Phase 2 Randomized Controlled Study of Revumenib as Maintenance Therapy After Allogeneic Hematopoietic Stem Cell Transplantation in Patients With KMT2Ar, NPM1m, or NUP98r Acute Myeloid Leukemia (AML)

Revumenib is a first in class oral menin inhibitor that targets a central oncogenic dependency shared across KMT2Ar, NPM1m, and NUP98r AML. In addition to suppressing leukemogenic transcriptional programs and promoting leukemic differentiation, menin inhibition has been shown to modulate epigenetic states linked to antigen presentation and immune recognition. These properties provide a strong biological rationale for evaluating revumenib as maintenance therapy following alloHCT, with the goal of suppressing residual leukemic clones while preserving or enhancing GVL activity during immune reconstitution.

开始日期2026-12-01

申办/合作机构

Center for International Blood & Marrow Transplant Research

[+2]

NCT07283640

/ Not yet recruiting临床1期IIT

A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia

To learn about the safety and effects of revumenib in combination with blinatumomab in patients with newly diagnosed or relapsed/refractory Ph-negative ALL with a KMT2A rearrangement.

开始日期2026-11-18

申办/合作机构

The University of Texas MD Anderson Cancer Center

[+2]

NCT07636564

/ Not yet recruiting临床2期IIT

A Phase II Randomized Study of Blinatumomab With or Without Revumenib for Patients With KMT2A-Translocation B-Cell Acute Lymphoblastic Leukemia (ALL)/ Acute Leukemia With Ambiguous Lineage (ALAL) With Persistent Measurable Residual Disease (MRD)

This phase II trial tests how well adding revumenib to usual treatment (blinatumomab) compared to usual treatment alone works in treating patients with B-cell acute lymphoblastic leukemia (B-ALL) or acute leukemia with ambiguous lineage (ALAL) with KMT2A-translocation. Revumenib binds to a protein called menin and keeps it from binding to another protein called KMT2A. This stops or slows the growth of leukemia cells with changes in the KMT2A gene. Blinatumomab binds to CD19, which is found on most B cells (a type of white blood cell) and some types of leukemia cells. It also binds to a protein called CD3, which is found on T cells (another type of white blood cell). This may help the immune system kill cancer cells. In addition to blinatumomab, usual treatment also includes dexamethasone, methotrexate, cyclophosphamide, cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, daunorubicin, vincristine and leucovorin. Dexamethasone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Methotrexate is in a class of medications called antimetabolites. It is also a type of antifolate. Methotrexate stops cells from using folic acid to make deoxyribonucleic acid (DNA) and may kill cancer cells. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's DNA and may kill cancer cells. It may also lower the body's immune response. Chemotherapy drugs, such as cytarabine, mercaptopurine, calaspargase pegol, doxorubicin, thioguanine, and daunorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Leucovorin is also being studied in the treatment of cancer. It is a type of chemoprotective agent and a type of chemosensitizing agent. Adding revumenib to usual treatment with blinatumomab may be safe, tolerable and more effective than blinatumomab alone in lowering the amount of leukemia in patients with B-ALL or ALAL with the KMT2A translocation.

开始日期2026-10-14

申办/合作机构

SWOG

[+1]

100 项与瑞维美尼相关的临床结果

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100 项与瑞维美尼相关的专利（医药）

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项与瑞维美尼相关的文献（医药）

2026-12-01·CURRENT TREATMENT OPTIONS IN ONCOLOGY

Menin Inhibitors: A New Era of Targeted Therapies in Acute Myeloid Leukemia

Review

作者: Reese, Mollie ; Hatfield, Jess ; Zeidner, Joshua F ; Peters, Daniel T

OPINION STATEMENT: Menin is involved in protein-protein interactions that are critical in the leukemogenesis of AML, particularly in patients with KMT2A rearrangements (KMT2Ar) and mutations in NPM1 (NPM1m). Revumenib is a first-in-class menin inhibitor approved by the U.S. Food and Drug Administration (FDA) in November 2024 for relapsed/refractory (R/R) acute leukemia with KMT2Ar. Revumenib was subsequently FDA-approved in October 2025 for R/R NPM1m AML, followed by approval of another oral menin inhibitor, ziftomenib, for R/R NPM1m AML in November 2025. These agents, along with other investigational menin inhibitors including bleximenib and enzomenib are being investigated in ongoing clinical trials as both single-agents and in combination with other chemotherapy agents in AML. Menin inhibitors have demonstrated clinical activity as single agents in KMT2Ar and NPM1m AML. However, the pharmacokinetics, safety profile, and selective activity varies among the available and investigational menin inhibitors. Despite these encouraging results, resistance mechanisms have been identified via mutations of the MEN1 gene and structural mutations in the menin binding pocket. As current and future clinical trials are completed, menin inhibitors are likely to play a large role in frontline and R/R treatment in KMT2Ar and NPM1m AML with likely expansion into populations of other genetic abnormalities.

2026-07-01·EUROPEAN JOURNAL OF HAEMATOLOGY

Targeting the Menin– KMT2A Axis in Acute Leukemia: From Epigenetic Dependency to Clinical Translation

Review

作者: Santino Caserta ; Massimo Gentile ; Maria Eugenia Alvaro ; Mamdouh Skafi ; Virginia Olivito ; Francesco Mendicino ; Ernesto Vigna ; Enrica Antonia Martino ; Eugenio Lucia ; Caterina Labanca ; Fortunato Morabito ; Nicola Amodio ; Antonella Bruzzese

ABSTRACT:

Acute leukemias characterized by a shared epigenetic dependency on the menin–KMT2A axis rely on aberrant HOX‐driven transcriptional programs that sustain leukemic self‐renewal and impair differentiation. This dependency is most evident in KMT2A‐rearranged and NPM1‐mutated acute myeloid leukemia (AML), but also extends to other HOX‐dependent entities, including leukemias with NUP98 rearrangements and UBTF tandem duplications, broadening the therapeutic relevance of menin inhibition. Menin acts as a central scaffold within chromatin‐associated complexes that maintain expression of HOXA cluster genes and MEIS1, integrating signals from epigenetic regulators and lineage‐specific transcription factors. Disruption of the menin–KMT2A interaction results in transcriptional reprogramming, induction of differentiation, and loss of leukemic stem cell properties, providing a strong mechanistic rationale for therapeutic targeting. This review synthesizes current knowledge on the molecular basis of menin dependency, with emphasis on structural insights, transcriptional circuitry, and lineage plasticity. We critically evaluate the preclinical and clinical development of menin inhibitors, including revumenib, ziftomenib, bleximinib, and icovamenib, summarizing efficacy signals in relapsed/refractory disease, safety profiles, and emerging resistance mechanisms. Special attention is given to combination strategies with venetoclax, FLT3 inhibitors, chemotherapy, and epigenetic agents, which aim to enhance response durability and mitigate resistance. Finally, we discuss ongoing clinical trials, unresolved challenges in patient selection and sequencing, and future directions for integrating menin inhibition into precision‐based treatment paradigms for acute leukemia.

2026-06-04·BLOOD

Overcoming menin inhibitor resistance in AML cells with combinations including BET proteins and a dual BRG1/BRM inhibitor

Article

作者: Hou, Hanxi ; Piel, Jessica ; Hammond, Danielle ; Hentemann, Murphy ; Malovannaya, Anna ; Fiskus, Warren ; Takahashi, Koichi ; Flores, Lauren B. ; Daver, Naval ; Kadia, Tapan M. ; Su, Xiaoping ; Senapati, Jayastu ; Issa, Ghayas C. ; Cuglievan, Branko ; Sasaki, Koji ; Jain, Antrix ; DiNardo, Courtney D. ; Collins, Mike ; Bhalla, Kapil N. ; Loghavi, Sanam ; Mill, Christopher P.

Abstract:

Menin inhibitors (MI) disrupt the binding of menin to mixed-lineage leukemia 1 (MLL1), leading to the repression of MLL1 or MLL1-fusion protein target genes, including reduced levels of HOXA9 and MEIS1 in acute myeloid leukemia (AML) with mutant NPM1 (mtNPM1) or MLL1 rearrangement (MLL1-r). Although MI are relatively well tolerated and induce clinical remissions, they are often short-lived due to the development of resistance followed by AML relapse. Through repeated shocks with the MI SNDX-50469, a precursor tool compound to revumenib, followed by recovery, we developed MI-resistant (MITR) AML MV4-11 and OCI-AML3 cells. Present studies show that compared with MI-sensitive parental cells, MITR cells exhibit an altered epigenome, transcriptome, and proteome, without menin mutations. Through a CRISPR screen, novel druggable MI coenrichments were identified and targeted, including BRD4, SMARCA4, and CREBBP. Cotreatment with the MI and the SMARCA4/SMARCA2 (BRG1/BRM) inhibitor FHD-286 or the BET proteins inhibitor OTX015 (birabresib) synergistically induced in vitro lethality in MITR and MI-resistant AML cells expressing the mutant menin (M327I), as well as in patient-derived (PD) AML cells with MLL1-r or mtNPM1 that exhibited ex vivo resistance to MI. Compared with each drug alone, cotreatment with SNDX-5613 (revumenib) and FHD-286 or OTX015 and FHD-286 significantly reduced the in vivo AML burden and improved survival of the immune-depleted mice, without inducing significant toxicity, in the xenograft models of MITR and MI-resistant PD MLL1-r AML cells. These findings highlight novel, targeted, drug combinations that overcome MI resistance in AML cells with MLL1-r or mtNPM1.

339

项与瑞维美尼相关的新闻（医药）

2026-07-14

·BioSpace

Syndax to Highlight Late-Stage Programs and Unveil New Pipeline Assets at R&D Event

– Expands pipeline with SNDX-4321, a novel, mutant-selective, allosteric EGFR inhibitor designed to address NSCLC patient populations with significant unmet needs – – SNDX-62122, a next-generation menin inhibitor, selected for development in MF, building on compelling preclinical results observed with revumenib in MF – – SNDX-62122 is the first candidate from the Company’s library of internally developed and wholly owned next-generation menin inhibitors that the Company plans to deploy in new areas – – Phase 2 trial of axatilimab in IPF on track for topline data in 4Q26 – – R&D Event featuring three thought leaders and members of Syndax’s leadership team to be held today at 8:30 a.m. ET – NEW YORK, July 14, 2026 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals (Nasdaq: SNDX), a commercial-stage biopharmaceutical company advancing innovative cancer therapies, today announced that the Company will highlight its late-stage programs and the next chapter of its R&D strategy, including new pipeline assets, during its R&D Event being held today from 8:30 a.m. to 11:00 a.m. EDT. “Today we are unveiling our new pipeline assets which reflect the continued evolution of our R&D capabilities, including our ability to leverage both external innovation and a library of internally developed next-generation menin inhibitors to expand our portfolio and create new growth opportunities,” said Michael A. Metzger, Chief Executive Officer. “With a robust financial foundation, a track record of success, and multiple near-term catalysts, Syndax is positioned to deliver the next breakthroughs for patients and drive long-term value for shareholders." “Syndax has established world-class R&D capabilities and strong partnerships with leading clinicians and scientists around the world to drive innovation and develop transformative new medicines for patients,” said Nick Botwood, MBBS, Head of Research & Development and Chief Medical Officer at Syndax. “Today’s event will highlight our strategy to expand our leadership in menin and CSF-1R inhibition and build our pipeline with two new differentiated assets supported by compelling preclinical data and mechanistic insights. With both Revuforj and Niktimvo, we demonstrated our ability to efficiently generate clinical data that validates new therapeutic targets, a strength we look forward to showcasing again as we advance the next chapter of our R&D strategy.” Guest speakers will include: Toby M. Maher, MD, PhD, Professor of Clinical Medicine and Director of Interstitial Lung Disease, Keck Medical School of University of Southern California, will present on idiopathic pulmonary fibrosis (IPF) and the potential for axatilimab in IPF. John D. Crispino, PhD, MBA, Director, Division of Experimental Hematology, St. Jude Children's Research Hospital, will present on the potential for menin inhibition in myelofibrosis (MF). Michael J. Eck, MD, PhD, Professor, Department of Cancer Biology, Dana-Farber Cancer Institute and Professor, Department of Biological Chemistry & Molecular Pharmacology, Harvard Medical School, will present on the development of SNDX-4321 for EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC). Highlighted R&D Day Topics SNDX-4321, a novel, mutant-selective, allosteric EGFR inhibitor for NSCLC SNDX-4321 is an EGFR inhibitor in development for NSCLC patient populations with significant unmet needs, such as those with L858R mutations, CNS metastases, atypical activating mutations, or acquired resistance to current therapies. In contrast to ATP-site directed third and fourth generation EGFR inhibitors, SNDX-4321 is a novel allosteric inhibitor which binds at a pocket adjacent to the ATP site that is only accessible in the presence of L858R and certain other EGFR mutations. The Company expects to submit an investigational new drug (IND) application for SNDX-4321 by the end of 2026 and to initiate a Phase 1 trial in EGFRm NSCLC in 2027. SNDX-4321 is an externally developed molecule that the Company has an exclusive worldwide license to develop and commercialize. During the R&D Event, the Company will highlight the potential advantages of an allosteric approach in EGFRm NSCLC and the supporting preclinical data. SNDX-62122, a candidate from the Company’s library of internally developed next-generation menin inhibitors, selected for development in MF SNDX-62122 is the first candidate from a library of wholly owned next-generation menin inhibitors that the Company intends to advance into new areas. SNDX-62122 is in development for MF, with submission of an IND and initiation of a Phase 1 trial in MF expected in 2027. During the R&D Event, the Company will highlight recently published revumenib preclinical data showing that menin is a novel dependency in proliferative megakaryocytes, major drivers of MF. The Company expects the development of SNDX-62122 to be informed and de-risked by a Phase 1/2 proof-of-principal trial of revumenib in MF that is expected to initiate in the fourth quarter of 2026 with initial clinical data expected in the second half of 2027. Ongoing late-stage trials of Revuforj ® (revumenib) and Niktimvo™(axatilimab-csfr) During the R&D event, the Company will highlight its late-stage revumenib and axatilimab programs in newly diagnosed acute leukemia and chronic GVHD, respectively, as well as the Phase 2 trial of axatilimab in IPF that is expected to readout in the fourth quarter of 2026. During the R&D event, Dr. Toby M. Maher will discuss the unmet patient needs, evolving treatment landscape, and the potential for axatilimab’s mechanism in IPF. Webcast Syndax will host an R&D Event today, July 14, 2026, from 8:30 a.m. to 11:00 a.m. ET in person and via webcast. The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website. Alternatively, the conference call may be accessed through the following link: . For those unable to join the live webcast, a replay will be available in the Investors section of the Company's website at after the event and will be available for a limited time. About Syndax Syndax Pharmaceuticals is a commercial-stage biopharmaceutical company advancing innovative cancer therapies. Highlights of the Company's pipeline include Revuforj ®  (revumenib), an FDA-approved menin inhibitor, and Niktimvo™ (axatilimab-csfr), an FDA-approved monoclonal antibody that blocks the colony stimulating factor 1 (CSF-1) receptor. Fueled by our commitment to reimagining cancer care, Syndax is working to unlock the full potential of its pipeline and is conducting several clinical trials across the continuum of treatment. For more information, please visit  or follow the Company on  X  and  LinkedIn . Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "anticipate," "believe," "could," "estimate," "expects," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative or plural of those terms, and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials, the reporting of clinical data for Syndax's product candidates, the acceptance of Syndax and its partners' products in the marketplace, sales, marketing, manufacturing and distribution requirements, and the potential use of its product candidates to treat various cancer indications and fibrotic diseases. Many factors may cause differences between current expectations and actual results, including: unexpected safety or efficacy data observed during preclinical or clinical trials; clinical trial site activation or enrollment rates that are lower than expected; changes to Revuforj's or Niktimvo’s commercial availability; changes in expected or existing competition; changes in the regulatory environment; failure of Syndax's collaborators to support or advance collaborations or product candidates; and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available. Syndax Contact Sharon Klahre Syndax Pharmaceuticals, Inc. sklahre@syndax.com Tel 781.684.9827 SNDX-G

临床1期临床2期

2026-07-13

·allsci.com

AB Science narrows pipeline to AML and ALS programs, discontinues three suspended studies

France-based AB Science SA (Euronext: AB) is narrowing its clinical focus to two programs — AB8939 in relapsed/refractory acute myeloid leukemia and masitinib in amyotrophic lateral sclerosis — while formally discontinuing three studies that had already suspended enrollment. The move signals a resource allocation decision by a small-cap company operating in two highly competitive indications. The three discontinued studies — a Phase II of masitinib in mast cell activation syndrome (AB20006), a Phase III in mastocytosis (AB15003), and a Phase III in progressive multiple sclerosis (AB20009) — were already dormant. AB Science stated the closures are not safety-related, framing them instead as a regulatory compliance measure for suspended trials with no prospect of near-term resumption. The discontinuations remove pipeline optionality but do not change the company’s near-term clinical trajectory. The more substantive update concerns AB8939, a microtubule-destabilizing agent designed to bypass two key resistance mechanisms in AML — P-glycoprotein-mediated drug efflux and myeloperoxidase-mediated drug inactivation. AB Science reported in late June the completion of Phase I, Step 3 — the maximum tolerated dose evaluation of AB8939 combined with AbbVie and Roche’s Venclexta (venetoclax) — and said the study’s Independent Data Monitoring Committee issued a preliminary favorable opinion. The company is now seeking regulatory authorization to initiate Phase I, Step 4, which will evaluate a triple combination of AB8939, venetoclax, and azacitidine. No numerical efficacy or safety data were disclosed. The R/R AML landscape has shifted substantially in recent years. Syndax Pharmaceuticals’ Revuforj (revumenib) received two separate US FDA approvals in 2024 and 2025 for KMT2A-translocated and NPM1-mutant AML, respectively, while Kura Oncology and Kyowa Kirin’s Komzifti (ziftomenib) gained approval for NPM1-mutant R/R AML in November 2025. These menin inhibitors are mutation-specific, which leaves a meaningful gap for mutation-agnostic approaches in patients who lack targetable alterations — the population AB8939 is theoretically positioned to address. Whether those preclinical findings translate into clinical benefit remains to be demonstrated. The masitinib ALS program presents its own complications. The Phase III trial AB23005, a 408-patient double-blind study comparing masitinib at 4.5 mg/kg/day plus riluzole against riluzole plus placebo, received regulatory approval in 2025 but has not yet enrolled a single patient. AB Science now says it will amend the protocol and resubmit before resuming the study. AB Science did not disclose the planned protocol amendments or the reasons for them. Masitinib previously generated Phase II/III data suggesting a slowing of disease progression in a subset of ALS patients, and AB Science submitted a marketing authorization application to the European Medicines Agency based on that dataset — an application that has not resulted in approval. The need to amend the confirmatory Phase III before it begins adds further delay to an already protracted regulatory path in a disease where riluzole and FDA’s Radicava (edaravone) remain the principal approved options. The pipeline update leaves AB Science focused on two lead programs at markedly different stages of development. For AB8939, the company is preparing to expand evaluation into a triple-combination regimen following the IDMC’s favorable opinion. For masitinib in ALS, the planned protocol amendment introduces additional uncertainty around the timeline for initiating the confirmatory Phase III study. This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/ Your email address will not be published. Required fields are marked * Comment * Name * Email * Website Privacy Terms About Us Copyright © 2026. AllSci Corp. All rights reserved.

临床3期上市批准临床2期临床1期

2026-07-05

·信狐药迅

四款2类国产新药：北京泰德罗哌卡因、江苏和晨阿比特龙、轩竹安奈拉唑钠和盛迪亚瑞康曲妥珠单抗提交上市申请|新受理（6.29-7.5）

本周药品注册受理数据，分门别类呈现，一目了然。(6.29-7.5）新药上市申请药品名称企业注册分类受理号盐酸罗哌卡因缓释溶液北京泰德制药股份有限公司 2.2 CXHS2600097 盐酸罗哌卡因缓释溶液北京泰德制药股份有限公司 2.2 CXHS2600096 盐酸罗哌卡因缓释溶液北京泰德制药股份有限公司 2.2 CXHS2600095 盐酸罗哌卡因缓释溶液北京泰德制药股份有限公司 2.2 CXHS2600094 醋酸阿比特龙软胶囊江苏和晨药业有限公司 2.2 CXHS2600093 安奈拉唑钠肠溶片轩竹(北京)医药科技有限公司 2.4 CXHS2600092 注射用瑞康曲妥珠单抗苏州盛迪亚生物医药有限公司 2.2 CXSS2600103 新药临床申请药品名称企业注册分类受理号 SYH2083滴眼液上海翊石医药科技有限公司 1 CXHL2600796 SYH2083滴眼液上海翊石医药科技有限公司 1 CXHL2600795 SYH2083滴眼液上海翊石医药科技有限公司 1 CXHL2600794 SYH2083滴眼液上海翊石医药科技有限公司 1 CXHL2600793 QLS1510片上海齐鲁制药研究中心有限公司 1 CXHL2600790 QLS1510片上海齐鲁制药研究中心有限公司 1 CXHL2600789 MDR-001片杭州德睿智药科技有限公司 1 CXHL2600788 MDR-001片杭州德睿智药科技有限公司 1 CXHL2600787 注射用JY1001 浙江杭煜制药有限公司 1 CXHL2600792 HS-10582片上海翰森生物医药科技有限公司 1 CXHL2600782 HS-10582片上海翰森生物医药科技有限公司 1 CXHL2600781 YF550片益祺生物科技(北京)有限公司 1 CXHL2600778 YF550片益祺生物科技(北京)有限公司 1 CXHL2600777 注射用PTT-121 北京炎明生物科技有限公司 1 CXHL2600780 AHB-137注射液杭州浩博医药有限公司 1 CXHL2600779 HCXT-2001片上海瀚辰星泰医药科技有限公司 1 CXHL2600770 HCXT-2001片上海瀚辰星泰医药科技有限公司 1 CXHL2600769 SZJ0107片安徽三之健医药科技有限公司 1 CXHL2600774 BB3008片北京伯汇生物技术有限公司 1 CXHL2600773 BB3008片北京伯汇生物技术有限公司 1 CXHL2600772 OV329胶囊缔脉生物医药科技(上海)有限公司 1 CXHL2600776 OV329胶囊缔脉生物医药科技(上海)有限公司 1 CXHL2600775 注射用HHK101 珠海市华海康医药科技有限责任公司 2.2 CXHL2600783 SQ-23082滴眼液沈阳兴齐眼药股份有限公司 2.2;2.4 CXHL2600786 SQ-23082滴眼液沈阳兴齐眼药股份有限公司 2.2;2.4 CXHL2600785 SQ-23082滴眼液沈阳兴齐眼药股份有限公司 2.2;2.4 CXHL2600784 F2008吸入粉雾剂苏州易合医药有限公司 2.2;2.4 CXHL2600791 CZ028 浙江萃泽生物医药有限公司 2.2;2.4 CXHL2600771 CM336注射液康诺亚生物医药科技有限公司 1 CXSL2600692 CM313(SC)注射液康诺亚生物医药科技有限公司 1 CXSL2600695 CM313(SC)注射液康诺亚生物医药科技有限公司 1 CXSL2600694 CM336注射液康诺亚生物医药科技有限公司 1 CXSL2600693 HXN6005注射液华深智药生物科技(苏州)有限公司 1 CXSL2600691 EA5注射液皮下制剂上海览屹医药科技有限公司 1 CXSL2600688 乐德奇拜单抗注射液先声药业有限公司 1 CXSL2600690 乐德奇拜单抗注射液先声药业有限公司 1 CXSL2600689 注射用VDJ010 北京伟德杰生物科技有限公司 1 CXSL2600687 NW-301V注射液新景智源生物科技(苏州)有限公司 1 CXSL2600686 人自体多克隆调节性T细胞注射液上海赛尔欣生物医疗科技有限公司 1 CXSL2600685 注射用VBC106 上海橙帆医药有限公司 1 CXSL2600684 注射用HC029 上海宏成药业有限公司 1 CXSL2600681 OX-1胶囊武汉康复得生物科技股份有限公司 1 CXSL2600680 SHR-4610注射液上海盛迪医药有限公司 1 CXSL2600683 注射用HS-20093 上海翰森生物医药科技有限公司 1 CXSL2600682 GLR1075注射液甘李药业股份有限公司 2.4 CXSL2600696 仿制药申请药品名称企业注册分类受理号乙酰半胱氨酸片广东赛康制药厂有限公司 3 CYHS2601581 注射用甲磺酸萘莫司他康普药业股份有限公司 3 CYHS2601580 注射用甲磺酸萘莫司他康普药业股份有限公司 3 CYHS2601579 铝碳酸镁混悬液江苏晨牌邦德药业有限公司 3 CYHS2601578 依替巴肽注射液天津天士力之骄药业有限公司 3 CYHS2601576 盐酸伐地那非口崩片江西汇仁药业股份有限公司 3 CYHS2601584 吡格列酮二甲双胍片北京太洋药业股份有限公司 3 CYHS2601583 枸橼酸西地那非口溶膜广州白云山医药集团股份有限公司白云山制药总厂 3 CYHS2601564 司美格鲁肽注射液浙江三生蔓迪药业有限公司 3 CYHS2601570 司美格鲁肽注射液浙江三生蔓迪药业有限公司 3 CYHS2601574 司美格鲁肽注射液浙江三生蔓迪药业有限公司 3 CYHS2601573 司美格鲁肽注射液浙江三生蔓迪药业有限公司 3 CYHS2601572 司美格鲁肽注射液浙江三生蔓迪药业有限公司 3 CYHS2601571 盐酸纳美芬注射液远大医药(中国)有限公司 3 CYHS2601540 盐酸多巴胺注射液江苏福邦药业有限公司 3 CYHS2601545 盐酸多巴胺注射液江苏福邦药业有限公司 3 CYHS2601544 盐酸多巴胺注射液江苏福邦药业有限公司 3 CYHS2601543 酮咯酸氨丁三醇片重庆圣华曦药业股份有限公司 3 CYHS2601541 盐酸异丙肾上腺素注射液四川美大康佳乐药业有限公司 3 CYHS2601553 帕拉米韦注射液辰欣药业股份有限公司 3 CYHS2601554 盐酸异丙肾上腺素注射液四川美大康佳乐药业有限公司 3 CYHS2601552 比拉斯汀口服溶液珠海北杉生物科技有限公司 3 CYHS2601558 注射用盐酸兰地洛尔康普药业股份有限公司 3 CYHS2601557 注射用盐酸兰地洛尔福安药业集团湖北人民制药有限公司 3 CYHS2601533 依普利酮片成都倍特药业股份有限公司 3 CYHS2601535 依普利酮片成都倍特药业股份有限公司 3 CYHS2601534 注射用甲磺酸萘莫司他成都青山利康药业股份有限公司 3 CYHS2601519 注射用甲磺酸萘莫司他成都青山利康药业股份有限公司 3 CYHS2601518 醋酸钙片黑龙江龙德药业有限公司 3 CYHS2601522 吡拉西坦注射液成都华宇制药有限公司 3 CYHS2601521 乙酰半胱氨酸片华益药业科技(安徽)有限公司 3 CYHS2601524 米诺地尔搽剂安徽得宏生制药有限公司 3 CYHS2601529 盐酸丁卡因凝胶湖南九典制药股份有限公司 3 CYHS2601527 盐酸丁卡因凝胶湖南九典制药股份有限公司 3 CYHS2601526 瑞加诺生注射液康普药业股份有限公司 3 CYHS2601525 氢溴酸吡西替尼片南京海纳制药有限公司 4 CYHS2601577 依达拉奉右莰醇注射用浓溶液四川健林药业有限责任公司 4 CYHS2601575 注射用阿莫西林钠克拉维酸钾广州艾奇西新药研究有限公司 4 CYHS2601582 盐酸氨溴索口服溶液江苏晨牌邦德药业有限公司 4 CYHS2601587 硫酸氨基葡萄糖胶囊海南万玮制药有限公司 4 CYHS2601586 10%脂肪乳(OO)/5.5%氨基酸(15)/葡萄糖(20%)注射液扬子江药业集团有限公司 4 CYHS2601585 阿达帕林过氧苯甲酰凝胶广东江正药业有限公司 4 CYHS2601562 依折麦布阿托伐他汀钙片(Ⅰ)、(Ⅱ) 浙江普利药业有限公司 4 CYHS2601566 二十碳五烯酸乙酯软胶囊浙江浙北药业有限公司 4 CYHS2601563 多替诺雷片齐鲁制药有限公司 4 CYHS2601567 硫酸氨基葡萄糖胶囊浙江前进药业有限公司 4 CYHS2601569 多替诺雷片齐鲁制药有限公司 4 CYHS2601568 依折麦布阿托伐他汀钙片(Ⅰ)、(Ⅱ) 浙江普利药业有限公司 4 CYHS2601565 二十碳五烯酸乙酯软胶囊(II) 哈尔滨誉衡制药有限公司 4 CYHS2601539 乳果糖口服溶液浙江美迪深生物医药有限公司 4 CYHS2601547 乳果糖口服溶液浙江美迪深生物医药有限公司 4 CYHS2601546 盐酸氨溴索口服溶液江苏欧歌制药有限公司 4 CYHS2601542 盐酸胺碘酮片上海理想制药有限公司 4 CYHS2601549 盐酸胺碘酮片上海理想制药有限公司 4 CYHS2601548 瑞维那新吸入溶液扬子江药业集团有限公司 4 CYHS2601556 依达拉奉右莰醇注射用浓溶液四川益生智同医药生物科技发展有限公司 4 CYHS2601555 四烯甲萘醌软胶囊华夏国药(菏泽)制药有限公司 4 CYHS2601551 艾瑞昔布片浙江华海制药科技有限公司 4 CYHS2601538 阿达帕林过氧苯甲酰凝胶遂成药业股份有限公司 4 CYHS2601561 阿达帕林过氧苯甲酰凝胶遂成药业股份有限公司 4 CYHS2601560 阿达帕林过氧苯甲酰凝胶遂成药业股份有限公司 4 CYHS2601559 蛋白琥珀酸铁口服溶液浙江普洛康裕制药有限公司 4 CYHS2601537 达罗他胺片齐鲁制药(海南)有限公司 4 CYHS2601536 艾托格列净片江苏德源药业股份有限公司 4 CYHS2601520 脂肪乳氨基酸(17)葡萄糖(19%)注射液江苏明德制药有限公司 4 CYHS2601523 依巴斯汀片江苏万高药业股份有限公司 4 CYHS2601530 莱博雷生片江苏宣泰药业有限公司 4 CYHS2601528 氟哌噻吨美利曲辛片远大医药(西安)有限公司 4 CYHS2601532 注射用阿奇霉素武汉市小铂生物科技有限公司 4 CYHS2601531 环索奈德吸入气雾剂上海上药信谊药厂有限公司 4 CYHL2600077 环索奈德吸入气雾剂上海上药信谊药厂有限公司 4 CYHL2600076 进口申请药品名称企业注册分类受理号氢溴酸尼罗司他片 MERCK SERONO LIMITED 5.1 JXHS2600074 氢溴酸尼罗司他片 MERCK SERONO LIMITED 5.1 JXHS2600073 帕博利珠单抗注射液 MSD International Business GmbH 2.2 JXSS2600056 AZD6234注射液 AstraZeneca AB 1 JXHL2600244 AZD6234注射液 AstraZeneca AB 1 JXHL2600243 AZD6234注射液 AstraZeneca AB 1 JXHL2600242 AZD6234注射液 AstraZeneca AB 1 JXHL2600241 AZD6234注射液 AstraZeneca AB 1 JXHL2600252 AZD6234注射液 AstraZeneca AB 1 JXHL2600250 AZD6234注射液 AstraZeneca AB 1 JXHL2600248 AZD6234注射液 AstraZeneca AB 1 JXHL2600247 AZD6234注射液 AstraZeneca AB 1 JXHL2600246 AZD6234注射液 AstraZeneca AB 1 JXHL2600245 AZD6234注射液 AstraZeneca AB 1 JXHL2600251 AZD6234注射液 AstraZeneca AB 1 JXHL2600249 AZD5305 AstraZeneca AB 1 JXHL2600257 PF-08653944注射液 Pfizer Inc. 1 JXHL2600256 PF-08653944注射液 Pfizer Inc. 1 JXHL2600255 PF-08653944注射液 Pfizer Inc. 1 JXHL2600254 PF-08653944注射液 Pfizer Inc. 1 JXHL2600253 Rinzimetostat (ORIC-944) ORIC Pharmaceuticals, Inc. 1 JXHL2600240 Golcadomide胶囊 Celgene Corporation 1 JXHL2600237 Golcadomide胶囊 Celgene Corporation 1 JXHL2600236 Golcadomide胶囊 Celgene Corporation 1 JXHL2600235 Golcadomide胶囊 Celgene Corporation 1 JXHL2600234 BMS-986458片 Bristol-Myers Squibb Company 1 JXHL2600233 BMS-986458片 Bristol-Myers Squibb Company 1 JXHL2600232 那米司特片 Boehringer lngelheim International GmbH 2.4 JXHL2600239 那米司特片 Boehringer lngelheim International GmbH 2.4 JXHL2600238 Rilzabrutinib片 Sanofi-Aventis Recherche & Developpement 2.4 JXHL2600231 Revumenib片 Syndax Pharmaceuticals, Inc. 2.4 JXHL2600230 Revumenib片 Syndax Pharmaceuticals, Inc. 2.4 JXHL2600229 Revumenib片 Syndax Pharmaceuticals, Inc. 2.4 JXHL2600228 DS-6000a Daiichi Sankyo, Inc. 1 JXSL2600151 中药相关申请药品名称企业注册分类受理号柴芍肠宁颗粒玉森(佛山)新药研发有限公司 1.1 CXZL2600058 骨龙胶囊东阿阿胶股份有限公司 2.3 CXZL2600057 桃红四物汤颗粒株洲千金药业股份有限公司 3.1 CXZS2600035 注：绿色字体部分为潜在首仿品种；咸达数据2026年5月每月药讯已出！关注“咸达数据”，微信关键词回复 ” 年+月，如202605” 获得最新药迅！不包含原料药、医用氧、注射用水、氯化钠或葡萄糖注射液等申请，不包含再注册、一次性进口、技术转移、复审申请。

申请上市

100 项与瑞维美尼相关的药物交易

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研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
NPM1突变急性髓系白血病	美国	Syndax Pharmaceuticals, Inc.	2025-10-24
KMT2A易位的急性白血病	美国	Syndax Pharmaceuticals, Inc.	2024-11-15

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
急性髓性白血病	临床3期	澳大利亚	Syndax Pharmaceuticals, Inc.	2025-11-25
急性髓性白血病	临床3期	奥地利	Syndax Pharmaceuticals, Inc.	2025-11-25
急性髓性白血病	临床3期	比利时	Syndax Pharmaceuticals, Inc.	2025-11-25
急性髓性白血病	临床3期	巴西	Syndax Pharmaceuticals, Inc.	2025-11-25
急性髓性白血病	临床3期	加拿大	Syndax Pharmaceuticals, Inc.	2025-11-25
急性髓性白血病	临床3期	法国	Syndax Pharmaceuticals, Inc.	2025-11-25
急性髓性白血病	临床3期	德国	Syndax Pharmaceuticals, Inc.	2025-11-25
急性髓性白血病	临床3期	以色列	Syndax Pharmaceuticals, Inc.	2025-11-25
急性髓性白血病	临床3期	意大利	Syndax Pharmaceuticals, Inc.	2025-11-25
急性髓性白血病	临床3期	马来西亚	Syndax Pharmaceuticals, Inc.	2025-11-25

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05731947 (CTgov)	临床1/2期	结直肠癌 \| 转移性结直肠癌	41	Revumenib (Phase 1a: Revumenib 160 mg Tablet or 163 mg Capsule)	襯艱餘鏇衊鑰艱蓋糧觸 = 淵繭積壓窪糧範積選願構憲壓蓋憲遞觸鏇餘鹽 (製憲築繭窪鹽選顧積顧, 簾窪蓋繭觸鑰艱艱選蓋 ~ 鬱築衊製齋觸鑰襯廠廠) 更多	-	2026-07-06
				Revumenib (Phase 1a: Revumenib 220 mg Tablet or 226 mg Capsule)	襯艱餘鏇衊鑰艱蓋糧觸 = 遞顧範範繭鹽獵鹹淵醖構憲壓蓋憲遞觸鏇餘鹽 (製憲築繭窪鹽選顧積顧, 觸顧構選獵構壓淵衊襯 ~ 簾願壓構鹹鹽鬱鑰獵窪) 更多
NCT07211958 (REVEAL-ND NPM1, ASCO2026 \| EHA2026)	临床3期	NPM1突变急性髓系白血病一线 NPM1 mutation	468	Revumenib + intensive chemotherapy	蓋簾憲顧繭築壓願鏇製(簾遞衊壓範願窪淵繭蓋) = 襯觸願顧製糧選夢選願顧襯襯襯鏇築膚餘憲鏇 (齋艱蓋鹹願廠夢襯餘選 )	积极	2026-05-29
				Placebo + intensive chemotherapy	積艱範餘積繭網鹽膚糧(鬱齋範積鹹觸襯餘網願) = 繭觸選鏇齋壓艱鹹繭鏇鏇顧顧餘繭積壓構齋選 (餘製夢遞鏇鹹鬱願衊網 ) 更多
NCT04065399 (AUGMENT-101, EHA2026)	临床1/2期	KMT2A rearrangement \| NPM1 mutation	335	Revumenib (KMT2A Rearrangement or NPM1 Mutation + Relapsed/Refractory Acute Leukemias)	憲憲齋築蓋艱網淵壓淵(襯鬱憲淵醖膚繭鹽餘選) = 廠鹽淵製蓋積淵顧衊獵衊壓艱餘遞醖獵醖繭簾 (網構衊鹽鹹鑰網築積餘 )	积极	2026-05-21
NCT06652438 (EVOLVE-2, EHA2026)	临床3期	急性白血病一线 NPM1 mutation \| KMT2A rearrangement	448	Revumenib + VEN/AZA	鏇憲鑰襯夢窪鹽廠窪艱(積衊鹽衊齋鑰鑰簾網鹹) = 積鏇衊顧憲網蓋餘鹹範醖憲壓願蓋夢醖壓積獵 (鏇積顧繭簾憲淵遞艱構 ) 更多	积极	2026-05-21
				Placebo + VEN/AZA	鹹蓋顧鑰鏇鏇壓窪襯廠(夢獵膚積築顧艱淵鏇範) = 網網淵構衊遞顧壓齋構築鹽構鏇範齋衊鑰鹽選 (壓鏇醖廠鏇遞觸艱醖積 )
NCT06226571 (SNDX-5613-0708, EHA2026)	临床1期	急性髓性白血病一线 KMT2A rearrangements \| NPM1 mutation \| NUP98 rearrangements	31	Revumenib + intensive chemotherapy	製壓夢獵顧獵襯鬱壓蓋(積醖壓餘衊範夢範蓋襯) = One DLT occurred (grade 3 QTcF prolongation) in DL1. 鹽鹹選廠築鑰顧獵齋夢 (積簾夢願齋積艱鏇繭製 ) 更多	积极	2026-05-12
				Revumenib + intensive chemotherapy
NCT04065399 (AUGMENT-101, EHA2026)	临床1期	急性白血病 NUP98-rearranged	26	Revumenib	網選膚蓋網衊積築積衊(艱襯衊廠壓窪壓觸齋簾) = 鹹鏇繭鏇夢顧夢鹹獵簾糧夢簾鑰衊製簾願憲醖 (選積製範製憲膚糧鹽鏇 ) 更多	积极	2026-05-12
NCT04065399 (AUGMENT-101, EHA2026)	临床1/2期	NPM1突变急性髓系白血病 NPM1-mutated	54	Revumenib (DNMT3A+FLT3)	憲獵築壓襯鑰鏇範觸範(廠糧艱廠餘鏇壓願膚鬱) = 窪鬱築鑰遞鬱艱觸憲鹹積淵醖醖齋淵鏇夢遞醖 (憲築醖積鹽鹹淵構憲遞, 7.8 ~ 55.1) 更多	积极	2026-05-12
				Revumenib (FLT3)	憲獵築壓襯鑰鏇範觸範(廠糧艱廠餘鏇壓願膚鬱) = 網廠鏇鬱餘遞願簾顧鑰積淵醖醖齋淵鏇夢遞醖 (憲築醖積鹽鹹淵構憲遞, 7.5 ~ 43.7) 更多
NCT04065399 (AUGMENT-101, EHA2026)	临床1/2期	维持 KMT2A \| NPM1 \| NUP98	15	Revumenib	憲廠艱鬱憲選構襯襯鑰(餘膚糧醖夢願蓋夢願糧) = 鹹築構製獵製淵鹹獵襯淵醖餘顧齋獵鑰遞淵襯 (夢齋餘簾遞選遞廠膚鑰 ) 更多	积极	2026-05-12
NCT05360160 (EHA2026)	临床1/2期	难治性急性髓细胞白血病 KMT2A rearrangement \| NPM1 mutation \| NUP98 rearrangement	42	Revumenib+ASTX727+Venetoclax	鬱夢醖餘齋製築顧壓鹹(獵淵鑰鹽餘窪壓鏇製鑰) = The most common all-grade adverse events were nausea (60%), vomiting (52%), QTc prolongation (50%), and hypokalemia (45%), mostly grade 1-2. Grade ≥3 events were most frequently febrile neutropenia (35%), thrombocytopenia (22%), lung infection (20%), and respiratory failure (15%). QTc prolongation grade ≥3 occurred in 2 pts (5%). Differentiation syndrome occurred in 4 pts (10%) [grade ≥3, in 5%], all resolved with steroids. 網顧衊繭網觸選觸觸繭 (遞遞鑰夢顧衊構壓簾構 ) 更多	积极	2026-05-12
				Revumenib+ASTX727+Venetoclax (KMT2A rearrangement)
NCT07356154 (EHA2026)	临床1/2期	KMT2A r \| NPM1 c \| NUP98 r	2	RevumenibMezigdomide + RevumenibMezigdomide	網顧鏇構積糧觸簾蓋夢(選艱積糧鹽繭選膚遞夢) = dose escalation is ongoing 鬱網鹹夢積艱繭鑰衊襯 (餘鑰夢衊積選觸鬱願壓 ) 更多	积极	2026-05-12