[Translation] A randomized, open-label, two-period, two-crossover bioequivalence study of ixazomib citrate capsules in cancer patients under fasting conditions

评价正大天晴药业集团股份有限公司提供的枸橼酸伊沙佐米胶囊（4mg）和Takeda Pharma A/S持证的枸橼酸伊沙佐米胶囊（恩莱瑞®）（4mg）在空腹状态下给药的人体生物等效性；观察受试制剂枸橼酸伊沙佐米胶囊（4mg，正大天晴药业集团股份有限公司）和参比制剂枸橼酸伊沙佐米胶囊（恩莱瑞®）（4mg，Takeda Pharma A/S持证）在肿瘤患者中的安全性

[Translation]

To evaluate the bioequivalence of ixazomib citrate capsules (4 mg) provided by Chia Tai Tianqing Pharmaceutical Group Co., Ltd. and ixazomib citrate capsules (Enlairui®) (4 mg) licensed by Takeda Pharma A/S when administered in the fasting state in humans; to observe the safety of the test formulation ixazomib citrate capsules (4 mg, Chia Tai Tianqing Pharmaceutical Group Co., Ltd.) and the reference formulation ixazomib citrate capsules (Enlairui®) (4 mg, licensed by Takeda Pharma A/S) in cancer patients.

Start Date13 Aug 2025

Sponsor / Collaborator

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

CTR20252862

/ RecruitingNot Applicable

评估受试制剂枸橼酸伊沙佐米胶囊（规格：4 mg）与参比制剂（恩莱瑞®，规格：4 mg）在患者空腹状态下的多中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验

[Translation] A multicenter, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study evaluating the bioequivalence of the test preparation, ixazomib citrate capsules (strength: 4 mg), and the reference preparation (Enlari®, strength: 4 mg) in patients under fasting conditions.

主要试验目的：研究空腹状态下单次口服受试制剂枸橼酸伊沙佐米胶囊（规格：4 mg，成都苑东生物制药股份有限公司生产）与参比制剂枸橼酸伊沙佐米胶囊（恩莱瑞®，规格：4 mg；Haupt Pharma Amareg GmbH生产）在多发性骨髓瘤患者体内的药代动力学特征，评价空腹状态口服两种制剂的生物等效性。次要试验目的：研究受试制剂枸橼酸伊沙佐米胶囊（规格：4 mg）和参比制剂枸橼酸伊沙佐米胶囊（恩莱瑞®，规格：4 mg）在患者中的安全性。

[Translation]

The primary objective of the study was to investigate the pharmacokinetic characteristics of a single oral dose of the test formulation, ixazomib citrate capsules (4 mg, manufactured by Chengdu Yuandong Biopharmaceutical Co., Ltd.), compared with the reference formulation, ixazomib citrate capsules (Enlairui®, 4 mg, manufactured by Haupt Pharma Amareg GmbH), in patients with multiple myeloma after fasting, and to evaluate the oral bioequivalence of the two formulations in the fasting state. The secondary objective was to investigate the safety of the test formulation, ixazomib citrate capsules (4 mg), compared with the reference formulation, ixazomib citrate capsules (Enlairui®, 4 mg).

Start Date12 Aug 2025

Sponsor / Collaborator

Chengdu Easton Biopharmaceuticals Co., Ltd.

CTR20250794

/ CompletedNot Applicable

预评估受试制剂枸橼酸伊沙佐米胶囊（规格：4 mg）与参比制剂（恩莱瑞®，规格：4 mg）在患者空腹状态下的单中心、开放、随机、单剂量、两周期、两序列、交叉生物等效性试验

[Translation] A single-center, open-label, randomized, single-dose, two-period, two-sequence, crossover bioequivalence study to pre-evaluate the test preparation Ixazomib citrate capsules (strength: 4 mg) and the reference preparation (Enlari®, strength: 4 mg) in patients with fasting state

