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Last update 24 Feb 2025

Hydroxychloroquine Sulfate

Last update 24 Feb 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+ [7]

Inactive Indication

COVID-19Primary Sjögren's syndrome

Originator Organization

Sanofi

Active Organization

Shanghai Zhongxi Sunve Pharmaceutical Co., Ltd.Sanofi KK

Novartis Pharmaceuticals Corp.

+ [6]

Inactive Organization

Sanofi

Viatris, 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

619

Clinical Trials associated with Hydroxychloroquine Sulfate

NCT05842174

/ Not yet recruitingPhase 1/2IIT

Targeting Ischemia-Induced Autophagy Dependence in Hepatocellular Carcinoma Through Image-guided Locoregional Therapy

Trans-arterial chemoembolization (TACE) is the most commonly used therapy for patients with unresectable hepatocellular carcinoma (HCC). TACE is a minimally invasive procedure that involves placing a catheter into the artery in the liver that feeds the tumor, administering chemotherapeutics and then blocking the artery with embolics in order to kill tumor cells by depriving them of essential oxygen and nutrients. While TACE has a proven survival benefit, local recurrence is common, and long-term survival rates are poor. Prior studies demonstrate that HCC cells survive the oxygen and nutrient deprivation through autophagy, a process of cellular self-eating, to provide nutrients required for survival. The proposed project will leverage this dependency to develop a novel approach to TACE that integrates autophagy inhibition to improve therapeutic response by increasing tumor cell killing and enhancing anti-tumor immunity.

Start Date17 Apr 2025

Sponsor / Collaborator

VA Office of Research and Development

NCT06816810

/ Not yet recruitingPhase 2IIT

TALLman Family Energizes Research To Help Alleviate Neuroinflammation in Parkinson's Disease - "TALLER THAN PD." A Phase 2 Futility Study to Evaluate the Efficacy, Safety and Tolerability of Hydroxychloroquine in Subjects With Early Treated Parkinson's Disease

The purpose of this study is to determine if hydroxychloroquine is safe to take and whether there is potential for it to slow the progression of PD symptoms. This will be done by comparing how PD symptoms progress throughout the study compared to how people with PD typically progress. Within PD, it is thought that an inflammation response is associated with abnormal forms of a protein called alpha-synuclein in the brain. Individuals who have taken this medication for other conditions have been shown to be less likely to develop PD than people who have not taken this medication. Therefore, it is hoped that the study drug may interrupt the inflammation response and in turn stop/delay the progression of PD.

Start Date01 Mar 2025

Sponsor / Collaborator

Ottawa Hospital Research Institute

ChiCTR2500096998

/ SuspendedNot ApplicableIIT

The study of effects of hydroxychloroquine on the titers of autoantibodies to glutamic acid decarboxylase antibody (GADA) and ß-cell function in patients with adult-onset latent autoimmune diabetes (LADA)

Start Date25 Feb 2025

Sponsor / Collaborator-

100 Clinical Results associated with Hydroxychloroquine Sulfate

100 Translational Medicine associated with Hydroxychloroquine Sulfate

100 Patents (Medical) associated with Hydroxychloroquine Sulfate

14,631

Literatures (Medical) associated with Hydroxychloroquine Sulfate

01 Dec 2025·JOURNAL OF CLINICAL IMMUNOLOGY

Diverse Clinical and Immunological Profiles in Patients with IPEX Syndrome: a Multicenter Analysis from Turkey

Article

Author: Bozkurt, Selcen ; Bilgic Eltan, Sevgi ; Yalcin Gungoren, Ezgi ; Bayram Catak, Feyza ; Kiykim, Ayca ; Can, Salim ; Amirov, Razin ; Ozen, Ahmet ; Baris, Safa ; Bal Cetinkaya, Fatma ; Bekis Bozkurt, Hayrunnisa ; Sahin, Ali ; Catak, Mehmet Cihangir ; Kasap, Nurhan ; Yorgun Altunbas, Melek ; Ozturk, Necmiye ; Yakici, Nalan ; Gemici Karaarslan, Betul ; Orhan, Fazil ; Cavkaytar, Ozlem ; Arga, Mustafa ; Karakoc-Aydiner, Elif

PURPOSE:

Immunodysregulation, Polyendocrinopathy, Enteropathy, and X-linked syndrome (IPEX), caused by pathogenic FOXP3 variants, is a rare autoimmune disorder with diverse clinical features, including early-onset diabetes, eczema, and enteropathy. Atypical cases show milder symptoms and unique signs, requiring different treatments. Therefore, there are ambiguities in the accurate diagnosis and management of IPEX. We sought to present clinical, genetic, and immunological assessments of 12 IPEX patients with long-term follow-up to facilitate the diagnosis and management of the disease.

