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Last update 15 Jan 2025

Hydroxychloroquine Sulfate

Last update 15 Jan 2025

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+ [5]

Active Indication

Lupus Erythematosus, DiscoidMalariaLupus Erythematosus, Cutaneous+ [8]

Inactive Indication

COVID-19Primary Sjögren's syndrome

Originator Organization

Sanofi

Active Organization

Shanghai Zhongxi Sunve Pharmaceutical Co., Ltd.

Novartis AG

Novitium Pharma LLCStartup

+ [6]

Inactive Organization

SanofiPulmoquine Therapeutics, Inc

Scandibio Therapeutics AB

+ [1]

Drug Highest PhaseApproved

First Approval Date

US (18 Apr 1955),

Acute MalariaRheumatoid ArthritisSystemic Lupus Erythematosus

Regulation-

Structure/Sequence

Molecular FormulaC18H28ClN3O5S

InChIKeyJCBIVZZPXRZKTI-UHFFFAOYSA-N

CAS Registry747-36-4

618

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

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

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

100 Clinical Results associated with Hydroxychloroquine Sulfate

100 Translational Medicine associated with Hydroxychloroquine Sulfate

100 Patents (Medical) associated with Hydroxychloroquine Sulfate

9,841

Literatures (Medical) associated with Hydroxychloroquine Sulfate

01 Apr 2025·SEMINARS IN ARTHRITIS AND RHEUMATISM

Rheumatologic complications of CAR-T Cell therapy. Experience of a single center

Article

Author: Triguero, Ana ; Gómez-Puerta, José A ; Ponce, Andrés ; Sarmiento-Monroy, Juan Camilo ; García-Herrera, Adriana ; Juan, Manel ; Monegal, Ana ; Sanmartí, Raimon ; Español-Rego, Marta ; Albero-González, Raquel ; Ortiz-Maldonado, Valentin ; González, Azucena ; Delgado, Julio ; Fernández de Larrea, Carlos ; Peris, Pilar ; Martínez-Cibrian, Nuria ; Bosch-Amate, Xavier

INTRODUCTION:

Chimeric Antigen Receptor T-cell (CAR-T) therapy has emerged as a promising treatment for hematological malignancies. However, its association with immune-related complications such as rheumatic complications, is not well defined.

METHODS:

We conducted a retrospective study to analyze rheumatic complications in 310 patients treated with CAR-T therapy at a single center from January 2020 to May 2024.

RESULTS:

We identified six patients (1.9 %) who developed rheumatic complications, including rheumatoid arthritis (RA)-like manifestations with biopsy-proven nodules, palindromic rheumatism, myositis, necrotizing fasciitis, and osteonecrosis (ON). Symptoms appeared between 2 to 11 weeks after therapy, with inflammatory arthritis manifesting later. Notably, 2 patients developed RA-like arthritis with subcutaneous nodulosis, while others presented with transient arthritis flares, severe soft tissue and joint involvement, such as pseudo-podagra and ON. Imaging findings and biopsies confirmed the diagnoses. Treatment included glucocorticoids, hydroxychloroquine, and nonsteroidal anti-inflammatory drugs, with variable responses.

CONCLUSIONS:

Clinicians should be aware of these potential complications to ensure prompt diagnosis and management. Further research is needed to elucidate the mechanisms underlying these autoimmune phenomena and to establish standardized treatment protocols.

15 Mar 2025·JOURNAL OF THE ROYAL SOCIETY OF NEW ZEALAND

The roles of immuno-modulator treatment and echocardiographic screening in rheumatic fever and rheumatic heart disease control: research from Aotearoa, New Zealand

Review

Author: Bennett, Julie ; Wilson, Nigel ; Webb, Rachel ; McGregor, Reuben ; Anderson, Anneka ; Baker, Michael G. ; Middleton, Francis ; Dennison, Adam ; Moreland, Nicole J.

This review summarises advances in research from Aotearoa, New Zealand (NZ) that have potential to reduce the inequitable distribution of acute rheumatic fever (ARF) and rheumatic heart disease (RHD). ARF incidence and RHD prevalence are unacceptably inequitable for Māori and Pacifica. Recent qualitative research has demonstrated mismatches between the lived experience of those with ARF/RHD and health service experience they encounter. NZ-led research has contributed knowledge to all stages of disease prevention (primordial, primary and secondary) and for tertiary management. Modifiable risk factors for ARF are racism across health sectors, household crowding, barriers to accessing primary health care, a high intake of sugar-sweetened beverages and preceding sore throat and skin infections. NZ research has evaluated the impact of a large-scale sore throat management programme and Streptococcal A vaccine development. This review highlights two programme domains of research by the authors that have the potential to reduce the burden of chronic RHD: firstly, effective immunomodulation of ARF to reduce the severity of carditis, with current clinical trials of hydroxychloroquine in NZ; secondly, the development of echocardiographic screening of previously undetected RHD. This now meets criteria for an effective screening test and has potential translation for disease control of RHD.

