

100 项与依达拉奉相关的临床结果

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100 项与依达拉奉相关的转化医学

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100 项与依达拉奉相关的专利（医药）

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3,858

项与依达拉奉相关的文献（医药）

2026-09-01·CURRENT MEDICINAL CHEMISTRY

Molecular and Biochemical Evidence of Edaravone's Impact on Dasatinib-induced AGS Cell Senescence: A Promising Strategy for Gastric Cancer Therapy

Article

作者: Haghi-Aminjan, Hamed ; Baeeri, Maryam ; Abdollahi, Mohammad ; Manavi, Mohammad Amin ; Khalid, Madiha ; Foroumadi, Roham ; Rahimifard, Mahban

Introduction::

Internal or external stress can induce cellular senescence, which reduces cell division. These metabolically active cells contribute to medication resistance. We examined the potential for edaravone (Eda) to cause apoptosis in dasatinib (Das)-induced senescent gastric adenocarcinoma cells (AGS). Our goal was to develop a new stomach cancer treatment.

Method::

All Eda doses evaluated were nontoxic to cells. Das decreased AGS cell survival in a dose-dependent manner. The study found that Das (5-10 μM) and Eda (100 μM) caused cell senescence in AGS cells. This was shown by increased β-galactosidase enzyme activity and reactive oxygen species levels and decreased telomerase enzyme activity. These are the biggest signs of aging.

Results::

This combination therapy also upregulated the expression of cell-senescence genes p53, p16, p21, and p38. This resulted in increased expression of inflammation genes such as TNF-α, IL-1β, and IL-6.

Conclusion::

The scratch assay showed that this combination medication down-regulated the cell migration-regulating MMP2 gene. Both Das and Eda decreased AGS cell proliferation, suggesting treatment with Eda may prevent metastasis.

2026-02-01·Central nervous system agents in medicinal chemistry

Dimethyl Fumarate Attenuates Behavioral and Structural Impairments Associated with Brain Ischemia in Rats

Article

作者: Namavar, Mohammad Reza ; Bakhtiari, Mohammad ; Emamghoreishi, Masoumeh ; Ardakani, Maryam Khastkhodaei

Introduction::

Ischemic stroke remains one of the leading causes of death and physical and mental disability. Oxidative stress, free radicals, and inflammation play critical roles in ischemic brain damage. Free radical scavengers such as edaravone and dimethyl fumarate (DMF), known for their antioxidant and anti-inflammatory properties, are considered promising targets for ischemic stroke treatment. This study aimed to assess the impact of these drugs on brain ischemia

Methods::

Forty-nine rats were randomly divided into seven groups: sham, edaravone, and DMF controls, as well as edaravone, DMF 5, 15, and 30 groups. Middle cerebral artery occlusion (MCAO) was induced in all groups except the sham group. The MCAO groups were administered with either the vehicle, edaravone (3 mg/kg), or DMF at doses of 5, 15, and 30 mg/kg twice daily for 14 days. Neurobehavioral assessments were conducted throughout the experiment, and anatomical changes in the brain were evaluated using stereological methods.

Results::

Edaravone and three doses of DMF improved neurobehavioral functions. All treated rats showed a reduction in the ischemic volume and cell loss in the brain regions when compared with the control animals. MCAO reduced the total number of neurons and just DMF doses had a significant effect on this factor. Interestingly, MCAO increased the number of non-neurons and only the DMF 30 group significantly decreased this parameter. DMF 30 was more effective in ischemic stroke.

Conclusions::

Although edaravone improved neurological functions and reduced the size of brain ischemia and cell loss, DMF, especially at higher doses, exerted a more beneficial effect on these parameters. Therefore, DMF could be proposed as a reinforcement to currently conventional therapies.

2026-01-01·JOURNAL OF ETHNOPHARMACOLOGY

Exploring the neuroprotective mechanism of the Mongolian medicine ZSP against acute ischemic stroke from TRPV1/NMDAR-mediated excitotoxicity

Article

作者: Cai, Ming-Yang ; Li, Xiaoxuan ; Wang, Rui-Kun ; Hu, Hanqiong ; Hurile, Bagen ; Yang, Zhen ; Li, Jing ; Wu, Jisiguleng ; Tong, Hai-Ying ; Yu, Xue ; Che, Limuge ; Liu, Zhen-Hong ; Wulan, Qiqige

ETHNOPHARMACOLOGICAL RELEVANCE:

Zhachong Thirteen Flavored Pill, a classical preparation of Mongolian medicine, is a commonly used formula in Mongolian medicine for the treatment of ischemic stroke, and it has good clinical efficacy in both the acute and postictal phases of AIS. However, the mechanism of its treatment of AIS is still unclear.

AIM OF THE STUDY:

This study aims to elucidate the molecular mechanism by which Zhachong Thirteen Flavored Pill alleviates cerebral ischemia-reperfusion (MCAO/R) injury through targeted regulation of TRPV1 channels and their downstream signaling pathways, and to validate its neuroprotective effects.

