更新于：2024-11-15

Methylprednisolone

甲泼尼龙

更新于：2024-11-15

概要

概要

基本信息

简介甲泼尼龙是一种小分子药物，通过调节NMDA受体和糖皮质激素受体的活性来发挥作用。它可作为NMDA受体调节剂和糖皮质激素受体激动剂。甲泼尼龙被用于治疗多发性硬化症、水肿、过敏反应和炎症等病症。这种药物由Pharmacia & Upjohn公司研制，并于1957年10月24日获得首次批准。甲泼尼龙可通过口服、注射和局部涂抹等方式给药，但需要在医生的指导下进行，以确保其安全性和疗效。由于甲泼尼龙具有免疫抑制和抗炎作用，因此它被广泛应用于许多疾病的治疗，包括关节炎、哮喘、皮肤炎症和类风湿性疾病等。虽然甲泼尼龙的使用会带来一些副作用，但在医生的指导下正确使用它，可以显著改善患者的生活质量。

药物类型

小分子化药

别名

(6α,11β)-11,17,21-trihydroxy-6-methylpregna-1,4-diene-3,20-dione、1-dehydro-6α-methylhydrocortisone、6α-methyl-11β,17α,21-triol-1,4-pregnadiene-3,20-dione

+ [7]

靶点

作用机制

GR激动剂(糖皮质激素受体激动剂)

治疗领域

肿瘤免疫系统疾病神经系统疾病+ [8]

在研适应症

多发性硬化症过敏胶原蛋白疾病+ [13]

非在研适应症

获得性免疫缺陷综合征移植物抗宿主病肺癌+ [4]

原研机构

Pfizer Inc.

在研机构

Oncotherapeutics, Inc.

Pfizer Inc.Pharmacia & Upjohn

+ [2]

非在研机构

Mallinckrodt Plc

2-BBB Medicines BV初创企业

Bristol Myers Squibb Co.

+ [1]

最高研发阶段批准上市

首次获批日期

美国 (1957-10-24),

过敏胶原蛋白疾病水肿+ [9]

最高研发阶段(中国)批准上市

特殊审评-

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结构

分子式C22H30O5

InChIKeyVHRSUDSXCMQTMA-PJHHCJLFSA-N

CAS号83-43-2

关联

779

项与甲泼尼龙相关的临床试验

NCT06522100 / Not yet recruiting临床3期IIT

Use of Glucocorticoids Therapy in Acute Myocarditis With Severe Left Ventricular Dysfunction: a Multicenter Randomized Controlled Trial

Refer to the "Detailed Description" section.

开始日期2025-02-01

申办/合作机构

Assistance Publique des Hôpitaux de Paris SA

NCT06489626 / Not yet recruiting临床4期IIT

The Effect of a Methylprednisolone Taper on Outcomes Following Total Knee Arthroplasty

Pain control and early range of motion following total knee arthroplasty are essential for patient satisfaction. Intraoperative steroids (dexamethasone) have been shown to have a significant effect in controlling acute pain following total knee arthroplasty. This study aims to evaluate the effect of a post-operative steroid (methylprednisolone) taper in improving functional and patient-reported outcomes following total knee arthroplasty. A taper means taking a high dose of a medication followed by taking lower doses and each following day until the medication is stopped.

开始日期2025-01-01

申办/合作机构

University of Pittsburgh

NCT06676579 / Not yet recruiting临床2期IIT

A Multi-Center, Phase II, Open Label, Randomized Trial Evaluating the Efficacy and Safety of Complement 5a Receptor Antagonist Avacopan in Crescentic IgA Nephropathy

The purpose of this study is to evaluate the efficacy and safety of Avacopan together with low-dose glucocorticoid in the treatment of patients with crescentic Imunoglobulin A Nephropathy (IgAN) and high risk of progression.

开始日期2024-12-02

申办/合作机构

Mayo Clinic

100 项与甲泼尼龙相关的临床结果

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100 项与甲泼尼龙相关的转化医学

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100 项与甲泼尼龙相关的专利（医药）

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18,995

项与甲泼尼龙相关的文献（医药）

2025-01-01·World neurosurgery: X

Evaluation of the Chetomin effect on histopathological features in a murine acute spinal cord injury model

Article

作者: Escobar-Valderrama, Manuel ; Reyes-Soto, Gervith ; Arango, David ; Alanis-Mendizabal, Jorge ; Bautista, Claudia J. ; Bautista, Claudia J ; Torres-Villalobos, Gonzalo ; Ramírez, Victoria ; Bravo-Reyna, Carlos César ; Miranda-Galván, Vladimir ; Vicuña, R. ; Vicuña, R

Background:

Several research studies have been focused on improving the treatment and prognosis of acute spinal cord injury, as part of this initiative we investigated the use of Chetomin to reduce the inflammatory response in this pathology.

Methods:

An experimental, prospective, cross-sectional study was performed using 42 Wistar rats where we analyzed the effect of Chetomin compared to methylprednisolone administered 1 and 8 h after the spinal cord injury in a murine model.

Results:

Chetomin administration 8h post-injury decreased IL-6 and VEGF expression; and, and its administration 1h post-injury decreased NF-kB expression.

Conclusions:

Chetomin has anti-inflammatory effects in acute spinal cord injury, whether these effects are observable with other proinflammatory markers should be investigated.

2024-12-31·Journal of pharmaceutical policy and practice

Methylprednisolone use in hospitalised COVID-19 patients: a retrospective study

Article

作者: Azemi, Nur Fatin Najwa ; Loon, Leong Chee ; Saffian, Shamin Mohd ; Khan, Rahela Ambaras ; Islahudin, Farida

Introduction:

Trials have demonstrated the benefits of methylprednisolone in the treatment of coronavirus disease 2019 (COVID-19). However, data on optimal dose, duration and timing of administration are limited. This study investigates the outcome of various methylprednisolone treatment regimens among hospitalised COVID-19 patients.