METHODS:

Clinical findings and treatment options of the patients were collected over time. Lymphocyte subpopulations, protein expressions, regulatory T (Treg) and circulating T follicular helper (cT_FH) cells, and T-cell proliferation were analyzed.

RESULTS:

Predominant presentations included autoimmunity (91.6%), failure to thrive (66.7%), and eczema (58.3%). There were four classical and eight atypical IPEX individuals. Allergic manifestations were more common in atypical patients. Notably, chronic diarrhea demonstrated heightened severity compared to other manifestations. Four patients (33.3%) demonstrated eosinophilia, and nine (75%) showed high serum IgE levels. Most patients exhibited normal percentages of Treg cells with reduced CD25, FOXP3, and CTLA-4 expressions, corrected after hematopoietic stem cell transplantation (HSCT). Compared to healthy controls, the T_H2-like skewing accompanied by reduced T_H17-like responses was observed in cT_FH and Treg cells of patients. Overall, nine patients (75%) received immunosuppressants (ISs), and six (50%) underwent HSCT, which was the only treatment revealing sustained control. Sirolimus was used in six patients and showed better control than other ISs.

CONCLUSIONS:

The first cohort from Turkey with long-term follow-up results, comparing typical and atypical cases, provides insights into the outcomes of different therapeutic modalities and T- cell subtype changes in IPEX syndrome.

01 Jun 2025·SEPARATION AND PURIFICATION TECHNOLOGY

A comparative study on the efficient removal of hydroxychloroquine via UV/peroxymonosulfate and UV/peroxydisulfate systems triggered by reactive oxygen species: Process behaviors and the functional relevance of singlet oxygen

Author: Yao, Zi-Jian ; Tian, Fu-Xiang ; Xu, Bin ; Mu, Xing-Yan ; Bi, Dong-Su ; Zhao, Dong-Sheng ; Mo, Chen-Cheng ; Ye, Jing ; Hu, Xiao-Jun

The efficient removal of hydroxychloroquine (HCQ) by UV/ peroxymonosulfate (UV/PMS) and UV/peroxydisulfate (UV/PDS) treatments triggered by reactive oxygen species (ROS) was comprehensively compared in terms of process behaviors and the functional relevance of singlet oxygen (1O2).Both UV/PMS and UV/PDS can remove HCQ quickly and the elimination rate followed the trend as UV/PMS > UV/PDS > UV/H2O2.The individual contribution of ROS was determined and the reaction rates of ROS with HCQ were ranked as SO4.- (1.44 x 1010 M-1.s-1) > HO. (4.03 x 109 M-1.s-1) >1O2 (1.85 x 108 M-1.s-1).The main operation factors influencing the HCQ degradation including UV intensity, PMS/PDS dosages, pH and water substrates were explored comparatively.UV/PMS showed strong resilience against interferences from natural organics and coexistent ions due to the action of 1O2.The radical and non-radical oxidation pathways of HCQ by ROS attack were postulated.The effects of pretreatments on disinfection byproducts (DBPs) production obeyed the tendency as PMS/Cl2≫ UV/PDS > UV/PMS.Although PMS/Cl2 (for 1O2 scenario) induced massive DBPs over UV/PMS and UV/PDS, UV/PMS effectively regulated DBPs risk by cooperation of radical and non-radical routes.Comprehensive investigations concentrating on the functional relevance of 1O2 regarding selective oxidability, resistance to water substrates and especially DBPs enhancement were conducted for the first time.The findings can also provide valuable inspirations for the UV/PMS application as a promising 1O2-related technol. for the HCQ elimination, taking into accounts of trade-offs among high efficiency, acceptable cost, insensitivity to environmental disturbance and reduced toxicity associated with DBPs.

