Last update 21 Dec 2024

Hydroxychloroquine Sulfate

Last update 21 Dec 2024

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

(±)-hydroxychloroquine, 2-((4-((7-chloro-4-quinolyl)amino)pentyl)ethylamino)ethanol, 2-(N-(4-(7-chlor-4-chinolylamino)-4-methylbutyl)ethylamino)ethanol

+ [22]

Target-

Mechanism

Autophagy inhibitors

Therapeutic Areas

Immune System DiseasesInfectious DiseasesSkin and Musculoskeletal Diseases+ [4]

Active Indication

Lupus Erythematosus, DiscoidMalariaLupus Erythematosus, Cutaneous+ [8]

Inactive Indication

COVID-19Primary Sjögren's syndrome

Originator Organization

Sanofi

Active Organization

Novartis AG

Novitium Pharma LLCStartup

Shanghai Zhongxi Sunve Pharmaceutical Co., Ltd.

+ [4]

Inactive Organization

SanofiPulmoquine Therapeutics, Inc

Sandoz International GmbH

+ [3]

Drug Highest PhaseApproved

First Approval Date

US (18 Apr 1955),

Acute MalariaRheumatoid ArthritisSystemic Lupus Erythematosus

Regulation-

Structure

Molecular FormulaC18H28ClN3O5S

InChIKeyJCBIVZZPXRZKTI-UHFFFAOYSA-N

CAS Registry747-36-4

619

Clinical Trials associated with Hydroxychloroquine Sulfate

NCT06408298 / Not yet recruitingEarly Phase 1IIT

A Randomized, Placebo Controlled Proof of Principle (Window of Opportunity) Study of Hydroxychloroquine (HCQ) in Prostate Cancer Patients Undergoing Radical Prostatectomy

This is randomized, double blind, placebo controlled proof of principle (window of opportunity) study of oral hydroxychloroquine in patients with resectable localized prostate cancer. To determine the effects of hydroxychloroquine (HCQ) on markers of autophagy, such as p62, LC3-II and NBR-1 in prostate cancer tissue of patients with resectable localized prostate cancer who undergo radical prostatectomy. To monitor/observe the safety and tolerability of daily oral hydroxychloroquine in the pre and perioperative period in patients who undergo radical prostatectomy. To evaluate the concentration of hydroxychloroquine in normal and prostate tumor tissue and to correlate prostate tissue concentrations with the plasma concentrations in these patients. To perform tumor genomic analysis (for common somatic mutations) and to correlate the molecular response to HCQ and presence/absence of such mutations.

Start Date01 Jan 2025

Sponsor / Collaborator

Dartmouth-Hitchcock Medical Center

NCT06652113 / Not yet recruitingNot ApplicableIIT

The Efficacy of Hydroxychloroquine Combined With Levothyroxine in Euthyroid Women With Thyroid Antibody Positive and Unexplained Recurrent Pregnancy Loss：A Multicenter, Randomized Controlled Study

The goal of this clinical trial is to learn if combined treatment of levothyroxine and hydroxychloroquine would improve the live birth of euthyroid women with thyroid peroxidase antibodies and unexplained recurrent pregnancy loss.
Researchers will compare combined treatment of levothyroxine and hydroxychloroquine to a treatment of levothyroxine alone to see if combined treatment works to improve live birth of euthyroid participants with thyroid peroxidase antibodies and unexplained recurrent pregnancy loss.
Participants will:
* Receive combined treatment of levothyroxine and hydroxychloroquine or treatment of levothyroxine alone every day at least 8 weeks before pregnancy, and continue their treatment till the end of pregnancy.
* Visit the clinic 4 weeks and 8 weeks after their treatments, and every 12 weeks before they get pregnant for checkups and tests. During their pregnancy, they will visit the clinic before gestation of 12 weeks, and will be followed up with phone call in the second trimester and after parturition.

Start Date01 Dec 2024

Sponsor / Collaborator

Sun Yat-Sen University

NCT06350630 / Not yet recruitingPhase 2IIT

Therapeutic Effect of Hydroxychloroquine on Immunoglobulin A (IgA)Nephropathy Course QUIgAN Study