METHODS:

At the cellular level, whole-cell patch-clamp was used to demonstrate the effect of Zhachong Thirteen Flavored Pill on the electrophysiology of TRPV1; the potential targets of Zhachong Thirteen Flavored Pill for the treatment of AIS were found through the use of network pharmacology, as well as the correlation between the core targets and TRPV1; MCAO/R model rats were replicated using the wire bolus method and divided into the sham-operation group, the model group, the edaravone group, as well as the equivalent dose and high dose of Zhachong Thirteen Flavored Pill groups. The effects of this formula on the volume of cerebral infarction in the MCAO/R model rats were evaluated by the mNSS scores, the grip traction test, and the TTC staining.

RESULTS:

Zhachong Thirteen Flavored Pill can target TRPV1, activate TRPV1 on TRPV1-HEK293 cells, and generate transmembrane currents; the core target is closely related to TRPV1; the binding energies of TRPV1 and NMDAR with CMGS, GCC, and LKL of AIS are all less than -7 kJ/mol; it can also lead to a increase in body weight of the MCAO/R model rat compared with that of the pre-modeling period, with no neurological deficits and normal muscle strength of the upper limbs. It reduced the infarct volume of rat brain tissue, upregulated the expression of NF-200 and NeuN, and downregulated the protein expression of Bax/Bcl-2, cytochrome C, and Cleaved-Caspase-3. The mRNA expression and protein expression of TRPV1, NMDAR1, NMDAR2B, pNMDAR2B, nNOS, CaMKII, and pCaMKⅡ were all downregulated compared with the model group.

CONCLUSION:

By inhibiting TRPV1, regulating NMDAR/PSD-95/nNOS, down-regulating the expression of nNOS, Zhachong Thirteen Flavored Pill can attenuate neuronal apoptosis caused by excitotoxicity to alleviate neuronal damage, reduce the volume of cerebral infarction, improve neurological deficits and physical dysfunction, and exert neuroprotective effects.

507

项与依达拉奉相关的新闻（医药）

2025-10-02

·PRNewswire

Mitsubishi Tanabe Pharma America to Present Eight ALS Research Posters at 2025 NEALS Annual Meeting

