Primary study objective: To study the effect of efavirenz on the pharmacokinetics of SHR1459 in healthy subjects. Secondary study objective: To observe the safety of single administration of SHR1459, multiple administration of efavirenz, and combination administration of the two drugs in healthy subjects.

Start Date04 Nov 2022

Sponsor / Collaborator

Shanghai Hengrui Pharmaceutical Co., Ltd.

[+1]

NCT05095337 / Active, not recruitingPhase 1

A Phase I Mass Balance and Biotransformation Study of [14C]SHR1459 in Chinese Healthy Adult Male Volunteers

Evaluate the Mass Balance and Biotransformation of [14C]SHR1459 in Healthy Adult Male Volunteers

Start Date07 Jun 2022

Sponsor / Collaborator

Jiangsu Hengrui Pharmaceuticals Co., Ltd.

100 Clinical Results associated with Edralbrutinib

100 Translational Medicine associated with Edralbrutinib

100 Patents (Medical) associated with Edralbrutinib

Literatures (Medical) associated with Edralbrutinib

01 Dec 2021·Clinical cancer research : an official journal of the American Association for Cancer ResearchQ1 · MEDICINE

Antitumor Activity of the Novel BTK Inhibitor TG-1701 Is Associated with Disruption of Ikaros Signaling in Patients with B-cell Non–Hodgkin Lymphoma

Q1 · MEDICINE

Article

Author: Fernández-Serrano, Miranda ; Profitós Pelejà, Núria ; Blecua, Pedro ; Musulen, Eva ; Menéndez, Pablo ; Esteller, Manel ; Ribeiro, Marcelo Lima ; De La Torre, Carolina ; Armengol, Marc ; Bosch, Francesc ; Vinyoles, Meritxell ; Normant, Emmanuel ; Santos, Juliana Carvalho ; Sedó Mor, Alícia ; Roué, Gaël ; Bech-Serra, Joan J. ; Miskin, Hari ; Reyes-Garau, Diana

Abstract:

Purpose::

Despite the remarkable activity of BTK inhibitors (BTKi) in relapsed B-cell non–Hodgkin lymphoma (B-NHL), no clinically-relevant biomarker has been associated to these agents so far. The relevance of phosphoproteomic profiling for the early identification of BTKi responders remains underexplored.

Experimental Design::

A set of six clinical samples from an ongoing phase I trial dosing patients with chronic lymphocytic leukemia (CLL) with TG-1701, a novel irreversible and highly specific BTKi, were characterized by phosphoproteomic and RNA sequencing (RNA-seq) analysis. The activity of TG-1701 was evaluated in a panel of 11 B-NHL cell lines and mouse xenografts, including two NF-κB- and BTKC481S-driven BTKi-resistant models. Biomarker validation and signal transduction analysis were conducted through real-time PCR, Western blot analysis, immunostaining, and gene knockout (KO) experiments.

Results::

A nonsupervised, phosphoproteomic-based clustering did match the early clinical outcomes of patients with CLL and separated a group of “early-responders” from a group of “late-responders.” This clustering was based on a selected list of 96 phosphosites with Ikaros-pSer442/445 as a potential biomarker for TG-1701 efficacy. TG-1701 treatment was further shown to blunt Ikaros gene signature, including YES1 and MYC, in early-responder patients as well as in BTKi-sensitive B-NHL cell lines and xenografts. In contrast, Ikaros nuclear activity and signaling remained unaffected by the drug in vitro and in vivo in late-responder patients and in BTKC481S, BTKKO, and noncanonical NF-κB models.

Conclusions::

These data validate phosphoproteomic as a valuable tool for the early detection of response to BTK inhibition in the clinic, and for the determination of drug mechanism of action.

News (Medical) associated with Edralbrutinib

01 Jun 2023

·www.prnewswire.com

Idiopathic Membranous Nephropathy Market to Register Immense Growth at a CAGR of 12% During the Study Period (2019-2032), Predicts DelveInsight

