Last update 24 Oct 2024

Dexamethasone

Last update 24 Oct 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

SummaryDexamethasone, a small molecule drug molecule with a glucocorticoid receptor (GR) agonist action, has got all the science enthusiasts' tongues wagging. The GR, which is widely distributed across various cell types, is responsible for myriad physiological responses, including immune and inflammatory responses. This small molecule drug, Dexamethasone, binds to the GR, which sends shockwaves of change through gene expression and protein synthesis, consequently giving inflammation and immune system activity a taste of their own medicine.When it comes to treating various conditions, Dexamethasone takes the crown. This potent drug has proved its mettle in treating an impressive range of conditions, including but not limited to actinic cheilitis, light chain (AL) amyloidosis, ocular inflammation, macular edema, and anaphylaxis. Back in the day, on October 30, 1958, the FDA gave the nod to Dexamethasone. It was a time when Merck & Co., Inc., a pharmaceutical company that hailed from the United States, hit the bull's eye with this innovative drug that promised a bright future.

Drug Type

Small molecule drug

Synonyms

Decadron Phosphate, Dexamethasone Intravitreal Implant, DEXTENZA

+ [47]

Target

Mechanism

GR agonists(Glucocorticoid receptor agonists)

Therapeutic Areas

NeoplasmsImmune System DiseasesInfectious Diseases+ [13]

Active Indication

Immunoglobulin Light-Chain AmyloidosisOcular inflammationOphthalmologic surgical procedures+ [69]

Inactive Indication

Acute otitis externaAdvanced Head and Neck Squamous Cell CarcinomaAge Related Macular Degeneration+ [45]

Originator Organization

Merck & Co., Inc.

Active Organization

Amgen, Inc.Janssen Research & Development LLCAbbVie Deutschland GmbH & Co. KG

+ [31]

Inactive Organization

Eli Lilly & Co.

Merck Sharp & Dohme Corp.Allergan Ltd. (Ireland)

+ [21]

Drug Highest PhaseApproved

First Approval Date

US (30 Oct 1958),

AnaphylaxisEndocrine System DiseasesEye Diseases+ [7]

RegulationOrphan Drug (US), Priority Review (CN)

Structure

Molecular FormulaC22H29FO5

InChIKeyUREBDLICKHMUKA-CXSFZGCWSA-N

CAS Registry50-02-2

4,048

Clinical Trials associated with Dexamethasone

NCT05521087 / WithdrawnPhase 1

A Phase I/Ib Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 ([KMT2A1], nucleophosmin 1 gene (NPM1), or nucleoporin alterations in Part 1 (Dose Escalation) and to further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).

Start Date26 Dec 2025

Sponsor / Collaborator

Janssen Research & Development LLC

CTRI/2024/10/074759 / Not yet recruitingNot ApplicableIIT

Effect of oral versus intravenous dexamethasone on duration of analgesia after osseous upper limb surgery under supraclavicular brachial plexus block - NIL

Start Date15 Sep 2025

Sponsor / Collaborator

Maulana Azad Medical College

NCT06616584 / Not yet recruitingPhase 2/3IIT

A Randomized Phase II/III Study of Docetaxel and Ramucirumab With or Without Cemiplimab for Participants Previously Treated With Platinum-Based Chemotherapy and Immunotherapy for Stage IV or Recurrent Non-Small Cell Lung Cancer (Lung-MAP Non-Matched Sub-Study)

This phase II/III Expanded Lung-MAP treatment trial compares the effect of adding cemiplimab to docetaxel and ramucirumab versus docetaxel and ramucirumab alone in treating patients with non-small cell lung cancer that is stage IV or that has come back after a period of improvement (recurrent). Cemiplimab is a monoclonal antibody that stimulates the immune system by blocking the PD-1 pathway. Tumors use the PD-1 pathway to escape attacks from the immune system. By blocking the PD-1 pathway, cemiplimab may help the immune system recognize and attack tumor cells. Docetaxel is in a class of medications called taxanes. It stops tumor cells from growing and dividing and may kill them. Ramucirumab is a monoclonal antibody that may prevent the growth of new blood vessels that tumors need to grow. Adding cemiplimab to usual treatment, docetaxel and ramucirumab, may kill more tumor cells compared to docetaxel and ramucirumab alone in treating patients with stage IV or recurrent non-small cell lung cancer.

Start Date11 Jul 2025

Sponsor / Collaborator

SWOG

[+2]

100 Clinical Results associated with Dexamethasone

100 Translational Medicine associated with Dexamethasone

100 Patents (Medical) associated with Dexamethasone

61,535

Literatures (Medical) associated with Dexamethasone

01 Feb 2025·BLOOD CELLS MOLECULES AND DISEASES

Hemophagocytic lymphohistiocytosis associated with immune checkpoint inhibitor use: A review of the current knowledge and future directions

Review

Author: Rangachari, Deepa ; Berwick, Shana ; Schoepflin, Zachary ; De Brabandt, Charlotte ; Walmsley, Charlotte S ; Patell, Rushad ; Walmsley, Charlotte S.

Hemophagocytic lymphohistiocytosis (HLH) is a severe and often lethal inflammatory syndrome characterized by excessive immune activation leading to fever, cytopenias, and multiorgan involvement. Immune checkpoint inhibitors (ICIs) are central to many contemporary cancer regimens, but their use is associated with immune-related adverse events. Here, we report a case of ICI-induced HLH successfully treated with single agent dexamethasone and provide a scoping review of the literature for cases of ICI-induced HLH with a focus on treatment strategies and outcomes. Using the Medline database, we searched for cases of ICI-associated HLH, with a total of 51 cases reported between 2017 and 2023. Our results underscore the severe nature of this disease, with a 13.7 % mortality rate across 51 case reports. Treatment strategies for ICI-induced HLH were variable: steroids alone (56.9 %), steroids with etoposide (17.6 %), steroids with tociluzumab (11.8 %), among other combinations. Our literature review indicates that steroids alone may be sufficient treatment in some cases of ICI-HLH, with comparable mortality with steroids alone (n = 29) (13.8 %) to that of cases treated with both steroids and immunomodulators (n = 15, 13.3 %). Moreover, all patients treated with steroids and tocilizumab survived (n = 6), suggesting that tocilizumab may be a reasonable next line of therapy when steroid monotherapy proves inadequate. We propose an outline for investigation and treatment of this rare complication of ICI use. Finally, we discuss possible future approaches to develop evidence-based strategies for the diagnosis and management of ICI-induced HLH including the importance of integrating the role of patient community involvement.

