A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of DNTH103 In Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)

The purpose of this Phase 3 study is to demonstrate the efficacy of DNTH103 as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).

Start Date10 Feb 2025

Sponsor / Collaborator

Dianthus Therapeutics, Inc.

NCT06537999

/ RecruitingPhase 2

A Phase 2, Randomized, Double-Blinded, Placebo-Controlled, Study to Evaluate Safety, Tolerability, Pharmacometrics, and Efficacy of DNTH103 in Adults With Multifocal Motor Neuropathy (MOMENTUM)

The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with multifocal motor neuropathy (MMN).

Start Date17 Sep 2024

Sponsor / Collaborator

Dianthus Therapeutics, Inc.

NCT06282159

/ Active, not recruitingPhase 2

A Phase 2, Randomized, Blinded, Placebo-Controlled, Study to Evaluate Safety, Tolerability, Pharmacometrics, and Efficacy of DNTH103 in Adults With Generalized Myasthenia Gravis (MAGIC)

The purpose of this Phase 2 study is to evaluate the safety, tolerability, pharmacometrics, and efficacy of DNTH103 in participants with generalized myasthenia gravis (gMG).

Start Date23 Feb 2024

Sponsor / Collaborator

Dianthus Therapeutics, Inc.

100 Clinical Results associated with Claseprubart

100 Translational Medicine associated with Claseprubart

100 Patents (Medical) associated with Claseprubart

Literatures (Medical) associated with Claseprubart

01 Nov 2022·ACS omega

Characteristics of Mechanical Properties and Thermal Behavior of Epoxy Nanocomposites and Coatings by Zinc Borate, Nano Silica, and Hardener

Article

Author: Huy, Cuong Huynh Le ; Thanh, An Truong

This study reports the ability of zinc borate (ZB) and nano silica (NS) in improving mechanical properties and thermal behavior of nanocomposites and coatings composed of epoxy resin EPIKOTE 1001 × 75 cured with hardener T31. The properties of the fabricated nanocomposites were characterized using scanning electron microscopy, transmission electron microscopy, thermogravimetric analysis, derivative thermogravimetry, differential scanning calorimetry, and dynamic mechanical analysis. With the addition content of 5 wt % ZB into epoxy resin (EPIKOTE 1001 × 75/T31/ZB-5), the impact strength of the fabricated epoxy polymer film increased by 50%, and the glass transition temperature (T _g) increased from 52 to 71 °C. By adding the content of 5 wt % ZB and 1 wt % NS into epoxy resin (EPIKOTE 1001 × 75/T31/ZB-5/NS-1), the impact strength of the formed epoxy nanocomposite films increased by 137.5%, and T _g increased from 52 to 82 °C. The results showed that 5 wt % ZB, 1 wt % NS, and hardener T31 improved the toughness and mechanical properties of epoxy polymer materials. The thermal stability of epoxy composite EPIKOTE 1001 × 75/T31/ZB-5 increased by 1.9% and that of epoxy nanocomposite EPIKOTE 1001 × 75/T31/ZB-5/NS-1 increased by 4.7%. The epoxy coating based on epoxy resin EPIKOTE 1001 × 75/T31/ZB-5/NS-1 achieved mechanical properties and had the strongest decomposition temperature at 642 °C.

01 Apr 2020·Journal of chromatography. AQ2 · CHEMISTRY

Potential of topological descriptors to model the retention of polychlorinated biphenyls in different gas chromatography stationary phases, including ionic liquid-based columns