As potential therapies are being investigated to manage idiopathic membranous nephropathy, it is safe to predict that the idiopathic membranous nephropathy market will experience significant reconstitution during 2023–2032. However, the challenges of the rigid and burdensome structure of regulatory authorities will decide the fate of all these pipeline therapies and the impact they will have on overall revenue generation. LAS VEGAS, June 1, 2023 /PRNewswire/ -- DelveInsight's Idiopathic Membranous Nephropathy Market Insights report includes a comprehensive understanding of current treatment practices, idiopathic membranous nephropathy emerging drugs, market share of individual therapies, and current and forecasted market size from 2019 to 2032, segmented into 7MM [the United States, the EU-4 (Italy, Spain, France, and Germany), the United Kingdom, and Japan] and China. Key Takeaways from the Idiopathic Membranous Nephropathy Market Report As per DelveInsight analysis, the idiopathic membranous nephropathy market size in the 7MM + China was approximately USD 220 million in 2022. According to the assessment done by DelveInsight, the estimated total prevalent idiopathic membranous nephropathy cases in the 7MM + China were approximately 380K in 2022. Leading idiopathic membranous nephropathy companies such as Hoffmann-La Roche, MorphoSys, Cerium Pharmaceuticals, BeiGene, Reistone Biopharma, Eternity Bioscience, GlaxoSmithKline, ValenzaBio, ACELYRIN, and others are developing novel Idiopathic Membranous Nephropathy drugs that can be available in the Idiopathic Membranous Nephropathy market in the coming years. The promising idiopathic membranous nephropathy therapies in the pipeline include GAZYVA (obinutuzumab), MOR202 (felzartamab), SNP-ACTH (1-39) Gel, BRUKINSA (zanubrutinib), SHR1459 (edralbrutinib), BENLYSTA (belimumab), VB119 , and others. Discover which therapies are expected to grab the major idiopathic membranous nephropathy market share @ Idiopathic Membranous Nephropathy Market Report Idiopathic Membranous Nephropathy Overview Membranous nephropathy is a kidney disease affecting the kidney's filters. It causes a rise in protein in the urine, impaired renal function, and edoema. It's also known as membranous glomerulopathy. Membranous nephropathy is a rare disease that affects the renal glomerulus, specifically the podocytes, which play an important role in limiting the permeability of the kidney to proteins. The most common membranous nephropathy symptom is swelling, often known as edema. This might range from minor to severe. Most patients have some edema, which is generally the initial symptom. Swelling in membranous nephropathy is usually slow compared to other disorders that cause protein in the urine and nephrotic syndrome, but it can sometimes be sudden. It usually begins in the feet, ankles, or legs, although it can develop elsewhere in the body, including the abdomen, hands, arms, and face. Protein in the urine is frequently used to make membranous nephropathy diagnosis. A blood test, a kidney biopsy, optical microscopy, immunofluorescence, electron microscopy, and antibody-guided diagnostics are also conducted. Idiopathic Membranous Nephropathy Epidemiology Segmentation DelveInsight estimates that there were approximately 380K prevalent cases of idiopathic membranous nephropathy in the 7MM in 2022. China contributed to the largest prevalent population of idiopathic membranous nephropathy, acquiring ~82% of the 7MM and China in 2022. Whereas EU4 and the UK for ~6%, and Japan accounted for ~ 5% of the total population share, in 2022. The idiopathic membranous nephropathy market report proffers epidemiological analysis for the study period 2019–2032 in the 7MM + China segmented into: Idiopathic Membranous Nephropathy Prevalence Idiopathic Membranous Nephropathy Prevalence by Antigens Idiopathic Membranous Nephropathy Treatment Market There is no cure for either primary or secondary membranous nephropathy. When treating individuals with the illness, doctors usually take a symptomatic approach and aim to improve the patient's immune system. Patients are put on supportive care as soon as the diagnosis is confirmed, regardless of the underlying cause, and this is continued throughout the duration of the condition. It includes careful blood pressure control, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker therapy to reduce proteinuria and increase the chances of spontaneous remission, statins for hyperlipidemia, salt restriction, diuretics to control edoema, and a low protein diet to allow for the replacement of urinary protein losses. In recent