主要试验目的：研究空腹状态下单次口服受试制剂枸橼酸伊沙佐米胶囊（规格：4 mg，成都苑东生物制药股份有限公司生产）与参比制剂枸橼酸伊沙佐米胶囊（恩莱瑞®，规格：4 mg；Haupt Pharma Amareg GmbH生产）在多发性骨髓瘤或淋巴瘤或晚期实体瘤患者体内的药代动力学特征，为正式人体生物等效性研究提供参考。次要试验目的：研究受试制剂枸橼酸伊沙佐米胶囊（规格：4 mg）和参比制剂枸橼酸伊沙佐米胶囊（恩莱瑞®，规格：4 mg）在患者中的安全性。

[Translation]

The main purpose of the study is to study the pharmacokinetic characteristics of the test preparation Ixazomib Citrate Capsules (Specification: 4 mg, produced by Chengdu Yuandong Biopharmaceutical Co., Ltd.) and the reference preparation Ixazomib Citrate Capsules (Enlairui®, Specification: 4 mg; produced by Haupt Pharma Amareg GmbH) in patients with multiple myeloma or lymphoma or advanced solid tumors after a single oral administration under fasting conditions, so as to provide a reference for formal human bioequivalence studies. The secondary purpose of the study is to study the safety of the test preparation Ixazomib Citrate Capsules (Specification: 4 mg) and the reference preparation Ixazomib Citrate Capsules (Enlairui®, Specification: 4 mg) in patients.

Start Date21 Mar 2025

Sponsor / Collaborator

Chengdu Easton Biopharmaceuticals Co., Ltd.

100 Clinical Results associated with Ixazomib citrate

100 Translational Medicine associated with Ixazomib citrate

100 Patents (Medical) associated with Ixazomib citrate

890

Literatures (Medical) associated with Ixazomib citrate

22 Jan 2026·JOURNAL OF MEDICINAL CHEMISTRY

Structure-Based Design of Pan-Selective Peptide Epoxyketones for the Three Human Immunoproteasome Active Sites

Article

Author: Groll, Michael ; Huber, Eva M. ; Wang, Xingzao ; Heinemeyer, Wolfgang ; Dekker, Patrick M. ; Overkleeft, Herman S. ; Maurits, Elmer ; Florea, Bogdan I.

The proteasome inhibitors bortezomib, carfilzomib, and ixazomib all act by inhibiting multiple active sites of both constitutive proteasomes and immunoproteasomes. These clinical anticancer drugs are effective, but also display side effects, and evidence is amassing that their toxicity arises from constitutive proteasome inhibition. In this work, we describe the structure-guided discovery of a new class of pan-immunoproteasome-selective inhibitors. We identified the peptide epoxyketone BocPip-Ser (8), which targets all three human immunoproteasome active sites potently and with excellent selectivity over constitutive proteasome active sites (IC₅₀ values for i-subunits ≤ 0.92 μM; IC₅₀ ratio β1c/β1i: 13, β2c/β2i: 14, β5c/β5i: 18; Table 1 and Figure 3). We propose compound 8 (BocPip-Ser), which is of a similar size and general properties as carfilzomib, as a lead compound for the development of improved drugs targeting hematological cancers, and possibly also autoimmune diseases, driven by immunoproteasome but not constitutive proteasome activities.

08 Jan 2026·ACS Medicinal Chemistry Letters

First-in-Class Potent, Dual HDAC6/Proteasome Inhibitors Lacking a Hydroxamic Acid Motif: Discovery of Novel Anti-Multiple Myeloma Agents

Article

Author: Aytenfisu, Asaminew H. ; MacKerell, Alexander D. ; Chan, Alexandria M. ; Jones, Jace W. ; Cottingham, Andrea L. ; Pearson, Ryan M. ; Fletcher, Steven ; Van Eker, Daniel ; Lowe, Brandon D.