01 Jan 2025·BIOCHIMICA ET BIOPHYSICA ACTA-MOLECULAR BASIS OF DISEASE

TMCO1 promotes ferroptosis and ECM deposition in glaucomatous trabecular meshwork via ERK1/2 signaling

Article

Author: Huang, Shouyue ; Zhang, Yang ; Yu, Huan ; Han, Ruiqi ; Chen, Junjue ; Shen, Bingqiao ; Xu, Shushu ; Yao, Huiping ; Zhong, Yisheng

Glaucoma, a leading cause of global blindness, is marked by irreversible retinal ganglion cells (RGCs) loss, elevated intraocular pressure (IOP), and extracellular matrix (ECM) deposition in the trabecular meshwork (TM). Transmembrane and coiled-coil domain protein 1 (TMCO1), implicated in calcium regulation, has potential links to primary open-angle glaucoma (POAG). Ferroptosis, an iron-dependent cell death mechanism driven by lipid peroxidation, is also observed in glaucoma. This study investigates the role of TMCO1 in POAG, focusing on its involvement in TM ECM deposition via ferroptosis induction and ERK1/2 phosphorylation inhibition. In both in vivo and in vitro models, we demonstrated that dexamethasone (DEX) stimulation upregulates TMCO1, leading to increased ECM deposition and ferroptosis in human trabecular meshwork cells (HTMCs). Furthermore, treatment with ferrostatin-1 (Fer-1), a ferroptosis inhibitor, significantly reduced ECM deposition and ferroptosis in HTMCs. These findings establish TMCO1 as a critical regulator of ferroptosis and ECM deposition through the ERK/MAPK pathway, positioning it as a promising therapeutic target for glaucoma.

01 Jan 2025·Ophthalmology science

Subconjunctival Administration of an Adeno-Associated Virus Expressing Stanniocalcin-1 Provides Sustained Intraocular Pressure Reduction in Mice

Article

Author: Chowdhury, Uttio Roy ; Anderson, Kjersten J. ; Omer, Mohammed E. ; Fautsch, Michael P ; Rinkoski, Tommy A. ; Fautsch, Michael P. ; Niknam, Parvin ; Omer, Mohammed E ; Roddy, Gavin W. ; Anderson, Kjersten J ; Pacheco Marrero, Johann M. ; Pacheco Marrero, Johann M ; Roddy, Gavin W ; Kohli, Darrell ; Rinkoski, Tommy A

Purpose:

To investigate subconjunctival administration of a single-stranded, adeno-associated virus, serotype 2, engineered to express stanniocalcin-1 with a FLAG tag (ssAAV2-STC-1-FLAG) as a novel sustained (IOP) lowering agent with a reduced ocular surface side effect profile.

Design:

In vivo preclinical investigation in mice.

Subjects:

C57BL/6J, DBA/2J, prostaglandin F (FP) receptor knockout mice.

Methods:

Normotensive C57BL/6J mice were treated with a subconjunctival injection of ssAAV2-STC-1-FLAG (2 μL; 6 × 10⁹ viral genomes [VGs]) in 1 eye and the same volume and concentration of ssAAV2-green fluorescent protein (GFP) or the same volume of phosphate-buffered saline in the fellow eye. Ocular hypertensive DBA/2J mice were subconjunctivally injected with 6 × 10⁹ VGs of ssAAV2-STC-1-FLAG or ssAAV2-GFP. Steroid-mediated ocular hypertension was induced in C57BL/6J mice with weekly injections of dexamethasone into the conjunctival fornix, and mice were then injected subconjunctivally with 6 × 10⁹ VGs of ssAAV2-STC-1-FLAG or ssAAV2-GFP. Prostaglandin F receptor knockout mice were injected subconjunctivally with 6 × 10⁹ VGs of ssAAV2-STC-1-FLAG or phosphate-buffered saline. An identical vector was constructed without the FLAG tag (ssAAV2-STC-1) and evaluated in normotensive C57BL/6J mice. Intraocular pressure was assessed using the Tonolab tonometer for all experiments. Tumor necrosis factor alpha (TNFα), a marker of ocular surface inflammation, was compared between subconjunctivally delivered ssAAV2-STC-1-FLAG and other treatments including daily topical latanoprost.

Main Outcome Measures:

Intraocular pressure assessment.

Results:

Subconjunctival delivery of ssAAV2-STC-1-FLAG significantly reduced IOP for 10 weeks post injection in normotensive mice. Maximal IOP reduction was seen at week 3 postinjection (17.4%; 17.1 ± 0.8 vs. 14.1 ± 0.8 mmHg, P < 0.001). After the IOP-lowering effect had waned, a second injection restored the ocular hypotensive effect. Subconjunctivally delivered ssAAV2-STC-1-FLAG lowered IOP in DBA/2J mice (16.9%; 17.8 ± 2.0 vs. 14.8 ± 0.9 mmHg, P < 0.001) and steroid-mediated ocular hypertensive mice (20.0%; 19.0 ± 0.6 vs. 15.2 ± 0.7 mmHg, P < 0.001) over the experimental period. This construct also reduced IOP to a similar extent in wild-type (15.9%) and FP receptor knockout (15.7%) mice compared with the fellow eye. A related construct also lowered IOP without the FLAG tag in a similar manner. Reduction in conjunctival TNFα was seen when comparing subconjunctivally delivered ssAAV2-STC-1-FLAG to daily topical latanoprost.

Conclusions:

Subconjunctival delivery of the STC-1 transgene with a vector system may represent a novel treatment strategy for sustained IOP reduction and improved ocular tolerability that also avoids the daily dosing requirements of currently available medications.