immunoglobulin A (IgA) nephropathy (Berger disease) is the most frequent primary glomerulonephritis worldwide. This disease accounts for about 5% of the causes of end stage renal disease in France, representing a major public health issue. Its pathophysiology seems to be triggered by mucosal immunity abnormalities leading to the systemic misaddressing of mucosal IgA, generation of circulating immunoglobulin A1 (IgA1) immune complexes finally deposited in renal glomeruli leading to renal tissue inflammation and scarring processes. Among this pathogeny, innate immunity is involved at several steps, including mucosal immunity.
In this regard, hydroxychloroquine has been shown to generate a global anti-inflammatory effect, particularly through its action on Toll like receptors and dendritic cells. This drug is well tolerated, widely used for other auto-immune diseases (e.g. Systemic Lupus Erythematosus) and very low priced.
One randomized controlled study conducted in China has recently shown a significant drop in proteinuria of IgA nephropathy patients treated with hydroxychloroquine (-48.4%) compared to the placebo group (+10.0%), after a quite short-term follow-up (6 months) and a moderate statistical power (30 patients in each group).
Considering (i) the potential mechanism of therapeutic effect on this disease, (ii) the well documented safety profile of the drug for rheumatologic indications and posologies, and its low cost (iii) its efficacy in reducing proteinuria in IgA nephropathy patients in a preliminary Chinese randomized control study, the investigators aim in this study at establishing the beneficial impact of hydroxychloroquine on IgA nephropathy in a double blind randomized controlled trial on a Caucasian French population with harder outcomes and a longer follow-up compared to the Chinese preliminary study.

Start Date01 Dec 2024

Sponsor / Collaborator

Centre Hospitalier Universitaire de Saint-Etienne

100 Clinical Results associated with Hydroxychloroquine Sulfate

100 Translational Medicine associated with Hydroxychloroquine Sulfate

100 Patents (Medical) associated with Hydroxychloroquine Sulfate

9,205

Literatures (Medical) associated with Hydroxychloroquine Sulfate

01 Mar 2025·Current diabetes reviews

Interferon Upregulation Associates with Insulin Resistance in Humans

Review

Author: Castro-Quintela, Elvira ; Adeva-Andany, Maria M. ; Carneiro-Freire, Natalia ; Adeva-Contreras, Lucia ; Fernandez-Fernandez, Carlos ; Ameneiros-Rodriguez, Eva

In humans, insulin resistance is a physiological response to infections developed to supply sufficient energy to the activated immune system. This metabolic adaptation facilitates the immune response but usually persists after the recovery period of the infection and predisposes the hosts to type 2 diabetes and vascular injury. In patients with diabetes, superimposed insulin resistance worsens metabolic control and promotes diabetic ketoacidosis. Pathogenic mechanisms underlying insulin resistance during microbial invasions remain to be fully defined. However, interferons cause insulin resistance in healthy subjects and other population groups, and their production is increased during infections, suggesting that this group of molecules may contribute to reduced insulin sensitivity. In agreement with this notion, gene expression profiles [transcriptomes] from patients with insulin resistance show a robust overexpression of interferon-stimulated genes [interferon signature]. In addition, serum levels of interferon and surrogates for interferon activity are elevated in patients with insulin resistance. Circulating levels of interferon-γ-inducible protein-10, neopterin, and apolipoprotein L1 correlate with insulin resistance manifestations, such as hypertriglyceridemia, reduced HDL-c, visceral fat, and homeostasis model assessment-insulin resistance. Furthermore, interferon downregulation improves insulin resistance. Antimalarials such as hydroxychloroquine reduce interferon production and improve insulin resistance, reducing the risk for type 2 diabetes and cardiovascular disease. In addition, diverse clinical conditions that feature interferon upregulation are associated with insulin resistance, suggesting that interferon may be a common factor promoting this adaptive response. Among these conditions are systemic lupus erythematosus, sarcoidosis, and infections with severe acute respiratory syndrome-coronavirus-2, human immunodeficiency virus, hepatitis C virus, and Mycobacterium tuberculosis.

01 Mar 2025·CURRENT PHARMACEUTICAL DESIGN

Network Pharmacological Analysis of Hydroxychloroquine Intervention in the Treatment of Iga Nephropathy

Article

Author: Guo, Kanglin ; Duo, Qian ; Zou, Mengxiao ; Cheng, Yichun ; Ge, Shuwang ; Xu, Gang

Background::

IgA nephropathy (IgAN) is the most prevalent primary glomerulonephritis globally and has a high propensity to develop into end-stage renal disease (ESRD). Hydroxychloroquine has been proven to reduce proteinuria in IgAN patients, but the precise mechanism remains unclear. Therefore, network pharmacology was used to investigate the mechanism.

Methods::

PubChem and SwissADME databases were utilized to acquire the structure of hydroxychloroquine. The SwissTargetPrediction, PharmMapper, DrugBank, TargetNet, and BATMAN-TCM databases were then utilized to obtain the targets. The target genes related to IgAN were then gathered from the databases, which included GeneCards, PHARMGKB, DrugBank, OMIM, and DisGeNET. Common targets were obtained by UniProt. Gene Ontology (GO) and Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analyses were performed to define the main molecular mechanisms and pathways. Furthermore, a protein-protein interaction (PPI) network was constructed using the STRING tool, and the core targets were obtained by Cytoscape. Finally, molecular docking between the core targets and hydroxychloroquine was performed.