Q2 · CHEMISTRY

Article

Author: Ros, M ; Sanz, M L ; Sanz, J ; Ramos, L ; Escobar-Arnanz, J

The aim of this study was to develop a statistical model based on a set of intuitive topological descriptors that will help to determine the influence of the polychlorinated biphenyls (PCBs) structural features on the chromatographic behavior of these analytes in a variety of gas chromatographic stationary phases, including the highly polar ionic liquid (IL)-based SLB-IL76 and SLB-IL60 columns. The model was developed using the stepwise multiple linear regression method, and constructed through several levels of increasing complexity to make evident the relative influence of the selected descriptors. The proposed model was easy to implement and provided similar satisfactory results irrespective of the dependent variables used (i.e., retention index or retention time) or the chromatographic conditions applied (i.e., pseudo-isotherm and programmed temperature) for IL-based phases. The model also allowed the correct prediction of the elution order of selected PCBs in these and other less polar phases evaluated (i.e., SW-10, DB-17, ZB-5 and HT-8). To our knowledge, this is the first models based on topological descriptors described in the literature that provided a satisfactory fitting of the PCB behavior in IL-based phases. Our results indicated that the mechanism governing the chromatographic separation of PCBs in these highly polar columns showed significant differences compared with those observed in other less polar stationary phases.

01 Apr 2008·Journal of chromatography. AQ2 · CHEMISTRY

Comprehensive two-dimensional gas chromatography in the screening of persistent organohalogenated pollutants in environmental samples

Q2 · CHEMISTRY

Article

Author: Bordajandi, L. R. ; Gonzalez, M. J. ; Sanz, J. ; Ramos, L. ; Ramos, J. J.

Separations of eight persistent organohalogenated classes of pollutants, organochlorinated pesticides (OCPs), polychlorinated biphenyls (PCBs), polychlorinated diphenyl ethers (PBDEs), polychlorinated dibenzo-p-dioxins (PCDDs), polychlorinated dibenzofurans (PCDFs), polychlorinated naphthalenes (PCNs), polychlorinated terphenyls (PCTs) and toxaphene (CTT) by comprehensive two-dimensional gas chromatography (GC x GC) were evaluated. Columns with different polarity and selectivity, including ZB-5, HT-8, DB-17 and BP-10, were selected as first dimension and combined with columns of increasing polarity in the second dimension, i.e. HT-8, BPX-50 and Carbowax (or Supelcowax-10). In total nine column combinations were tested. Because the main interest of the study was fast screening of the test xenobiotic families in complex matrices, in all cases, attention was primarily focussed on group-type separation. Nevertheless, within-group separation was also considered, especially for those classes containing particularly toxic congeners, such as PCBs and PCDD/Fs. Although none of the assayed column sets allowed the simultaneous and complete separation of all pollutants classes, some column combinations provided satisfactory separations among selected families and the rest of pollutants investigated. That was, for instance, the case of HT-8 x BPX-50 for PBDEs and PCDD/Fs, DB-17 x HT-8 for PCNs and OCPs and BP-10 x BPX-50 for CTT, PCDD/Fs and PBDEs. The feasibility of the proposed approach for the fast screening of the target classes of pollutants in complex samples was illustrated by the analysis of food and marine fat samples prepared using simplified miniaturised sample treatment methods.

News (Medical) associated with Claseprubart

17 Oct 2025

·www.globenewswire.com

Dianthus Therapeutics Announces Exclusive License Agreement with Leads Biolabs for DNTH212, a First and Potentially Best-In-Class, Phase 1 Ready Bifunctional BDCA2 & BAFF/APRIL Inhibitor for Severe Autoimmune Diseases