Motivated by promising clinical trial data for the combination of the histone deacetylase 6 (HDAC6) inhibitor ricolinostat with the proteasome inhibitor bortezomib in relapsed/refractory multiple myeloma (MM) patients, we engineered dual HDAC6/proteasome inhibitors. FDA-approved HDAC inhibitors suffer from off-target effects, which have been attributed, in part, to their lack of HDAC isoform selectivity. Furthermore, they are potentially mutagenic, because of their indispensable hydroxamic acid zinc-binding groups (ZBGs). Deploying the HDAC6-selective phenyl-4-hydroxamic acid motif, and O-carbamoylated hydroxamates as hydroxamic acid surrogates, then grafting to the electrophilic boronic acid warhead of bortezomib/ixazomib, we discovered several dual HDAC6/proteasome inhibitors that were potent in cell-free assays, inhibiting the chymotrypsin-like (CL) proteasomal activity on par with that of bortezomib, and many compounds demonstrated selectivity for HDAC6 over HDAC1 as predicted. Moreover, several dual HDAC6/proteasome inhibitors were submicromolar inhibitors of MM cell growth. Of particular interest, AMC-3-030 with an O-(N-phenylcarbamoyl)-hydroxamate ZBG emerged as an exciting lead for further studies.

31 Dec 2025·Future Science OA

Pharmacoeconomic evaluation of carfilzomib versus ixazomib for the treatment of relapsed and refractory multiple myeloma

Article

Author: You, Ruxu ; Ma, Yuanyuan ; Wang, Lin ; Chen, Fen ; Zhang, Yu ; Liu, Jinyu ; Lin, Xihan

OBJECTIVE:

This study assesses the cost-effectiveness of carfilzomib plus lenalidomide and dexamethasone (KRd) versus ixazomib plus lenalidomide and dexamethasone for relapsed and refractory multiple myeloma (RRMM) in China.

METHODS:

A survival model was used to analyze health states and costs over a lifetime, with a 4-week cycle. Treatment effects on progression-free survival (PFS) and overall survival (OS) were modeled using hazard ratios (HRs) derived from the network meta-analysis (NMA). Health state utility values and disutility values for adverse events were obtained from published literature. Direct medical costs included drug costs, disease management costs, and costs associated with adverse event management. Costs and utilities were discounted by 5% annually. Both one-way and probabilistic sensitivity analyses were conducted.

RESULTS:

The carfilzomib combination was found to be cost-effective, saving $127,513.22 per additional quality-adjusted life year (QALY) gained compared to the ixazomib combination. Sensitivity analysis showed that ixazomib's price, progression state utility, and carfilzomib's price significantly affected the results. At a $40,023.27 willingness-to-pay (WTP) threshold, the carfilzomib combination has a 100% probability of being cost-effective.

CONCLUSIONS:

The study shows that, based on evidence from indirect comparisons, KRd is a cost-effective treatment option for RRMM patients in China.

News (Medical) associated with Ixazomib citrate

07 Aug 2025

·www.prnewswire.com

Nuvalent Highlights Pipeline and Business Achievements, Reiterates Key Anticipated Milestones, and Reports Second Quarter 2025 Financial Results