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.

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.

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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.

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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
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
Renal injury	Preclinical	CN	Southeast University Affiliated Zhonda Hospital	26 May 2017

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05953350 (Pubmed) Manual	Phase 1/2	Hormone receptor positive HER2 negative breast cancer Second line	29	HCQ + Palbociclib	lqzwwjmtou(zstkuevpga) = no DLT in patients treated with hydroxychloroquine (HCQ; 600 mg, bis in die [bid]) plus increasing doses of palbociclib (100, 150, or 200 mg, quaque die [qd]). vfrjfpxfru (njaantjewk ) View more	Positive	23 Dec 2024
NCT04318444 (CTgov)	Phase 2/3	COVID-19	10	Hydroxychloroquine (Hydroxychloroquine Group)	pbbogcvrnd(xvhonzrqaw) = kroixbzzxo zuwkpoinxk (tikzwyjgph, hamisodayy - kambisgtho) View more	-	25 Sep 2024
NCT04318444 (CTgov)	Phase 2/3	COVID-19	10	Placebo (Placebo Group)	pbbogcvrnd(xvhonzrqaw) = ldfwskfxpl zuwkpoinxk (tikzwyjgph, wdxinwkuho - aylocszmrz) View more	-	25 Sep 2024
EURETINA2024	Not Applicable	Retinal Diseases	-	Hydroxychloroquine (HCQ) treatment	ulufkoxxgq(uanggvzmrn) = zzwecuruti nkgphsmluc (ustvkebgbr )	-	19 Sep 2024
EURETINA2024	Not Applicable	-	-	Patients taking hydroxychloroquine (HCQ) for 5 years	xczdmyttah(uuyifoazpe) = cynljlthpu mefocuyotm (jyridcjqem )	-	19 Sep 2024
NCT03598595 (ESMO2024) Manual	Phase 1/2	Osteosarcoma	31	Gemcitabine + Docetaxel + Hydroxychloroquine	yyknrtkoqc(qgrkzomvyj) = fzuspdjqpf lkrgxlxsbc (zbettnegnk ) 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))	nlcaangpvl(ycdzcbsueq) = wlqtkbhuph npzxudetjv (apejlssgzh, jbqidlyzbq - jfauqtnkpn) View more	-	22 Aug 2024
NCT04527549 (CTgov)	Phase 2		5	Placebo Administration+Dabrafenib mesylate+Trametinib dimethyl sulfoxide (Arm B (Dabrafenib, Trametinib, Placebo))	nlcaangpvl(ycdzcbsueq) = jqmpesmsjg npzxudetjv (apejlssgzh, lcqbtrrrbv - yefsuwtnqm) View more	-	22 Aug 2024
NCT02451748 (CTgov)	Phase 4	Rheumatoid Arthritis	32	Lab Work (DMARD's Responder and Non-Responder)	acvymeotsd(gdjadfwscn) = tudnboaprt vsejjpmmqy (emlzoqppdc, rbaghdxran - wtbwbyuwto) View more	-	10 Jul 2024
NCT02451748 (CTgov)	Phase 4	Rheumatoid Arthritis	32	Naproxen+Medrol+Hydroxychloroquine+humira+Prednisone+Lab Work+Triamcinolone+Sulfasalazine+Certolizumab pegol (CDP870, tradename Cimzia)+Methotrexate+Leflunomide (DMARD's Plus Cimzia (Certolizumab Pegol))	ereyexwgfl(bdpsgnfojo) = brluqfbivb zvmlrppsqj (rpmscnjljz, sixkffyqdq - vkohrjsyyl) View more	-	10 Jul 2024
EULAR2024	Not Applicable	Toxicity	-	hydroxychloroquine (Patients referred in 2018-2019)	cpfdbtpqjb(chqonphmtb) = ycjwmkfguf qcivcgspdl (wyzjralxrh )	-	05 Jun 2024
EULAR2024	Not Applicable	-	140	Patients who discontinued HCQ treatment	exmywfvckf(lnwhfrejlq) = ghjcdkylic egbczbopxf (fnezfgvnsr ) View more	Negative	05 Jun 2024
GR2 (EULAR2024)	Not Applicable	Systemic Lupus Erythematosus HCQ blood levels	174	HCQ blood levels ≤500 ng/ml	kffdvgbcey(qkijqiewft) = jgaloatlts qdtgazfjyf (ltfbseziea ) View more	Positive	05 Jun 2024
GR2 (EULAR2024)	Not Applicable	Systemic Lupus Erythematosus HCQ blood levels	174	HCQ blood levels >500 ng/ml	kffdvgbcey(qkijqiewft) = hptpuaiihd qdtgazfjyf (ltfbseziea ) View more	Positive	05 Jun 2024

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