Financial Disclosures:

Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

1,070

News (Medical) associated with Dexamethasone

23 Oct 2024

·www.prnewswire.com

Anti-CD38 mAb Market to Accelerate Substantially During the Study Period (2020-2034) Owing to a Strong Uptake of DARZALEX in Multiple Myeloma and Expected Entry of anti-CD38 mAbs in Autoimmune Diseases | DelveInsight

The anti-CD38 mAb market is projected to experience substantial growth in the coming years owing to strong uptake of DARZALEX (along with DARZALEX FASPRO), the expected entry of subcutaneous formulation of SARCLISA in Multiple Myeloma. This growth is also driven by a rising number of cancer and autoimmune disorder diagnoses, as well as an increasing number of Anti-CD38 mAbs undergoing clinical trials and seeking approval. LAS VEGAS, Oct. 23, 2024 /PRNewswire/ -- DelveInsight's Anti-CD38 mAb Market Insights report includes a comprehensive understanding of current treatment practices, emerging anti-CD38 mAb, market share of individual therapies, and current and forecasted anti-CD38 mAb market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Anti-CD38 mAb Market Report As per DelveInsight's analysis, the total market size of anti-CD38 mAb in the 7MM is expected to surge significantly by 2034. Multiple Myeloma is the only indication for which anti-CD38 therapies, Johnson&Johnson's (J&J) DARZALEX and Sanofi's SARCLISA have been approved until now. Around 50% of DARZALEX usage comes from second-line treatment in Multiple Myeloma. Additionally, in the frontline multiple myeloma clinical trials, DARZALEX has emerged triumphant, surpassing all expectations and solidifying its position as the gold standard of therapy. Its unparalleled effectiveness and exceptional safety profile have exceeded rivals' predictions and soon positioned DARZALEX to dominate the multiple myeloma market. The filing submission of SARCLISA subcutaneous in 3L R/R MM (IRAKLIA) is anticipated in 2025 and beyond. Somehow, SARCLISA is way behind DARZALEX in terms of market expansion, and DARZALEX has also got an early mover advantage of over 4 years. Multiple Myeloma is the leading indication, other emerging indications with commercial opportunity include Systemic Lupus Erythematosus (SLE), Chronic Kidney Disease (CKD), and IgA Nephropathy Leading emerging anti-CD38 mAb companies such as Takeda Pharmaceuticals, HI-Bio, Genmab, CASI Pharmaceuticals, and others are developing novel anti-CD38 mAb that can be available in the market in the coming years. Some of the key anti-CD38 mAb in the pipeline include Mezagitamab (TAK-079), Felzartamab, GEN3014, CID-103 , and others. In June 2024, data from the IMROZ Phase III study by Sanofi demonstrated that SARCLISA is the first anti-CD38 to significantly improve progression-free survival in combination with bortezomib, lenalidomide, and dexamethasone (VRd) for newly diagnosed transplant-ineligible multiple myeloma. In May 2024, Biogen and Human Immunology Biosciences (HI-Bio), announced the companies have entered into a definitive agreement under which Biogen has agreed to acquire HI-Bio for USD 1.15 billion upfront and up to USD 650 million in potential milestone payments. Discover which therapies are expected to grab the anti-CD38 mAb market share @ Anti-CD38 mAb Market Report Anti-CD38 mAb Market Dynamics The market for anti-CD38 mAbs has undergone significant growth and transformation in recent years, driven primarily by the increasing prevalence of multiple myeloma and the d emand for more effective treatment options. The market dynamics are further influenced by ongoing research into the broader application of anti-CD38 mAbs beyond multiple myeloma. There is growing interest in exploring their efficacy in other CD38-expressing malignancies, such as chronic lymphocytic leukemia and certain solid tumors. Additionally, research into combination therapies, where anti-CD38 mAbs are paired with immune checkpoint inhibitors, CAR-T cells, or other novel agents, is expanding the horizon for these treatments. Such advancements are likely to further propel the market, attracting substantial investment and fueling innovation. However, challenges such as biosimilar competition, pricing pressures, and the need for differentiation in a crowded market pose potential hurdles. The entrance of biosimilars could reduce costs but also threaten market share for existing products. Companies must navigate these challenges through strategic pricing, market access strategies, and continuous innovation to maintain their competitive edge. The anti-CD38 mAb market is poised for continued expansion, with a promising pipeline of new therapies and combinations on the horizon, making it a dynamic and evolving sector within oncology. Anti-CD38 mAb Treatment Market Monoclonal antibodies targeting CD38 are crucial in the treatment of newly diagnosed and refractory multiple myeloma. Currently, DARZALEX and SARCLISA are the two approved anti-CD38 therapies. SARCLISA is a prescription medication used to treat multiple myeloma in adults. It is administered alongside pomalidomide and dexamethasone for patients who have undergone at least two previous treatments, including lenalidomide and a proteasome inhibitor. Additionally, SARCLISA is used with carfilzomib and dexamethasone for patients who have received one to three prior therapies that were either ineffective or have stopped working. In March 2020, the US FDA approved SARCLISA in combination with pomalidomide and dexamethasone for multiple myeloma patients who had at least two prior therapies, including lenalidomide and a proteasome inhibitor. Later, in May 2020, the European Commission approved SARCLISA. By March 2021, the US FDA also approved SARCLISA with carfilzomib and dexamethasone for those with relapsed or refractory multiple myeloma who had received one to three previous treatments. DARZALEX is an innovative monoclonal antibody that the US FDA approved for treating multiple myeloma in patients with at least one prior treatment. It works by inducing tumor cell death through several mechanisms, including antibody-dependent cell-mediated cytotoxicity, complement-dependent cytotoxicity, and antibody-dependent cellular phagocytosis. In November 2015, the FDA granted DARZALEX accelerated approval as a monotherapy for multiple myeloma patients who had undergone at least three prior treatments. By November 2016, it was also approved for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for patients who had received at least one prior therapy. From 2015 to 2021, DARZALEX gained further approvals for use in various drug