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Last update 07 Jul 2026

Selinexor

Last update 07 Jul 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Small molecule drug

Synonyms

CRM1-nuclear-export-inhibitor, NEXPOVIO, Selinexor

+ [13]

Target

ACADS x XPO1

Action

inhibitors

Mechanism

ACADS inhibitors(acyl-CoA dehydrogenase short chain inhibitors), XPO1 inhibitors(Exportin-1 protein inhibitors)

Therapeutic Areas

NeoplasmsImmune System DiseasesHemic and Lymphatic Diseases+ [9]

Active Indication

Follicular LymphomaRefractory Multiple MyelomaRelapse multiple myeloma+ [68]

Inactive Indication

Acute Myeloid Leukemia with FLT3/ITD MutationAcute Promyelocytic LeukemiaAdenocarcinoma of prostate+ [67]

Originator Organization

Karyopharm Therapeutics, Inc.

Active Organization

Antengene Corp. Ltd.

Barbara Ann Karmanos Cancer Institute

National Cancer Institute

+ [13]

Inactive Organization

The University of Texas MD Anderson Cancer Center

Takeda Pharmaceutical Co., Ltd.

Millennium Pharmaceuticals, Inc.

+ [1]

License Organization

FORUSTherapeutics, Inc.

Antengene Corporation Co., Ltd.

Foundation Medicine, Inc.

+ [12]

Drug Highest PhaseApproved

First Approval Date

United States (03 Jul 2019),

Multiple Myeloma

RegulationFast Track (United States), Accelerated Approval (United States), Orphan Drug (United States), Orphan Drug (European Union), Conditional marketing approval (China), Orphan Drug (South Korea), Orphan Drug (Australia), Priority Review (South Korea), Priority Review (United States), Priority Review (China)

Structure/Sequence

Molecular FormulaC17H11F6N7O

InChIKeyDEVSOMFAQLZNKR-RJRFIUFISA-N

CAS Registry1393477-72-9

231

Clinical Trials associated with Selinexor

NCT07632170

/ Not yet recruitingNot ApplicableIIT

The Efficacy and Safety of Selinisole Combined With Azacitidine and Venetoclax in the Treatment of Newly Diagnosed High-risk Myeloid Tumors With TP53 Mutations: A Multicenter, Single-arm, Prospective Study

Patients with high-risk myeloid tumors accompanied by TP53 mutations have a poor survival prognosis, and there are still many unmet treatment needs. The current treatment regimens have many limitations. Selinisol, as a novel export protein inhibitor, has good anti-tumor activity. The current preclinical and preliminary clinical research results abroad suggest its effectiveness and safety. This study aims to evaluate the efficacy and safety of AZA combined with selinisole (with or without venetoclax) in the treatment of patients with high-risk myeloid tumors with TP53 mutations through a multicenter, prospective clinical study.

Start Date01 Nov 2026

Sponsor / Collaborator

Peking Union Medical College Hospital

NCT07479979

/ RecruitingPhase 1/2IIT

Phase Ib/II Study of Selinexor in Combination With Carfilzomib, Subcutaneous Isatuximab Administered Via Investigational Device and Dexamethasone (SCID) for Patients With Relapsed and/or Relapsed Refractory Multiple Myeloma

The primary objective of this Phase Ib/II trial is to study the safety and tolerability of the combination of selinexor, carfilzomib, isatuximab-OBDS (on body delivery system) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma, who have received at least one line of therapy. The phase Ib portion comprises the safety run-in with 6-12 patients, with the option to reduce the selinexor dose from 40 mg to 20 mg if the higher dose reaches the prescribed toxicity threshold. The Phase II portion of the trial will test the Recommended Phase 2 Dose (RP2D) in an expansion cohort of up to 50 patients.