research, alkylating drugs used in combination with corticosteroids produced positive results in membranous nephropathy patients. Immunosuppressive therapy (such as steroids and alkylating agents, calcineurin inhibitors (CNIs), and rituximab) are among the medications used to treat membranous nephropathy patients. Alkylating drugs, steroids, and calcineurin inhibitors (CNIs) have formed the foundation of immunosuppression and immunosuppressive medications. Though they are partially effective in reducing proteinuria in membranous nephropathy patients, they have also been linked to greater relapse rates and significant adverse responses. To know more about idiopathic membranous nephropathy treatment guidelines, visit @ Idiopathic Membranous Nephropathy Management Idiopathic Membranous Nephropathy Pipeline Therapies and Key Companies GAZYVA (obinutuzumab): Hoffmann-La Roche MOR202 (felzartamab): MorphoSys SNP-ACTH (1-39) Gel: Cerium Pharmaceuticals BRUKINSA (zanubrutinib): BeiGene SHR1459 (edralbrutinib): Reistone Biopharma/Eternity Bioscience BENLYSTA (belimumab): GlaxoSmithKline VB119: ValenzaBio/ACELYRIN Learn more about the FDA-approved drugs for idiopathic membranous nephropathy @ Drugs for Idiopathic Membranous Nephropathy Treatment Idiopathic Membranous Nephropathy Market Dynamics The dynamics of the idiopathic membranous nephropathy market are expected to change in the coming years. Increased research activities and the discovery of new biomarkers and therapeutic targets, will result in the development of improved medicines in the future. Although rituximab is effective, patients can acquire medication resistance over time. Roche's Obinutuzumab is being developed with improved efficacy, which will aid in overcoming the limits of current therapy. Moreover, the rapid incidence of progression and remission in membranous nephropathy patients provides pharmaceutical companies with an opportunity to develop therapies to address the inadequacies and capture a largely untapped idiopathic membranous nephropathy market. Only a few drugs, such as Obinutuzumab, are in the latter stages of development. As a result, it opens the door for additional pharmaceutical companies to enter the idiopathic membranous nephropathy market with fresh therapeutic choices. However, several factors may impede the growth of the idiopathic membranous nephropathy market. Due to knowledge gaps and a lack of clarity about membranous nephropathy pathology, there is an urgent scarcity of large-scale clinical studies assessing therapy alternatives in membranous nephropathy. The outcomes of idiopathic membranous nephropathy treatment candidates that are in various stages of clinical development and are expected to be launched are not available. As a result, establishing the safety and efficacy of these medications is difficult. Moreover, as membranous nephropathy is a rare indication, it is often overshadowed by more common and fatal renal diseases, thereby influencing the whole research and development process. Almost 30% of membranous nephropathy cases develop into ESRD, yet the therapeutic landscape is devoid of recognized medicines, leading to a high fatality rate. Scope of the Idiopathic Membranous Nephropathy Market Report Therapeutic Assessment: Idiopathic Membranous Nephropathy current marketed and emerging therapies Idiopathic Membranous Nephropathy Market Dynamics: Attribute Analysis of Emerging Idiopathic Membranous Nephropathy Drugs Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Idiopathic Membranous Nephropathy Market Access and Reimbursement Discover more about idiopathic membranous nephropathy drugs in development @ Idiopathic Membranous Nephropathy Clinical Trials Table of Contents Related Reports Idiopathic Membranous Nephropathy Epidemiology Forecast Idiopathic Membranous Nephropathy Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, and idiopathic membranous nephropathy epidemiology trends. Nephrotic Syndrome Pipeline Nephrotic Syndrome Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nephrotic syndrome companies, including GlaxoSmithKline, Goldfinch Bio, Inc., Travere Therapeutics, Inc., Aurinia Pharmaceuticals, Bristol-Myers Squibb, ChemoCentryx, SynAct Pharma AB, among others. Nephrotic Syndrome Market Nephrotic Syndrome Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key nephrotic syndrome companies, including GlaxoSmithKline, Goldfinch Bio, Inc., Travere Therapeutics, Inc., Aurinia Pharmaceuticals, Bristol-Myers Squibb, ChemoCentryx, SynAct Pharma AB, 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] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