DNTH212 is a bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function Demonstrated superior inhibition of pDCs vs. litifilimab in vitro and superior Ig reductions vs. povetacicept in NHPs highlight the potential for improved clinical benefit in severe autoimmune diseases DNTH212 has the potential to be a first line biologic in multiple autoimmune disorders with patient-friendly S.C. self-administration and Q4W or less frequent dosing IND cleared by FDA in September 2025 and expected to clear in China in Q4’25. Phase 1 study of DNTH212 expected to initiate in Q4’25 with top-line results in healthy volunteers in 2H’26 Pro forma estimated cash of ~$525 million; reaffirms runway into 2028 Investor conference call and webcast to be held today at 8:00 a.m. ET Oct. 16, 2025 -- Dianthus Therapeutics, Inc. (Nasdaq: DNTH), a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases, today announced it has entered into an exclusive licensing agreement with Nanjing Leads Biolabs Co., Ltd. (“Leads” (9887.HK) for DNTH212 (being developed in China by Leads Biolabs as LBL-047), a first and potentially best-in-class bifunctional BDCA2 and BAFF/APRIL inhibitor. DNTH212 is an investigational, extended half-life bifunctional fusion protein targeting plasmacytoid dendritic cell (pDC) BDCA2 to reduce Type 1 interferon production, while simultaneously inhibiting BAFF/APRIL to suppress B cell function. By targeting both the innate and adaptive immune systems via two clinically validated pathways that are known drivers of autoimmune disease pathogenesis, this complementary and differentiated approach has the potential to address multiple autoimmune indications with improved outcomes. “We are excited to partner with Leads Biolabs and build upon our vision of becoming a leading autoimmune-focused biopharmaceutical company with the addition of DNTH212 to our pipeline,” said Marino Garcia, Chief Executive Officer of Dianthus Therapeutics. “Both claseprubart and DNTH212, with their validated mechanisms of action and patient friendly convenience of infrequent S.C. self-administration, have the potential to significantly improve the lives of patients suffering from a range of severe autoimmune disorders. We look forward to leveraging the pipeline-in-a-product potential of DNTH212.” pDCs are specialized immune cells that produce large amounts of Type 1 interferons (IFN- and IFN-). High levels of Type 1 interferon drive chronic inflammation and tissue damage, making Type 1 interferon inhibition a promising therapeutic strategy in multiple autoimmune diseases. DNTH212 demonstrated comparable IFNα inhibition and superior pDC depletion in-vitro compared to litifilimab, a late-stage clinically validated BDCA2 monoclonal antibody. BAFF/APRIL activation of B cells generate autoantibodies against tissues that trigger inflammation and tissue damage. Inhibiting BAFF/APRIL has been shown to be a clinically validated therapeutic strategy in numerous autoimmune diseases. DNTH212 demonstrated superior inhibition of immunoglobulins (i.e. IgM, IgA, and IgG) in non-human primates compared to povetacicept, a late-stage clinically validated BAFF/APRIL inhibitor. “The medical team is ready to exploit the full potential of this unique asset targeting both the innate and adaptive immune systems,” said Dr. Simrat Randhawa, Head of Research & Development of Dianthus Therapeutics. “Autoimmune experts have been asking for combination biologic approaches for years so we expect an enthusiastic reception from them as we roll out our target indications.” A two-part Phase 1 study in China in healthy volunteers (Part A) and patients with systemic lupus erythematosus (Part B) is expected to initiate by year end 2025, with top-line results in healthy volunteers expected in the second half of 2026. “We are pleased to partner with Dianthus, a leading biotechnology company with a proven track record of executing complex global clinical trials and delivering meaningful results for patients,” said Dr. Xiaoqiang Kang, Founder, Chairman and CEO of Leads Biolabs. “This collaboration reinforces our commitment to advancing highly innovative drug candidates into the clinic to address serious autoimmune conditions, while further diversifying our pipeline and positioning Leads Biolabs for long-term growth. Dianthus’ deep experience and expertise in this space will be invaluable as we work to bring LBL-047 to patients worldwide.” Dianthus Therapeutics, Inc. is a clinical-stage biotechnology company dedicated to developing next-generation therapies to transform the treatment of severe autoimmune diseases. Based in New York City and Waltham, Mass., Dianthus is comprised of an experienced team of biotech and pharma executives who aim to deliver transformative medicines for people living with severe autoimmune and inflammatory diseases. Founded in 2012, Leads Biolabs is a clinical-stage biotechnology company developing innovative therapies for underserved medical needs in oncology, autoimmune, and other severe diseases in China and globally. A front-runner in next-generation immuno-oncology, the company has a pipeline of 14 drug candidates, including six clinical-stage programs, four of which are among the most advanced in their class. Leads Biolabs leverages proprietary platforms, including LeadsBody™ (CD3 T-cell engager) and X-body™ (4-1BB engager), along with integrated capabilities across discovery, translational medicine, clinical development, CMC, and business development. The innovative nature and competitive strengths of its drug candidates, combined with a proactive strategy, efficient clinical validation, and global perspective, position Leads Biolabs as a preferred partner for leading biopharmaceutical companies and venture capital investors. The content above comes from the network. if any infringement, please contact us to modify.