Methods:

A retrospective cohort study was conducted on hospitalised adult COVID-19 patients admitted between June and August 2021 in general COVID-19 wards, treated with methylprednisolone. Clinical outcomes evaluated include in-hospital mortality, thirty-day mortality, clinical efficacy (C-reactive protein (CRP), total white blood cells (TWBC) and oxygen requirement) as well as the safety of methylprednisolone.

Results:

Of 278 patients, 1(0.4%) received weight-based dosing of 1 mg/kg/day, 101(36.3%) received weight-based dosing of 2 mg/kg/day, 130(46.8%) received fixed dosing methylprednisolone 250 mg/day and 46(16.5%) received fixed dosing methylprednisolone 500 mg/day. There was a significant difference in in-hospital mortality rates following different methylprednisolone doses whereby in-hospital mortality occurred in 22.5% (n = 23) of patients with 1 or 2 mg/kg/day methylprednisolone, 32.3% (n = 42) with 250 mg/day and 39.1% (n = 18) with 500 mg/day (p = 0.023). On the other hand, no significant difference in thirty-day mortality, clinical efficacy and safety was observed between different dosing regimens (p > 0.05).

Conclusion:

The use of methylprednisolone weight-based dosing in hospitalised COVID-19 patients should be considered due to the positive outcome associated with lower in-hospital mortality.

2024-12-31·RENAL FAILURE

Plasmapheresis, immunosuppressive therapy and anti-GBM disease prognosis: a cohort study of 107 patients

Article

作者: Fu, Ping ; Zhao, Yuliang ; Wei, Wei ; Huang, Yongxiu ; Liu, Ying ; Zhang, Ling ; Li, Jian ; Yang, Yingying ; Yang, Letian ; Wang, Bo ; Liu, Caihong ; Wu, Yiting

BACKGROUND:

Anti-glomerular basement membrane (anti-GBM) disease presents with rapidly progressive glomerulonephritis and alveolar hemorrhage, requiring urgent management. In this study, we analyzed the relationship between plasmapheresis strategy, immunosuppressive therapy and the prognosis of anti-GBM disease patients.

METHOD:

We screened newly diagnosed anti-GBM disease patients at West China Hospital of Sichuan University from 2010 to 2021. The primary outcome was a composite endpoint of in-hospital death or dialysis dependency upon discharge.

RESULTS:

This study enrolled 107 anti-GBM disease patients. The use of plasmapheresis was independently associated with a reduced risk of primary outcome (OR: 0.179, 95% Cl: 0.051-0.630, p = 0.007), better 2-year (HR: 0.146; 95% CI: 0.038-0.553; p = 0.005) and 8-year patient survival (HR: 0.309; 95% CI: 0.112-0.850; p = 0.023). Restricted cubic spline regression suggested that patients with 5-10 sessions of plasmapheresis had already achieved maximum risk reduction in the primary outcome. Patients who started plasmapheresis at lower serum creatinine (42.9% vs. 96.2%, p < 0.001) or lower anti-GBM antibody levels (44.4% vs. 93.3%, p = 0.030) had lower risk of primary outcome than those at higher levels. Use of high-dose methylprednisolone (p = 0.505), pulsed cyclophosphamide (p = 0.343) or ANCA positivity (p = 0.115) were not related to primary outcome in anti-GBM disease.

CONCLUSION:

Plasmapheresis was protective for both in-hospital outcome and long-term survival in anti-GBM disease. Patients who initiated plasmapheresis early had a better prognosis and might only need 5-10 plasmapheresis sessions to achieve maximal risk reduction. Use of high-dose methylprednisolone or cyclophosphamide pulses was not related to improved short- or long-term outcomes in anti-GBM disease.

项与甲泼尼龙相关的新闻（医药）

2024-11-14

·GlobeNewswire-Health Care

Pacira Announces 104-Week Safety and Efficacy Data Following Local Administration of PCRX-201 for Moderate to Severe Osteoarthritis of the Knee