Initiated rolling NDA submission for zidesamtinib for TKI pre-treated patients with advanced ROS1-positive NSCLC, with target completion in the third quarter of 2025 Initiated ALKAZAR Phase 3 randomized, controlled trial of neladalkib for front-line ALK-positive NSCLC Topline pivotal data for neladalkib for TKI pre-treated patients with advanced ALK-positive NSCLC expected by year-end 2025 Preliminary data for neladalkib in patients with ALK-positive solid tumors beyond NSCLC to be presented at the ESMO Congress 2025 Jason Waters, MBA, promoted to Senior Vice President, Commercial CAMBRIDGE, Mass., Aug. 7, 2025 /PRNewswire/ -- Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline and business achievements, reiterated key anticipated milestones, and reported second quarter 2025 financial results. "With the initiation of our rolling NDA submission for zidesamtinib in TKI pre-treated advanced ROS1-positive NSCLC and the dosing of the first patient in our ALKAZAR Phase 3 trial of neladalkib in TKI-naïve advanced ALK-positive NSCLC, 2025 has been marked by transformative milestones towards our mission to discover, develop, and deliver precisely targeted therapies for patients with cancer," said Alexandra Balcom, Chief Financial Officer of Nuvalent. "We remain focused on continuing to deliver value that is grounded in prioritizing patient impact with topline pivotal data from our ALKOVE-1 trial of neladalkib in TKI pre-treated advanced ALK-positive NSCLC expected by year-end and the first report of preliminary data for other ALK-positive solid tumors at ESMO, continued momentum in our HEROEX-1 trial of NVL-330 for HER2-altered NSCLC, and a robust discovery pipeline." "In parallel to our continued execution against development and regulatory milestones, we are actively building the strong commercial infrastructure needed to achieve our vision of becoming a fully integrated, commercial-stage biopharmaceutical company," said James Porter, Ph.D., Chief Executive Officer of Nuvalent. "Today we are proud to announce the promotion of Jason Waters to Senior Vice President, Commercial, in recognition of his leadership in establishing our commercial strategy and shaping a launch-ready organization that extends from our founding values of Patient Impact, Empowerment, and Collaboration. Supported by a growing team and strong cash runway into 2028, we believe we are well-positioned to achieve our goals." Recent Pipeline Achievements and Anticipated Milestones ROS1 Program The company has initiated its rolling NDA submission for zidesamtinib, a novel ROS1-selective inhibitor, in tyrosine kinase inhibitor (TKI) pre-treated patients with advanced ROS1-positive non-small cell lung cancer (NSCLC). The FDA agreed to accept the NDA for participation in the Real-Time Oncology Review (RTOR) pilot program, which facilitates earlier submission of topline efficacy and safety results prior to the submission of the complete application, to support an earlier start to the FDA's evaluation of the application. Completion of the NDA submission is targeted for the third quarter of 2025. The NDA submission is based on positive pivotal data for TKI pre-treated patients with advanced ROS1-positive NSCLC enrolled in the global ARROS-1 Phase 1/2 clinical trial. These data were recently reported along with preliminary data from the ongoing Phase 2 TKI-naïve cohort of ARROS-1, in which a total of 104 patients had been enrolled as of June 16, 2025. The company continues to engage with the FDA on potential opportunities for line-agnostic expansion. ALK Program Nuvalent recently announced the dosing of the first patient in ALKAZAR, the company's global Phase 3 randomized, controlled trial designed to evaluate neladalkib for the treatment of patients with TKI-naïve ALK-positive NSCLC. Patients will be randomized 1:1 to receive neladalkib monotherapy or alectinib monotherapy, a front-line standard of care, reflecting input from collaborating physician-scientists and alignment with global regulatory agencies. Evaluation of neladalkib is ongoing in the ALKOVE-1 Phase 1/2 trial for patients with advanced ALK-positive NSCLC and other solid tumors: The company expects to report pivotal data for TKI pre-treated patients with advanced ALK-positive NSCLC by year-end 2025. The company will present preliminary data from the Phase 2 exploratory cohort for patients with ALK-positive solid tumors beyond NSCLC during a poster presentation at the European Society for Medical Oncology (ESMO) Congress 2025, taking place October 17-21, 2025, in Berlin, Germany. Details of the presentation are as follows: Title: Neladalkib (NVL-655) efficacy and safety in patients with ALK-positive solid tumors in the ALKOVE-1 study Presentation Number: 972P Session Category: Poster Session Session Title: Developmental Therapeutics Presentation Date and Time: Sunday, October 19, 2025, 12:00 – 12:45 CEST Location: Hall 25 Presenter: Benjamin J. Solomon, MBBS, Ph.D. (Peter MacCallum Cancer Centre, Melbourne, Australia) HER2 Program Enrollment is ongoing in the HEROEX-1 Phase 1a/1b clinical trial evaluating the overall safety and tolerability of NVL-330 for pre-treated patients with HER2-altered NSCLC. Additional objectives include determination of the recommended Phase 2 dose, characterization of NVL-330's pharmacokinetic profile, and preliminary evaluation of anti-tumor activity. The company expects to continue to progress the HEROEX-1 trial throughout 2025. Business Updates Jason Waters, MBA, Promoted to Senior Vice President, Commercial: Jason joined Nuvalent in 2024, bringing more than 20 years of experience in biopharma, and 15 years in commercial oncology focused on product launches and commercialization. Most recently, Jason served as the Head of Commercial at Mersana Therapeutics, where he led launch preparedness efforts and companion diagnostic strategy for the market entry of a novel antibody-drug conjugate. Prior to this, he held various commercial leadership roles