combinations. Their effectiveness in managing multiple myeloma and plasma cell disorders has been confirmed by numerous Phase III clinical trials. Moreover, CD38-targeted therapies are being explored for other conditions such as primary immune thrombocytopenia, IgA nephropathy, antibody-mediated transplant rejection, lupus nephritis, and various hematologic cancers. Learn more about the FDA-approved anti-CD38 mAb @ Anti-CD38 mAb Drugs Key Emerging Anti-CD38 mAb and Companies Several key players, including Takeda Pharmaceuticals, HI-Bio, CASI Pharmaceuticals, and others, are involved in developing drugs for Anti-CD38 mAb for various indications such as multiple myeloma, myasthenia gravis, and others. Mezagitamab is a fully human IgG1 monoclonal antibody that targets CD38 and is being developed by Takeda for the treatment of multiple myeloma, myasthenia gravis, and primary immune thrombocytopenia. On March 14, 2024, the FDA granted Fast Track designation and Orphan Drug status to mezagitamab for idiopathic thrombocytopenic purpura (ITP). Takeda also revealed plans to begin a global Phase III trial for mezagitamab in ITP later in 2024. The drug is currently in Phase II of clinical development. HI-Bio's leading candidate, felzartamab, is a fully human anti-CD38 monoclonal antibody. Clinical studies have demonstrated its ability to selectively target and deplete CD38+ cells, including plasma cells and NK cells, potentially enabling broader therapeutic applications and enhanced clinical outcomes across various immune-mediated diseases. Felzartamab has been granted Breakthrough Therapy and Orphan Drug Designations by the FDA for primary membranous nephropathy and also received Orphan Drug Designation for treating antibody-mediated kidney transplant recipients. Phase II trials have been completed for primary membranous nephropathy and antibody-mediated transplant rejection, with ongoing studies in IgA nephropathy. HI-Bio intends to progress each of these indications to Phase III. The anticipated launch of these emerging therapies are poised to transform the anti-CD38 mAb market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the anti-CD38 mAb market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about anti-CD38 mAb clinical trials, visit @ Anti-CD38 mAb Treatment Drugs Anti-CD38 mAb Overview Anti-CD38 monoclonal antibodies (mAbs) are a class of therapeutic agents that target CD38, a surface protein widely expressed on plasma cells, including malignant ones in multiple myeloma. By binding to CD38, these mAbs can induce direct cytotoxicity, promote antibody-dependent cellular cytotoxicity (ADCC), and facilitate complement-dependent cytotoxicity (CDC) to destroy the targeted cells. Beyond their role in multiple myeloma, anti-CD38 mAbs are being explored for their potential in treating other hematologic malignancies and autoimmune diseases. CD38 is not only a marker for plasma cells but also involved in processes like calcium signaling and NAD+ metabolism, which are crucial for cell survival and proliferation. By targeting CD38, these antibodies can modulate the immune microenvironment, making them a promising tool for both oncology and immunology. The ongoing research is focused on optimizing their efficacy, managing resistance, and exploring their use in combination with other immunotherapies to enhance patient outcomes. Anti-CD38 mAb Epidemiology Segmentation Epidemiology assessed for multiple myeloma showed that the United States, in 2023, accounted for 36,800 incident cases of multiple myeloma. The anti-CD38 mAb market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Incident Cases of Selected Indication for Anti-CD38 mAb Total Eligible Patient Pool for Anti-CD38 mAb in Selected Indication Total Treatable Cases of Selected Indications for Anti-CD38 mAb Scope of the Anti-CD38 mAb Market Report Anti-CD38 mAb Therapeutic Assessment: Anti-CD38 mAb current marketed and emerging therapies Anti-CD38 mAb Market Dynamics: Conjoint Analysis of Emerging Anti-CD38 mAb Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Anti-CD38 mAb Market Access and Reimbursement Discover more about anti-CD38 mAb in development @ Anti-CD38 mAb Clinical Trials Table of Contents Related Reports Multiple Myeloma Market Multiple Myeloma Market Insight, Epidemiology and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key multiple myeloma companies, including Johnson & Johnson (Janssen), Pfizer, AbbVie and Roche (Genentech), Regeneron Pharmaceuticals, Bristol-Myers Squibb, Celgene, Roche (Genentech), Arcellx, Novartis, Regeneron Pharmaceuticals, BeiGene, CARsgen Therapeutics, Cartesian Therapeutics, C4 Therapeutics, Heidelberg Pharma, Bristol-Myers Squibb, RAPA Therapeutics, AbbVie (TeneoOne), Takeda , among others. Multiple Myeloma Pipeline Multiple Myeloma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key multiple myeloma companies, including Janssen, Pharmacyclics, Novartis, Incyte Corporation, Gracell Biotechnology, SpringWorks Therapeutics, Sana Biotechnology, Cytovia Therapeutics, Pfizer, MorphoSys, Biokine Therapeutics, Arcellx, Rapa Therapeutics, iTeos Therapeutics, Sorrento Therapeutics, CARsgen, Ascentage Pharma, Cartesian Therapeutics, Bristol-Myers Squibb, Juno Therapeutics, Nanjing IASO Biotherapeutics, Arch Oncology, Oncoceutics, TeneoBio, Nerviano Medical Sciences, among others. Relapse/Refractory Multiple Myeloma Market Relapse/Refractory Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key R/R multiple myeloma companies, including NexImmune, Amgen, AbbVie, Allogene Therapeutics, Precision Biosciences, Takeda Oncology, ORIC Pharmaceuticals, Ionis Pharmaceuticals, Cellectis S.A., YZY Biopharma, Janssen Research & Development, Bristol Myers Squibb, Lava Therapeutics, Prelude Therapeutics, among others. Relapse/Refractory Multiple Myeloma Pipeline Relapse/Refractory Multiple Myeloma Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key R/R multiple myeloma companies, including Bristol-Myers Squibb, I-MAB Biopharma, Pfizer, Arcellx, Gilead Sciences, Novartis, Array Biopharma, Hrain Biotechnology Co., Ltd., Cartesian Therapeutics, Xencor, Takeda, Sorrento Therapeutics, Heidelberg Pharma AG, Ichnos Sciences, Allogene Therapeutics, Harpoon Therapeutics, Cellectis, Poseida Therapeutics, Regeneron Pharmaceuticals, ONK Therapeutics, TeneoOne, iTeos Therapeutics, Oricell Therapeutics, Anaveon AG, Luminary Therapeutics, Seagen Inc., Trillium Therapeutics Inc., Virtuoso BINco, Inc., Seagen Inc., Trillium Therapeutics Inc., among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Drug ApprovalOrphan DrugFast TrackPhase 3Immunotherapy