License out/inImmunotherapy

16 Oct 2025

·www.fiercebiotech.com

Dianthus offers up to $1B for China biotech\'s autoimmune \'pipeline in a product\'

Dianthus will pay the Chinese biotech $30 million in upfront and near-term milestones for ex-China rights to the asset.\n Dianthus Therapeutics is offering Nanjing Leads Biolabs up to $1 billion biobucks for licensing rights to a bispecific antibody designed to treat certain autoimmune disorders.Under the terms of the deal, Dianthus will pay the Chinese biotech $30 million in upfront cash and near-term milestones, plus an $8 million milestone payment tied to the start of a Dianthus-led phase 1 study, according to an Oct. 16 release.Leads Biolabs could also garner up to an additional $962 million in development, regulatory and sales-based milestones across multiple indications, plus tiered royalties.In return, U.S. biotech Dianthus will gain the exclusive ability to develop and commercialize the asset—freshly dubbed DNTH212—except in the Greater China area.DNTH212, also known as LBL-047, is a first-in-class bifunctional BDCA2 and BAFF/APRIL inhibitor with best-in-class potential, according to the release.The candidate is made to block two clinically validated pathways that are known drivers of several autoimmune diseases. The companies hope the program will improve clinical benefit and offer subcutaneous self-administration delivery with infrequent dosing.During an Oct. 16 investor call, Dianthus management said DNTH212 has potential in conditions such as Sjögren\'s syndrome, systemic lupus erythematosus (SLE), dermatomyositis, hidradenitis suppurativa, scleroderma and pemphigus vulgaris.A two-part phase 1 study in China recruiting both healthy participants and patients with SLE is slated to start by the end of this year, Dianthus said. Topline results from the healthy volunteer portion of the trial are expected in the second half of next year.After doling out the upfront $30 million, Dianthus expects to have a $525 million cash runway, money the company believes will stretch into 2028. “We look forward to leveraging the pipeline-in-a-product potential of DNTH212,” Dianthus CEO Marino Garcia said in the release. “We are excited to partner with Leads Biolabs and build upon our vision of becoming a leading autoimmune-focused biopharmaceutical company with the addition of DNTH212 to our pipeline,” Garcia said. Dianthus also boasts claseprubart, an antibody taking aim at generalized myasthenia gravis, in its pipeline. The candidate is also designed to boost patient convenience via less frequent self-administration. In September, the biotech said a phase 2 trial comparing claseprubart to placebo hit the primary endpoint measuring safety and tolerability, while also demonstrating efficacy.“Overall, we view the deal, albeit early, as bolstering Dianthus’s emerging best-in-class positioning among the competitive autoimmune landscape for minimal impact to the balance sheet,” analysts at William Blair wrote in an Oct. 16 note.The analysts highlighted DNTH212’s unique dual mechanism tackling both innate and acquired immune inhibition, noting that safety will be top of mind when evaluating the phase 1 data. As for Leads Biolabs, the Nanjing-based biotech recently debuted on the Hong Kong stock exchange, raising $189 million through an initial public offering.Since emerging in 2012, Leads Biolabs has built out a pipeline consisting of 14 candidates, with six currently in the clinic. The biotech’s immune-oncology portfolio includes monoclonal and bispecific antibodies, T cell engagers and antibody drug conjugates.

$Dianthus offers up to $1B for China biotech\'s autoimmune \'pipeline in a product\'$