at GSK, including Field Vice President and US Brand Lead for ZEJULA®, where he led the integration and multiple launches of the brand following the acquisition of TESARO in acquisition in 2019. At TESARO, Jason served as the Global Brand Lead for ZEJULA®, coordinating its EU launch. Earlier in his career, Jason was Senior Director, Sales Strategy at Takeda Oncology, where he contributed to the launches of subcutaneous VELCADE® and NINLARO®. He also held various sales, operational, and leadership roles at Sanofi, Aventis, and Abbott Laboratories. Christy Oliger Appointed to Board of Directors: Nuvalent announced the appointment of Christy Oliger to its board of directors. Ms. Oliger brings more than 30 years of commercial and business experience in the pharmaceutical and biotechnology industry to the Nuvalent board. Most recently, Ms. Oliger served as Senior Vice President of the Oncology Business Unit at Genentech, where she was responsible for all commercial activities in the U.S. During her 20-year tenure at Genentech, Ms. Oliger held a number of senior leadership roles in both commercial and research and development across a variety of therapeutic areas, including oncology, neurology, rare disease, respiratory, dermatology and immunology. Prior to Genentech, she held management positions at Schering-Plough. Second Quarter 2025 Financial Results Cash Position: Cash, cash equivalents and marketable securities were $1.0 billion as of June 30, 2025. Nuvalent continues to believe its existing cash, cash equivalents and marketable securities will be sufficient to fund its current operating plan into 2028. R&D Expenses: Research and development (R&D) expenses were $80.9 million for the second quarter of 2025. G&A Expenses: General and administrative (G&A) expenses were $23.7 million for the second quarter of 2025. Net Loss: Net loss was $99.7 million for the second quarter of 2025. About Nuvalent Nuvalent, Inc. (Nasdaq: NUVL) is a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for patients with cancer, designed to overcome the limitations of existing therapies for clinically proven kinase targets. Leveraging deep expertise in chemistry and structure-based drug design, we develop innovative small molecules that have the potential to overcome resistance, minimize adverse events, address brain metastases, and drive more durable responses. Nuvalent is advancing a robust pipeline with investigational candidates for ROS1-positive, ALK-positive, and HER2-altered non-small cell lung cancer, and multiple discovery-stage research programs. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, implied and express statements regarding Nuvalent's strategy, business plans, and focus; the period over which Nuvalent estimates its cash, cash equivalents and marketable securities will be sufficient to fund its future operating expenses and capital expenditure requirements; the expected timing of data announcements, NDA submissions and FDA product approvals; the preclinical and clinical development programs for zidesamtinib, neladalkib and NVL-330; the potential benefits and effects of Nuvalent's product development candidates; the design and enrollment of the ARROS-1, ALKAZAR, ALKOVE-1, and HEROEX-1 trials; the potential of Nuvalent's pipeline programs, including zidesamtinib, neladalkib and NVL-330; the implications of data readouts and presentations; Nuvalent's research and development programs for the treatment of cancer; and risks and uncertainties associated with drug development. The words "may," "might," "will," "could," "would," "should," "expect," "plan," "anticipate," "aim," "goal," "intend," "believe," "expect," "estimate," "seek," "predict," "future," "project," "potential," "continue," "target" or the negative of these terms and similar words or expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. You should not place undue reliance on these statements or the scientific data presented. Any forward-looking statements in this press release are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation: risks that Nuvalent may not fully enroll its clinical trials or that enrollment will take longer than expected; unexpected concerns that may arise from additional data, analysis, or results obtained during preclinical studies or clinical trials; the risk that results of earlier clinical trials may not be predictive of the results of later-stage clinical trials; the risk that data from our clinical trials may not be sufficient to support registration and that Nuvalent may be required to conduct one or more additional studies or trials prior to seeking registration of our product candidates; the occurrence of adverse safety events; risks that the FDA may not approve our potential products on the timelines we expect, or at all; risks of unexpected costs, delays, or other unexpected hurdles; risks that Nuvalent may not be able to nominate drug candidates from its discovery programs; the direct or indirect impact of public health emergencies or global geopolitical circumstances on the timing and anticipated timing and results of Nuvalent's clinical trials, strategy, and future operations; the timing and outcome of Nuvalent's planned interactions with regulatory authorities; and risks related to obtaining, maintaining, and protecting Nuvalent's intellectual property. These and other risks and uncertainties are described in greater detail in the section entitled "Risk Factors" in Nuvalent's Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as well as any prior and subsequent filings with the Securities and Exchange Commission. In addition, any forward-looking statements represent Nuvalent's views only as of today and should not be relied upon as representing its views as of any subsequent date. Nuvalent explicitly disclaims any obligation to update any forward-looking statements. SOURCE Nuvalent, Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Executive ChangePhase 3Phase 1Financial Statement

09 Jun 2025

·www.activebiotech.com

Results from tasquinimod study in heavily pretreated patients with relapsed refractory multiple myeloma presented at ASCO 2025 available on Active Biotech’s website

Lund, June 9, 2025 – Active Biotech (NASDAQ Stockholm; ACTI) announced today that study results of its clinical drug candidate tasquinimod in heavily pretreated patients with relapsed refractory multiple myeloma (RRMM) are now available on Active Biotech’s website. The results were presented in a poster at the American Society of Clinical Oncology (ASCO) annual meeting May 30 – June 1, 2025. A total of 17 patients received tasquinimod in combination with ixazomib (proteasome inhibitor, PI), lenalidomide (Imid), and dexamethasone (IRd). Patients were heavily pretreated with a median of 7 prior lines of therapy (range 4-19) and all were triple-class refractory with 71% (12 patients) refractory to their most recent Imid/PI combination. In the total combination cohort, there was one partial response and 7 minimal responses which resulted in a 47% Clinical Benefit Rate (CBR). Among the 12 patients refractory to their latest Imid/PI combination there was one durable partial response (lasting 19.8 months) and three minimal responses (lasting 1.2, 1.5 and 6.7 months) resulting in a CBR of 33%. These patients were unlikely to respond to IRd alone and the result suggests synergistic efficacy of tasquinimod with the IRd combination. The results highlight the potential for targeting the tumor microenvironment with tasquinimod to augment the efficacy of other myeloma therapies. Tasquinimod was well tolerated in combination with IRd and the safety profile was in line with previous experience. The most common treatment emergent adverse events included fatigue, gastrointestinal events, pain and respiratory infections. Mostly of mild to moderate grade. The study (NCT04405167), was conducted at Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA with Dr. Dan Vogl as Principal Investigator. Full study results are being analyzed and will be published in a Scientific Journal. Information on the presentation: Abstract 7555, Clinical Activity of Novel Targeting of S100A9 with Tasquinimod for Relapsed and Refractory Multiple Myeloma (RRMM), Dan T. Vogl et al. was presented as a poster at the poster session Hematologic malignancies – Plasma cell dyscrasia on June 1, 2025. The poster is now available on Active Biotech’s website.