Start Date01 Jul 2026

Sponsor / Collaborator

Hoosier Cancer Research Network

[+3]

NCT07626021

/ Not yet recruitingPhase 2IIT

An Open-Label, Single-Arm Phase II Study of Selinexor Monotherapy for Cytoreduction in Patients With BCR::ABL1-Negative Myeloproliferative Neoplasms

Myeloproliferative neoplasms are chronic blood cancers in which the bone marrow produces too many blood cells. Patients with Philadelphia chromosome-negative myeloproliferative neoplasms, including polycythemia vera, essential thrombocythemia, and primary myelofibrosis, may need treatment to reduce high blood cell counts, relieve disease-related symptoms, and lower the risk of complications. However, currently available cytoreductive treatments may be ineffective, poorly tolerated, or inconvenient for some patients.
Selinexor is an oral selective inhibitor of nuclear export that has shown antitumor activity in several hematologic malignancies. This study will evaluate the effectiveness and safety of selinexor used alone as cytoreductive treatment in patients with Philadelphia chromosome-negative myeloproliferative neoplasms who have an indication for cytoreductive therapy.
This is a prospective, single-arm, open-label phase II study conducted at a single center. Eligible participants will receive oral selinexor, with dose adjustments based on tolerability and blood cell counts. Participants will be followed for treatment response, symptom improvement, and side effects for up to 6 months. The results of this study may help determine whether selinexor could provide a potential treatment option for patients with Philadelphia chromosome-negative myeloproliferative neoplasms who have limited cytoreductive therapy choices.

Start Date01 Jul 2026

Sponsor / Collaborator

Zhongshan Hospital Xiamen University

100 Clinical Results associated with Selinexor

100 Translational Medicine associated with Selinexor

100 Patents (Medical) associated with Selinexor

709

Literatures (Medical) associated with Selinexor

31 Dec 2026·ANNALS OF MEDICINE

Efficacy and safety of Ruxolitinib-based combination therapy in the patients with Myelofibrosis (MF): a systematic review and meta-analysis

Review

Author: Li, Yuxin ; Sun, Wanling ; Cao, Yaofang ; Hui, Wuhan ; Tan, Shuai

BACKGROUND:

Myelofibrosis (MF) is a chronic myeloproliferative neoplasm. Although Ruxolitinib, a JAK1/2 inhibitor, remains the cornerstone of MF treatment, it does not reverse disease progression, and resistance frequently emerges. These limitations have prompted investigation into combination therapies targeting pathways beyond the JAK-STAT axis. This meta-analysis aims to evaluate the efficacy and safety of Ruxolitinib-based combination therapies in patients with MF.

METHODS:

We conducted a systematic search of databases for studies published through August 1, 2025. Thirteen distinct Ruxolitinib-based combination regimens were included. Primary efficacy endpoints were ≥35% spleen volume reduction at 24 weeks (SVR35) and ≥50% reduction in total symptom score (TSS50). Safety endpoints focused on the incidence of grade 3/4 thrombocytopenia and anemia. Subgroup analyses were performed based on prior JAK inhibitor exposure and therapeutic mechanism of action.

RESULTS:

A total of 19 studies comprising 1,088 patients were included in the meta-analysis. Among JAK inhibitor-naïve patients, the combination of Ruxolitinib with Selinexor demonstrated the highest efficacy (SVR35: 92%; TSS50: 78%), followed by Ruxolitinib plus BMS-986158 (SVR35: 90%). For patients with prior JAK inhibitor exposure, Ruxolitinib plus Siremadlin (SVR35: 45%) showed notable activity.

CONCLUSION:

For JAK inhibitor-naïve patients, Ruxolitinib-based combination regimens demonstrated satisfactory clinical responses and the potential for meaningful disease control. For patients with prior JAK inhibitor exposure, the addition of combination therapy drugs may further enhance the efficacy. Personalized treatment selection remains essential, as therapeutic efficacy is significantly influenced by prior JAK inhibitor exposure.

01 Oct 2026·CANCER LETTERS

NPM1 mutation promotes creatine anabolism by FTO-dependent m6A demethylation to drive macrophage M2 polarization in acute myeloid leukemia

Article

Author: Lei, Xin-Xing ; Long, Zi-Jie ; Liu, Jia-Jun ; Lin, Zhi-Li ; Wang, Jun-Dan ; Liu, Quentin ; Zhang, Ling ; Liao, Chen-Jia ; Peng, Zi-Zhen