05 Aug 2021

·www.globenewswire.com

A Robust Neuromyelitis Optica Spectrum Disorder Pipeline Domain Witnesses Several Novel and Promising Therapies in Different Stages of Clinical Development Expected to Enter the Market by the Next Dec

Los Angeles, USA, Aug. 04, 2021 (GLOBE NEWSWIRE) -- A Robust Neuromyelitis Optica Spectrum Disorder Pipeline Domain Witnesses Several Novel and Promising Therapies in Different Stages of Clinical Development Expected to Enter the Market by the Next Decade DelveInsight’s analysis demonstrates a robust Neuromyelitis Optica Spectrum Disorder Pipeline with 15+ active players in the domain working on 15+ pipeline therapies. DelveInsight’s ‘Neuromyelitis Optica Spectrum Disorder Pipeline Insights’ report presents an exhaustive coverage of the available therapies, Neuromyelitis Optica Spectrum Disorder emerging therapies in different phases of clinical development, key companies working in the Neuromyelitis Optica Spectrum Disorder pipeline domain, and future potential of the space. Some of the notable pointers extracted from the Neuromyelitis Optica Spectrum Disorder Pipeline report: Request for Sample to know more about the therapies expected to make grab the maximum patient pool @ Neuromyelitis Optica Spectrum Disorder Emerging Therapies and Forecast The Neuromyelitis Optica Spectrum Disorder Pipeline reports lays down a comprehensive structure of the ongoing clinical trials, partnerships taking place in the domain, recent happenings in space, and growth prospects across the Neuromyelitis Optica Spectrum Disorder domain. Neuromyelitis Optica Spectrum Disorder Overview Neuromyelitis Optica Spectrum Disorder (NMOSD), also referred to as Devic disease, is a chronic condition that causes inflammation of the optic nerve and spinal cord thereby affecting the brain and spinal cord. The condition is an autoimmune disorder, however, the exact pathophysiology and cause of the autoimmunity remain unclear. Discover more about the disease, treatments, and pipeline therapies @ NMOSD Pipeline Assessment Neuromyelitis Optica Spectrum Disorder Pipeline Drugs Request for Sample to know more @ Neuromyelitis Optica Spectrum Disorder Pipeline Analysis, Key Companies, and Futuristic Trends Neuromyelitis Optica Spectrum Disorder Therapeutics Assessment The Neuromyelitis Optica Spectrum Disorder Pipeline report presents a holistic picture of the Neuromyelitis Optica Spectrum Disorder emerging novel therapies segmented by Stage, Product Type, Route of Administration, Molecule Type, Target, and Mechanism of Action. By Product Type By Stage By Molecule Type By Route of Administration By Mechanism of Action By Targets For rich insights into merging therapies and assessment, visit NMOSD Pipeline Emerging Novel Therapies Scope of the Neuromyelitis Optica Spectrum Disorder Pipeline Report Coverage: GlobalKey Players: Alexion Pharmaceuticals, RemeGen, Reistone Biopharma, Chord Therapeutics, Nihon Pharmaceuticals, Harbour BioMed, Bio-Thera Solutions, Abide Therapeutics, Bionure, Boston Pharmaceuticals, and TG Therapeutics among others.Key Neuromyelitis Optica Spectrum Disorder Pipeline Therapies: Ravulizumab, Telitacicept, SHR1459, CRD1, HBM9161, BAT4406F, ABX-1431, BN201, ARN-6039, and Ublituximab among others.Discover more about the scope of the report @ Neuromyelitis Optica Spectrum Disorder Emerging Therapies, Treatments, and Ongoing Clinical Trials Table of Contents Learn more about the report offerings @ Neuromyelitis Optica Spectrum Disorder Pipeline Therapies and Emerging Trends Audit the market before venturing with DelveInsight’s Due Diligence Services Related Reports Neuromyelitis Optica Spectrum Disorder MarketDelveInsight's "Neuromyelitis Optica Spectrum Disorder (Neuromyelitis Optica Spectrum Disorder) Market Insights, Epidemiology and Market Forecast-2028" report. Pompe Disease Market Insight Epidemiology And Market ForecastDelveInsight's "Pompe Disease Market Insights, Epidemiology and Market Forecast-2028" report. Spinal Muscular Atrophy Sma Market Insight Epidemiology And Market ForecastDelveInsight's 'Spinal Muscular Atrophy (SMA) - Market Insights, Epidemiology and Market Forecast-2028' report. Spinocerebellar Ataxias Market Insights Epidemiology And Market ForecastDelveInsight's 'Spinocerebellar Ataxia (SCA) - Market Insights, Epidemiology and Market Forecast-2028’ report. Acute Ischemic Stroke Market InsightsDelveInsight’s ‘Acute Ischemic Stroke (AIS) - Market Insights, Competitive Landscape and Market Forecast–2026’ report. Adult Intraventricular Hemorrhage MarketDelveInsight’s ‘Adult Intraventricular Haemorrhage Market Insights, Competitive Landscape and Market Forecast-2026’ report. Carotid Stenotic Scan Devices MarketDelveInsight’s ‘Carotid Stenotic Scan Devices Market Insights, Competitive Landscape and Market Forecast-2026’ report. Browse through our posts Dynamics Of Schizophrenia MarketAlzheimer’s Disease Market LandscapeAdvancements in Neuromodulation in the Neurological Disorders MarketDeep Brain Stimulation Devices and Changing Market Landscape 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. For more insights, visit Pharma, Healthcare, and Biotech News