-- Poster to be presented at ACR Convergence annual meeting --PARSIPPANY, N.J., Nov. 14, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX), the industry leader in the delivery of innovative, non-opioid pain therapies to transform the lives of patients, today announced new data demonstrating its gene therapy for osteoarthritis candidate, PCRX-201 (enekinragene inzadenovec), provided sustained improvements in knee pain, stiffness, and function to 104 weeks following local administration, with a well-tolerated safety profile. The data, which indicate a potential for sustained clinical efficacy in patients with moderate to severe osteoarthritis of the knee (OAK), will be presented during a poster session at the American College of Rheumatology’s annual ACR Convergence meeting on Sunday, November 17 from 10:30 am – 12:30 pm EST. “The results of this large phase 1 study demonstrate durable pain relief across all levels of disease severity for at least 2 years following a single injection. This is promising, considering traditional pain management interventions provide an average of three to six months of effect,” said Stanley Cohen, MD, a board-certified rheumatologist and Co-Medical Director of the Metroplex Clinical Research Center in Dallas, TX, who was lead investigator in this trial and primary author on the poster presentation. “Unlike other treatments that temporarily alleviate symptoms, PCRX-201 addresses a root cause of osteoarthritis knee pain—inflammation—to help control patients’ pain for years rather than months.” The new data is derived from an open-label, phase 1 trial investigating the safety and efficacy of PCRX-201 administered via ultrasound-guided intraarticular injection in 72 patients with OAK graded at 2, 3, or 4 on the Kellgren-Lawrence scale, a semiquantitative method for evaluating the severity of osteoarthritis on a scale of 0-4. Participants were broken into two cohorts. The first cohort received one of three doses of PCRX-201. The second cohort received concurrent pretreatment with an intraarticular corticosteroid (methylprednisolone 40 mg), a technique common in gene therapy dosing to improve tolerability and gene transfer. Pain and function benefits were observed at all doses and across both cohorts over the full 104 weeks studied, with patients in the second cohort achieving greater pain reduction and fewer adverse events (AEs). Additional results in the pretreated cohort, across all doses, include: 48%-65% improvement in pain from baseline, as measured by the Western Ontario and McMaster Universities Arthritis Index-A (WOMAC-A)53%-72% improvement in stiffness from baseline, as measured by WOMAC-B Improvements in function from baseline, as measured by the Knee Injury and Osteoarthritis Outcome Score (KOOS) Activities of Daily Living (ADL) scale, that were similar to improvements in WOMAC-A and WOMAC-B By 16 weeks more than 70% of participants achieved greater than 50% reductions from baseline pain. No serious treatment-emergent AEs related to the treatment or procedure were reported regardless of steroid pretreatment or dose level administered. Treatment-related joint effusions (swelling) were the most common AE, occurring in 36% of patients who received steroid pretreatment vs 61% of patients who were not pretreated. The majority of effusions were mild to moderate in severity and resolved in a median of 33 days among patients in the pretreated group. “We look forward to continuing to advance the clinical investigation of PCRX-201 following these promising results, with a Phase 2, double-blind, active-controlled study planned for 2025,” said Frank D. Lee, chief executive officer of Pacira BioSciences. “Unlike traditional gene therapies, which are administered systemically and have primarily been limited to the treatment of rare diseases, we believe PCRX-201 holds the broad potential to provide a long-term pain management solution for the 14 million U.S. patients suffering from the negative impacts of osteoarthritis of the knee. With a local administration that delivers relief directly to the source—the knee joint capsule—PCRX-201 is on the leading edge of what could be possible for gene therapies and offers patients the hope for a long-lasting pain management solution that improves their ability to comfortably engage in activities of daily living, like climbing stairs and exercising.” PCRX-201 is a locally administered gene therapy, designed to produce interleukin-1 receptor antagonist (IL-1Ra), a naturally occurring, anti-inflammatory protein with a proven mechanism of action that reduces interleukin-1 (IL-1) signaling, a known factor in the development and progression of osteoarthritis of the knee. Unlike systemically administered gene therapies, PCRX-201 delivers the medicine where it matters to reduce pain and disability and potentially slow structural progression at the site of the disease. PCRX-201 uses an inducible promoter to mimic the body’s natural response to inflammation by “turning on” the expression of IL-1Ra when inflammation is present in the joint and turning off IL-1Ra expression once inflammation is quelled. In March 2024, PCRX-201 became the first-ever gene therapy product candidate in osteoarthritis to receive Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA). RMAT designation provides the benefits of intensive FDA guidance on efficient drug development, including the ability for early interactions with the FDA to discuss surrogate or intermediate endpoints, potential ways to support accelerated approval and satisfy post-approval requirements, potential priority review of the Biologics License Application (BLA), and other opportunities to expedite development and review. PCRX-201 was also granted Advanced Therapy Medicinal Products (ATMP) designation by the European Medicines Agency in May 2023. About Pacira BioSciencesPacira BioSciences delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, interscalene brachial plexus nerve block in adults, sciatic nerve block in the popliteal fossa in adults, and adductor canal block in adults for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and ioveraº®, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The company is also advancing the development of PCRX-201, a novel locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, visit www.pacira.com. Forward-Looking StatementsAny statements in this press release about Pacira’s future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “should,” “will,” “would,” and similar expressions, constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to our future outlook, our intellectual property and patent terms, our growth and future operating results and trends, our strategy, plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio, development programs, development of products, strategic alliances, plans with respect to the Non-Opioids Prevent Addiction in the Nation (“NOPAIN”) Act and other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the integration of our new chief executive officer; risks associated with acquisitions, such as the risk that the acquired businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; our manufacturing and supply chain, global and U.S. economic conditions (including inflation and rising interest rates), and our business, including our revenues, financial condition, cash flow and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, ZILRETTA and iovera°; the rate and degree of market acceptance of EXPAREL, ZILRETTA and iovera°; the size and growth of the potential markets for EXPAREL, ZILRETTA and iovera° and our ability to serve those markets; our plans to expand the use of EXPAREL, ZILRETTA and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL, ZILRETTA and iovera°; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of U.S. Food and Drug Administration supplemental New Drug Applications and premarket notification 510(k)s; the related timing and success of European Medicines Agency Marketing Authorization Applications; our plans to evaluate, develop and pursue additional product candidates utilizing our proprietary multivesicular liposome (“pMVL”) drug delivery technology; the approval of the commercialization of our products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; our commercialization and marketing capabilities; our ability to successfully complete capital projects; the outcome of any litigation; the ability to successfully integrate any future acquisitions into our existing business; the recoverability of our deferred tax assets; assumptions associated with contingent consideration payments; assumptions used for estimated future cash flows associated with determining the fair value of the Company; the anticipated funding or benefits of our share repurchase program; and factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the Securities and Exchange Commission (the “SEC”). In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. Except as required by applicable law, we undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, and readers should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

临床结果临床1期临床2期基因疗法上市批准

2024-11-13

·PRNewswire

DURECT Corporation Reports Third Quarter 2024 Financial Results and Provides Business Update