01 Apr 2025·Current Research in Translational Medicine

Trends in drug repurposing: Advancing cardiovascular disease management in geriatric populations

Review

Author: Moka, Murali Krishna ; D K, Sriram ; Rathakrishnan, Deepalaxmi ; Jagadeeshwaran, V ; George, Melvin

Drug repurposing is a promising strategy for managing cardiovascular disease (CVD) in geriatric populations, offering efficient and cost-effective solutions. CVDs are prevalent across all age groups, with a significant increase in prevalence among geriatric populations. The middle-age period (40-65 years) is critical due to factors like obesity, sedentary lifestyle, and psychosocial stress. In individuals aged 65 and older, the incidence of CVDs is highest due to age-related physiological changes and prolonged exposure to risk factors. In this review we find that certain drugs, such as non-cardiovascular drugs like anakinra, probenecid, N-acetyl cysteine, quercetin, resveratrol, rapamycin, colchicine, bisphosphonates, hydroxychloroquine, SGLT-2i drugs, GLP-1Ras drugs and sildenafil are recommended for drug repurposing to achieve cardiovascular benefits in geriatric patients. However, agents such as canakinumab, methotrexate, ivermectin, erythromycin, capecitabine, carglumic acid, chloroquine, and furosemide are constrained in their therapeutic use and warrant meticulous consideration, rendering them less favorable for this specific application. This review emphasizes the importance of exploring alternative therapeutic strategies to improve outcomes in geriatric populations and suggests drug repurposing as a promising avenue to enhance treatment efficacy.