23 Oct 2024

·pipelinereview.com

DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible

Phase 3 PERSEUS study of daratumumab subcutaneous (SC) formulation in combination with bortezomib, lenalidomide and dexamethasone induction and consolidation, followed by daratumumab SC and lenalidomide maintenance showed a 58 percent reduction in risk of disease progression or death 1 New regimen reinforces daratumumab SC as a foundational element for optimising frontline treatment of patients with newly diagnosed multiple myeloma, and significantly delaying disease progression 2 BEERSE, Belgium I October 23, 2024 I Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) approved the indication extension for DARZALEX ® (daratumumab) subcutaneous (SC) formulation in combination with bortezomib, lenalidomide and dexamethasone (daratumumab-VRd) in patients with newly diagnosed multiple myeloma (NDMM) who are eligible for an autologous stem cell transplant (ASCT). 3 Patients will have the opportunity to receive this daratumumab SC-based quadruplet therapy at initial diagnosis, providing them with a new treatment shown to significantly improve outcomes. This approval is supported by data from the Phase 3 PERSEUS study, which evaluated daratumumab SC-based quadruplet regimen for induction and consolidation therapy, followed by daratumumab SC and lenalidomide (D-R) maintenance therapy, compared to bortezomib, lenalidomide and dexamethasone (VRd) during induction and consolidation, followed by lenalidomide (R) maintenance in 709 patients with NDMM eligible for ASCT. 4 “Multiple myeloma is a complex and highly varied disease, which reinforces the need for continuous innovation in first-line treatment strategies to deepen responses, reduce relapse and ultimately improve long-term outcomes,” said Dr. Paula Rodriguez-Otero, Department of Hematology, Cancer Center Clínica Universidad de Navarra, Pamplona, Navarra, Spain.* “The EC approval of this daratumumab SC-based quadruplet regimen offers a practice-changing new option, that has shown the potential to significantly improve progression-free survival, complete response rates, and MRD-negativity status compared to the current standard of care.” Findings from the PERSEUS study, after a median follow-up of 47.5 months, demonstrated a significant improvement in the primary endpoint of progression-free survival (PFS), with the daratumumab-VRd regimen reducing the risk of disease progression or death by 58 percent compared to VRd (hazard ratio [HR], 0.42; 95 percent confidence interval [CI], 0.30-0.59; p <0.0001). 1 Treatment with daratumumab-VRd resulted in deeper responses compared to VRd with overall minimal residual disease (MRD)-negativity rate assessed at 10 -5 of 75.2 percent vs 47.5 percent ( p <0.001), complete response or better of 87.9 percent vs 70.1 percent (p<0.001) and importantly, sustained MRD negativity for ≥12 months of 64.8 percent vs 29.7 percent, respectively. 1 “The European Commission’s approval of this daratumumab quadruplet regimen marks a pivotal step forward in the treatment of newly diagnosed multiple myeloma,” said Edmond Chan, MBChB, M.D. (Res), Senior Director, EMEA Therapeutic Area Lead Haematology, Innovative Medicine, Johnson & Johnson. “By incorporating daratumumab SC into this regimen we are further optimising frontline therapy for patients, building on our aim to transform outcomes, and establish new standards of care for eligible patients from induction through to maintenance.” The overall safety profile of daratumumab-VRd was consistent with the known safety profiles for daratumumab SC and VRd. 2 The most common haematologic adverse reactions (≥20 percent) in patients with multiple myeloma who received daratumumab-VRd vs VRd were neutropenia (69.2 percent vs 58.8 percent), thrombocytopenia (48.4 percent vs 34.3 percent) and anaemia (22.2 percent vs 20.7 percent). 2 The most common non-hematologic adverse reactions (≥20 percent) in patients with multiple myeloma who received daratumumab-VRd vs VRd were peripheral neuropathy (53.6 percent vs 51.6 percent), fatigue (23.9 percent vs 26.5 percent), peripheral oedema (20.5 percent vs 21.3 percent), pyrexia (31.6 percent vs 31.4 percent), upper respiratory infection (31.6 percent vs 25.1 percent), COVID-19 (35.0 percent vs 23.9 percent), constipation (33.9 percent vs 34.0 percent), diarrhoea (61.0 percent vs 54.2 percent), back pain (22.8 percent vs 19.0 percent), insomnia (27.1 percent vs 17.6 percent), asthenia (26.8 percent vs 25.6 percent) and rash (23.4 percent vs 27.1 percent). 2 “Since its first approval in 2016, over half a million patients worldwide have been treated with daratumumab, and today’s approval reinforces our commitment to bringing this transformative therapy to more patients as a first-line treatment, where it has the greatest potential for impact,” said Jordan Schecter, M.D., Vice President, Disease Area Leader, Multiple Myeloma, Innovative Medicine, Johnson & Johnson. “At Johnson & Johnson, we continually challenge ourselves to one day eliminate cancers like multiple myeloma, and today’s milestone marks a significant step toward achieving that goal.” About the PERSEUS study The PERSEUS study ( NCT03710603 ) is being conducted in collaboration with the European Myeloma Network as the sponsor. 4 PERSEUS is an ongoing, randomised, open-label, Phase 3 study comparing the efficacy and safety of daratumumab-VRd and autologous stem cell transplant (ASCT) followed by D-R maintenance vs VRd and ASCT followed by R maintenance in patients with TE NDMM (n=355). 2 The primary endpoint is PFS, and secondary endpoints include overall complete response or better rate, overall MRD-negativity (in patients with complete response or better), and OS. 2 Daratumumab SC was discontinued after at least 24 months of D-R maintenance therapy in patients who had a complete response or better and had sustained MRD-negative status for at least 12 months. 2 The median age is 61.0 (range, 32-70) years for patients in the daratumumab-VRd arm and 59.0 (range, 31-70) years for patients in the VRd arm. 2 The study is being conducted in 13 countries in Europe and Australia. 