Clinical ResultASCOClinical Study

26 Feb 2025

·pipelinereview.com

Kangpu Biopharmaceuticals Received IND Approval from NMPA for KPG-818 to Treat Relapsed/Refractory Multiple Myeloma

HEFEI, China I February 25, 2025 I Kangpu Biopharmaceuticals, Ltd. (“Kangpu”) today announced that the Company has received IND approval from the CDE (Center for Drug Evaluation) of China National Medical Products Administration (NMPA) for KPG-818 for the treatment of relapsed/refractory multiple myeloma (RRMM). KPG-818 is a novel oral molecular glue modulator of the E3 ubiquitin ligase complex CRL4-CRBN. It demonstrated high cereblon (CRBN) binding affinity and potent degradation of Aiolos (IKZF3) and Ikaros (IKZF1), two members of the Ikaros family of zinc-finger transcription factors associated with B-cell development. KPG-818 possesses immunomodulatory, anti-angiogenic, and anti-tumor effects. The Phase I clinical trial of KPG-818 in the United States for the treatment of various hematological tumors has been completed. Preliminary results indicate that in RRMM patients who have previously received two immunomodulatory drugs (lenalidomide and pomalidomide), at least one proteasome inhibitor (bortezomib, ixazomib, or carfilzomib), and a CD38 monoclonal antibody (daratumumab or isatuximab), KPG-818 demonstrated good safety, tolerability, pharmacokinetic characteristics, and encouraging therapeutic effects. About Kangpu Biopharmaceuticals Kangpu Biopharmaceuticals, Ltd. is a clinical-stage company focused on the discovery and development of innovative therapeutics for the treatment of solid tumors, hematologic malignancies, autoimmune diseases, and inflammatory disorders through novel solutions, including targeted protein degradation. Kangpu has developed a robust pipeline of potential first-in-class and best-in-class drug candidates based on proprietary technology platforms, including NeoMIDES ® , gDACs ® , and X-SYNERGY ® . For more information, please visit www.KangpuGroup.com . SOURCE: Kangpu Biopharmaceuticals

Phase 1INDClinical ResultImmunotherapyPhase 2

100 Deals associated with Ixazomib citrate

External Link

KEGG	Wiki	ATC	Drug Bank
D10131	Ixazomib citrate	L01XX50	DB09570

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Multiple Myeloma	United States	Takeda Pharmaceuticals U.S.A., Inc.	20 Nov 2015