- Seeking to initiate Phase 3 registrational trial for larsucosterol with topline results expected within two years of initiation - Webcast of Earnings Call Today, November 13 at 4:30 p.m. ET CUPERTINO, Calif., Nov. 13, 2024 /PRNewswire/ -- DURECT Corporation (Nasdaq: DRRX) today announced financial results for the three months ended September 30, 2024 and provided a business update. "We remain focused on preparations for the Phase 3 trial for larsucosterol in severe alcohol-associated hepatitis (AH), including discussions with U.S. clinical sites and hepatologists, to streamline the initiation process," stated James E. Brown, D.V.M., President and CEO of DURECT. "Our goal is to begin the trial as soon as possible, subject to obtaining sufficient funding, which should enable us to report topline data within two years of trial initiation. If successful, the FDA has agreed that a single Phase 3 trial may be sufficient to support a New Drug Application (NDA). We believe the selected primary endpoint of 90-day survival is clinically meaningful and provides the greatest probability of success based on the Phase 2b AHFIRM data. We look forward to initiating the trial as soon as possible. We believe that larsucosterol, if approved, could provide physicians with a much-needed treatment that could significantly improve the current 90-day mortality rates of approximately 30%." Recent business highlights and updates: DURECT announced details on the design of its planned registrational Phase 3 trial to evaluate the safety and efficacy of larsucosterol for the treatment of patients with severe alcohol-associated hepatitis (AH). The trial will be a randomized, double-blind, placebo-controlled, multi-center study conducted in the U.S. The primary endpoint will be 90-day survival. The trial design incorporates feedback we received from the U.S. FDA during a Type B meeting held under Breakthrough Therapy Designation (BTD) as well as learnings from our prior Phase 2b AHFIRM trial in AH. DURECT's goal is to begin the trial as soon as possible, subject to obtaining sufficient funding, with topline results expected within two years of trial initiation. DURECT plans to deliver an oral and two poster presentations at The Liver Meeting 2024, organized by the American Association for the Study of Liver Diseases (AASLD), to be held November 15-19, 2024 in San Diego, California. These presentations will showcase additional data from the completed Phase 2b AHFIRM trial which evaluated larsucosterol for the treatment of alcohol-associated hepatitis (AH). The data further support the design of the Company's planned Phase 3 trial of larsucosterol, including the importance of timely treatment in clinical outcomes. Top line data from AHFIRM were previously announced in November 2023. On November 8, 2024, DURECT received notice that Innocoll Pharmaceuticals is terminating its license agreement for POSIMIR® (bupivacaine solution), effective in May 2025. Innocoll has committed to transfer all data and know-how related to POSIMIR to DURECT, and the company is evaluating next steps with respect to the commercialization of POSIMIR. Financial Highlights for Q3 2024: Total revenues were $1.9 million and net loss was $4.3 million for the three months ended September 30, 2024 compared to total revenues of $1.7 million and net loss of $3.0 million for the three months ended September 30, 2023. Cash, cash equivalents and investments were $10.5 million at September 30, 2024, compared to $29.8 million at December 31, 2023. Debt at September 30, 2024 was $10.5 million, compared to $16.7 million at December 31, 2023. Earnings Conference Call We will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss the Third Quarter 2024 results and provide a corporate update: Participants can use guest dial-in numbers above to reach an operator or they can click the Call me™ link for instant telephone access to the event (dial-out). The Call me™ link will be made active 15 minutes prior to the scheduled start time. The live audio webcast of the presentation will be also available on DURECT's homepage at on the "Events" page, under the "Investors" section. If you are unable to participate during the live webcast, the call will be archived on DURECT's website under the same section, following the completion of the call. About the AHFIRM Trial AHFIRM was a Phase 2b randomized, double-blind, placebo-controlled, international, multi-center study conducted in subjects with severe alcohol-associated hepatitis ( AH) to evaluate the sa Fety and eff Icacy of la Rsucosterol treat Ment (AHFIRM). The study was comprised of three arms and enrolled 307 patients, with approximately 100 patients in each arm: (1) Placebo, which consists of standard of care, with or without methylprednisolone capsules at the investigators' discretion; (2) larsucosterol (30 mg); and (3) larsucosterol (90 mg). Patients in the larsucosterol arms received the same supportive care without steroids. The primary outcome measure was the 90-day incidence of mortality or liver transplantation for patients treated with larsucosterol compared to those treated with placebo, and the key secondary endpoint was 90-day survival. The Company enrolled patients at clinical trial sites across the U.S., EU, U.K., and Australia. In November 2023, the Company announced topline data for the AHFIRM Trial. Reflecting the life-threatening nature of AH and the lack of therapeutic options, the U.S. Food and Drug Administration (FDA) has granted larsucosterol Fast Track Designation and Breakthrough Therapy Designation for the treatment of AH. For more information, refer to ClinicalTrials.gov Identifier: NCT04563026. About Alcohol-associated Hepatitis (AH) AH is an acute form of alcohol-associated liver disease (ALD) associated with long-term heavy alcohol intake, often following a recent period of increased consumption (i.e., a binge). AH is typically characterized by severe inflammation and liver cell damage, potentially leading to life-threatening complications including liver failure, acute kidney injury and multi-organ failure. There are no FDA approved therapies for AH, and a retrospective analysis of 77 