Results::

167 common target genes were acquired by overlapping. The core targets were TNF, ALB, IL1B, JUN, FOS, SRC, and MMP9. The GO and KEGG results showed the targets to be related to the production of inflammatory cytokines and chemokines and were engaged in the toll-like receptor (TLR) signaling pathway. At the same time, the molecular docking results showed that the core targets all combined with hydroxychloroquine closely.

Conclusion::

This study proved that hydroxychloroquine may treat IgAN through the TLR signaling pathway, and the restraint of TNF, TLR, IL1B, and JUN may be essential for the treatment.

01 Jan 2025·JOURNAL OF COLLOID AND INTERFACE SCIENCE

LaCo0.95Mo0.05O3/CeO2 composite can promote the effective activation of peroxymonosulfate via Co3+/Co2+ cycle and realize the efficient degradation of hydroxychloroquine sulfate

Article

Author: Ding, Huiwen ; Wang, Jianqiao ; Xiao, Pengfei ; Xie, Haijiao ; Jiang, Tianqi

Hydroxychloroquine sulfate (HCQ) is extensively utilized due to its numerous therapeutic effects. Because of its properties of high solubility, persistence, bioaccumulation, and biotoxicity, HCQ can potentially affect water bodies and human health. In this study, the LaCo_0.95Mo_0.05O₃-CeO₂ material was successfully prepared by the sol-gel process, and it was applied to the experiment of degrading HCQ by activating peroxymonosulfate (PMS). The results of characterization analysis showed that LaCo_0.95Mo_0.05O₃-CeO₂ material had good stability, and the problem of particle agglomeration had been solved to some extent. Compared with LaCo_0.95Mo_0.05O₃ material, it had a larger specific surface area and more oxygen vacancies, which was helpful to improve the catalytic activity for PMS. Under optimal conditions, the LaCo_0.95Mo_0.05O₃-CeO₂/PMS system degraded 95.5 % of HCQ in 10 min. The singlet oxygen, superoxide radicals, and sulfate radicals were the main radicals for HCQ degradation. The addition of Mo⁶⁺/Mo⁴⁺ and Ce⁴⁺/Ce³⁺ promoted the redox cycle of Co³⁺/Co²⁺ and enhanced the degradation rate of HCQ. Based on density functional theory and experimental analysis, three HCQ degradation pathways were proposed. The analysis of T.E.S.T software showed that the toxicity of HCQ was obviously reduced after degradation. The LaCo_0.95Mo_0.05O₃-CeO₂/PMS system displayed excellent reusability and the ability to remove pollutants in a wide range of real-world aqueous environments, with the ability to treat a wide range of pharmaceutical wastewater. In summary, this study provides some ideas for developing heterogeneous catalysts for advanced oxidation systems and provide an efficient, simple, and low-cost method for treating pharmaceutical wastewater that has good practical application potential.

News (Medical) associated with Hydroxychloroquine Sulfate

19 Nov 2024

·www.prnewswire.com

Systemic Lupus Erythematosus Clinical Trial Pipeline Gains Momentum as 120+ Key Companies at the Forefront | DelveInsight