News (Medical) associated with Hydroxychloroquine Sulfate

28 Jan 2025

·endpts.com

The RFK question: Trump's HHS nominee splits biopharma before moment of truth

Robert F. Kennedy Jr. will sit before a Senate committee on Wednesday and provide the first substantive glimpse into how he may run the nation’s health department. Capitol Hill’s questioning could reveal what a Kennedy-led HHS would look like, and most critically, which version of the polarizing 71-year-old would steer the ship if confirmed. Decades of lawsuits, speeches and books have shown Kennedy to be a fierce adversary of vaccination. But he has also tried to address concerns over that history, saying he won’t “ take away anybody’s vaccines, ” and he’s “all for the polio vaccine.” Biopharmaceutical executives and insiders have voiced split opinions on what Kennedy could mean for the drug industry and the nation’s health. In recent interviews, leaders have ranged from enthusiastic support to full-blown opposition. The Senate Finance Committee will hold the first of two confirmation hearings in Washington on Wednesday starting at 10 a.m., and is expected to ask about Kennedy’s views on topics ranging from vaccines to drug pricing to abortion. The Senate Health Committee will hold a courtesy hearing on Thursday, but only the Finance Committee will vote on whether to advance Kennedy’s nomination to the full Senate. Kennedy’s nomination fight is expected to be among the closest for Trump’s cabinet picks. Some Kennedy allies fear he may not have enough support to be confirmed, the Financial Times reported Monday . ( Endpoints News is a part of the FT Specialist group, but does not share reporting or content.) Democrats are expected to be nearly unanimous in opposing Kennedy. They could use the hearings to try to “bait him into giving more left-leaning answers” on topics like drug pricing, Barrett Thornhill, a partner at Forbes Tate Partners and former congressional staffer, said on a Monday call previewing the hearing hosted by Evercore ISI. Kennedy can afford few defections from Republicans, who hold 53 of the Senate’s 100 seats. Thornhill said Sens. John Thune (R-SD), Bill Cassidy (R-LA), James Lankford (R-OK), and Thom Tillis (R-NC) would be “good barometers to watch for” in the hearing. Other GOP senators are seeking public commitments from Kennedy on issues from abortion to climate change to vaccines. Vaccine policy is a small fraction of the job of running HHS, an 83,000-person agency that oversees other medical and research organizations like the FDA, NIH and CDC. Kennedy’s views on other topics, like tackling chronic disease and fighting ultra-processed foods, may find some mutual ground during Wednesday’s hearing. The committee is also likely to ask questions on the public communications freeze within the health agencies, NIH grant review delays and other effects of the transition to the new administration. What unites most biopharma executives is a belief that Kennedy will bring change. An Endpoints 100 survey from December found 69% of industry executives believe Kennedy will affect vaccine and drug development. Even more — about 75% — believe that health policy changes under Trump and Kennedy will be for the worse. But as Kennedy’s bid to run HHS has gone from a far-fetched hypothetical to reality, some industry leaders appear to be warming up to him. Patrick Soon-Shiong, the Los Angeles biotech billionaire who oversees dozens of startups, told Endpoints he’s sat down with Kennedy twice over the past couple of months and concluded there’s a “completely different story” to Kennedy than his public portrayal. Soon-Shiong, who tried developing his own Covid-19 vaccine candidate during the pandemic, said they dove into the science behind Kennedy’s vaccine doubts. Kennedy framed his worries as about specific excipients, or inactive ingredients like mercury, found in certain vaccines. Soon-Shiong said Kennedy told him that he’s not trying to block vaccines; he just wants them studied. Soon-Shiong said he supports Kennedy for health secretary. “If you just come from the science, he’s looking at the science,” he added. Other industry heavyweights have stopped well short of criticizing Kennedy. Pfizer CEO Albert Bourla, for instance, has met with Trump and Kennedy in Mar-a-Lago. He said he sees opportunities and risks in working with them in a recent interview with Semafor . “The new administration, they have a boldness,” Bourla said, while discussing the idea of pursuing something like an Operation Warp Speed for cancer with the new administration. “They go for it when they go, right? So the question is, how to influence the environment so that they would go for it in the right way?” It’s hard to tell how much of Kennedy’s biopharma support (or lack of opposition) is genuine versus genuflecting. There is certainly a pragmatism in not making enemies with a new administration. On the other side, former FDA head and Pfizer board member Scott Gottlieb has been vocal in his opposition to Kennedy. He said he fears childhood vaccination rates may decline further, leading to outbreaks of vaccine-preventable diseases. “I’ve been very clear he shouldn’t be health secretary,” Gottlieb said earlier this month at an Endpoints event. “I have a lot of concerns about the positions he’s taken.” Bob Nelsen, co-founder and managing director of ARCH Venture Partners, has changed his tune on Kennedy. When Kennedy was running for president in 2023, Nelsen called him a “dangerous conspiracy theorist, who has contributed to many deaths with his anti-vaccine lies.” Nelsen was far more ambiguous when asked about Kennedy earlier this month at Endpoints’ JPM event. He declined to say if he supports or opposes Kennedy, but said he backs “anybody that wants to stir it up” in Washington — and that Kennedy fits that bill. “He will be confirmed and he will stir things up,” Nelsen said, also adding that he “needs to be educated on some things when it comes to immunity.” George Yancopoulos, Regeneron’s chief scientific officer, echoed a similarly vague tone when asked about Trump’s health nominees. “I welcome and I like people who want to challenge the status quo and try to improve things,” Yancopoulos said in an interview. He added that his primary concern was maintaining a strong FDA with the approval bar of randomized, placebo-controlled trials. Marc Samuels, CEO of the consultancy ADVI Health, told Endpoints he didn’t think Kennedy would pursue what he calls his “curiosities,” which would include removing FDA staff, as he has promised. “I don’t think there’s going to be hysterics,” Samuels said, noting that it’s unlikely Kennedy, for instance, will throw a wrench into user fees as he’s suggested. “Looking at the picture as a whole from 60,000 feet, user fees are useful. It means that taxpayers aren’t footing the bill for the whole process.” Regarding Trump’s push on healthcare, Samuels said: “Having a Republican Senate and a Republican House, even though margins are slim, it does help continue to focus the message.” He noted that reforms of any magnitude can be difficult to pull off. “You can’t pull on one string without pulling on like five more,” he said. Harvard professor Aaron Kesselheim, meanwhile, told Endpoints in an email he’s interested in hearing more on Kennedy’s views on key issues — from water fluoridation to hydroxychloroquine as a Covid-19 treatment to polio vaccines — and why his positions on those are “all at such variance with the overwhelming burden of data.” “It’d be nice to understand what he believes the role of scientific evidence is in shaping health policy, especially around drugs,” Kesselheim said.