Research to feature RADICAVA ORS® (edaravone), biomarker findings, real-world safety data and digital health innovation JERSEY CITY, N.J., Oct. 2, 2025 /PRNewswire/ -- Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that eight poster presentations highlighting new research in amyotrophic lateral sclerosis (ALS) will be shared at the Northeast Amyotrophic Lateral Sclerosis Consortium (NEALS) 2025 Annual Meeting, taking place Oct. 7-10 in Clearwater, Florida and online. "We look forward to presenting a wide range of new ALS research at this year's NEALS meeting, from real-world data on RADICAVA ORS to advances in digital health and insights into the diagnostic journey," said Gustavo A. Suarez Zambrano, M.D., Vice President of Medical Affairs, MTPA. "These studies reflect our commitment to addressing unmet needs in ALS care and to developing innovative solutions aimed at improving outcomes for people living with ALS." RADICAVA ORS Data: New data will be presented on the safety and a potential biomarker for RADICAVA ORS, as well as long-term outcomes from real-world registry studies. A three-year pharmacovigilance analysis of more than 12,000 U.S. patients with ALS reported no new safety concerns. In addition, an exploratory post hoc analysis of neutrophil-to-lymphocyte ratio (NLR) examined treatment response by baseline NLR, with findings suggesting potential utility of NLR as a prognostic biomarker. An encore analysis from the SUNRISE Japan study compared with the Japanese Consortium for ALS Research (JaCALS) registry will provide additional insights into the long-term outcomes in real-world ALS patients treated with edaravone. Neutrophil-to-Lymphocyte Ratio as a Novel Biomarker for Edaravone Oral Suspension–Treated Patients With Amyotrophic Lateral Sclerosis vs Propensity Score–Matched PRO-ACT Historical Placebo Controls (Manabu Hirai, M.S.; MTPC) Poster Session 1: 4:30 p.m. – 6:30 p.m. EDT, October 8 Safety Data Summarizing 3 Years of Radicava ORS® (Edaravone) Using Postmarketing Pharmacovigilance From United States–based Patients With Amyotrophic Lateral Sclerosis (Stephen Apple, M.D.; MTPA) Poster Session 2: 4:20 p.m. – 6:20 p.m. EDT, October 9 Evaluation of Long-Term Prognosis of Edaravone in ALS Patients: A Real-World Comparative Study Using SUNRISE Japan and JaCALS Registry Data (Manabu Hirai, M.S.; MTPC) Poster Session 2: 4:20 p.m. – 6:20 p.m. EDT, October 9 Digital Health Insights: Three posters will highlight the potential role of smartphone-based, at-home telespirometry in ALS management. A prospective six-month study evaluated edaravone-treated patients and reported differences in ALS Functional Rating Scale-Revised (ALSFRS-R) decline based on non-invasive ventilation (NIV) status. Further analyses emphasized the importance of accounting for NIV use in clinical studies. A separate outcomes study also assessed the feasibility, ease of use and perceived benefits of at-home telespirometry, with participants reporting increased involvement in care and greater awareness of symptoms. At-Home Telespirometry Identifies Significantly Slower Decline of ALS Functional Rating Scale-Revised Total Score but not Erect/Supine Slow Vital Capacity in Edaravone-Treated ALS Subjects Not Requiring Non-Invasive Ventilation [NCT05106569] (Eufrosina I. Young, M.D.; SUNY Upstate Medical University) Poster Session 1: 4:30 p.m. – 6:30 p.m. EDT, October 8 Smartphone Application–Mediated, Supervised, At-Home Telespirometry Identifies Statistically Significant Differences in Erect and Supine Slow Vital Capacity and ALSFRS-R Decline as a Function of Non-invasive Ventilation Treatment Status in Multicenter, Prospective, Longitudinal, Observational Clinical Study [NCT05106569] (Eufrosina I. Young, M.D.; SUNY Upstate Medical University) Poster Session 1: 4:30 p.m. – 6:30 p.m. EDT, October 8 Smartphone Application–Mediated, Respiratory Therapist–Supervised, At-Home Telespirometry Erect/Supine Slow Vital Capacity Measurements in Subjects With ALS: Patient-Reported 5-Item Likert Scale Feasibility and Participation End-of-Study Outcomes Questionnaire Confirms Ease of Implementation and Identifies Per-Subject Benefits (Eufrosina I. Young, M.D.; SUNY Upstate Medical University) Poster Session 1: 4:30 p.m. – 6:30 p.m. EDT, October 8 Diagnostic Journey and Disease Burden: Posters will share real-world data from the Adelphi ALS Disease Specific Programme highlighting some of the challenges faced by patients and caregivers: median time for first consultation to ALS diagnosis was approximately five months, and one in four patients was initially misdiagnosed, contributing to delays in care. Additional findings showed a substantial financial burden and that more than 90% of patients relied on caregiver support, most often from partners or spouses. Characteristics and Disease Burden of People With Amyotrophic Lateral Sclerosis in a United States-Based Population: Analysis of Real-World Data (Malgorzata Ciepielewska, M.S.; MTPA) Poster Session 1: 4:30 p.m. – 6:30 p.m. EDT, October 8 Diagnostic Journey in a United States-Based Population of People With Amyotrophic Lateral Sclerosis: Analysis of Real-World Data (Malgorzata Ciepielewska, M.S.; MTPA) Poster Session 2: 4:20 p.m. – 6:20 p.m. EDT, October 9 About RADICAVA ORS® (edaravone) The U.S. Food and Drug Administration (FDA) approved RADICAVA ORS® (edaravone) on May 12, 2022, for the treatment of amyotrophic lateral sclerosis (ALS). In 2024, the FDA granted RADICAVA ORS Orphan Drug Exclusivity based on its major contribution to patient care by providing an oral suspension route of administration that avoids the burdens of IV administration. RADICAVA ORS is taken daily for 14 consecutive days followed by a 14-day drug-free period for the initial treatment cycle. For subsequent treatment cycles, RADICAVA ORS is taken for 10 days within a 14-day period followed by a 14-day drug-free period. Each 105 mg (5mL) dose of RADICAVA ORS should be taken in the morning after overnight fasting. Patients should not eat or drink (except water) within one hour after taking RADICAVA ORS.1 Edaravone was discovered and developed for ALS by Mitsubishi Tanabe Pharma Corporation (MTPC) and commercialized in the U.S. by Mitsubishi Tanabe Pharma America, Inc. (MTPA). The MTPC group companies began researching ALS in 2001 through an iterative clinical platform over a 13-year period. In 2015, edaravone was approved as RADICUT® for the treatment of ALS in Japan and South Korea. Marketing authorizations were subsequently granted in Canada (October 2018), Switzerland (January 2019), Indonesia (July 2020), Thailand (April 2021), Malaysia (December 2021), Australia (February 2023) and Brazil (February 2024). Marketing authorization for RADICAVA® Oral Suspension was granted in Canada (November 2022) and Switzerland (May 2023), and RADICUT® Oral Suspension 2.1% was granted regulatory approval in Japan in December 2022. To date, in the U.S., RADICAVA ORS, along with the previously available IV RADICAVA® (edaravone), have been used to treat over 19,000 people with ALS, with over 2.5-million days of therapy, and have been prescribed by over 2,600 HCPs.2-4 INDICATION RADICAVA ORS® (edaravone) is indicated for the treatment of amyotrophic lateral sclerosis (ALS). IMPORTANT SAFETY INFORMATION Hypersensitivity Reactions RADICAVA ORS® (edaravone) is contraindicated in patients with a history of hypersensitivity to edaravone or any of the inactive ingredients of this product. Hypersensitivity reactions (redness, wheals, and erythema multiforme) and cases of anaphylaxis (urticaria, decreased blood pressure, and dyspnea) have occurred. Patients should be monitored carefully for hypersensitivity reactions. If hypersensitivity reactions occur, discontinue RADICAVA ORS, treat per standard of care, and monitor until the condition resolves. Sulfite Allergic Reactions RADICAVA ORS contain sodium bisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown but occurs more frequently in asthmatic people. Adverse Reactions The most common adverse reactions (≥10%) reported in RADICAVA® (edaravone)-treated patients and at least 2% more frequently than placebo were contusion (15% vs 9%), gait disturbance (13% vs 9%), and headache (10% vs 6%), respectively. In an open label study, fatigue was also observed in 7.6% of patients receiving RADICAVA ORS. Pregnancy Based on animal data, RADICAVA ORS may cause fetal harm. To report suspected adverse reactions or product complaints, contact Mitsubishi Tanabe Pharma America, Inc., at 1-888-292-0058. You may also report suspected adverse reactions to the FDA at 1-800-FDA-1088 or . Please see the full Prescribing Information, also available at . About Mitsubishi Tanabe Pharma America, Inc. Based in Jersey City, N.J., Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly-owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC). It was established by MTPC to develop and advance our pipeline as well as commercialize approved pharmaceutical products in North America. For more information, please visit or follow us on X (formerly Twitter), Facebook and LinkedIn. About Mitsubishi Tanabe Pharma Corporation Mitsubishi Tanabe Pharma Corporation (MTPC) is one of the oldest pharmaceutical companies in the world, founded in 1678. MTPC is headquartered in Doshomachi, Osaka, the birthplace of Japan's pharmaceutical industry. MTPC sets the MISSION of "Creating hope for all facing illness." To that end, MTPC is working on the disease areas of central nervous system, immuno-inflammation, diabetes and kidney, and cancer. MTPC is focusing on "precision medicine" to provide drugs with high treatment satisfaction and additionally working to develop "around the pill solutions" to address specific patient concerns based on therapeutic medicine, including prevention of diseases, pre-symptomatic disease care, prevention of aggravation and prognosis. For more information, go to . Media inquiries: [email protected] 1 RADICAVA and RADICAVA ORS Prescribing Information. Jersey City, NJ: Mitsubishi Tanabe Pharma America, Inc.; 2022 2 Data on file. Mitsubishi Tanabe Pharma America, Inc. 3 Data on file. Mitsubishi Tanabe Pharma America, Inc. 4 Data on file. Mitsubishi Tanabe Pharma America, Inc. SOURCE Mitsubishi Tanabe Pharma America WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