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease characterized by inflammation and tissue damage across multiple organ systems, such as the skin, joints, kidneys, heart, and brain. The incidence of autoimmune diseases, including SLE, has been increasing globally, with a significant impact on demand for targeted and effective therapies. LAS VEGAS, Nov. 19, 2024 /PRNewswire/ -- DelveInsight's ' Systemic Lupus Erythematosus Pipeline Insight 2024 ' report provides comprehensive global coverage of pipeline systemic lupus erythematosus therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the systemic lupus erythematosus pipeline domain. Key Takeaways from the Systemic Lupus Erythematosus Pipeline Report DelveInsight's systemic lupus erythematosus pipeline report depicts a robust space with 120+ active players working to develop 140+ pipeline therapies for systemic lupus erythematosus treatment. Key systemic lupus erythematosus companies such as Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others are evaluating new systemic lupus erythematosus drugs to improve the treatment landscape. Promising systemic lupus erythematosus pipeline therapies such as Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others are under different phases of systemic lupus erythematosus clinical trials. In October 2024, the FDA approved the investigational new drug (IND) application for Cullinan Therapeutics' CLN-978 to treat systemic lupus erythematosus (SLE). In September 2024, Cartesian Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis (JDM). In September 2024, Caribou Biosciences announced that the U.S. Food and Drug Administration (FDA) had granted fast-track designation to CAR T-cell therapy CB-010 for systemic lupus erythematosus (SLE). In September 2024, UCB and Biogen reported successful results from their Phase III clinical trial of the PHOENYCS GO study, which tested dapirolizumab pegol as a treatment for moderate-to-severe systemic lupus erythematosus. In August 2024, Conduit Pharmaceuticals announced they will be conducting a Phase IIa clinical trial to evaluate AZD1656 for the treatment of multiple autoimmune diseases, including systemic lupus erythematosus (SLE). In July 2024, the first individual received the therapy Descartes-08 to treat systemic lupus erythematosus. This therapy has been previously administered to patients with myasthenia gravis, a long-term autoimmune disorder characterized by muscle weakness. In February 2024, Idorsia Pharmaceuticals formed a major global research and development partnership with Viatris to advance and commercialize two Phase III assets, selatogrel and cenerimod, on a global scale. Request a sample and discover the recent advances in systemic lupus erythematosus treatment drugs @ Systemic Lupus Erythematosus Pipeline Report The systemic lupus erythematosus pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage systemic lupus erythematosus drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the systemic lupus erythematosus clinical trial landscape. Systemic Lupus Erythematosus Overview Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which the immune system mistakenly attacks healthy tissues in various parts of the body. The exact cause of SLE is unknown, but it is believed to result from a combination of genetic, environmental, and hormonal factors. Common triggers include infections, sunlight exposure, and certain medications. Women, particularly of childbearing age, are more commonly affected. Symptoms of SLE vary widely and can affect many organ systems, leading to a wide range of clinical presentations. Common symptoms include fatigue, joint pain, skin rashes, photosensitivity, and fever. More severe cases can affect the kidneys, heart, lungs, and central nervous system, potentially leading to life-threatening complications. Diagnosis of SLE is based on a combination of clinical features and laboratory tests. The antinuclear antibody (ANA) test is a common initial screening tool, but additional tests like anti-double stranded DNA (anti-dsDNA) and anti-Smith antibodies, as well as assessments of kidney and liver function, are often necessary. Diagnosis can be challenging because SLE symptoms often mimic those of other diseases. Treatment for SLE focuses on managing symptoms and preventing flares. Mild cases may be treated with nonsteroidal anti-inflammatory drugs (NSAIDs) and antimalarial drugs like hydroxychloroquine. More severe cases may require corticosteroids, immunosuppressive drugs such as azathioprine, methotrexate, or newer biologics like belimumab. Lifestyle modifications, such as avoiding excessive sun exposure and managing stress, are also essential in controlling the disease. Find out more about systemic lupus erythematosus treatment drugs @ Drugs for Systemic Lupus Erythematosus Treatment A snapshot of the Systemic Lupus Erythematosus Pipeline Drugs mentioned in the report: Learn more about the emerging systemic lupus erythematosus pipeline therapies @ Systemic Lupus Erythematosus Clinical Trials Systemic Lupus Erythematosus Therapeutics Assessment The systemic lupus erythematosus pipeline report proffers an integral view of the systemic lupus erythematosus emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Systemic Lupus Erythematosus Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Intra-articular, Intraocular, Intrathecal, Intravenous, Ophthalmic, Oral, Parenteral, Subcutaneous, Topical, Transdermal Therapeutics Assessment By Molecule Type: Oligonucleotide, Peptide, Small molecule Therapeutics Assessment By Mechanism of Action: Antibody-dependent cell