studies published between 1971 and 2016, which included data from 8,184 patients, showed the overall mortality from AH was 26% at 28 days, 29% at 90 days and 44% at 180 days. A subsequent global study published in December 2021, which included 85 tertiary centers in 11 countries across 3 continents, prospectively enrolled 2,581 AH patients with a median Model of End-Stage Liver Disease (MELD) score of 23.5, reported mortality at 28 and 90 days of approximately 20% and 31%, respectively. Stopping alcohol consumption is necessary, but frequently not sufficient for recovery in many moderate (defined as MELD scores of 11-20) and severe (defined as MELD scores >20) patients, and therapies that reduce liver inflammation, such as corticosteroids, are limited by contraindications, have not been shown to improve survival at 90 days or one year, and have demonstrated an increased risk of infection. While liver transplantation is becoming more common for ALD patients, including AH patients, the total number of such transplants is still relatively small, and limited by organ availability. Average charges for a liver transplant exceed $875,000, and patients require lifelong immunosuppressive therapy to prevent organ rejection. About Larsucosterol Larsucosterol is an endogenous sulfated oxysterol and an epigenetic modulator. Epigenetic regulators are compounds that regulate patterns of gene expression without modifying the DNA sequence. DNA hypermethylation, an example of epigenetic dysregulation, results in transcriptomic reprogramming and cellular dysfunction, and has been reported in many acute (e.g., AH) and chronic diseases (e.g., MASH). As an inhibitor of DNA methyltransferases (DNMT1, DNMT3a and 3b), larsucosterol inhibits DNA methylation, which subsequently modulates expression of genes that are involved in cell signaling pathways associated with stress responses, cell death and survival, and lipid biosynthesis. This may ultimately lead to improved cell survival, reduced inflammation, and decreased lipotoxicity. As an epigenetic modulator, the proposed mechanism of action provides further scientific rationale for developing larsucosterol for the treatment of acute organ injury and certain chronic diseases. About DURECT Corporation DURECT is a late-stage biopharmaceutical company pioneering the development of epigenetic therapies that target dysregulated DNA methylation to transform the treatment of serious and life-threatening conditions, including acute organ injury. Larsucosterol, DURECT's lead drug candidate, binds to and inhibits the activity of DNA methyltransferases, epigenetic enzymes that are elevated and associated with hypermethylation found in AH patients. Larsucosterol is in clinical development for the potential treatment of AH, for which the FDA has granted a Fast Track and a Breakthrough Therapy designation; MASH is also being explored. In addition, POSIMIR®(bupivacaine solution) for infiltration use, a non-opioid analgesic utilizing the innovative SABER®platform technology, is FDA-approved. For more information about DURECT, please visit and follow us on X (formerly Twitter) at . DURECT Forward-Looking Statements This press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, relating to: the Company's ability to commence a Phase 3 trial of larsucosterol and report top-line data within two years of initiation, the potential for a single Phase 3 trial of larsucosterol, if successful, to support an NDA filing, and the potential uses and benefits of larsucosterol in patients with AH and potentially other indications. Actual results may differ materially from those contained in the forward-looking statements contained in this press release, and reported results should not be considered as an indication of future performance. The potential risks and uncertainties that could cause actual results to differ from those projected include, among other things, the risks that the Company is unable to raise sufficient capital to commence the Phase 3 trial of larsucosterol in AH, trial enrollment or completion takes longer than anticipated, future clinical trials of larsucosterol are delayed or do not confirm the results from subset analyses of the AHFIRM trial, including geographic or other segmentation, or of earlier clinical or pre-clinical trials, or do not demonstrate the safety or efficacy of larsucosterol in a statistically significant manner; the risk that the FDA or other government agencies may require additional clinical trials for larsucosterol before approving larsucosterol for the treatment of AH, and that larsucosterol may never be approved; and risks related to the sufficiency of our cash resources, our anticipated capital requirements, our need or desire for additional financing, our ability to continue to meet the minimum bid price for continued listing on Nasdaq, our ability to obtain capital to fund our operations and expenses, and our ability to continue to operate as a going concern. Further information regarding these and other risks is included in DURECT's most recent Securities and Exchange Commission (SEC) filings, including its annual report on Form 10-K for the year ended December 31, 2023 and quarterly report on Form 10-Q for the quarter ended September 30, 2024, when filed, under the heading "Risk Factors." These reports are available on our website under the "Investors" tab and on the SEC's website at . All information provided in this press release and in the attachments is based on information available to DURECT as of the date hereof, and DURECT assumes no obligation to update this information as a result of future events or developments, except as required by law. NOTE: POSIMIR® is a trademark of Innocoll Pharmaceuticals, Ltd. in the U.S. and a trademark of DURECT Corporation outside of the U.S. SABER® is a trademark of DURECT Corporation. Other referenced trademarks belong to their respective owners. Larsucosterol is an investigational drug candidate under development and has not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities for any indication. SOURCE DURECT Corporation WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床2期突破性疗法临床3期快速通道临床结果