18 Jun 2021

·www.biospace.com

TG Therapeutics Announces Preclinical and Clinical Data Evaluating TG-1701 at the 16th International Congress on Malignant Lymphoma

NEW YORK, June 18, 2021 (GLOBE NEWSWIRE) -- TG Therapeutics, Inc. (NASDAQ: TGTX), today announced data from two presentations evaluating TG-1701, the Company’s investigational once-daily, oral BTK inhibitor, presented today during the 16th International Congress on Malignant Lymphoma (ICML). One presentation evaluated TG-1701 preclinically and the other included Phase 1 data evaluating TG-1701 as a monotherapy and as a triple therapy in combination with ublituximab, the Company’s novel glycoengineered anti-CD20 monoclonal antibody, and UKONIQ® (umbralisib), the Company’s once-daily, inhibitor of PI3K-delta and CK1-epsilon in patients with front line or relapsed/refractory non-Hodgkin’s lymphoma (NHL) and chronic lymphocytic leukemia (CLL). The Phase 1 data presented today were previously presented at the 2021 American Society of Clinical Oncology (ASCO) annual meeting and the 2021 European Hematology Association annual meeting. PRESENTATION HIGHLIGHTS: Poster Presentation Title: Antitumoral activity of the novel BTK inhibitor TG-1701 is associated with disruption of Ikaros signaling and improvement of anti-CD20 therapy in B-cell non-Hodgkin lymphoma TG-1701 is a novel irreversible BTK inhibitor currently in Phase 1 clinical development, as monotherapy or in combination with ublituximab and UKONIQ (umbralisib). In patient samples from a Phase 1 clinical trial of TG-1701, phosphoproteomic analysis differentiated early and late CLL responders to TG-1701 therapy. Disruption of an active Ikaros pathway is a signature of early responders, while absence of Ikaros modulation upon TG-1701 therapy is a signature of non-/late responders. TG-1701 did not impair FcγR-driven ADCC and ADCP and cooperated with U2 in in vitro and in vivo models of BTKi-sensitive and BTKi-resistant B-NHL. Poster Presentation Title: TG-1701, A Selective Bruton Tyrosine Kinase (BTK) Inhibitor, as Monotherapy and in Combination with Ublituximab and Umbralisib (U2) in Patients with B-cell Malignancies A total of 125 patients with R/R CLL or B-cell lymphoma have been treated with TG-1701, with patients receiving monotherapy in the dose-escalation cohort (n=25), 200 mg in a dose-expansion cohort (n=61), 300 mg in a CLL dose-expansion cohort (n=20), or TG-1701 in combination with U2 in the dose escalation cohort (n=19). TG-1701 monotherapy was well tolerated and the maximum tolerated dose was not reached up to 400 mg QD. Adverse Events (AEs) of special interest in patients treated with 200 mg and 300 mg QD of TG-1701 (n=81), included Grade 3 hypertension (4.9%), atrial fibrillation (1.2%), and no instances of major bleeding observed. Grade 3 AEs occurring in ≥10% of patients treated with U2+1701 included diarrhea (11%), neutropenia (11%), ALT increase (16%), and AST increase (16%), and Grade 4 AEs occurring in ≥10% of patients treated with U2+1701 included neutropenia (11%). At a median follow up of 12.2 months in the 200 mg QD monotherapy expansion cohorts, overall response rates (ORR) were: 95% (19/20) in CLL, 65% (13/20) in mantle cell lymphoma (MCL), and 95% (19/20) in Waldenstrom macroglobulinemia (WM). 100% ORR observed at a median follow up of 8.6 months in the 300 mg CLL monotherapy cohort (n=19). At a median follow up of 15.6 months, the 1701+U2 dose escalation (using doses of 100mg to 300 mg QD of TG-1701) resulted in 79% ORR, with 21% CR rate across patients with WM, CLL, marginal zone lymphoma (MZL), diffuse large B-cell lymphoma (DLBCL) and follicular lymphoma (FL) (n=19). Data presented at ICML 2021 is available on the Publications page of the Company’s website at . ABOUT TG THERAPEUTICS, INC. TG Therapeutics is a fully-integrated, commercial stage biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell malignancies and autoimmune diseases. In addition to an active research pipeline including five investigational medicines across these therapeutic areas, TG has received accelerated approval from the U.S. FDA for UKONIQ® (umbralisib), for the treatment of adult patients with relapsed/refractory marginal zone lymphoma who have received at least one prior anti-CD20-based regimen and relapsed/refractory follicular lymphoma who have received at least three prior lines of systemic therapies. Currently, the Company has two programs in Phase 3 development for the treatment of patients with relapsing forms of multiple sclerosis (RMS) and patients with chronic lymphocytic leukemia (CLL) and several investigational medicines in Phase 1 clinical development. For more information, visit , and follow us on Twitter @TGTherapeutics and Linkedin. UKONIQ® is a trademark of TG Therapeutics, Inc. Cautionary Statement This press release contains forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements include but are not limited to statements regarding the expectations and plans for clinical trials evaluating TG-1701 as monotherapy and in combination with UKONIQ® (umbralisib) and ublituximab (U2), the availability of results from those trials, and the potential of TG-1701 as a treatment for CLL. In addition to the risk factors identified from time to time in our reports filed with the U.S. Securities and Exchange Commission, factors that could cause our actual results to differ materially are the following: the risk that interim, top-line, or other early clinical trial results, including the clinical studies evaluating TG-1701 in combination with U2, will not be reproduced in final data sets or in future studies; the risk that the safety pro with TG-1701 as monotherapy and in combination with U2, may change as additional patients are exposed for longer durations; the risk that TG-1701 as monotherapy or in combination with U2 will not prove to be safe and efficacious; the uncertainties inherent in research and development; the risk that the ongoing COVID-19 pandemic and associated government control measures have an adverse impact on our research and development plans or commercialization efforts; and the risk that preclinical findings will not be validated in clinical trials. Further discussion about these and other risks and uncertainties can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 and in our other filings with the U.S. Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at . The information found on our website is not incorporated by reference into this press release and is included for reference purposes only. CONTACT: Investor Relations Email: ir@tgtxinc.com Telephone: 1.877.575.TGTX (8489), Option 4 Media Relations: Email: media@tgtxinc.com Telephone: 1.877.575.TGTX (8489), Option 6