cytotoxicity, Cell death inhibitors, Cell death stimulants, Immunomodulators, CD40 ligand inhibitors, Sphingosine 1 phosphate receptor modulators, Calcineurin inhibitors, Immunosuppressants, Janus kinase 1 inhibitors, TYK2 kinase inhibitors, B cell activating factor inhibitors, Tumour necrosis factor ligand superfamily member 13 inhibitors Key Systemic Lupus Erythematosus Companies: Roche, ImmuPharma, UCB, Idorsia Pharmaceuticals, Biogen, AbbVie, Bristol-Myers Squibb, Vera Therapeutics, Beijing Mabworks Biotech Co., Ltd., BeiGene, Jiangsu Renocell Biotech Company, AstraZeneca, Pfizer, Red de Terapia Celular, Kira Pharmacenticals (US), LLC., Jemincare, Galapagos NV, Alumis, argenx, Gilead Sciences, Novartis, Zenas Biopharma, Horizon Therapeutics, Provention Bio, Janssen Research & Development, Eli Lilly and Company, Medsenic, Sanofi, Merck KGaA, Resolve Therapeutics, ILTOO, Janssen, Alpine Immune Sciences, Kezar Life Sciences, Neovacs, Kangpu Biopharmaceuticals, Cartesian Therapeutics, Apellis Pharmaceuticals, Inc., Alexion Pharmaceuticals, Inc., Q32 Bio Inc., Conduit Pharmaceuticals, Miltenyi Biomedicine GmbH, Kyverna Therapeutics, ImmPACT Bio, Genrix (Shanghai) Biopharmaceutical Co., Ltd., Gracell Biotechnologies (Shanghai) Co., Ltd., Cabaletta Bio, Tenet Medicines, Ascentage Pharma Group Inc., InnoCare, Eisai, Sorrento Therapeutics, Carna Bioscience, Yake Biotechnology, Equillium, Daiichi Sankyo Company, SinoMab Bioscience Ltd, Citryll BV, Sareum, Shanghai Junshi Biosciences, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Millennium Pharmaceuticals, Inc., Takeda, Synthekine, Hangzhou Sumgen Biotech Co., Ltd., Sana Biotechnology, Hoffmann-La Roche, Guangdong Ruishun Biotech Co., Ltd, Shanghai Ming Ju Biotechnology Co., Ltd., Autolus Limited, Nkarta, Inc., Luminary Therapeutics, Kyowa Kirin Co., Ltd., Shanghai Ming Ju Biotechnology, IGM Biosciences, Inc., GlaxoSmithKline, Fate Therapeutics, Cugene Inc., Century Therapeutics, Inc., Cullinan Therapeutics Inc., Juno Therapeutics, Inc., EdiGene Inc., Atara Biotherapeutics, Annexon, Inc., Adicet Therapeutics, Bioray Laboratories, PersonGen BioTherapeutics (Suzhou) Co., Ltd., Juventas Cell Therapy Ltd., Nanjing Bioheng Biotech Co., Ltd., Pregene ShenZhen Biotechnology, Artiva Bio, KeyMed Biosciences, IASO, JW Therapeutics, ROME Therapeutics, Ventus Therapeutics, Allosite Therapeutics, iCell Gene Therapeutics, Caribou Biosciences, LongBio Pharma, Amytrx Therapeutics, Corestem, Eliem Therapeutics, SinoMab Bioscience Ltd., and others. Key Systemic Lupus Erythematosus Pipeline Therapies: Obinutuzumab, Lupuzor (IPP-201101), Dapirolizumab pegol, Cenerimod, BIIB059, Upadacitinib, Deucravacitinib, Atacicept, MIL62, Zanubrutinib, RY_SW01 cell injection|Basic treatment, Ravulizumab, Rapcabtagene autoleucel, PF-06823859, Mesenchymal stem cells (MSC), KP104, JMKX000189, Iptacopan, GLPG3667|Placebo, ESK-001, Elsubrutinib, Efgartigimod alfa, Edecesertib, Ianalumab, Obexelimab (XmAb5871), Daxdilimab (VIB7734), PRV-3279, Nipocalimab, ABBV 599, NKTR-358 (LY3471851), Arscimed, SAR441344, Enpatoran, RSLV-132, Aldesleukin, Daratumumab, Branebrutinib, BMS-986256, ALPN-101, KZR-616, IFNα kinoid, KPG 818, Descartes-08, CFZ533, APL-2, ALXN2050, ADX-097, AZD1656, MB-CART19.1, KYV-101, IMPT-514, GR1603, GC012F Injection, CABA-201, Budoprutug, APG-2575, ICP-022, E6742, ALPN-303, AC0058, Mosunetuzumab, AS-0871, CD19/BCMA CAR T-cells, PF-06835375, EQ001 (Itolizumab), DS-7011a, SM03, CIT-013, SDC-1801, UBP1213, TQB3702, TAK-079, TAK-007, SYNCAR-001, SG301, SC291, RO7507062, RJMty19 (CD19-CAR-DNT cells), Relma-cel, PIT565, Obecabtagene autoleucel (obe-cel), NKX019, LMY-920, KK4277, JWCAR201, Imvotamab, GSK4527363, GSK4347859, FT819, CUG252, CNTY-101, CLN-978, CC-97540, Belantamab, ATHENA CAR-T ATA3219, ANX009, ADI-001, BRL-301, T-cell injection targeting CD19 chimeric antigen receptor, CNCT19, RD06-04, PRG-2311, PRG-1801, AlloNK, CM313, CT103A, JWCAR 029, Research program: endogenous reverse transcriptase inhibitors, VENT 03, ONT01, BCMA-CD19 cCAR T cells, CB-010, LP-005, AMTX 100, CE211AT15, TN-119, SN1011, QX002N, RSLV-145, Recombinant human plasma gelsolin, LN-008, TST 008, IBL 100s, and others. Dive deep into rich insights for new drugs for systemic lupus erythematosus treatment, visit @ Systemic Lupus Erythematosus Drugs Table of Contents For further information on the systemic lupus erythematosus pipeline therapeutics, reach out @ Systemic Lupus Erythematosus Treatment Drugs Related Reports Systemic Lupus Erythematosus Market Systemic Lupus Erythematosus Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, market share of the individual therapies, and key SLE companies including Biogen, Novartis, MorphoSys, Idorsia Pharmaceuticals, Viatris, RemeGen, UCB Pharma, Genentech, Bristol Myers Squibb, AbbVie, among others. Systemic Lupus Erythematosus Epidemiology Systemic Lupus Erythematosus Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical, and forecasted SLE epidemiology in the 7MM. Lupus Nephritis Market Lupus Nephritis Market Insights, Epidemiology, and Market Forecast – 2034 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 lupus nephritis companies, including NOVARTIS, MORPHOSYS, ASTRAZENECA, ROCHE, KEZAR LIFE SCIENCES, ALEXION PHARMACEUTICALS, NOVARTIS, CABALETTA BIO, among others. Lupus Nephritis Pipeline Lupus Nephritis Pipeline Insight – 2024 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key lupus nephritis companies, including Inflection Biosciences, Equillium, Roche, Horizon Therapeutics, BeiGene, Janssen Research & Development, ImmPACT Bio, 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