2024-11-09

·医药地理

扫描二维码即可下载《数图药讯》2024年第45期目录政策解读 1. 上海阳光医药采购网：关于开展第十批国家组织药品集中采购相关药品信息填报工作的通知 2. 国家药监局：关于批准医用增材制造技术医疗器械标准化技术归口单位换届的公告（2024年第132号） 3. 国家药监局药审中心：关于发布《司美格鲁肽注射液生物类似体重管理适应症临床试验设计指导原则》的通告（2024年第46号） 4. 国家医保局：关于开展医保支付方式改革典型案例征集活动的公告 5. 国家医保局：民政部办公厅关于进一步做好医疗救助对象信息共享工作的通知 6. 上海阳光医药采购网：关于市药市所开展“政府开放日”活动的通知行业动态 1. 药讯动态：重磅获批 2. 药讯动态：重磅临床 3. 药企动态：市场动态零售品类数据洞见 1. 心肌炎疾病治疗药品销售品种分析 2. 复方鱼腥草零售放大市场销售分析 3. 复方鱼腥草零售放大市场销售企业分析政策解读 1、上海阳光医药采购网：关于开展第十批国家组织药品集中采购相关药品信息填报工作的通知为做好第十批国家组织药品集中采购工作，进一步优化工作流程，建立常态化工作机制，自2024年11月1日起，联合采购办公室开展第十批国家组织药品集中采购相关药品信息填报工作，并将有关事项进行通知。具体信息可登录上海阳光采购网官网查看。附件：药品填报范围.pdf 相关文件请扫描上方二维码查看 2、国家药监局：关于批准医用增材制造技术医疗器械标准化技术归口单位换届的公告（2024年第132号）国家药监局批准医用增材制造技术医疗器械标准化技术归口单位换届，现予公布（详见附件）。附件：第二届医用增材制造技术医疗器械标准化技术归口单位组成方案.doc 相关文件请扫描上方二维码查看 3、国家药监局药审中心：关于发布《司美格鲁肽注射液生物类似体重管理适应症临床试验设计指导原则》的通告（2024年第46号）为指导司美格鲁肽注射液生物类似药体重管理适应症临床试验设计，在国家药品监督管理局的部署下，药审中心组织制定了《司美格鲁肽注射液生物类似药体重管理适应症临床试验设计指导原则》（见附件）。根据《国家药监局综合司关于印发药品技术指导原则发布程序的通知》（药监综药管〔2020〕9号）要求，经国家药品监督管理局审查同意，现予发布，自发布之日起施行。附件：司美格鲁肽注射液生物类似药体重管理适应症临床试验设计指导原则.pdf 相关文件请扫描上方二维码查看 4、国家医保局：关于开展医保支付方式改革典型案例征集活动的公告为深入贯彻落实党的二十届三中全会精神，持续深化医保支付方式改革，更好发挥医保促进三医协同发展和治理的积极作用，全面总结梳理各地在深入推进医保支付方式改革过程中的典型经验做法，讲好“医保支付改革故事”，分享“医保支付改革经验”，用好“医保支付方式改革方法”，现面向社会开展医保支付改革典型案例征集活动。欢迎各地医疗保障行政部门、医保经办机构和定点医疗机构参加。附件：医保支付改革方式典型案例征集活动申报表.docx 相关文件请扫描上方二维码查看 5、国家医保局：民政部办公厅关于进一步做好医疗救助对象信息共享工作的通知党中央高度重视困难群众医疗救助工作，要求按救助对象类别及时精准实施救助保障。但在实际工作中还存在信息尚未有效协同，共享不及时等问题。为全面落实医疗救助制度，切实减轻困难群众和重特大疾病患者家庭医疗费用负担，现就进一步做好医疗救助对象信息共享工作通知。具体信息请登录国家医保局官网查看。 6、上海阳光采购网：关于市药市所开展“政府开放日”活动的通知为进一步畅通政企沟通渠道，及时回应企业关切，促进信息共享，提高沟通效率，更好助力优化营商环境，构建亲清政商关系，上海市医药集中招标采购事务管理所（以下简称“市药事所”）即日起将开展“政府开放日”活动，并将有关事项进行通知。具体信息可登录上海阳光采购网官网查看。行业动态 01 药讯动态：重磅获批和重磅临床最近重磅获批辉瑞研发的甲苯磺酸他拉唑帕利胶囊的上市申请获得NMPA批准。本次申报上市的适应症为：用于转移性去势抵抗性前列腺癌（mCRPC）成人患者。百时美施贵宝申报的纳武利尤单抗注射液（商品名：欧狄沃®）获得NMPA批准。联合顺铂及吉西他滨用于不可切除或转移性尿路上皮癌成人患者的一线治疗。艾伯维（AbbVie）申报的CD3/CD20双抗艾可瑞妥单抗注射用浓溶液新药上市申请获得CDE受理。杭州中美华东制药有限公司研发的乌司奴单抗注射液获得NMPA上市批准，申报上市的适应症为治疗成年中重度斑块状银屑病。浙江普利药业有限公司自主研发的新药左亚叶酸钙注射液上市申请获得NMPA批准，主要用于胃癌和结直肠癌的治疗。最近重磅临床中山莱博瑞辰生物医药有限公司申报的创新药“注射用RAB001”获得NMPA药品审评中心批准一项新的临床试验默示许可，拟用于治疗骨坏死。艾赛普生物申报的领先品种注射用iSAP-0909获得FDA的新药临床试验申请（IND）许可，适应症为非肌层浸润性膀胱癌（NMIBC）的辅助诊断和术中定位。康诺亚申报的CM512注射液获得CDE批准临床，拟用于治疗哮喘、慢性阻塞性肺疾病（COPD）。汇宇制药及其子公司汇宇海玥申报的1类新药HYP-6589片获得CDE批准临床，拟用于治疗晚期实体瘤。北京质肽生物医药科技有限公司申报的ZT006片获得CDE临床试验默示许可。该药物拟开发用于成人2型糖尿病患者的血糖控制。 02 药企动态：市场动态 11月3日，苏州珀罗汀生物技术有限公司与上海玄刃科技有限公司举行合作签约仪式，实现蛋白表达自动化高通量合成，加速无细胞蛋白表达技术自动化高通量的产业化进程。 11月4日，Royalty Pharma和Syndax Pharmaceuticals共同宣布，双方达成一项价值 3.5 亿美元的合成专利费融资协议，该协议基于Niktimvo （axatilimab-csfr）在美国的净销售额。根据协议条款，Syndax收到了3.5亿美元的预付款，以换取Niktimvo美国净销售额的13.8%的特许权使用费。向Royalty Pharma支付的特许权使用费最高将达到2.35倍。 11月6日，GHO Capital Partners LLP和Ampersand Capital Partners宣布他们已就Avid达成最终合并协议，由GHO和Ampersland管理的基金以价值约11亿美元的全现金交易收购。且GHO和Ampersand将以每股12.50美元的现金收购Avid股东持有的所有已发行股份。零售品类数据洞见 01 心肌炎疾病治疗药品销售品种分析图1：2019-2024年Q2心肌炎疾病治疗药品零售（放大市场）品种销售额数据来源：中国药品零售数据库RPDB药店数据中国医药工业信息中心心肌炎疾病主要指心肌的炎性疾病，可呈急性、亚急性或慢性，相对算是比较常见的疾病。根据RPDB数据库，心肌炎治疗药品中，销售额相对较高的药品：有转移因子口服液、甲泼尼龙片、地高辛片、辅酶Q10片等。 02 复方鱼腥草零售放大市场销售分析图2: 2019-2024年Q2复方鱼腥草零售（放大市场）销售额数据来源：中国药品零售数据库RPDB药店数据中国医药工业信息中心复方鱼腥草胶囊可用于因外感风热引起的咽喉疼痛，急性咽炎，风热型扁桃体炎等疾病的治疗。根据RPDB数据库，2020年-2024年Q2，复方鱼腥草零售（放大市场）销售额波动幅度较大，2020年总销售额达11.18亿元，同比增长率为50.21％，2023年销售额有所下降。 03 复方鱼腥草零售放大市场销售企业分析图3: 2019-2024年Q2复方鱼腥草零售（放大市场）销售企业分析数据来源：中国药品零售数据库RPDB药店数据中国医药工业信息中心根据RPDB数据库，复方鱼腥草零售放大市场销售企业业绩较好的公司：浙江康恩贝中药有限公司、广西百琪药业有限公司、浙江惠松制药有限公司、浙江国镜药业有限公司等。来源：医药地理、国家药监局、国家药监局审评中心、腾讯、新浪等。 END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