Phase 1License out/inPhase 2ADC

08 Sep 2025

·www.fiercebiotech.com

Dianthus\' gMG prospect blooms, with phase 2 win setting up pivotal plans

Dosing is central to Dianthus Therapeutics\' plans to differentiate its candidate in a competitive market. \n Dianthus Therapeutics is advancing its challenge for the increasingly competitive generalized myasthenia gravis (gMG) market, outlining plans to move into phase 3 on the back of hits in a midphase study.The phase 2 trial compared two doses of claseprubart, an antibody engineered to selectively target the classical pathway, to placebo in 65 adults with AChR-positive gMG. Patients received claseprubart every two weeks via subcutaneous injection. While the primary endpoint looked at safety and tolerability, the secondary endpoint data provided a glimpse of the efficacy of the drug candidate. At the low dose, Dianthus reported a 4.6-point improvement on MG-ADL, a scale that measures the impact of gMG on daily functions. The improvement rose to 5.4 points on the high dose. Adjusted for placebo, the improvements on the low and high doses were 1.8 points and 2.6 points, respectively.Dianthus shared the results alongside data on QMG, a physician\'s score of disease severity. QMG scores improved 4.4 points and 4.5 points, respectively, on the low and high doses. Scores improved by two points in the placebo arm. Dianthus also reported statistically significant improvements on other measures of gMG. The biotech shared cross-trial comparisons to show how claseprubart performed against AstraZeneca’s Soliris and Ultomiris and UCB’s Zilbrysq. Claseprubart outperformed the competition in the data shared by Dianthus, with the caveat that such cross-trial comparisons can be unreliable. The company found the drug candidate was generally well tolerated, giving it a data set to inform talks with the FDA and preparations for phase 3. Dianthus plans to test two regimens of the low dose in phase 3, with patients receiving the study drug every two or four weeks. Dianthus didn’t test four-week dosing in the phase 2 study, but the lack of statistical difference between the low and high doses, coupled with evidence such as half-life data, led it to speculate that a less-frequent regimen could work. The two-week dose is Dianthus’ target product profile, but CEO Marino Garcia sees an opportunity to go beyond the base case.“Why not go further? Why not push that differentiation? I don\'t see much of a downside to be honest,” Garcia said on a call with investors to discuss the data. Dosing is central to Dianthus’ plans to differentiate its candidate in a competitive market. The company said more than 80% of patients with AChR-positive gMG have yet to switch to a biologic, despite the availability of C5 inhibitors such as Ultomiris and FcRn drugs, including argenx’s Vyvgart. Dianthus has identified intravenous and high-volume subcutaneous dosing as a barrier to uptake of rival drugs.That thinking led Dianthus to develop an autoinjector. The overarching goal is to combine the efficacy of C5 inhibitors such as Ultomiris with the safety of C1 blockers such as Enjaymo and the convenience of Dupixent. Analysts at Evercore ISI said in a note to clients that: “Both doses clearly met all the bull case efficacy bars” the firm had discussed in preview ahead these data. They added that the biotech “convincingly” matched the C5s. It didn’t see a dose response, thus “opening the door to a longer Q4W dosing interval.”

$Dianthus\' gMG prospect blooms, with phase 2 win setting up pivotal plans$

Clinical ResultPhase 2Phase 3

100 Deals associated with Claseprubart

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 3	United States	Dianthus Therapeutics, Inc.	10 Feb 2025
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 3	China	Dianthus Therapeutics, Inc.	10 Feb 2025
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 3	Argentina	Dianthus Therapeutics, Inc.	10 Feb 2025
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 3	Australia	Dianthus Therapeutics, Inc.	10 Feb 2025
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 3	Brazil	Dianthus Therapeutics, Inc.	10 Feb 2025
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 3	Bulgaria	Dianthus Therapeutics, Inc.	10 Feb 2025
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 3	Colombia	Dianthus Therapeutics, Inc.	10 Feb 2025
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 3	Denmark	Dianthus Therapeutics, Inc.	10 Feb 2025
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 3	France	Dianthus Therapeutics, Inc.	10 Feb 2025
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 3	Germany	Dianthus Therapeutics, Inc.	10 Feb 2025

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06282159 (MAGIC, GlobeNewswire) Manual	Phase 2	Myasthenia Gravis AChR antibody positive	65	Claseprubart 300 mg	lyauwfowgh(iikzimgtnr) = Claseprubart was generally well tolerated and demonstrated a clinical safety profile in both treatment arms comparable to placebo. No infection signal was observed, including no related serious bacterial infections in the treatment arms; the only related serious adverse event (SAE) of infection occurred in the placebo arm. There were no symptoms indicative of autoimmune activation. Injection site reactions (ISRs) were infrequent and generally mild, and there were no claseprubart discontinuations from RCT due to related AEs. iveyuauycr (rztobmvgjd )	Positive	08 Sep 2025
				Claseprubart 600 mg

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