Phase 3Phase 2Fast TrackCell Therapy

19 Nov 2024

·endpts.com

Biogen, UCB detail response rates in Phase 3 lupus trial after surprising success

Biogen and UCB on Tuesday shared an expanded dataset for their Phase 3 lupus program, which they said two months ago succeeded in a pivotal trial. In the 321-patient study, dapirolizumab pegol achieved a 49.5% response rate after 48 weeks when combined with the standard of care, compared to a 34.6% response rate from the standard of care alone. The difference between the trial arms was statistically significant with a p-value of 0.0110, Biogen said. The drug also succeeded on several secondary endpoints, including the rates at which patients tapered off their corticosteroids. There were 156 patients whose steroid use was above 7.5 mg per day, and 72.4% who took dapirolizumab pegol reduced their steroid use by week 48 to at most 7.5 mg per day, compared to 52.9% in the standard of care arm. The nominal p-value was 0.0404. Additionally, there was a higher rate of serious side effects in the standard of care group — 9.9% of patients who took dapirolizumab pegol reported side effects, compared to 14.8% in the standard of care group. Coming off the surprising topline win in September, the results help establish the case for continuing the program after it failed a Phase 2 study in 2018. At the time, dapirolizumab pegol had only been slated for one Phase 3 study instead of the requisite two needed for FDA approval. But with the success this week, planning for another trial is already in progress. Most of the details remain a secret, Biogen immunology chief Diana Gallagher told Endpoints News , but the study is expected to start before the end of the year and will run for another 48 weeks. “It’ll have a lot of similarities to what we’ve done before,” she said. In the Phase 3 study, researchers evaluated patients’ responses using a composite lupus symptom score called British Isles Lupus Assessment Group-based Composite Lupus Assessment, or BICLA for short. A higher response rate is associated with improved symptoms across all affected organs from baseline measurements, Biogen said. The standard of care for lupus has remained largely static over many decades, with the two most commonly used treatments being steroids: hydroxychloroquine and prednisone, according to Duke University rheumatologist and the study’s principal investigator Megan Clowse. But the former is typically used in only the most severe cases to prevent death, while the latter comes with “terrible” side effects. “The real unmet need for patients living with lupus is, number one, being able to get away from chronic prednisone use,” Clowse said. There have been two approvals since 2011 in lupus — one for GSK’s Benlysta, and another for AstraZeneca’s Saphnelo. They have helped somewhat, but their impact is still limited, Clowse said. If dapirolizumab pegol gets past the finish line, it will continue to help patients control their inflammatory symptoms for longer periods of time and won’t “require six horse pills every day,” she said, referring to steroids. Much of the recent buzz around lupus R&D has dealt with CD19-targeting CAR-T. Dapirolizumab pegol takes a different approach, inhibiting CD40L signaling, according to Biogen. It’s hard to make a direct comparison to studies because the only published CAR-T data in lupus are in academic settings from a small number of extremely sick patients, according to Biogen’s Gallagher. But there will still be space for dapirolizumab pegol in the market, given that CD40L inhibition is not a currently available option for lupus patients, she added. “It’s pretty profound,” Gallagher said. “You really hit B cells, T cells. It really resets immunologically, but it’s well-tolerated based on our available data.”