上市批准临床结果孤儿药

2025-09-19

·PRNewswire

DarwinCell Showcases novel MSC-based drug ALT001 at the 150th American Neurological Association Annual Meeting

BALTIMORE, Sept. 19, 2025 /PRNewswire/ -- The 150th American Neurological Association Annual Meeting (ANA 2025) was successfully held in Baltimore, USA, from September 13 to 16, 2025. The conference brought together leading global experts, scholars, and industry leaders in the field of neuroscience to discuss the latest research advances and therapeutic strategies for neurological diseases. DarwinCell delivered an oral presentation in the "Neuromuscular Disease SIG" session and presented a poster showcasing the latest research data on its novel MSC-based drug ALT001 for the treatment of amyotrophic lateral sclerosis (ALS). The company's poster, recognized for its innovation and scientific value, received the "Abstract of Distinction" at this year's Annual Meeting and attracted wide attention on site. Continue Reading Clinically, ALS is characterized by progressively developing skeletal muscle weakness, atrophy, fasciculations, bulbar palsy, and pyramidal tract signs, ultimately leading to death due to respiratory and circulatory system failure. The age of onset is trending younger, with a minority of patients developing symptoms as early as around 20 years old [1]. The incidence of ALS in China is approximately 0.6 per 100,000 people, with a prevalence of about 3.1 per 100,000 and a typical survival period of 3-5 years [2-5]. Currently, the primary treatments available in China are still Riluzole and Edaravone [4], highlighting an urgent need for new therapeutic approaches. ALT001 demonstrates promising clinical benefits. Both in vitro studies and IIT studies on more than 40 ALS patients are conducted. In vitro experiments showed that cells treated with ALT001 restored cell viability after oxidative damage. Progressive loss of anterior horn motoneurons and muscle atrophy due to the lack of neuronal innervation are hallmarks of ALS. We found that ALT001 protected motoneurons against neurotoxicity, and ameliorated muscle atrophy in SOD1G93A mice. In agreement with these results, the mutant mice treated with ALT001 exhibited improved motor functions and extended lifespan in comparison to mice treated with vehicle or Riluzole. We then carried out multiple IITs including a double-blinded study on the safety and the efficacy of ALT001 on ALS patients. After 2-weeks of administration of ALT001, most patients reported positive outcomes, as demonstrated by elevated performance, ALSFRS-R and modified Norris scores. "We are greatly honored to share the latest data on ALT001 at this global academic forefront conference," said Ms. Wang Yu, Founder and CEO of DarwinCell. "These results reinforce our confidence in further developing ALT001 for ALS and other major neurological diseases. ALT001 is designed to combine the functional diversity of cell therapies with the practicality of traditional biologics, aiming to provide patients with more effective, safer, and accessible treatment options. The company remains committed to being clinically-oriented and driven by scientific innovation, continuously deepening our presence in neuroscience and regenerative medicine. Darwin will fully advance the IND application processes for ALT001 in both China and the U.S., hoping to bring new hope to patients worldwide as soon as possible." About DarwinCell DarwinCell founded in 2016, is a national high-tech enterprise focused on innovative treatments for neurological diseases. Leveraging its proprietary protein polymer extraction technology (ECIWEP), the company has built a comprehensive technology platform from drug discovery to clinical translation. Through deep collaborations with numerous leading medical and research institutions, DualityBio is dedicated to becoming an internationally leading innovator in neural repair technology. For more information, please visit . Reference [1]Chinese Society of Neurology, Amyotrophic Lateral Sclerosis Collaboration Group. (2022). Chinese Expert Consensus on the Diagnosis and Treatment of Amyotrophic Lateral Sclerosis (2022). Chinese Journal of Neurology, 55(6), 8. [2]Feldman EL, Goutman SA, Petri S, et al. Amyotrophic lateral sclerosis. *Lancet*. 2022;400(10360): 1363-1380. [3]van Es MA,Hardiman O,Chio A,et al. Amyotrophic lateral sclerosis[J].Lancet,2017,390 (10107):2084-2098. [4]NORRIS S P, LIKANJE M N, ANDREWS J A. Amyotrophic lateral sclerosis: update onclinicalmanageme nt[J]. Curr Opin Neurol. 2020; 33(5):641- 648. [5]Talbott EO, Malek AM, Lacomis D. The epidemiology of amyotrophic lateral sclerosis. *Handb Clin Neurol*. 2016;138: 225-238. SOURCE Darwincell Biotech WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床研究临床结果细胞疗法