Nucleophosmin 1-mutant (NPM1^MU) acute myeloid leukemia (AML) represents a distinct molecular subtype, yet the mechanisms underlying NPM1 mutation-driven malignant transformation remain incompletely understood. Here, we find prevalent copy number variations (CNVs) of N⁶-methyladenosine (m⁶A) key regulators in NPM1 wild-type (NPM1^WT) AML patients, whereas such alterations are rarely detected in NPM1^MU subgroup. Moreover, a reduction in m⁶A modification is observed in leukemic cells overexpressing NPM1^MU protein, concomitant with an increase in FTO expression. Co-immunoprecipitation shows that NPM1^MU protein mislocates in the cytoplasm and binds to FTO to block its ubiquitin-proteasome degradation through K422 specific site. Of note, creatine metabolism-related signaling and FTO-mediated macrophage M2 polarization signaling are enriched in NPM1^MU patients according to TCGA data analysis. Indeed, FTO promotes creatine anabolism in NPM1^MU leukemic cells by stabilizing the mRNA of GAMT, a key enzyme in the creatine synthesis pathway. Creatine facilitates macrophage M2 polarization, as evidenced by the upregulation of M2 polarization-related genes (CD206, CCL2, IL-10 and CXCL13). This effect is abrogated upon FTO knockdown in leukemic cells. Selinexor, an exportin 1 inhibitor to impede NPM1^MU export from nucleus, enhances FTO degradation and reduces macrophage M2 polarization. This work reveals that FTO-creatine signaling plays an oncogenic role in NPM1^MU AML, guiding more effective therapy strategies and clinical benefits for this distinctly leukemic entity.

01 Jul 2026·AMERICAN JOURNAL OF HEMATOLOGY

Navigating the Post‐ BCMA / GPRC5D Landscape: Efficacy of Selinexor, Bortezomib, and Dexamethasone After Sequential Immunotherapy Failure in Penta‐Refractory Multiple Myeloma—A Multicenter Analysis

Article

Author: Bartke, Leandra ; Harzer, Marie ; Brioli, Annamaria ; Khandanpour, Cyrus ; Cords, Leon ; Hillmann, Stefan M. ; Al‐Bazaz, Maximilian ; Weisel, Katja ; Holtick, Udo ; Bokemeyer, Carsten ; Artzenroth, Jule ; Kamili, Abdulaziz ; Leypoldt, Lisa ; Schaefers, Christoph ; Leitner, Theo ; Vorwerk, Jan ; Salwender, Hans ; Sonnemann, Piet ; Maulhardt, Markus ; Brinkert, Kerstin ; Kosch, Ricardo ; Richardson, Tim ; Alsdorf, Winfried

ABSTRACT:

Patients with relapsed/refractory multiple myeloma (RRMM) who are penta‐drug refractory, defined as resistant to two proteasome inhibitors, two immunomodulatory agents, and an anti‐CD38 monoclonal antibody, face a dismal prognosis, particularly after exposure to T‐cell–redirecting therapies. Selinexor, an oral exportin‐1 inhibitor, offers a distinct mechanism of action and may retain efficacy in this difficult setting. We conducted a retrospective analysis at six German tertiary centers (2023–2025) to evaluate the efficacy and safety of selinexor plus bortezomib and dexamethasone (SVd) in penta‐refractory MM after both BCMA‐ and GPRC5D‐targeted therapies. Eighteen patients were identified, with a median of seven prior lines of therapy. High‐risk cytogenetic abnormalities were present in seven cases, including del17p in six. The overall response rate (ORR) was 61%, including one complete, five very good partial, and five partial responses, and median progression‐free survival (PFS) was 4.3 months. Among nine patients (50%) with extramedullary disease (EMD), three achieved complete and one near‐complete EMD resolution. Two patients who had relapsed after CAR T‐cell treatment with idecabtagene vicleucel achieved partial and very good partial responses and were successfully transitioned to a second CAR T‐cell therapy with ciltacabtagene autoleucel. Hematologic toxicities under SVd were manageable, and no treatment‐related deaths occurred. SVd demonstrates meaningful activity in patients with penta‐refractory MM and prior failure of BCMA/GPRC5D‐targeted immunotherapies. The ORR of 61%, disease control in 78% of patients, and median PFS of 4.3 months support further evaluation of SVd in this highly refractory setting after failure of BCMA‐ and GPRC5D‐directed approaches.

344

News (Medical) associated with Selinexor

01 Jul 2026

·www.prnewswire.com

Karyopharm Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

NEWTON, Mass., July 1, 2026 /PRNewswire/ -- Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the Company granted an aggregate of 1,649 restricted stock units (RSUs) to four newly-hired employees. These RSU awards were granted as of June 30, 2026 (the "Grant Date") pursuant to the Company's 2022 Inducement Stock Incentive Plan, as amended, as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4). Each RSU award will vest over three years, with 33 1/3% of the shares underlying the RSU award vesting on each of the three consecutive anniversaries of the Grant Date. The vesting of each RSU award is subject to the employee's continued service as an employee of, or other service provider to, Karyopharm through the applicable vesting dates. About Karyopharm Therapeutics Karyopharm Therapeutics is a commercial-stage pharmaceutical company pioneering the science of nuclear export inhibition to develop differentiated therapies for patients with cancer. The Company's lead therapy, XPOVIO® (selinexor), is a first-in-class inhibitor of exportin 1 (XPO1). XPOVIO is marketed by the Company in the U.S. for adults with relapsed or refractory multiple myeloma and is approved as XPOVIO or NEXPOVIO® in more than 50 ex-U.S. countries and territories. Building on its leadership in XPO1 biology, Karyopharm is advancing selinexor's potential in hematologic and solid tumor cancers, including in myelofibrosis and TP53 wild-type endometrial cancer. The Company is also exploring opportunities to evaluate XPO1 inhibition across myeloproliferative neoplasms and TP53 wild-type driven solid tumors using next-generation compounds, including eltanexor. Headquartered in Newton, Massachusetts, Karyopharm has an established, efficient and scalable commercial infrastructure to bring novel therapeutic options to patients with cancer. For more information, visit and follow Karyopharm on LinkedIn and on X at @Karyopharm. XPOVIO® and NEXPOVIO® are registered trademarks of Karyopharm Therapeutics Inc. SOURCE Karyopharm Therapeutics Inc. 21% more press release views with Request a Demo

Drug ApprovalFast Track

22 Jun 2026

·www.prnewswire.com

Antengene Announces Exclusive License Agreement with MPM BioImpact-Established K2 Therapeutics for ATG-106 and Option for Undisclosed Bispecific TCE

ATG-106 is a first-in-class CDH6 x CD3 bispecific T cell engager (TCE) in preclinical development for the treatment of solid tumors K2 Therapeutics, established by MPM BioImpact, obtains exclusive global rights to develop and commercialize ATG-106 outside Greater China Antengene receives upfront and near-term considerations of approximately USD 20 million for ATG-106; eligible to receive up to USD 960.5 million in future milestones K2 Therapeutics enters into option agreement with Antengene to obtain exclusive global rights to develop and commercialize an undisclosed preclinical bispecific TCE candidate outside Greater China The deal underscores AnTenGager® platform's differentiated capabilities in developing next-generation novel TCEs with broad applicability, and also marks the second transaction involving an AnTenGager® TCE, following the global exclusive license agreement with UCB for ATG-201 announced in March 2026 BOSTON, SINGAPORE and HONG KONG, June 21, 2026 /PRNewswire/ -- Antengene Corporation Limited (" Antengene", SEHK: [6996 HK]), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies indications, today announced that it has entered into an exclusive license agreement (" License Agreement") with K2 Therapeutics for ATG-106, a preclinical CDH6 x CD3 bispecific T cell engager (TCE) in development for solid tumors. Antengene also announced that it has entered into an option agreement (" Option Agreement") to grant K2 Therapeutics the option to obtain exclusive global rights to develop and commercialize an undisclosed preclinical bispecific TCE candidate. Across both the License Agreement and the Option Agreement, K2 Therapeutics' rights extend globally, excluding Greater China. K2 Therapeutics, established by MPM BioImpact, is a biotech company and scalable hub-and-spoke engine built for global impact, with search and development capabilities unconstrained by modality or geography. MPM BioImpact is a world-leading biotechnology investment firm, with over 30 years' experience creating and investing in innovative companies. "We are very pleased to expand our partnerships with our TCE pipeline with this important collaboration around our AnTenGager® platform," said Dr. Jay Mei, Founder, Chairman and Chief Executive Officer of Antengene. "We believe ATG-106, our CDH6 x CD3 bispecific TCE reflects the differentiated design of AnTenGager® TCEs and their potential in solid tumors. AnTenGager® TCEs are designed to address key challenges that have historically limited first-generation TCEs in solid tumors, particularly with respect to safety and tolerability. By combining steric hindrance-based masking with our proprietary fast on/off CD3 binder, AnTenGager® TCEs are designed to activate T cells in a disease-associated antigen-gated manner, with the potential to reduce cytokine release syndrome and T cell exhaustion while maintaining potent anti-tumor activity." Both ATG-106 and the undisclosed program leverage Antengene's proprietary AnTenGager® platform, which offers a differentiated TCE approach, where binding of the TCE arm (CD3) is sterically masked in the absence of target antigen binding providing potent activity and better tolerability. "We are excited to license ATG-106, a highly differentiated CDH6 x CD3 bispecific TCE, as well as a second promising TCE program enabled by the cutting-edge AnTenGager® platform," said Frank Neumann, M.D., Ph.D., Chief Medical Officer of K2 Therapeutics. "CDH6 is an attractive target given its overexpression in tumors such as ovarian and renal cancers, and its limited expression in normal adult tissues. We believe the unique design of ATG-106 has the potential to meaningfully advance the field of solid tumor TCEs. We look forward to advancing ATG-106 toward the clinic and to delivering meaningful benefit to patients." Under the License Agreement, Antengene is entitled to upfront and near-term considerations of approximately USD 20 million, consisting of cash and a minority equity stake in a newly established asset company and subsidiary of K2 Therapeutics, subject to the satisfaction of certain near-term conditions. Antengene is also eligible to receive developmental, regulatory and sales milestone payments of up to USD 960.5 million related to ATG-106, plus tiered royalties on future net sales. Under the Option Agreement, upon exercise of the option, Antengene is entitled to receive upfront and near-term considerations of approximately USD 20 million, consisting of an option exercise fee, near-term payment and upfront payment, as well as a minority equity stake in the related asset company. Antengene would also be eligible to receive developmental, regulatory and sales milestone payments of up to USD 960.5 million related to the undisclosed TCE program, plus tiered royalties on future net sales. About Antengene Antengene Corporation Limited ( "Antengene", SEHK: 6996.HK) is a global, R&D-driven, commercial-stage biotech company focused on developing first-in-class/best-in-class therapeutics for diseases with significant unmet medical needs. Its pipeline spans from preclinical to commercial stages, with key investigational candidates including ATG-022 (CLDN18.2 ADC), ATG-037 (oral CD73 inhibitor), ATG-101 (PD-L1 x 4-1BB bispecific antibody), ATG-125 (B7-H3 × PD-L1 bispecific ADC), ATG-207 (αCD3-TGF-β bifunctional fusion protein), as well as T cell engager (TCE) programs developed using Antengene's proprietary AnTenGager® platform. AnTenGager®, is Antengene's proprietary TCE 2.0 platform, featuring "2+1" bivalent binding for low expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform's broad applicability across autoimmune disease, solid tumors and hematological malignancies, with programs targeting CD19 x CD3 (ATG-201 for B cell-related autoimmune diseases; partnered with UCB), CDH6 x CD3 (ATG-106 for ovarian cancer and kidney cancer), ALPPL2 x CD3 (ATG-112 for gynecological tumors, digestive system malignancies, bladder cancer and NSCLC), LY6G6D x CD3 (ATG-110 for microsatellite-stable colorectal cancer), GPRC5D x CD3 (ATG-021 for multiple myeloma), LILRB4 x CD3 (ATG-102 for acute myeloid leukemia and chronic myelomonocytic leukemia) and FLT3 x CD3 (ATG-107 for acute myeloid leukemia). To date, Antengene has obtained 33 investigational new drug (IND) approvals in the U.S. and Asia, and obtained new drug application (NDA) approvals in 10 Asia Pacific markets. Its lead commercial asset, XPOVIO® (selinexor), is approved in the Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia, and has been included in the national insurance schemes in five of these markets (Mainland of China, Taiwan China, Australia, South Korea and Singapore). About K2 Therapeutics K2 Therapeutics is a biotech company built for global impact, with search and development capabilities unconstrained by modality or geography. K2 Therapeutics identifies the world's most innovative assets and translates them into great medicines through a disciplined development approach led by experienced drug developers. The Company aims to build a pipeline focused on high-potential first- and best-in-class assets with meaningful potential for patient impact worldwide. About MPM BioImpact MPM BioImpact is a world-leading biotechnology investment firm with over 30 years of expertise creating and investing in innovative companies to deliver transformative therapies to patients. Its experienced and dedicated team of investment professionals, entrepreneurs, advisors and leading scientists translate scientific discoveries into breakthrough medicines and potential cures. The Firm manages over $3.5 billion AUM across early-stage venture funds, private/public impact funds and public equities funds. For more information, visit Forward-looking statements The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, please see the other risks and uncertainties described in the Company's Annual Report for the year ended December 31, 2025, and the documents subsequently submitted to the Hong Kong Stock Exchange. For more information, please contact: Investor Contacts: Donald Lung E-mail: [email protected] BD Contacts: Ariel Guo E-mail: [email protected] SOURCE Antengene Corporation Limited 21% more press release views with Request a Demo

License out/inDrug ApprovalNDA

15 Jun 2026

·www.prnewswire.com

Antengene Receives IND Approval for ATG-201 (CD19 × CD3 TCE) in Autoimmune Disease in China

June 9, 2026 -- Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies indications, today announced that China's National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application for the Phase I ATTRACT study of ATG-201, a CD19/CD3 bispecific T-cell engager antibody, for the treatment of B cell related autoimmune diseases. ATG-201 is a CD19 targeting bispecific TCE incorporating steric hindrance masking technology, designed to eliminate CD19-expressing B cells. This bispecific interaction with T and B cells through CD3 and CD19 has demonstrated potential in treating B cell-driven diseases by leveraging the body's own immune system for precise and potent action. Antengene plans to promptly initiate and advance the Phase I ATTRACT study in China, while concurrently preparing for the clinical development of ATG-201 in Australia. The ATTRACT study will be led by Prof. Zhanguo Li from Peking University People's Hospital as the principal investigator. This is a Phase I clinical study designed to evaluate the safety, tolerability and preliminary efficacy of ATG-201 monotherapy in adult patients with B cell related autoimmune diseases. The study will consist of two phases: dose escalation and dose expansion. The primary objectives of the study are to evaluate the safety and tolerability of ATG-201 monotherapy and to determine its recommended Phase II dose (RP2D). Secondary objectives include evaluating the pharmacokinetic (PK) and pharmacodynamic (PD) profiles, immunogenicity, preliminary efficacy of ATG-201. Professor Zhanguo Li stated, "It is a great honor to lead the first-in-human (FIH) trial of Antengene's investigational drug ATG-201. Significant unmet clinical needs remain in patients with refractory B cell‑mediated autoimmune diseases, including low remission rates, high relapse risk, and long‑term safety concerns. ATG‑201, a dual CD3/CD19 T‑cell engager, redirects and activates autologous T cells to achieve precise elimination of pathogenic B cells—a novel mechanism that may overcome current therapeutic limitations. Our team, in close collaboration with the sponsor, Antengene, will rigorously conduct this Phase I study to evaluate the safety and preliminary efficacy." Antengene and UCB have entered into an agreement that grants UCB a worldwide exclusive license to develop, manufacture, and commercialize ATG-201, along with access to its associated manufacturing technology. Antengene will conduct the FIH phase I clinical trials in China and Australia, and thereafter transfer all further clinical development activities to UCB. The clinical trial application approval of ATG-201 by China's NMPA marks a critical step forward for Antengene as the company expands its strategic focus from oncology and hematology to include autoimmune diseases. This milestone demonstrates Antengene's determination and strong execution capabilities as it actively expands into autoimmune diseases, a therapeutic area with significant unmet need and growth potential. Looking ahead, Antengene will remain guided by unmet clinical needs, and continue to develop more first-in-class and/or best-in-class innovative therapies, bringing transformative treatment options to patients worldwide. Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) is a global, R&D-driven, commercial-stage biotech company focused on developing first-in-class/best-in-class therapeutics for diseases with significant unmet medical needs. Its pipeline spans from preclinical to commercial stages, with key investigational candidates including ATG-022 (CLDN18.2 ADC), ATG-037 (oral CD73 inhibitor), ATG-101 (PD-L1 x 4-1BB bispecific antibody), ATG-125 (B7-H3 × PD-L1 bispecific ADC), ATG-207 (αCD3-TGF-β bifunctional fusion protein), as well as T cell engager (TCE) programs developed using Antengene's proprietary AnTenGager® platform. AnTenGager®, is Antengene's proprietary TCE 2.0 platform, featuring "2+1" bivalent binding for low expressing targets, steric hindrance masking, and proprietary CD3 sequences with fast on/off kinetics to minimize cytokine release syndrome (CRS) and enhance efficacy. These characteristics support the platform's broad applicability across autoimmune disease, solid tumors and hematological malignancies, with programs targeting CD19 x CD3 (ATG-201 for B cell-related autoimmune diseases; partnered with UCB), CDH6 x CD3 (ATG-106 for ovarian cancer and kidney cancer), ALPPL2 x CD3 (ATG-112 for gynecological tumors, digestive system malignancies, bladder cancer and NSCLC), LY6G6D x CD3 (ATG-110 for microsatellite-stable colorectal cancer), GPRC5D x CD3 (ATG-021 for multiple myeloma), LILRB4 x CD3 (ATG-102 for acute myeloid leukemia and chronic myelomonocytic leukemia) and FLT3 x CD3 (ATG-107 for acute myeloid leukemia). To date, Antengene has obtained 33 investigational new drug (IND) approvals in the U.S. and Asia, and obtained new drug application (NDA) approvals in 10 Asia Pacific markets. Its lead commercial asset, XPOVIO® (selinexor), is approved in the Mainland of China, Taiwan China, Hong Kong China, Macau China, South Korea, Singapore, Malaysia, Thailand, Indonesia and Australia, and has been included in the national insurance schemes in five of these markets (Mainland of China, Taiwan China, Australia, South Korea and Singapore). The content above comes from the network. if any infringement, please contact us to modify.

License out/inINDDrug Approval

100 Deals associated with Selinexor

External Link

KEGG	Wiki	ATC	Drug Bank
D11222	Selinexor	L01XX66	DB11942

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Follicular Lymphoma	Indonesia	Antengene Corp. Ltd.	05 Mar 2025
Refractory Multiple Myeloma	China	Karyopharm Therapeutics, Inc.	14 Dec 2021
Relapse multiple myeloma	China	Karyopharm Therapeutics, Inc.	14 Dec 2021
Diffuse large B-cell lymphoma recurrent	Israel	Karyopharm Therapeutics, Inc.	04 Feb 2021
Diffuse large B-cell lymphoma refractory	Israel	Karyopharm Therapeutics, Inc.	04 Feb 2021
Diffuse Large B-Cell Lymphoma	United States	Karyopharm Therapeutics, Inc.	22 Jun 2020
Multiple Myeloma	United States	Karyopharm Therapeutics, Inc.	03 Jul 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Refractory acute myeloid leukemia	Phase 3	China	Antengene Corp. Ltd.	29 Jan 2023
Relapsing acute myeloid leukemia	Phase 3	China	Antengene Corp. Ltd.	29 Jan 2023
Endometrial Carcinoma	Phase 3	China	Antengene Corp. Ltd.	27 Oct 2021
Endometrial Carcinoma	Phase 3	China	Karyopharm Therapeutics, Inc.	27 Oct 2021
Post-polycythemia vera myelofibrosis	Phase 3	United States	Karyopharm Therapeutics, Inc.	11 Mar 2021
Post-polycythemia vera myelofibrosis	Phase 3	Australia	Karyopharm Therapeutics, Inc.	11 Mar 2021
Post-polycythemia vera myelofibrosis	Phase 3	Belgium	Karyopharm Therapeutics, Inc.	11 Mar 2021
Post-polycythemia vera myelofibrosis	Phase 3	Bulgaria	Karyopharm Therapeutics, Inc.	11 Mar 2021
Post-polycythemia vera myelofibrosis	Phase 3	Canada	Karyopharm Therapeutics, Inc.	11 Mar 2021
Post-polycythemia vera myelofibrosis	Phase 3	Czechia	Karyopharm Therapeutics, Inc.	11 Mar 2021

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04562389 (SENTRY, EHA2026)	Phase 3	Myelofibrosis	353	Selinexor+Ruxolitinib	kmosirzjqx(icrkskzjxq) = qmnvmtdphy qofkuepsth (tszbxihotd ) View more	Positive	02 Jun 2026
NCT04562389 (SENTRY, EHA2026)	Phase 3	Myelofibrosis	353	Placebo+Ruxolitinib	kmosirzjqx(icrkskzjxq) = dqufoaoagg qofkuepsth (tszbxihotd ) View more	Positive	02 Jun 2026
NCT02835222 (ASCO2026)	Phase 2	Acute Myeloid Leukemia	57	Selinexor + standard intensive induction and consolidation chemotherapy	pdvaczxkkb(bqcxrnzstb) = acsdpucomb qonsmslyhs (jjfbwqcdbu ) View more	Positive	29 May 2026
NCT02835222 (ASCO2026)	Phase 2	Acute Myeloid Leukemia	57	Standard intensive induction and consolidation chemotherapy	pdvaczxkkb(bqcxrnzstb) = mdwkqefysk qonsmslyhs (jjfbwqcdbu ) View more	Positive	29 May 2026
NCT06062641 (EHA2026)	Phase 2	Diffuse large B-cell lymphoma recurrent TP53 mutation \| TP53 deletion	47	Selinexor + R-GDP	ladeazimyi(iveeiaynpt) = futfpfhnxx dytvefxvhp (hfpewdovpf ) View more	Positive	12 May 2026
NCT05577364 (XPLORE, EHA2026)	Phase 1/2	Diffuse Large B-Cell Lymphoma First line EBV-DNA	27	Selinexor + R-CHOP	zmusevsldn(eynfdgesdx) = jypficyprx yyuwohwhpt (nslxwieixl ) View more	Positive	12 May 2026
ChiCTR2300069941 (EHA2026)	Phase 1	AIDS-Related Diffuse Large Cell Lymphoma First line	10	Selinexor plus R-EPOCH (HIV-associated DLBCL)	cscyoreqko(nzeaqkblxm) = jeusmijqfr kzuabglliz (lisppngdhh ) View more	Positive	12 May 2026
EHA2026	Phase 2	Acute Myeloid Leukemia \| High Risk Myelodysplastic Syndrome	20	Decitabine, Venetoclax, and Selinexor (DVS) regimen	umrlhutjcl(iiptjsrhys) = tclxmbftfm htjaucmzog (mutqmbtgzi ) View more	Positive	12 May 2026
NCT05980806 (SENTRY2, EHA2026)	Phase 2	Myelofibrosis	58	Selinexor 40 mg QW	szmifbxlgl(tvwcsburnl) = hgtyfrihze opndbifvyy (tkykbrujhj ) View more	Positive	12 May 2026
NCT05980806 (SENTRY2, EHA2026)	Phase 2	Myelofibrosis	58	Selinexor 60 mg QW	szmifbxlgl(tvwcsburnl) = iafqkmkzxs opndbifvyy (tkykbrujhj ) View more	Positive	12 May 2026
NCT05422027 (EHA2026)	Phase 1/2	Multiple Myeloma First line	30	Bortezomib 1.3mg/m²Lenalidomide 25mgSelinexor 60 mg qw + Bortezomib 1.3mg/m²Lenalidomide 25mgSelinexor 60 mg qw² + Bortezomib 1.3mg/m²Lenalidomide 25mgSelinexor 60 mg qw + Bortezomib 1.3mg/m²Lenalidomide 25mgSelinexor 60 mg qw0mg	pfxhbihdpb(wsmcboaijm) = gpatcttsty hotjkswnlu (obwvyrztbz ) View more	Positive	12 May 2026
EUCTR2021-006229-23-IT (EHA2026)	Phase 2	Peripheral T-Cell Lymphoma	30	Selinexor+Ifosfamide+Etoposide+Dexamethasone	ikklamhcjr(rrevfjexia) = tehwcmwecx zqekmwuhxj (kfukecqfef ) View more	Negative	12 May 2026
NCT05422066 (EHA2026)	Phase 2	Diffuse Large B-Cell Lymphoma First line	45	Selinexor in combination with the R-CHOP regimen	ywuvuarlzq(snghgxmgry) = emsrjiliss vburylyoni (rzaayviwhg, 63.9 - 100) View more	Positive	12 May 2026

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