Clinical ResultPhase 3Phase 2ImmunotherapyCell Therapy

14 Nov 2024

·endpts.com

Trump picks vaccine skeptic Kennedy to lead HHS, in what would be an upheaval of US health policy

President-elect Donald Trump has picked Robert F. Kennedy Jr. to be his next HHS secretary, likely giving the government’s most powerful healthcare post to a vaccine skeptic whose controversial views would be a huge break with decades of US health and scientific policies. “For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation and disinformation when it comes to public health,” Trump said in a social media post announcing the selection. Kennedy is a longtime anti-vaccine crusader and environmental advocate who dropped out of the presidential race to endorse Trump in August. His “Make America Healthy Again” platform — a riff on Trump’s campaign slogan — emerged as a priority from various members of the former president’s camp, including Trump himself. HHS is a massive agency that oversees nearly $2 trillion in federal spending. Its sub-agencies include the governance of Medicare and Medicaid, drug and food regulation at the FDA, the sprawling scientific work of the NIH, and numerous other bodies overseeing everything from public health to biodefense. Last month, Kennedy gave a preview of what his leadership of the agency would mean. In a post on X, he said that “FDA’s war on public health is about to end,” and calling for stopping what he called the suppression of “psychedelics, peptides, stem cells, raw milk, hyperbaric therapies, chelating compounds, ivermectin, hydroxychloroquine, vitamins, clean foods, sunshine, exercise, nutraceuticals and anything else that advances human health and can’t be patented by Pharma.” Biotech stocks fell on reports of the pick, with the Nasdaq Biotech Index declining 2.4% at the close. Shares of vaccine makers fell as well, with Moderna $MRNA dropping 5.6% after the news broke and Pfizer $PFE down 2.6%. Trump has promised to give Kennedy wide latitude on healthcare issues. “I’m gonna let him go wild on health,” Trump said at an October campaign event in Madison Square Garden in New York. “I’m gonna let him go wild on the food. I’m gonna let him go wild on the medicines.” A name mentioned as a possible FDA pick under a Kennedy HHS is Casey Means, a Stanford-trained physician-turned-wellness advocate who might prove to be almost as controversial as Kennedy. Means, like Kennedy, has raised questions about the safety of vaccines, implying a link to autism. Such a link has never been proven, and an older study that has been the basis of many of those claims has been retracted and debunked. In addition to Kennedy’s anti-vaccine views, he has threatened to eliminate portions of federal health agencies and push out or discipline staff. “If you work for the FDA and are part of this corrupt system, I have two messages for you: 1. Preserve your records, and 2. Pack your bags,” Kennedy said in the October post on X . He has also espoused a number of more mainstream positions, including calling for a focus on wellness and the prevention of chronic disease, overhauling regulations for direct-to-consumer pharmaceutical ads, having Americans pay no more than other developed nations for drugs, and eliminating many pollutants and additives from the food supply, according to an opinion piece he wrote for the Wall Street Journal in September . But many of those views have been overshadowed by Kennedy’s embrace of conspiracy theories, such as his apparent support for the idea that high-altitude airplane contrails are in fact a government program to disperse chemicals. (They are actually condensed water.) Those positions could make for a less-than-certain Senate confirmation process, since they would almost certainly include a thorough review of his many controversial positions that are at odds with much of the healthcare establishment, as well as a number of recent personal scandals . Kennedy would hardly be the only controversial choice for the Trump administration. This week, he said he had chosen former Rep. Matt Gaetz of Florida to be his attorney general . Gaetz has been the subject of an ethics complaint over allegations of sex trafficking, as well as a fierce Trump ally and critic of the Department of Justice. Editor’s note: This story has been updated throughout with new details.

VaccineExecutive Change

100 Deals associated with Hydroxychloroquine Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
D02114	Hydroxychloroquine Sulfate	P01BA02	DB01611

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Lupus Erythematosus, Discoid	US	Novitium Pharma LLCStartup	14 Jan 2022
Malaria	US	Novitium Pharma LLCStartup	14 Jan 2022
Lupus Erythematosus, Cutaneous	JP	Sanofi KK	03 Jul 2015
Acute Malaria	US	Concordia Pharmaceuticals, Inc.	18 Apr 1955
Rheumatoid Arthritis	US	Concordia Pharmaceuticals, Inc.	18 Apr 1955
Systemic Lupus Erythematosus	US	Concordia Pharmaceuticals, Inc.	18 Apr 1955

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
COVID-19	Phase 3	US	Novartis Pharmaceuticals Corp.	01 May 2020
Primary Sjögren's syndrome	Phase 3	FR	Sanofi	01 Mar 2008
Secondary malignant neoplasm of pancreas	Phase 2	IE	Novartis AG	31 May 2023
Pancreatic adenocarcinoma	Phase 2	US	West Virginia University Hospitals, Inc.	04 Feb 2020
Advanced Pancreatic Adenocarcinoma	Phase 1	US	Novartis Pharmaceuticals Corp.	18 Jan 2019
Pancreatic adenocarcinoma metastatic	Phase 1	US	Novartis Pharmaceuticals Corp.	18 Jan 2019
Pancreatic carcinoma non-resectable	Phase 1	US	Novartis Pharmaceuticals Corp.	18 Jan 2019
Rheumatic Diseases	Phase 1	-	Sandoz International GmbH	01 Jul 1993