4 Data from the PERSEUS study were featured as a late-breaking oral presentation (LBA-1) at the 2023 American Society of Hematology (ASH) Annual Meeting and were simultaneously published in The New England Journal of Medicine in 2023. About Daratumumab and Daratumumab SC Johnson & Johnson is committed to exploring the potential of daratumumab for patients with multiple myeloma across the spectrum of the disease. In August 2012 , Janssen Biotech, Inc., a Johnson & Johnson company and Genmab A/S entered a worldwide agreement, which granted Johnson & Johnson an exclusive licence to develop, manufacture and commercialise daratumumab. Since launch, daratumumab has become a foundational therapy in the treatment of multiple myeloma, having been used in the treatment of more than 548,000 patients worldwide. 5 Daratumumab is the only CD38-directed antibody approved to be given subcutaneously to treat patients with multiple myeloma. 2 Daratumumab SC is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE ® drug delivery technology. 6 CD38 is a surface protein that is present in high numbers on multiple myeloma cells, regardless of the stage of disease. 3 Daratumumab binds to CD38 and inhibits tumour cell growth causing myeloma cell death. 3 Daratumumab may also have an effect on normal cells. 3 Data across ten Phase 3 clinical trials, in both the frontline and relapsed settings, have shown that daratumumab-based regimens resulted in significant improvement in progression-free survival and/or overall survival. 7,8,9,10,11,12,13,14,15,16 For further information on daratumumab, please see the Summary of Product Characteristics at: https://www.ema.europa.eu/en/documents/product-information/darzalex-epar-product-information_en.pdf . About Multiple Myeloma Multiple myeloma is currently an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow. 17,18 In multiple myeloma, these malignant plasma cells continue to proliferate, accumulating in the body and crowding out normal blood cells, as well as often causing bone destruction and other serious complications. 18 In the European Union, it is estimated that more than 35,000 people were diagnosed with multiple myeloma in 2022, and more than 22,700 patients died. 19 Whilst some patients with multiple myeloma initially have no symptoms, others can have common signs and symptoms of the disease, which can include bone fracture or pain, low red blood cell counts, fatigue, high calcium levels, infections, or kidney damage. 20 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.innovativemedicine.jnj.com/emea. Follow us at www.linkedin.com/company/jnj-innovative-medicine-emea . Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., and Janssen Research & Development, LLC are Johnson & Johnson companies. 1 Rodriguez-Otero P, et al., Daratumumab (DARA) + bortezomib/lenalidomide/dexamethasone (VRd) in transplant-eligible (TE) patients (pts) with newly diagnosed multiple myeloma (NDMM): Analysis of minimal residual disease (MRD) in the PERSEUS trial. ASCO 2024. Oral presentation. 7502. 2 Sonneveld P, et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med 2024; 390:301-313. 3 European Medicines Agency. DARZALEX (daratumumab) Summary of Product Characteristics. October 2024. 4 ClinicalTrials.gov. Identifier NCT03710603. https://www.clinicaltrials.gov/study/NCT03710603 . Last accessed: October 2024. 5 Johnson & Johnson [data on file]. RF-430506. Number of patients treated with DARZALEX ® worldwide as of 30 June 2024. 6 Janssen EMEA. European Commission Grants Marketing Authorisation for DARZALEX ® (Daratumumab) Subcutaneous Formulation for All Currently Approved Daratumumab Intravenous Formulation Indications. Available at: www.businesswire.com/news/home/20200604005487/en/European-Commission-GrantsMarketingAuthorisation-for-DARZALEX%C2%AE%E2%96%BC-daratumumab-SubcutaneousFormulation-for-all-CurrentlyApproved-Daratumumab-Intravenous-Formulation-Indications . Last accessed: October 2024. 7 Moreau P, et al. Bortezomib, thalidomide, and dexamethasone with or without daratumumab before and after autologous stem-cell transplantation for newly diagnosed multiple myeloma (CASSIOPEIA): a randomised, openlabel, phase 3 study. Lancet 2019;394(10192):29-38. 8 Facon T, et al. MAIA Trial Investigators. Daratumumab plus Lenalidomide and Dexamethasone for Untreated Myeloma. N Engl J Med 2019;380(22):2104-2115. 9 Mateos MV, et al. Overall survival with daratumumab, bortezomib, melphalan, and prednisone in newly diagnosed multiple myeloma (ALCYONE): a randomised, open-label, phase 3 trial. The Lancet 2020;395:P132-141. 10 Dimopoulos MA, et al. APOLLO Trial Investigators. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol 2021;22(6):801-812. 11 Palladini G, et al. Daratumumab plus CyBorD for patients with newly diagnosed AL amyloidosis: safety run-in results of ANDROMEDA. Blood 2020;2;136(1):71-80. 12 Chari A, et al. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood 2017;130(8):974-981. 13 Bahlis NJ, et al. Daratumumab plus lenalidomide and dexamethasone in relapsed/refractory multiple myeloma: extended follow-up of POLLUX, a randomized, open-label, phase 3 study. Leukemia 2020;34(7):1875-1884. 14 Mateos MV, et al. Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Patients With Previously Treated Multiple Myeloma: Three-year Follow-up of CASTOR. Clin Lymphoma Myeloma Leuk 2020;20(8):509-518. 15 Sonneveld, P. et al. Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med 2024;390(4):301-313. DOI: 10.1056/NEJMoa23120 16 Usmani, S Z. et al. Daratumumab + Bortezomib/Lenalidomide/Dexamethasone in Patients With Transplant-ineligible or Transplant-deferred Newly Diagnosed Multiple Myeloma: Results of the Phase 3 CEPHEUS Study. Oral presentation. 21 st International Myeloma Society (IMS) Annual Meeting. September 25 – 28, 2024. 17 Abdi J, et al. Drug resistance in multiple myeloma: latest findings on molecular mechanisms. Oncotarget 2013;4(12):2186-2207. 18 American Society of Clinical Oncology. Multiple myeloma: introduction. Available at: https://www.cancer.net/cancer-types/multiple-myeloma/introduction. Last accessed: October 2024. 19 ECIS – European Cancer Information System. Estimates of cancer incidence and mortality in 2022, by country. Multiple myeloma. Available at: https://ecis.jrc.ec.europa.eu/explorer.php?$0-0$1-All$2-All$4-1,2$3-51$6-0,85$5-2022,2022$7-7$CEstByCountry$X0_8-3$X0_19-AE27$X0_20-No$CEstBySexByCountry$X1_8-3$X1_19-AE27$X1_-1-1$CEstByIndiByCountry$X2_8-3$X2_19-AE27$X2_20-No$CEstRelative$X3_8-3$X3_9-AE27$X3_19-AE27$CEstByCountryTable$X4_19-AE27 . Last accessed: October 2024. 20 American Cancer Society. Multiple myeloma: early detection, diagnosis and staging. Available at: https://www.cancer.org/content/dam/CRC/PDF/Public/8740.00.pdf . Last accessed: October 2024. SOURCE: Janssen