2025-09-18

·医药经济报

石药60亿大品种守擂！复星突围未果，先声双线夹击

石药集团开发的重磅国产脑卒中原研化药丁苯酞继续守擂。 9月17日，NMPA发布了最新一批药品通知件送达信息。值得注意的是，锦州奥鸿药业申报的SBK010口服溶液赫然在列，此产品正是备受业界关注的丁苯酞改良新药。此番SBK010口服溶液出现在药品通知件中，意味着其申报上市未果。石药集团的丁苯酞是国内脑卒中治疗领域的超级单品，常年销售额超过60亿元，拥有胶囊剂和注射剂两大剂型。丁苯酞可观的市场规模，早已吸引着丽珠制药、复星医药等诸多国内药企的战略布局，但至今仍未有仿制药和改良新药成功突围。不过随着同类创新药相继获批，丁苯酞在脑卒中治疗领域正在迎来更多对手。石药构筑坚固壁垒复星改良新药破局丁苯酞的研发始于中国医学科学院对芹菜籽活性成分的系统研究。1978年，研究人员首次从水芹籽中分离出左旋丁苯酞，最初探索抗癫痫方向，但因安全性问题搁置。1986年，研究人员将该药转向脑缺血治疗研究，证实其具有保护线粒体功能、可重建脑缺血区微循环。 1999年，石药集团以5000万元高价购入专利，启动Ⅱ/Ⅲ期临床试验（总有效率70.3%）。2005年，丁苯酞软胶囊（恩必普）获批上市，成为继青蒿素、双环醇后我国第三个自主知识产权1类新药，为国际急性缺血性脑卒中治疗领域增加又一治疗选择。2010年，石药集团的丁苯酞氯化钠注射液获批上市，全方位布局脑卒中治疗领域。自2005年软胶囊上市以来，恩必普已成长为年销售额超66亿元的国产重磅药物，届时占石药集团营收近三成，并成功进入美国FDA孤儿药快速审批通道，成为中国医药自主创新的标杆案例。一直以来，丁苯酞软胶囊和注射液仿制药的上市存在两重阻碍，核心障碍在于其尚未列入参比制剂目录，即使好多企业目前都已完成BE试验，也无法进行仿制药上市申报；二是原研专利的保护。为了保障自身拳头产品在市场中行稳致远，石药集团采取了多维防御策略。在2015年和2021年，石药集团分别提交丁苯酞治疗血管性痴呆（缺血性脑卒中后遗症）及化疗所致周围神经病变预防治疗两项新适应症的临床申请，持续拓展产品生命周期。目前，丁苯酞软胶囊的血管性痴呆适应症已进入Ⅲ期临床，而紫杉类所致周围神经病变适应症也正处于Ⅱ期临床阶段。此番向石药集团专利壁垒发起进攻的SBK010口服溶液是由成都施贝康开发的丁苯酞改良新药，其于2024年9月申报上市，后转让给复星医药子公司锦州奥鸿药业。 SBK010口服溶液以2.2类改良新药路径实现战略突破。该创新剂型既规避了参比制剂遴选导致的仿制药申报障碍，又不同于注射剂需开展III期大临床的研发门槛。在石药注射剂型仿制受阻、软胶囊仿制停滞、参比制剂悬而未决的僵局中，SBK010口服溶液通过口服液改良剂型的差异化设计，成功绕开原研企业构建的核心防线，为市场竞争开辟新赛道。复星医药公告表明，针对SBK010口服溶液的累计研发投入约为1321万元，其中包括许可费。从2024年9月27日提交申报到2025年9月16日出现在药品通知件中，意味着SBK010口服溶液的改良新途径也并非坦途。对于复星医药而言，这条开辟性路径现阶段或仍存在诸多悬而未决的技术难题，也留给业界无限想象空间。不过可以肯定的是，石药集团丁苯酞防线稳固如山，成功守住市场壁垒。细分市场硝烟再起群雄并起猛攻原研近年来，国内缺血性脑卒中急性期主要治疗药物年销售额均超过百亿元。米内网数据显示，在中国公立医疗机构终端，2020-2022年丁苯酞的整体销售额均保持在60亿元以上，是国产原研化药的畅销品种。2023年上半年，丁苯酞在神经系统药物销售榜单中位居TOP1。近年丁苯酞的销售情况（单位：万元）来源：米内网中国公立医疗机构药品终端竞争格局在2023年国内缺血性脑卒中急性期主要治疗药物市场中，丁苯酞作为石药集团的核心品种，凭借69.68亿元销售额，拿下54.19%的市场份额。但市场充满变数。今年8月，石药集团发布的2025年中期业绩报告数据显示，上半年实现营业收入132.73亿元，同比下滑18.5%。其中，神经系统药物实现销售收入37.55亿元，同比降低28.3%；拳头产品丁苯酞因医保政策调整，销售额出现一定程度回落。通过同步实施专利组合策略（核心专利保护期延至2032年）、参比制剂策略（未列入国家仿制药目录）及专利诉讼应对三位一体的防御机制，石药集团为丁苯酞构筑起涵盖技术、法规、法律维度的竞争壁垒，但仍有不少药企选择挑战。 2016年，丽珠制药抓住政策窗口期，在无参比制剂和临床数据的情况下率先申报仿制生产，之后丽珠集团利民制药厂于2017年提交了丁苯酞氯化钠注射液的4类仿制上市申请。同年，南京优科制药也提交了丁苯酞注射液的2.2类新药临床申请，成为第一批抢攻的国内企业，尽管最终等来的是“批准临床”结果，但其先锋意义依然重大。随后，四川汇宇制药、河北仁合益康药业等5家国内药企均携丁苯酞注射液的2.2类新药陆续加入战局。截至目前，仍未有其他国内药企提交丁苯酞注射液的上市申请并在审，改良型新药能否实现突围，还有待观察。值得关注的是，丽珠医药与石药集团的对垒甚是激烈。石药集团通过诉讼策略全力维护自身利益，指控丽珠医药侵犯其ZL02123000.5号专利，要求撤回申请并索赔百万元。尽管丽珠医药在北京知识产权法院获得不侵权认定，但最高法2019年6月裁定仿制申报属行政许可行为而非专利实施，此举使石药集团战术失利但战略得以实现。后续广东省高院于2021年驳回丽珠医药再审申请，致其批文作废。随着新注册管理办法实施，丽珠医药丧失仿制机会，石药成功狙击对手，形成完美防守闭环。这场持续五年的拉锯战彰显了专利药企通过法律手段维护市场独占性的有效性。业内观点分析认为，丁苯酞作为国产脑保护剂领军品种，石药集团通过拓展新适应症和剂型创新巩固市场，在遭遇丽珠医药、复星医药等多家企业的仿制冲击下，顺利验证了法律手段在维护原研药市场独占性中的关键作用以及石药集团维护自身产品安全性的不俗实力。值得注意的是，在脑卒中赛道，更多创新药接踵而至。2020年7月，先声药业自主研发的脑血管病领域1类新药先必新（依达拉奉右莰醇注射用浓溶液）获NMPA批准上市，为我国卒中患者治疗带来新选择。先必新作为依达拉奉接棒产品，2020年上市至2023年销售额已达23.45亿元，仅次于丁苯酞。 2024年12月，先声药业的先必新舌下片国内获批上市，有望于今年开始放量，带动先必新注射剂销售良好增长。先声药业预计，先必新注射剂/舌下片的销售峰值分别有望达到30亿~35 亿元/15 亿元左右。脑卒中百万赛道鹿死谁手，犹未可知。编辑：范晓艳版式编辑：余远泽审校：马飞、张松 PTK7靶点再蒙阴影，艾伯维、辉瑞接连退出，礼来、科伦博泰接棒攻坚暂停药品采购资格公告5连发！价格治理升级释放强烈信号 BMS剥离重大资产，诺和诺德、默沙东相继裁员，跨国药企集体转型？ www.yyjjb.com.cn 洞悉行业趋势长按关注医药经济报《中国处方药》学术公众号聚焦药学学术和循证研究长按关注中国处方药《医药经济报》终端公众号记录药品终端产经大事件长按关注21世纪药店