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100 Deals associated with Edralbrutinib

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Idiopathic Membranous Glomerulonephritis	Phase 2	CN	Reistone Biopharma Co. Ltd.Startup	15 Dec 2021
B-cell lymphoma refractory	Phase 2	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	01 Oct 2021
Neuromyelitis Optica	Phase 2	CN	Reistone Biopharma Co. Ltd.Startup	24 Dec 2020
B-cell lymphoma recurrent	Phase 2	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	-
Glomerulonephritis, Membranous	Phase 2	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	-
B-Cell Malignant Neoplasm	Phase 1	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	04 Nov 2022
Rheumatoid Arthritis	Phase 1	CN	Jiangsu Hengrui Pharmaceuticals Co., Ltd.	28 Jun 2020
B-Cell Lymphoma	Phase 1	AU	TG Therapeutics, Inc.	10 Sep 2018
B-Cell Lymphoma	Phase 1	PL	TG Therapeutics, Inc.	10 Sep 2018
Chronic Lymphocytic Leukemia	Phase 1	AU	TG Therapeutics, Inc.	10 Sep 2018

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03671590 (TG-1701, ICML2021)	Phase 1	Chronic Lymphocytic Leukemia	123	TG-1701 monotherapy	pkdizyfzbl(znmhumnret) = xozzmdbfzx ljlgotnnyn (vhusyotwtb ) View more	Positive	17 Jun 2021
				TG-1701+U2 combination	alddnyilje(ffvwfmsoky) = ovidaunokx ysbtjxxfaj (lrgcqkzivj ) View more
NCT03671590 (TG-1701, EHA2021)	Phase 1	Chronic Lymphocytic Leukemia \| Lymphoma	123	TG-1701 monotherapy	aiadmbjuak(dczsuygtni) = jtxxdkjnxh otgnvnclzo (gjefytcmem ) View more	-	09 Jun 2021
				TG-1701+U2 combination	sjlghvupjq(jjfbvykjtn) = jhfmqeypzd pviavjjzpd (bdpgdyvpuf )
NCT03671590 (ASCO2021)	Phase 1	Chronic Lymphocytic Leukemia	123	TG-1701 monotherapy	cyxwryxzro(celxdommgj) = TEAEs leading to TG-1701 dose reduction occurred in 6.5% of pts. TEAEs leading to treatment discontinuation occurred in 1.6% of pts (AF, COVID-19) dcmnttyfpv (lywollaywy )	-	28 May 2021

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