Phase 3Clinical ResultDrug ApprovalLicense out/inASH

23 Oct 2024

·www.pharmaceutical-technology.com

J&J’s Darzalex combination gains expanded label for multiple myeloma in Europe

J&J’s Darzalex-VRd can now be given to newly diagnosed MM patients eligible for ASCT. Credit: Michael Vi/Shutterstock The European label for Johnson and Johnson Innovation Medicine’s (J&J) Darzalex (daratumumab) has been expanded to include patients with newly diagnosed multiple myeloma (MM) eligible for autologous stem cell transplant (ASCT). The label expansion for the anti-CD38 antibody was supported by data from the ongoing Phase III PERSEUS trial that was submitted to to the European Medicines Agency in March 2024. Darzalex initially received approval as a monotherapy for MM from the EC in May 2016. Along with MM, the antibody is marketed for treating primary system amyloidosis, and is in clinical studies for a range of oncological, immunological, and metabolic disorders. Projections from GlobalData estimate the drug will generate $11.5bn in revenue this year, set to increase to an annual $20bn in revenue by 2030. GlobalData is the parent company of Pharmaceutical Technology . See Also: TreeFrog and University of Pittsburgh probe TLS role in immuno-oncology Be Bio raises $82m to advance haemophilia B gene therapy to Phase I/II trial Co-formulated with Halozyme’s Enhanze drug delivery technology, Darzalex is the only subcutaneous, CD38-targeting MM treatment approved. The PERSEUS trial (NCT03710603) found that a Darzalex-VRd quadruple regimen resulted in a 58% reduced risk of disease progression or death compared to bortezomib, lenalidomide, and dexamethasone alone. Among 709 randomised MM patients, Darzalex therapy led to improved minimal residual disease (MRD) negativity (75.2% vs 47.5%), complete response (87.9% vs 70.1%), and sustained MRD negativity for ≥12 months (64.8% vs 29.7%). The quadruple regimen of Darzalex with bortezomib, lenalidomide, and dexamethasone received US Food and Drug Administration (FDA) approval for the same indication in July 2024, following FDA approvals to treat MM for Darzalex with bortezomib, thalidomide and dexamethasone (VDd) in 2019 and as a monotherapy in 2015. In the UK, Darzalex monotherapy was approved to treat MM by the National Institute for Health and Care Excellence (NICE) in January 2018. NICE later published guidance recommending Darzalex VDd for MM in April 2023.

Phase 3Drug ApprovalImmunotherapyGene Therapy

100 Deals associated with Dexamethasone

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KEGG	Wiki	ATC	Drug Bank
D00292	Dexamethasone	D07AB19 H02AB02 D10AA03	DB01234

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Immunoglobulin Light-Chain Amyloidosis	JP	Nichi-Iko Pharmaceutical Co., Ltd.	25 Aug 2021
Ocular inflammation	US	Ocular Therapeutix, Inc.	30 Nov 2018
Ophthalmologic surgical procedures	US	Ocular Therapeutix, Inc.	30 Nov 2018
Post procedural inflammation	US	EyePoint Pharmaceuticals, Inc.	09 Feb 2018
Diabetic macular oedema	EU	AbbVie Deutschland GmbH & Co. KG	26 Jul 2010
Diabetic macular oedema	IS	AbbVie Deutschland GmbH & Co. KG	26 Jul 2010
Diabetic macular oedema	LI	AbbVie Deutschland GmbH & Co. KG	26 Jul 2010
Diabetic macular oedema	NO	AbbVie Deutschland GmbH & Co. KG	26 Jul 2010
Retinal vein occlusion-related macular edema	EU	AbbVie Deutschland GmbH & Co. KG	26 Jul 2010
Retinal vein occlusion-related macular edema	IS	AbbVie Deutschland GmbH & Co. KG	26 Jul 2010
Retinal vein occlusion-related macular edema	LI	AbbVie Deutschland GmbH & Co. KG	26 Jul 2010
Retinal vein occlusion-related macular edema	NO	AbbVie Deutschland GmbH & Co. KG	26 Jul 2010
Uveitis, Posterior	EU	AbbVie Deutschland GmbH & Co. KG	26 Jul 2010
Uveitis, Posterior	IS	AbbVie Deutschland GmbH & Co. KG	26 Jul 2010
Uveitis, Posterior	LI	AbbVie Deutschland GmbH & Co. KG	26 Jul 2010
Uveitis, Posterior	NO	AbbVie Deutschland GmbH & Co. KG	26 Jul 2010
Multiple Myeloma	JP	Bristol Myers Squibb Co.	18 Jun 2010
Retinal Vein Occlusion	US	AbbVie, Inc.	17 Jun 2009
Nausea and vomiting	JP	Nichi-Iko Pharmaceutical Co., Ltd.	15 Sep 2005
Blepharitis	JP	Santen Pharmaceutical Co., Ltd.	03 Feb 1970

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Pain, Postoperative	NDA/BLA	SG	AffaMed Therapeutics Co., Ltd.	19 Feb 2024
Endophthalmitis	Phase 3	US	Oculis SA	18 Dec 2023
Uveitis	Phase 3	CN	Ocumension Therapeutics	22 Aug 2022
Pain	Phase 3	US	Oculis SA	01 Jun 2022
Retinal Neoplasms	Phase 3	US	AbbVie, Inc.	12 Oct 2021
Plasmacytoma	Phase 3	US	Biologics, Inc.	01 Dec 2015
Plasmacytoma	Phase 3	US	Millennium Pharmaceuticals, Inc.	01 Dec 2015
Meniere Disease	Phase 3	US	Otonomy, Inc.	27 Oct 2015
Eye Pain	Phase 3	-	Ocular Therapeutix, Inc.	01 Apr 2014
Cataract	Phase 3	US	Icon Bioscience, Inc.	01 Jan 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01255358 (IEDAT-01, CTgov)	Phase 2	Ataxia Telangiectasia	22	Dexamethasone (ERY-DEX)	wxrraquozt(ypbfwmwhfi) = dyoxktkxin hvlglcwpwu (lbbjericld, gajyejeswc - vmrwwlqefl) View more	-	10 Oct 2024
				Dexamethasone (Ery-Dex)	kpyyjuitvz(helppxjzxb) = beiqtdpkzi zulydpvgwk (jjiznuydke, rwftonfwir - ivohoydemy) View more
NCT02692248 (phase II, CTgov)	Phase 2	Diffuse Large B-Cell Lymphoma \| Diffuse large B-cell lymphoma recurrent	64	Ibrutinib+Gemcitabine+Oxaliplatin+Dexamethasone+Rituximab	fistiyjtyl(pcijomimwy) = kfunlqcago buolhbbtxp (bmjfcvsbym, gmfjwftuyu - gmrbzzeqou) View more	-	10 Oct 2024
NCT02004275 (Alliance A061202, Pubmed \| Blood Adv) Manual	Phase 2	Relapse multiple myeloma	30	Ixazomib, Pomalidomide, Dexamethasone	tqzyrmxeph(oxnayoxtai) = More hematologic toxicities were seen with the triplet therapy vlscofgclp (iyiphrzeac ) View more	Positive	08 Oct 2024
				Pomalidomide, Dexamethasone
NCT03859024 (CTgov)	Phase 4	Urethral Stricture \| Pain, Postoperative	48	Acetaminophen+Ibuprofen 800 mg+Oxycodone (Standard Protocol)	oftmbgitzx(mqwcenqnlp) = ajpeemmumv tmudtkjhve (nfunfzpfkw, ikjrqmgnux - xuylnbxogg) View more	-	19 Sep 2024
				Acetaminophen+Ibuprofen 800 mg+celebrex+Dexamethasone+Oxycodone+Bupivacaine+Gabapentin (Enhanced Recovery Protocol)	oftmbgitzx(mqwcenqnlp) = zdqzvlxjrf tmudtkjhve (nfunfzpfkw, igrhssiwcm - cjelgrrlxa) View more
NCT02002598 (CTgov)	Phase 1/2	Multiple Myeloma	23	Bendamustine+Carfilzomib+Dexamethasone	eeszlddrip(ryeenvpenc) = xpyokkkurp fmqqlddbxx (yhvkinetpb, awccddltgg - andnsfauwc) View more	-	19 Sep 2024
ESMO2024	Not Applicable	Neoplasms	-	Dexamethasone	wvybebfvvd(wutqfvhdqh) = ijbwzgowsg utexygoubc (hhdjcinmtu, 0.2) View more	-	15 Sep 2024
				Placebo	wvybebfvvd(wutqfvhdqh) = xwcxkniitx utexygoubc (hhdjcinmtu, 0.3) View more
NCT04879823 (CTgov)	Phase 3	Analgesia	222	Acetaminophen+Ibuprofen+Dexamethasone (Dexamethasone)	jstthhhmps(pokyypedui) = vknkaeozrj dxokwqiwft (bbkjwbukvn, knzxbbjmiq - szepmqzvnq) View more	-	05 Sep 2024
				Placebo+Acetaminophen+Ibuprofen (Placebo)	jstthhhmps(pokyypedui) = uebcrweuwr dxokwqiwft (bbkjwbukvn, jmwimazvfl - ljrkbfyfpl) View more
NCT06086418 (Pubmed \| Reg Anesth Pain Med)	Phase 4	Adjuvant neutrophil-to-lymphocyte ratio (NLR) \| platelet-to-lymphocyte ratio (PLR)	90	0.5% ropivacaine with saline	qzkmdovcqh(naqpyystzg) = lcyiqndyca nfycinzoyt (loniwnixou, 1.1)	Positive	29 Aug 2024
				0.5% ropivacaine plus dexamethasone 0.1 mg/kg	qzkmdovcqh(naqpyystzg) = mwdllnknxz nfycinzoyt (loniwnixou, 2.5)
NCT04650893 (CTgov)	Phase 3	Deglutition Disorders \| Dysphonia \| Specific Language Disorder	33	Placebo (Control)	ynstxktjac(jbwpnnlxwe) = ujhbjpxjzk gndinizucb (rwcklutzzy, ebmyzkyipp - ysbpqmqlvx) View more	-	23 Aug 2024
				Intravenous Ketorolac (Ketorolac)	ynstxktjac(jbwpnnlxwe) = thvrzgukwr gndinizucb (rwcklutzzy, ajfyjnwiif - wyoauwjuve) View more
NCT04836780 (EARLY-DEX COVID-19, Pubmed)	Phase 3	COVID-19 elevated lactate dehydrogenase levels \| C-reactive protein levels \| lymphocyte count	-	Dexamethasone	ebwdhsuqjo(txogkajxcl) = hbbseundnb amtylmuezm (qwztnyxgpx ) View more	Negative	17 Jul 2024
				dexamethasone (Standard care)	egqnqciifx(bwahlgbjfn) = fyxwrfqxsr arrlbojkpl (zesahfetxm )

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