临床3期孤儿药专利到期上市批准申请上市

100 项与依达拉奉相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D01552	依达拉奉	N07XX14	DB12243

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
肌萎缩侧索硬化	日本	Mitsubishi Tanabe Pharma Corp.	2015-06-26
脑梗塞	日本	Mitsubishi Tanabe Pharma Corp.	2015-06-26
急性缺血性卒中	中国	先声药业有限公司	2003-12-31

未上市

10 条进展最快的记录,

后查看更多信息

适应症	最高研发状态	国家/地区	公司	日期
青少年肌萎缩性侧索硬化症2	临床3期	日本	Mitsubishi Tanabe Pharma Corp.	2011-12-01
阿尔茨海默症	临床3期	荷兰	Treeway BV	-
阿尔茨海默病引起的痴呆症	临床2期	中国	上海澳宗生物科技有限公司	2025-09-15
自闭症谱系障碍	临床2期	中国	上海澳宗生物科技有限公司	2025-01-13
雄激素不敏感综合征	临床2期	中国	上海澳宗生物科技有限公司	2023-09-19
自闭症	临床2期	中国	上海澳宗生物科技有限公司	-
肝损伤	临床1期	日本	Mitsubishi Tanabe Pharma Corp.	2016-11-16
慢性肾病	临床1期	日本	Mitsubishi Tanabe Pharma Corp.	2016-10-27
缺血性卒中	临床前	中国	同济大学	2025-08-01
心血管疾病	临床前	中国	北京大学	2025-03-18

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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


NCT05151471 \| NCT04165824 \| NCT04569084 \| NCT04577404 (MT-1186-A04, Pubmed) 人工标引	N/A	肌萎缩侧索硬化	420	Edaravone oral suspension	糧艱範蓋醖構壓觸網淵(構築鹽淵簾衊範願獵獵) = 78 edaravone oral suspension-treated patients from Studies MT-1186-A02/A04 demonstrated a survival benefit versus 78 matched PRO-ACT placebo patients (p = 0.005) 鹽壓鏇製簾糧襯窪淵築 (淵築襯築製製積鹽糧糧 ) 更多	积极	2025-07-01
NCT04569084 (MT-1186-A02, Pubmed \| Muscle Nerve)	临床3期	肌萎缩侧索硬化	180	Edaravone oral suspension (105‐mg dose) administered Once Daily	醖築鏇簾製鑰餘艱遞糧(衊艱製夢蓋遞糧願淵窪): P-Value = 0.777 更多	不佳	2025-06-06
				Edaravone oral suspension (105‐mg dose) administered according to the approved On/Off regimen including placebo
NCT05151471 (MT-1186-A04, CTgov)	临床3期	肌萎缩侧索硬化	202	Edaravone (Edaravone 105 mg (Once Daily))	遞壓觸廠獵襯衊蓋壓鹽(簾蓋構構夢鬱製鹹繭簾) = 鏇壓顧廠願窪網簾網鹹網膚憲範選艱繭觸觸壓 (願製網鏇憲膚願構壓鑰, 築鬱願鏇淵網糧壓顧構 ~ 顧獵憲製襯壓範艱襯夢) 更多	-	2025-03-27
				Edaravone (Edaravone 105 mg (on/Off))	遞壓觸廠獵襯衊蓋壓鹽(簾蓋構構夢鬱製鹹繭簾) = 觸顧網願醖遞鬱願鏇糧網膚憲範選艱繭觸觸壓 (願製網鏇憲膚願構壓鑰, 獵積壓網夢壓鏇觸淵鑰 ~ 願鏇鏇憲壓獵憲鏇築餘) 更多
NCT04569084 (MT-1186-A02, CTgov)	临床3期	肌萎缩侧索硬化	384	Edaravone (Edaravone 105 mg (Once Daily))	網網繭艱觸艱膚獵淵襯(淵簾鬱壓選艱窪齋獵醖) = 獵醖壓範簾觸獵襯選遞窪築蓋鏇鏇構窪鬱齋顧 (鬱餘獵願壓廠鏇襯齋獵, 繭壓網鹽鏇鬱網遞夢壓 ~ 獵築餘獵網範鬱齋鬱蓋) 更多	-	2025-03-27
				Edaravone (Edaravone 105mg (2 Weeks On/Off ))	網網繭艱觸艱膚獵淵襯(淵簾鬱壓選艱窪齋獵醖) = 餘壓壓範壓夢積積鏇膚窪築蓋鏇鏇構窪鬱齋顧 (鬱餘獵願壓廠鏇襯齋獵, 襯繭膚艱齋積壓膚鬱襯 ~ 獵積衊糧製築築獵簾襯) 更多
NCT05178810 (ADOREXT \| ADORE, CTgov)	临床3期	肌萎缩侧索硬化	313	FAB122 (FAB122)	顧窪築壓顧糧構選夢鑰(顧繭網鹽積獵範衊製構) = 製廠觸繭夢遞積築衊簾蓋觸膚製膚鹽餘鏇範淵 (構襯餘願膚構夢衊願網, 7.9) 更多	-	2025-03-18
				Placebo (Placebo)	顧窪築壓顧糧構選夢鑰(顧繭網鹽積獵範衊製構) = 願蓋網願範鏇艱繭鬱鏇蓋觸膚製膚鹽餘鏇範淵 (構襯餘願膚構夢衊願網, 8.4) 更多
NCT05866926 (ADOREXT, CTgov)	临床3期	肌萎缩侧索硬化	201	FAB122 (FAB122)	襯獵積夢網築遞積憲夢 = 範範顧鏇鏇願壓廠願艱膚繭構壓網襯鑰衊構蓋 (遞繭觸鹹廠鏇遞夢齋積, 夢餘夢築顧醖鏇積廠壓 ~ 網願繭糧糧餘願齋淵鏇) 更多	-	2025-03-04
				FAB122 (Placebo)	襯獵積夢網築遞積憲夢 = 鏇艱願夢積襯獵遞淵網膚繭構壓網襯鑰衊構蓋 (遞繭觸鹹廠鏇遞夢齋積, 遞襯齋廠構窪窪蓋鑰艱 ~ 夢鬱鹽鬱遞築獵鹹範淵) 更多
NCT05568615 (CTgov)	临床3期	肌萎缩侧索硬化	15	MT-1186	鑰選鹹鬱鹹衊選醖醖築 = 製鏇襯蓋醖鹹餘廠蓋築鏇窪顧窪顧夢鹹繭選廠 (廠繭衊選鑰膚簾獵襯襯, 遞簾壓鹽鏇範窪顧觸鬱 ~ 鹽選遞鏇鹹鑰餘夢鹹艱) 更多	-	2025-02-03
NCT03346538 (CTgov)	临床2期	急性缺血性卒中	17	Approved dosing regimen placebo+Continuous infusion high-dose MCI-186 (Continuous Infusion High-dose Group (Group H))	鹹襯窪鹹夢膚廠觸齋窪 = 鑰鹹網餘衊糧觸齋鑰艱鬱淵鏇淵鬱顧壓壓襯鏇 (糧觸餘膚艱製網鬱膚顧, 築鑰簾壓壓衊鏇襯餘網 ~ 構範構齋壓糧鹹糧淵構) 更多	-	2025-01-09
				Approved dosing regimen placebo+Continuous infusion low-dose MCI-186 (Continuous Infusion Low-dose Group (Group L))	鹹襯窪鹹夢膚廠觸齋窪 = 醖艱壓廠蓋壓繭窪鏇築鬱淵鏇淵鬱顧壓壓襯鏇 (糧觸餘膚艱製網鬱膚顧, 構顧範構襯鹹鹹網繭獵 ~ 衊鑰憲顧窪鏇構構獵鹹) 更多
NCT04577404 (MT-1186-A03, CTgov)	临床3期	肌萎缩侧索硬化	124	MT-1186	壓憲遞襯鹹餘壓餘夢衊 = 繭鏇餘夢艱獵餘選餘觸艱簾鬱鏇積糧遞選鑰衊 (觸艱蓋築艱鹹廠鹹簾鹹, 憲鬱選顧壓憲壓齋製顧 ~ 鹽艱築積顧艱壓鬱壓齋) 更多	-	2024-08-28
NCT04577404 (MT-1186-A03, Biospace) 人工标引	临床3期	肌萎缩侧索硬化	-	RADICAVA ORS	鑰壓願願鹽窪製夢積窪(鑰願鹹願衊獵繭網簾蓋) = fall, muscular weakness, dyspnea, constipation, and dysphagia. 選顧憲鹹醖醖網鏇遞餘 (衊觸獵製選鬱簾夢繭網 )	积极	2024-06-17