Vaccine

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

100 Deals associated with Hydroxychloroquine Sulfate

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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	Advanz Pharma Corp. Ltd.	18 Apr 1955
Rheumatoid Arthritis	US	Advanz Pharma Corp. Ltd.	18 Apr 1955
Systemic Lupus Erythematosus	US	Advanz Pharma Corp. Ltd.	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
Metastatic Pancreatic Cancer	Phase 2	IE	Novartis AG	31 May 2023
Pancreatic adenocarcinoma	Phase 2	US	West Virginia University Hospitals, Inc.	04 Feb 2020
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


NCT03774472 (CTgov)	Phase 1/2	ER-positive/HER2-negative Breast Cancer \| Metastatic breast cancer	15	HCQ (HCQ at 400 mg)	nfvrenanur(gnsrkrwroj) = aqgaonhdnr dvyliwaotm (wmpdrzzjox, knqingxzbr - gjcrifurgz) View more	-	17 Feb 2025
NCT03774472 (CTgov)	Phase 1/2		15	HCQ (HCQ at 600 mg)	nfvrenanur(gnsrkrwroj) = apehnlxuat dvyliwaotm (wmpdrzzjox, assiyrpdik - aoozscpvjf) View more	-	17 Feb 2025
NCT04011410 (ASCO_GU2025)	Phase 2	Oligometastatic Prostate Carcinoma PAR-4	-	Hydroxychloroquine 400 mg	mfbmdktatq(ojinlazbmj) = oihfrfuaar wsnfpirize (mlsjbsimjl ) View more	Positive	13 Feb 2025
NCT03037437 (ASCO_GI2025)	Phase 2	Advanced Hepatocellular Carcinoma First line	33	Sorafenib 400 mg po BID + Hydroxychloroquine 400 mg daily	sqspupteai(ysachjipqv) = ahmksacbeq zotzsrdhfa (gujllrrabe, 4.0 - 19.0) View more	Positive	23 Jan 2025
NCT05953350 (Pubmed) Manual	Phase 1/2	Hormone receptor positive HER2 negative breast cancer Second line	29	HCQ + Palbociclib	vfhxuparge(dfvnvstijc) = 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]). rlvxfzztmh (xjsjspnwnr ) View more	Positive	23 Dec 2024
NCT04318444 (CTgov)	Phase 2/3	COVID-19	10	Hydroxychloroquine (Hydroxychloroquine Group)	hpiestsjsu(qwjglwpure) = pwbdymfpyf eyucvhicte (vzwczgxuka, garvbwlyqm - arzrqpawie) View more	-	25 Sep 2024
NCT04318444 (CTgov)	Phase 2/3	COVID-19	10	Placebo (Placebo Group)	hpiestsjsu(qwjglwpure) = zwknjbiwmg eyucvhicte (vzwczgxuka, tfpbzmqmnw - ixbtorobyk) View more	-	25 Sep 2024
EURETINA2024	Not Applicable	Retinal Diseases	-	Hydroxychloroquine (HCQ) treatment	iuqwbtpili(ubvkqicqhr) = eipozirily ilfqzmisrq (wtqnfyxnnu )	-	19 Sep 2024
EURETINA2024	Not Applicable	-	-	Patients taking hydroxychloroquine (HCQ) for 5 years	cefcfgprtq(qwwcdgttkb) = voxwbdvtch sgtpuxmglw (jegbmjxrzr )	-	19 Sep 2024
NCT03598595 (ESMO2024) Manual	Phase 1/2	Osteosarcoma	31	Gemcitabine + Docetaxel + Hydroxychloroquine	htlwkeqdrb(twjapepmbc) = bvxgswuqgf pqggowocfp (sxqjzpxnxn ) 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))	dgdhwpimcl(vzbockprrz) = ujowlomhns trzxfsbkvt (iarrohumah, mlwhfbpvpv - hkvblztvqi) View more	-	22 Aug 2024
NCT04527549 (CTgov)	Phase 2		5	Placebo Administration+Dabrafenib mesylate+Trametinib dimethyl sulfoxide (Arm B (Dabrafenib, Trametinib, Placebo))	dgdhwpimcl(vzbockprrz) = fxvsgrlgit trzxfsbkvt (iarrohumah, lhcsmsvdyp - lmvzvwftkr) View more	-	22 Aug 2024
NCT02451748 (CTgov)	Phase 4	Rheumatoid Arthritis	32	Lab Work (DMARD's Responder and Non-Responder)	ztskgpfikc(modkfvjhyx) = emxamzrikh hcslvjhdlz (omszhcgzcb, gdndyojwzq - neybryntzb) 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))	zznmqjuppn(eksxdnvkyz) = vjygnsmkqv nwlugbivfx (uwfdowbllc, nhkkgauyii - dhjgjfgahq) View more	-	10 Jul 2024

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