生物类似药带量采购

100 项与甲泼尼龙相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D00407	甲泼尼龙	D07AA01 D10AA02 H02AB04	DB00959

研发状态

批准上市

10 条最早获批的记录,

后查看更多信息

适应症	国家/地区	公司	日期
多发性硬化症	日本	Pfizer Inc.	2017-01-04
过敏	美国	Pfizer Inc.	1957-10-24
胶原蛋白疾病	美国	Pfizer Inc.	1957-10-24
水肿	美国	Pfizer Inc.	1957-10-24
内分泌系统疾病	美国	Pfizer Inc.	1957-10-24
眼部疾病	美国	Pfizer Inc.	1957-10-24
胃肠道疾病	美国	Pfizer Inc.	1957-10-24
血液疾病	美国	Pfizer Inc.	1957-10-24
炎症	美国	Pfizer Inc.	1957-10-24
肿瘤	美国	Pfizer Inc.	1957-10-24
呼吸系统疾病	美国	Pfizer Inc.	1957-10-24
风湿性疾病	美国	Pfizer Inc.	1957-10-24
皮肤疾病	美国	Pfizer Inc.	1957-10-24

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
移植物抗宿主病	临床3期	美国	Mallinckrodt Plc	2006-01-01
移植物抗宿主病	临床3期	澳大利亚	Mallinckrodt Plc	2006-01-01
移植物抗宿主病	临床3期	奥地利	Mallinckrodt Plc	2006-01-01
移植物抗宿主病	临床3期	比利时	Mallinckrodt Plc	2006-01-01
移植物抗宿主病	临床3期	加拿大	Mallinckrodt Plc	2006-01-01
移植物抗宿主病	临床3期	法国	Mallinckrodt Plc	2006-01-01
移植物抗宿主病	临床3期	德国	Mallinckrodt Plc	2006-01-01
移植物抗宿主病	临床3期	意大利	Mallinckrodt Plc	2006-01-01
移植物抗宿主病	临床3期	荷兰	Mallinckrodt Plc	2006-01-01
移植物抗宿主病	临床3期	瑞士	Mallinckrodt Plc	2006-01-01

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT02451748 (CTgov)	临床4期	类风湿关节炎	32	Lab Work (DMARD's Responder and Non-Responder)	淵簾網簾襯願獵蓋夢鏇(糧醖遞範齋廠願築夢願) = 淵願鑰夢顧積憲餘壓選繭鬱範選蓋簾獵觸製遞 (遞淵衊齋鹹壓齋醖遞窪, 構襯襯製遞窪獵築憲鏇 ~ 範築鬱壓製鹽積夢夢獵) 更多	-	2024-07-10
				Naproxen+Medrol+Hydroxychloroquine+humira+Prednisone+Lab Work+Triamcinolone+Sulfasalazine+Certolizumab pegol (CDP870, tradename Cimzia)+Methotrexate+Leflunomide (DMARD's Plus Cimzia (Certolizumab Pegol))	齋蓋蓋淵夢襯蓋鏇遞鹹(艱夢獵蓋鏇製淵範顧窪) = 膚選憲鹽餘壓範鑰鏇觸廠窪齋膚艱衊網構簾齋 (窪範憲齋壓鏇範餘衊選, 築醖簾鑰夢淵願鹹觸衊 ~ 鹹醖壓鏇鬱憲廠鹹獵餘) 更多
NCT03110822 (Pubmed) 人工标引	临床1期	多发性骨髓瘤	29	Ruxolitinib+methylprednisolone+lenalidomide	築醖製網築鹽糧窪廠鬱(鏇鬱蓋積願簾鹽齋壓窪) = 夢廠衊網壓鑰簾積選衊鑰膚顧網醖製蓋鬱壓鑰 (鏇壓鏇鹽鹹夢餘顧鹽觸 ) 更多	积极	2024-04-20
NCT01560052 (TESTING, ISN WCN2024) 人工标引	N/A	免疫球蛋白a肾病	503	methylprednisolone (proteinuria group 1)	夢衊壓顧衊獵淵選廠糧(簾鏇廠齋築鏇衊窪範夢) = 製鏇遞鬱鬱積願鏇鹹選淵餘淵顧鬱壓醖鹹襯鏇 (襯選壓蓋廠獵獵鑰膚構 )	积极	2024-04-01
				placebo (proteinuria group 1)	夢衊壓顧衊獵淵選廠糧(簾鏇廠齋築鏇衊窪範夢) = 糧鹽襯鑰憲觸衊網餘膚淵餘淵顧鬱壓醖鹹襯鏇 (襯選壓蓋廠獵獵鑰膚構 )
NCT04438382 (CTgov)	临床2期	恶性实体肿瘤 \| 血液肿瘤 \| 肺炎	1	Methylprednisolone+Infliximab+Prednisone (Arm A (Infliximab))	鹹繭廠願觸鬱蓋鬱窪膚(築艱襯顧鏇糧顧鬱襯窪) = 夢鬱廠構選餘製簾遞網蓋淵遞壓構選選鑰淵糧 (鬱製襯膚襯糧築襯襯築, 鏇餘網襯積餘顧淵繭觸 ~ 遞鑰壓繭鏇範廠鬱獵鏇) 更多	-	2024-03-26
				Methylprednisolone+Prednisone+Intravenous Immunoglobulin Therapy (Arm B (Intravenous Immunoglobulin Therapy))	鹹繭廠願觸鬱蓋鬱窪膚(築艱襯顧鏇糧顧鬱襯窪) = 糧觸鹽獵夢壓觸淵憲遞蓋淵遞壓構選選鑰淵糧 (鬱製襯膚襯糧築襯襯築, 鹽選蓋壓淵觸構膚選壓 ~ 願衊觸顧窪糧願齋築廠) 更多
APAO2024	N/A	格雷夫斯眼病	88	Weekly EUGOGO Protocol	淵蓋簾積範衊觸齋顧齋(廠鬱鹽構齋襯網蓋鹹壓) = 網願衊夢鹽鹽壓憲衊製構襯廠築艱獵廠鏇壓夢 (構遞廠鏇壓鏇襯顧鬱夢 )	积极	2024-02-22
				3 Weekly Low Dose Intravenous Methylprednisolone (IVMP)	淵蓋簾積範衊觸齋顧齋(廠鬱鹽構齋襯網蓋鹹壓) = 鬱蓋鹽構糧願顧願艱鑰構襯廠築艱獵廠鏇壓夢 (構遞廠鏇壓鏇襯顧鬱夢 )
NCT03094663 (IPACK, CTgov)	临床4期	镇痛 \| 膝关节病变	86	Cefazolin+8 MHz. Chiba needle+Methylprednisolone+epinephrine+Dexamethasone+Bupivacaine 25cc (Peri-Articular Injections Only)	築繭鹽醖餘繭憲鬱鏇鏇(艱膚艱顧顧膚選鏇製範) = 積廠築繭膚鬱憲廠築繭襯鏇鬱蓋鏇製襯願觸積 (窪齋鹽選鬱鹽憲觸顧繭, 選構鹽醖衊襯範築廠淵 ~ 願艱顧夢鏇淵製觸窪繭) 更多	-	2024-01-23
				Cefazolin+8 MHz. Chiba needle+Methylprednisolone+epinephrine+Dexamethasone+Bupivacaine 25cc (Peri-Articular Injections, Adductor Canal Block, and IPACK)	築繭鹽醖餘繭憲鬱鏇鏇(艱膚艱顧顧膚選鏇製範) = 鏇餘醖淵夢鏇廠鬱範網襯鏇鬱蓋鏇製襯願觸積 (窪齋鹽選鬱鹽憲觸顧繭, 觸顧鑰蓋鹽鑰鬱蓋夢獵 ~ 鑰繭窪觸蓋齋構鹽願夢) 更多
NCT04624776 (STEROHCA, Pubmed \| Intensive Care Med)	临床2期	院外心脏停搏 interleukin 6 (IL-6) \| neuron-specific enolase (NSE)	137	Methylprednisolone 250 mg	顧繭鹹艱襯齋鹹鏇壓鏇(範廠遞膚廠醖壓窪餘衊) = 鹹鑰構憲襯獵範廠襯獵遞鬱製醖積獵蓋鑰壓膚 (艱鑰構艱願選顧鏇艱窪 ) 更多	积极	2023-12-01
				Placebo	顧繭鹹艱襯齋鹹鏇壓鏇(範廠遞膚廠醖壓窪餘衊) = 製鑰鹹憲糧簾夢齋積構遞鬱製醖積獵蓋鑰壓膚 (艱鑰構艱願選顧鏇艱窪 ) 更多
NCT05113901 (CTgov)	临床4期	-	4	Methylprednisolone (Methylprednisolone Taper)	鏇衊淵鏇憲憲獵鏇構壓(選蓋齋糧遞糧蓋艱醖襯) = 壓願齋鏇鏇遞製範觸窪鹹製憲壓艱簾憲廠構繭 (築遞築鏇簾網憲壓鹽築, 簾積鹹壓鏇網簾淵憲簾 ~ 網餘遞範衊獵獵顧壓網) 更多	-	2023-10-23
				Placebo (Placebo Taper)	鑰膚鬱窪製壓網鹽製遞(鬱築範窪築構網糧選鏇) = 壓網淵願簾衊鹹鏇蓋顧遞鑰遞蓋衊鬱齋網蓋窪 (簾醖醖鏇範壓窪衊壓鬱, 淵顧膚構鹹壓窪齋網夢 ~ 衊鬱壓範鹽範觸醖遞衊) 更多
EADV2023	N/A	普遍性脱发	15	Pulse methylprednisolone therapy + Methotrexate + Light emitting diode therapy	範構窪憲築鏇構膚醖壓(簾壓鑰鹽壓夢糧憲鹽鏇) = 網選網淵遞壓顧夢網觸製廠淵蓋壓繭醖範網簾 (選窪鬱蓋選觸鑰醖鏇觸 ) 更多	-	2023-10-11
IEC2023	N/A	癫痫性脑病	-	Pulse IV steroids (standard regimen)	網鬱鬱選鹹遞觸壓構衊(簾範夢獵鹽淵蓋齋鹽鹹) = 構鑰網鹹繭壓鏇選糧憲淵鬱簾願糧遞構廠鏇顧 (廠淵鑰鹹鹹選鏇衊糧餘, 3.0)	-	2023-09-04
				Pulse IV steroids (extended regimen)	網鬱鬱選鹹遞觸壓構衊(簾範夢獵鹽淵蓋齋鹽鹹) = 淵遞廠構網廠齋繭構繭淵鬱簾願糧遞構廠鏇顧 (廠淵鑰鹹鹹選鏇衊糧餘, 6.5)