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Plasmacytoma	Phase 3	United States	Millennium Pharmaceuticals, Inc.	01 Dec 2015
Spondylocarpotarsal Synostosis	Phase 3	United States	Takeda Pharmaceutical (China) Co. Ltd.	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	United States	Millennium Pharmaceuticals, Inc.	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	United States	Haupt Pharma Amareg GmbH	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	Japan	Millennium Pharmaceuticals, Inc.	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	Japan	Takeda Pharmaceutical (China) Co. Ltd.	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	Japan	Haupt Pharma Amareg GmbH	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	Argentina	Haupt Pharma Amareg GmbH	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	Argentina	Millennium Pharmaceuticals, Inc.	17 Mar 2015
Spondylocarpotarsal Synostosis	Phase 3	Argentina	Takeda Pharmaceutical (China) Co. Ltd.	17 Mar 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02389517 (CTgov)	Phase 2	Multiple Myeloma \| Residual Neoplasm	42	Lenalidomide+Ixazomib Citrate+Dexamethasone (Arm I (Ixazomib Citrate, Lenalidomide, Dexamethasone))	uuhsqxxrtl = lerblhlkjv srpovbpkms (ujzxobepew, onsipabzpf - cbdwrsvfob) View more	-	22 Jan 2026
				Lenalidomide (Arm II (Lenalidomide))	uuhsqxxrtl = mzipjvncqh srpovbpkms (ujzxobepew, wtxbcnbmyd - aympbbbzyj) View more
NCT02339922 (ASH2025)	Phase 1	First line	33	Rituximabixazomib (Long term ixazomib)	haefxsmpom(eutntqpwmt) = 7 patients (back pain, thrombocytopenia, neutropenia, leukopenia, ALT increase, thromboembolic event, nausea/vomiting, second cancer) huxgusrgwu (bpxtphzgbb )	Positive	06 Dec 2025
ASH2025	Not Applicable	Multiple Myeloma First line	146	Ixazomib-based regimens	qjtoxldrsq(tdstjdbimx) = dmxeesoozy mnboqpdtcb (rbnlvgrazd ) View more	Positive	06 Dec 2025
DeRIVE (ASH2025)	Phase 2	Multiple Myeloma	52	Daratumumab, ixazomib and dexamethasone (DId)	qcocebprmi(jqjcnlstdd) = kjyehndsdh ldrfdqwqvr (iteijuoaeg ) View more	Positive	06 Dec 2025
				Daratumumab, bortezomib and dexamethasone (DVd) followed by daratumumab, ixazomib and dexamethasone (DId)	qcocebprmi(jqjcnlstdd) = swocrylowk ldrfdqwqvr (iteijuoaeg ) View more
NCT04009109 (AFT-41, ASH2025)	Phase 2	Multiple Myeloma First line \| Induction	79	Daratumumab+Lenalidomide+Ixazomib+Dexamethasone	rugjrneojc(qqwnrsxela) = lqgerkfied nbzebfktmr (vbuluaqndr, 86.1 - 98.4) View more	Positive	06 Dec 2025
NCT03506373 (CTgov)	Phase 2	Waldenstrom's macroglobulinaemia recurrent \| Waldenstrom's macroglobulinaemia refractory	21	Pharmacokinetic Study+Ibrutinib+Ixazomib Citrate	ovzfwriarb = llgghczdvw ymgmmlmdtr (arrieajfve, uxphanhsac - yzdfwccjyi) View more	-	18 Sep 2025
NCT02542657 (Pubmed \| Blood Neoplasia)	Phase 1/2	Refractory Multiple Myeloma	28	Clarithromycin+Ixazomib+Pomalidomide+Dexamethasone	juqqkfydie(jaqbadjnvh) = mgozhwqpgw ofdgvwagam (onowfngcua ) View more	Positive	01 Aug 2025
NCT03817320 (CTgov)	Phase 1/2	Recurrent Adult Acute Lymphoblastic Leukemia \| pediatric lymphoblastic non-Hodgkin's lymphoma \| Recurrent Childhood Acute Lymphoblastic Leukemia ... View more	24	Ixazomib+Doxorubicin+Hydrocortisone+Asparaginase+Dexamethasone+Methotrexate+Vincristine+Cytarabine (Ixazomib Dose Level 1 (Stratum A))	gldybloxna = vxthorxseu mabudtkwcp (mqzmaczjgo, tbtsbsktib - dwpxweabrs) View more	-	17 Jun 2025
				Ixazomib+doxorubicin+Hydrocortisone+Asparaginase+Dexamethasone+Methotrexate+Vincristine+Cytarabine (Ixazomib Dose Level 2 (Stratum A))	gldybloxna = xzbhjodyum mabudtkwcp (mqzmaczjgo, aleayvxtcc - wtyqznlmlj) View more
NCT03012880 (CTgov)	Phase 2	Multiple Myeloma	80	lenalidomide+ixazomib citrate+daratumumab+dexamethasone (Cohort A)	vguimetrts = yeixpcmpbf tqjqkudusk (eiwaxqkjdr, omqrlctwhh - rnacsttcho) View more	-	04 Jun 2025
				lenalidomide+ixazomib citrate+daratumumab+dexamethasone (Cohort B)	vguimetrts = pvtdregior tqjqkudusk (eiwaxqkjdr, lopmosmemo - jbtfjzjlwa) View more
PB2971 (EHA2025)	Not Applicable	Multiple Myeloma	63	Ixazomib/cyclophosphamide/dexamethasone (ICd)	wlxpltfbce(lrjauykjin) = ykzhbfzpta ammynyktel (ykitmyyhsv ) View more	Positive	14 May 2025
				Lenalidomide/cyclophosphamide/dexamethasone (RCd)	wlxpltfbce(lrjauykjin) = nygxryigcv ammynyktel (ykitmyyhsv ) View more

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