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04318444 (CTgov)	Phase 2/3	COVID-19	10	Hydroxychloroquine (Hydroxychloroquine Group)	vrnjwddhkq(utidfcwxsl) = bseighjmyz erbbnozkpi (fuftqygcpp, pacgdmprdb - yddxwkmuey) View more	-	25 Sep 2024
				Placebo (Placebo Group)	vrnjwddhkq(utidfcwxsl) = epxhreofvq erbbnozkpi (fuftqygcpp, oebyzpwxug - zketexivzr) View more
EURETINA2024	Not Applicable	-	-	Patients taking hydroxychloroquine (HCQ) for 5 years	unkuefjjfw(altophobex) = npyxounpft ifgfmjhmto (oqdbclgcac )	-	19 Sep 2024
EURETINA2024	Not Applicable	Retinal Diseases	-	Hydroxychloroquine (HCQ) treatment	gyokkfjras(kheptwlwlx) = vvsjcedaps ofpfwfgjnp (xmcpndkxpr )	-	19 Sep 2024
NCT03598595 (ESMO2024) Manual	Phase 1/2	Osteosarcoma	31	Gemcitabine + Docetaxel + Hydroxychloroquine	xwnyrekuxr(ujddansvgj) = eshhpjlcds tkynikenhj (dmwqkzwwmr ) View more	Positive	14 Sep 2024
NCT04527549 (CTgov)	Phase 2	Melanoma, Cutaneous Malignant \| Unresectable Melanoma \| Locally Advanced Melanoma	5	Dabrafenib mesylate+Hydroxychloroquine+Trametinib dimethyl sulfoxide (Arm A (Dabrafenib, Trametinib, Hydroxychloroquine))	bwcyarzcvc(ehnqgnedvj) = wpyiehrmsq pjokwvkdqa (ontlbjjqjn, moifshritr - kpqwfisbjk) View more	-	22 Aug 2024
				Placebo Administration+Dabrafenib mesylate+Trametinib dimethyl sulfoxide (Arm B (Dabrafenib, Trametinib, Placebo))	bwcyarzcvc(ehnqgnedvj) = fyjavbvhgr pjokwvkdqa (ontlbjjqjn, eytrhoxihj - xgtbkausfd) View more
NCT02451748 (CTgov)	Phase 4	Rheumatoid Arthritis	32	Lab Work (DMARD's Responder and Non-Responder)	lgleqxqelb(edraiiinxa) = wsnjirjwdy xmllxbkwtl (hiediahbrw, rcjjblnbap - gplqdwnpgy) View more	-	10 Jul 2024
				Naproxen+Medrol+Hydroxychloroquine+humira+Prednisone+Lab Work+Triamcinolone+Sulfasalazine+Certolizumab pegol (CDP870, tradename Cimzia)+Methotrexate+Leflunomide (DMARD's Plus Cimzia (Certolizumab Pegol))	dancwrgvua(ckgzaecwcr) = ltqmznvqxx lxgafasxwb (vectbipwtd, jycmykxxgo - knictmfyno) View more
GR2 (EULAR2024)	Not Applicable	Systemic Lupus Erythematosus HCQ blood levels	174	HCQ blood levels ≤500 ng/ml	chfxivsmzx(rcxllphmjh) = vwgclvicyf zefafgaqeu (aoxsbswxlz ) View more	Positive	05 Jun 2024
				HCQ blood levels >500 ng/ml	chfxivsmzx(rcxllphmjh) = nafbzxiflt zefafgaqeu (aoxsbswxlz ) View more
EULAR2024	Not Applicable	Toxicity	-	hydroxychloroquine (Patients referred in 2018-2019)	vyljzczlou(wemtfdjqdw) = piaqqtkiae iqumzcbble (npooeiiizu )	-	05 Jun 2024
EULAR2024	Not Applicable	Retinal Diseases	-	HYDROXYCHLOROQUINE (HCQ) (HCQR patients)	otqnpgkoyx(afsqwzwfyi) = bwpvwqqvsl epqawzagyx (pftqnfhmvp, 48 - 62)	-	05 Jun 2024
				HYDROXYCHLOROQUINE (HCQ) (Controls)	otqnpgkoyx(afsqwzwfyi) = ijflrywyon epqawzagyx (pftqnfhmvp, 48 - 62)
EULAR2024	Not Applicable	Lupus Erythematosus	223	Therapeutic HCQ blood levels (750-1200 ng/ml)	bevygdhjby(ofyznsbdid) = evvskxlxxy nwovyyqgqe (dcbcaqscys )	Positive	05 Jun 2024

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis