RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union)

Structure/Sequence

Molecular FormulaC33H42F3N9O2S2

InChIKeyBGGALFIXXQOTPY-NRFANRHFSA-N

CAS Registry2134675-36-6

Clinical Trials associated with Ziftomenib

NCT06930352

/ Not yet recruitingPhase 2IIT

Frontline Ziftomenib in NPM1-Mutated or KMT2A-Rearranged Acute Myeloid Leukemia in Patients Not Eligible for Intensive Induction or Other Therapy

This phase II trial tests how well ziftomenib works in treating patients with NPM1 mutated or KMT2A rearranged acute myeloid leukemia (AML) and are not eligible to receive standard therapy. AML is often due to genetic changes in the cancer cells, including mutations in the NPM1 gene and rearrangements involving the KMT2A gene. These mutations result in activation of the menin pathway. Menin is a type of protein in the body that helps to regulate some of the naturally occurring processes in the body, but can also be involved in some types of cancers. Ziftomenib blocks this menin pathway and may prevent the cancer cells from continuing to grow. Giving ziftomenib may kill more cancer cells in patients with NPM1 mutated or KMT2A rearranged AML that are not eligible to receive standard therapy.

Start Date10 Jan 2026

Sponsor / Collaborator

Ohio State University Comprehensive Cancer Center

[+1]

NCT07007312

/ RecruitingPhase 3

Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia

Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations. Ziftomenib is a type of therapy known to target the menin pathway in cancer cells.
This protocol has 2 separate studies that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) AML treatments in patients with certain genetic mutations who have not received any treatment for their AML. In the first study, the Nonintensive Therapy Study, older patients or those with serious medical problems will receive the SOC therapies venetoclax (ven) and azacitidine (aza), plus either ziftomenib or a placebo. In the second study, the Intensive Therapy Study, medically fit patients will receive (a) the SOC therapies cytarabine and daunorubicin, plus either ziftomenib or a placebo during a first treatment phase called induction, (b) cytarabine plus either ziftomenib or a placebo during a second treatment phase called consolidation, and (c) ziftomenib or a placebo during a third treatment phase called maintenance.
The physician will determine which study is the appropriate treatment for the patient, but neither the patient nor their physician will know whether the patient has been assigned to receive ziftomenib or a placebo. This design is called "double-blinded".

Start Date26 Sep 2025

Sponsor / Collaborator

Kura Oncology, Inc.

NCT06769490

/ RecruitingPhase 1

Phase 1 Dose Escalation and Expansion of Ziftomenib in Combination With Quizartinib in Acute Myeloid Leukemia

The goal of this all-oral combination is to deliver safe and effective therapy for the largest portion of AML subtypes (NPM1mt, KMT2Ar, NUP98r
40-45%).

Start Date10 Jul 2025

Sponsor / Collaborator-

100 Clinical Results associated with Ziftomenib

100 Translational Medicine associated with Ziftomenib

100 Patents (Medical) associated with Ziftomenib

Literatures (Medical) associated with Ziftomenib

01 Nov 2025·CURRENT OPINION IN ONCOLOGY

The role of menin inhibitors in acute myeloid leukemia

Review

Author: Marconi, Giovanni ; Isidori, Alessandro

Purpose of review:

Acute myeloid leukemia (AML) characterized by NPM1 mutations or KMT2A rearrangements depends on abnormal epigenetic programs mediated by menin, a critical scaffold protein for sustaining the expression of oncogenic HOX/MEIS1 genes. Therefore, menin inhibitors have become a promising class of AML treatments.

Recent findings:

Early-phase trials have shown that agents such as revumenib, ziftomenib, bleximenib, and enzomenib are active, particularly in relapsed/refractory disease, with 23–48% of patients achieving composite complete remission. However, the durability of single-agent treatment remains limited, and resistance mechanisms, such as MEN1 mutations or transcriptional reprogramming, have been identified. Consequently, combination approaches involving venetoclax, hypomethylating agents, or chemotherapy are being investigated to improve response depth and duration. Recent SAVE, KOMET-007, and cAMeLot-2 trials have demonstrated high overall response rates (68%-100%) and encouraging MRD-negative complete remissions when combining menin inhibitors with venetoclax-based regimens. This has been observed even in patients who have previously received venetoclax. Combinations with intensive chemotherapy (e.g., 7 + 3) in the frontline setting have also yielded high CRc rates (up to 94% in NPM1-mutated AML) without exacerbating toxicity.

Summary:

These findings justify the integration of menin inhibitors into the AML therapeutic landscape, and support ongoing randomized trials to confirm their benefit in both frontline and relapse or refractory settings.

01 Sep 2025·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Menin inhibitors in KMT2A-rearranged and NPM1-mutated acute leukemia: A scoping review of safety and efficacy

Article

Author: Kalfah, Anas ; Dali, Sara Al ; Mohamed, Shehab F ; Al-Mashdali, Abdulrahman F

BACKGROUND:

Menin inhibitors represent a novel therapeutic approach targeting the Menin-KMT2A interaction in acute leukemias with KMT2A rearrangements or NPM1 mutations. This scoping review synthesizes current clinical evidence for emerging Menin inhibitors in development.

METHODS:

We systematically analyzed clinical trials, conference proceedings, and regulatory documents regarding Menin inhibitors in clinical development through December 2024. Primary outcomes included response rates, minimal residual disease (MRD) status, and safety profiles.

RESULTS:

Thirteen clinical trials investigating six Menin inhibitors (Revumenib, Ziftomenib, Bleximenib, BMF-219, DS-1594, and Enzomenib) were identified. Revumenib demonstrated consistent efficacy across five pivotal trials, achieving MRD-negative rates of 70-90 % in both KMT2A-rearranged and NPM1-mutated leukemias, leading to FDA approval in November 2024. Ziftomenib showed particular efficacy in NPM1-mutated cases but exhibited a higher incidence of differentiation syndrome (30 %) in KMT2A-rearranged patients. Bleximenib reported a 93 % overall response rate, pending MRD validation. Early resistance emergence, primarily through MEN1 mutations, was observed across trials, emerging as early as two treatment cycles.

CONCLUSIONS:

Menin inhibitors demonstrate promising clinical activity in molecularly defined leukemias, with Revumenib establishing proof-of-concept for this therapeutic approach. However, challenges remain, including resistance development, optimal timing of therapy initiation, and determination of effective combination strategies. Larger randomized trials with extended follow-up are needed to establish long-term efficacy and safety profiles. The rapid clinical development of multiple agents in this class suggests an expanding role for Menin inhibitors in leukemia treatment paradigms.

01 Feb 2025·CTS-Clinical and Translational Science

Pharmacokinetics and ADME Characterization After Oral and Intravenous Administration of [¹⁴C]‐Ziftomenib in Healthy Male Participants

Article

Author: Mitra, Amitava ; El‐Shahat, Taha ; Leoni, Mollie ; Dale, Stephen ; Tabachri, Marilyn ; Ahsan, Julie Mackey

ABSTRACT:

Ziftomenib, a potent, selective inhibitor that binds menin at the lysine methyltransferase 2 interaction site, has demonstrated promising clinical activity with manageable toxicity in heavily pretreated patients with acute myeloid leukemia (AML) and nucleophosmin 1 mutations. This phase 1, open‐label study characterized the absorption, metabolism, excretion, and bioavailability of ziftomenib in healthy men and comprised two parts. In part A, a single oral dose of ziftomenib 400 mg (containing 250 μCi [14C]‐ziftomenib) was given to evaluate routes and rates of elimination, total radioactivity, and other pharmacokinetic parameters. In part B, a single oral dose of ziftomenib 400 mg followed by an intravenous dose of ziftomenib < 100 μg (containing 1 μCi [14C]‐ziftomenib) was administered to evaluate absolute bioavailability (both n = 8 patients). A median tmax of 3.5 h and an elimination t1/2 of 61.5 h demonstrated rapid ziftomenib absorption and enabled once‐daily dosing. Total radioactivity recovery was 89.7% in feces and 0.5% in urine over 480 h. Absolute bioavailability of 12.9% was observed. Ziftomenib was primarily metabolized by oxidation, N‐demethylation, and N‐dealkylation, with 19 metabolites recovered in plasma. All metabolites were considered minor (< 10% of total drug‐related exposure). Ziftomenib was the most abundant plasma component (> 10% of total drug‐related exposure). In conclusion, ziftomenib underwent limited metabolism following absorption and was primarily excreted as unchanged parent drug in feces. Ziftomenib was well tolerated with no new safety concerns in healthy men. Considering the pharmacokinetic profile and manageable safety outcomes, these findings support further clinical investigation of ziftomenib as treatment for AML.

151

News (Medical) associated with Ziftomenib

24 Oct 2025

·endpoints.news

FDA rejects Sydnexis’ myopia drug for kids; Chugai to buy Renalys for $98M upfront

Plus, news about Kura Oncology, X4 Pharmaceuticals, Coya Therapeutics, Harbour BioMed and Silver Creek: 👁️ FDA rejects Sydnexis’ experimental myopia drug: The company said the regulator does not believe the data that Sydnexis submitted support SYD-101’s effectiveness, even though the drug met the primary endpoint in a Phase 3 trial. The FDA did not cite any safety or quality issues in the complete response letter, according to Sydnexis. SYD-101 is used to slow the progression of nearsightedness in children. Though “surprised” by the FDA’s decision, Sydnexis said it plans to address the FDA’s concerns. — Jaimy Lee 💰 Chugai is buying Renalys Pharma for $98M upfront: As part of the deal, the Japanese drugmaker is getting the rights to Filspari in Japan, South Korea and Taiwan. The drug, which was developed by Travere Therapeutics, is approved to treat IgA nephropathy in the US and Europe. The deal also includes up to about $105 million in milestones. — Jaimy Lee 🧾 Kura Oncology records $30M milestone: It received the payment from Kyowa Kirin after the first patient was dosed in a registrational study of ziftomenib in patients with certain forms of acute myeloid leukemia. — Jaimy Lee 💸 X4 Pharmaceuticals’ $135M offering: The company is selling 45.8 million shares at $2.90 apiece. — Jaimy Lee 💵 Coya Therapeutics also revealed a stock sale: The biotech aims to raise $20 million by selling about 3.6 million shares at $5.50 each. — Jaimy Lee 🧪 Harbour BioMed shares Phase 2 colorectal cancer data: Among 23 evaluable patients, Harbour’s anti-CTLA-4 drug induced eight partial responses. That’s good for an objective response rate of 34.8%. The Shanghai-based biotech tested porustobart (formerly HBM4003) in combination with BeOne’s Tevimbra in patients with microsatellite-stable metastatic colorectal cancer. Immunotherapy has traditionally performed relatively poorly when used to treat patients with this kind of cancer. — Max Gelman 🧠 Silver Creek’s Phase 2 stroke data: The California biotech’s growth factor candidate, called scp776, achieved an average 2.26-point improvement on the NIH Stroke Scale versus placebo. The treatment also produced a 15% increase in the “relative proportion” of patients becoming functionally independent. The trial enrolled 119 patients with acute ischemic stroke. — Ayisha Sharma

Clinical ResultPhase 2Drug ApprovalPhase 3Immunotherapy

24 Oct 2025

·ir.kuraoncology.com

Kura Oncology Receives $30 Million Development Milestone Payment in Ziftomenib AML Program with Kyowa Kirin

- Milestone triggered by dosing of first patient in frontline AML Phase 3 clinical program- SAN DIEGO , Oct. 24, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced receipt of a $30 million milestone payment under its collaboration agreement with Kyowa Kirin in connection with the dosing of the first patient in the KOMET-017 Phase 3 registrational trials of ziftomenib, a once-daily, investigational oral menin inhibitor. Kura and Kyowa Kirin announced the launch of the KOMET-017 trials on September 29, 2025 . KOMET-017 (NCT07007312) comprises two independent, global, randomized double-blind, placebo-controlled Phase 3 trials to evaluate ziftomenib in combination with both intensive and non-intensive chemotherapy regimens in patients with newly diagnosed NPM1-mutated (NPM1-m) or KMT2A-rearranged (KMT2A-r) acute myeloid leukemia (AML). Kura believes KOMET-017 is the only menin inhibitor program actively pursuing registrational trials across both intensive and non-intensive chemotherapy settings. About Kura OncologyKura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. Kura’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura is developing ziftomenib, a menin inhibitor targeting certain genetic drivers of acute myeloid leukemias and continues to pioneer advancements in menin inhibition for acute leukemias and solid tumors and in farnesyl transferase inhibition to address mechanisms of adaptive and innate resistance in the treatment of solid tumors. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn. Forward-Looking Statements This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include, among other things, statements regarding the therapeutic potential of ziftomenib and the KOMET-017 trial being the only menin inhibitor program actively pursuing registrational trials across both intensive and non-intensive chemotherapy settings. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, the risk that the collaboration with Kyowa Kirin is unsuccessful, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Kura faces, please refer to Kura’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Kura Contact Investors and Media: Greg Mann 858-987-4046gmann@kuraoncology.com Source: Kura Oncology, Inc.

Phase 3License out/in

18 Oct 2025

·www.globenewswire.com

Kura Oncology Announces Preliminary Data from Its Farnesyl Transferase Inhibitor (FTI) Programs at the 2025 European Society for Medical Oncology (ESMO) Congress

FTI mechanism addresses innate and adaptive resistance pathways common to targeted oncology therapies Early clinical and preclinical data support darlifarnib’s potential to enhance clinical benefit of PI3Kα-, KRAS- and tyrosine kinase inhibitors 50% objective response rate and 80% disease control rate in renal cell carcinoma (RCC) cohort of darlifarnib plus cabozantinib in ongoing dose-escalation clinical trial Kura Oncology to host a virtual investor event today, October 18, 2025, at 10:30 a.m. PT / 1:30 p.m. ET / 7:30 p.m. CEST SAN DIEGO, Oct. 18, 2025 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced new preliminary data from its farnesyl transferase inhibitor (FTI) programs – darlifarnib (KO-2806) and tipifarnib – presented at the 2025 European Society for Medical Oncology (ESMO) Congress in Berlin, Germany, from October 17 – 21, 2025. “Kura Oncology is pioneering the use of FTIs in combination with tyrosine kinase inhibitors (TKIs), PI3Kα inhibitors and KRAS inhibitors to address mechanisms of innate and adaptive resistance, thereby enhancing and extending the clinical benefit of these single-agent targeted therapies,” said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. “The clinical data reported here at ESMO 2025 build on our preclinical presentation from last month and underscore darlifarnib’s transformative potential as a versatile combination partner to major classes of precision medicines.” Darlifarnib as Monotherapy in Advanced Solid Tumors – FIT-001 Phase 1 Trial HRAS-mutant (HRAS-m) tumors are sensitive to FTIsManageable safety and tolerability profile at doses from 3 to 10 mg per dayEncouraging antitumor activity in advanced HRAS-m solid tumors across multiple dose levels, demonstrating on-target activity and a broad therapeutic windowData support further evaluation of KO-2806 in combinations across tumor types Darlifarnib + Cabozantinib in Renal Cell Carcinoma – FIT-001 Phase 1 Trial FTI mechanism blocks hyperactivated mTORC1 signaling in tumor endothelial cellsManageable safety profile in RCC patients across multiple doses, including at the full label dose of cabozantinibAntitumor activity observed across all doses in RCC, including in prior cabozantinib-exposed patients ORR: 33%–50% in ccRCC (17-50% in patients with prior cabozantinib exposure)DCR: 80%–100% in ccRCC Dose-escalation study ongoing and Phase 1b dose-expansion planned to assess optimal biologically active dose for combination Tipifarnib + Alpelisib in PIK3CA-altered Head and Neck Squamous Cell Carcinoma – KURRENT-HN Phase 1 Trial FTI mechanism blocks hyperactivated mTORC1 signaling in squamous tumor cellsManageable safety profile in HNSCC patients across multiple dosesRobust antitumor activity was observed in heavily pretreated patients with relapsed or metastatic HNSCC with PIK3CA alterations ORR: 47% was observed at a daily dose of tipifarnib 1200 mg + alpelisib 250 mgAlpelisib monotherapy provides modest clinical benefit (ORR: 0%; BOR: SD)1 and tipifarnib monotherapy not expected to provide clinical benefit in this population Data generation options for darlifarnib + PI3Kα inhibitor combinations in solid tumors are being assessed “These results highlight the potential of FTIs to meaningfully enhance the clinical activity of PI3Kα inhibitors in molecularly selected patients,” said Glenn Hanna, M.D., Director, Center for Cancer Therapeutic Innovation, Medical Oncologist, Center for Head & Neck Oncology, Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School – an investigator on both the FIT-001 and KURRENT-HN trials. “Darlifarnib demonstrates robust activity in HRAS-mutant solid tumors, which are typically very challenging to treat using existing therapies. In addition, the combination of tipifarnib and alpelisib demonstrated robust antitumor activity in heavily pretreated patients with relapsed or metastatic HNSCC with PIK3CA alterations — a population where monotherapy alpelisib provides only modest clinical benefit. These combination data are very exciting and set the stage for combining darlifarnib with PI3Kα inhibitors.” Juric et al. J Clin Oncol 2018;36(13):1291-9. PresentationsThe presentations are available on Kura’s website at www.kuraoncology.com under the Posters and Presentations tab in the Farnesyl Transferase Inhibition section, and in the ESMO Congress 2025 online program. Virtual Investor EventKura will host a webcast and conference call today, October 18, 2025, at 10:30 a.m. PT / 1:30 p.m. ET / 7:30 p.m. CEST featuring management and Glenn A. Hanna, M.D., Director, Center for Cancer Therapeutic Innovation Medical Oncologist, Center for Head & Neck Oncology, Dana-Farber Cancer Institute and Associate Professor of Medicine, Harvard Medical School. The live webcast and replay will be available on the Company’s website at www.kuraoncology.com under the Investors tab in the Events and Presentations section. About Kura OncologyKura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline of small molecule drug candidates is designed to target cancer signaling pathways and address high-need hematologic malignancies and solid tumors. Kura is developing ziftomenib, a menin inhibitor targeting certain genetic drivers of acute myeloid leukemias, and continues to pioneer advancements in menin inhibition for acute leukemias and solid tumors and in farnesyl transferase inhibition to address mechanisms of adaptive and innate resistance in the treatment of solid tumors. For additional information, please visit the Kura website at https://kuraoncology.com/ and follow us on X and LinkedIn. Forward-Looking Statements This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include, among other things, statements regarding the potential of FTIs to address resistance mechanisms in cancer, the potential benefits of combining FTIs with targeted therapies, and the potential of FTIs to impact patients with cancer. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, and other interactions with regulatory bodies, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties Kura faces, please refer to Kura’s periodic and other filings with the Securities and Exchange Commission, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. Conflict of Interest DisclosureDr. Hanna's disclosures include institutional research support and an advisory role with Kura Oncology, Inc. Kura ContactInvestors and Media:Greg Mann858-987-4046gmann@kuraoncology.com

Phase 1Clinical ResultASCO

100 Deals associated with Ziftomenib

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute myeloid leukemia with mutated NPM1	NDA/BLA	United States	Kura Oncology, Inc.	08 Apr 2025
Acute Lymphoblastic Leukemia	Phase 2	United States	Kura Oncology, Inc.	12 Sep 2019
Acute Lymphoblastic Leukemia	Phase 2	Belgium	Kura Oncology, Inc.	12 Sep 2019
Acute Lymphoblastic Leukemia	Phase 2	Canada	Kura Oncology, Inc.	12 Sep 2019
Acute Lymphoblastic Leukemia	Phase 2	France	Kura Oncology, Inc.	12 Sep 2019
Acute Lymphoblastic Leukemia	Phase 2	Germany	Kura Oncology, Inc.	12 Sep 2019
Acute Lymphoblastic Leukemia	Phase 2	Italy	Kura Oncology, Inc.	12 Sep 2019
Acute Lymphoblastic Leukemia	Phase 2	Poland	Kura Oncology, Inc.	12 Sep 2019
Acute Lymphoblastic Leukemia	Phase 2	Spain	Kura Oncology, Inc.	12 Sep 2019
Acute Lymphoblastic Leukemia	Phase 2	United Kingdom	Kura Oncology, Inc.	12 Sep 2019

Clinical Result

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04067336 (KOMET-001, ASCO2025) Manual	Phase 1/2	Acute myeloid leukemia with mutated NPM1 NPM1 Mutation	112	Ziftomenib 600 mg QDZiftomenib 600 mg QD (Phase 1b/2)	ozeqalmhyr(mwiotcpczg) = pkxwtarqoq nbbsvvgaqb (fimmyvpoml, 17 - 34) View more	Positive	30 May 2025
				Ziftomenib 600 mg QDZiftomenib 600 mg QD (Phase 2)	ozeqalmhyr(mwiotcpczg) = jkzexosqhh nbbsvvgaqb (fimmyvpoml, 15 - 33)
NCT04067336 (KOMET-001, EHA2025)	Phase 1/2	Acute myeloid leukemia with mutated NPM1 NPM1-mutant	112	Ziftomenib 600 mg QD	qamzlkakog(utodjqaaro) = jcofzguzqi cobrnfdiwp (sbwnjmxefc, 17 - 34) View more	Positive	22 May 2025
NCT05735184 (KOMET-007, EHA2025)	Phase 1	Acute myeloid leukaemia with 11q23 abnormality \| Acute myeloid leukemia with mutated NPM1 NPM1-m \| KMT2A-r	51	Ziftomenib 600 mg QD + 7+3 induction	smisbotwvj(avpyaaiabb) = febrile neutropenia (47%), decreased platelet count (31%), anemia (22%), decreased neutrophil count (20%), decreased white blood cell count (16%) nbgnfvozdz (mtjxbrfyei ) View more	Positive	14 May 2025
NCT04067336 (KOMET-001, Company_Website) Manual	Phase 1/2	Acute Myeloid Leukemia NPM1 Mutation	-	Ziftomenib	gmgwmmxweb(aqymihrhhm) = The KOMET-001 trial achieved its primary endpoint of CR plus CR with partial hematological recovery (CRh) and the primary endpoint was statistically significant. oodwboxxpz (iddmshvder ) Met View more	Positive	07 Feb 2025
KOMET-007 (GlobeNewswire) Manual	Phase 1	Acute myeloid leukemia with mutated NPM1 \| Acute Leukemia with a KMT2A Translocation First line NPM1 Mutation \| KMT2A Rearrangement	54	ziftomenib +venetoclax/azacitidine	lbvcjzttnz(epcaaepmpv) = puchgxjcxi zbluvjfuqp (xdntrceicp ) View more	Positive	09 Dec 2024
				Ziftomenib+cytarabinecytarabine/daunorubicindaunorubicin	lbvcjzttnz(epcaaepmpv) = kbcpiihxye zbluvjfuqp (xdntrceicp ) View more
ASH2024	Not Applicable	-	-	Ziftomenib 200 mg	hdmodciayo(mgcuohuzut) = jiwmtwyuwl bmtomdhkjh (yrcnufafib ) View more	-	08 Dec 2024
				Ziftomenib 400 mg	hdmodciayo(mgcuohuzut) = crfpbmjajf bmtomdhkjh (yrcnufafib ) View more
ASH2024	Not Applicable	-	-	Ziftomenib 200 mg	yunxubknxa(zereditdte) = ojdruoeqdd vxkutzgtkh (sezuycqsgn )	-	07 Dec 2024
				Ziftomenib 400 mg	yunxubknxa(zereditdte) = lngvfsaqzc vxkutzgtkh (sezuycqsgn )
NCT04067336 (KOMET-001, Pubmed \| Lancet Oncol) Manual	Phase 1/2	Acute Myeloid Leukemia NPM1 Mutation \| KMT2A Rearrangement	83	Ziftomenib 50-1000 mg	jjxnbnjoqf(jdbdkhcejj) = the most common grade 3 or worse treatment-emergent adverse events were anaemia (20 [24%]), febrile neutropenia (18 [22%]), pneumonia (16 [19%]), differentiation syndrome (12 [15%]), thrombocytopenia (11 [13%]), and sepsis (ten [12%]). hfqqrijrla (yraipjodef ) View more	Positive	01 Oct 2024
NCT05735184 (KOMET-007, Corporate Publications) Manual	Phase 1	Acute myeloid leukaemia with 11q23 abnormality \| Acute myeloid leukemia with mutated NPM1 First line KMT2A Rearrangement \| NPM1 Mutation	20	ziftomenib+SOC	qsogxhfril(ikxftookvb) = No differentiation syndrome events of any grade were reported, and no dose-limiting toxicities, evidence of QTc prolongation, drug-drug interactions or additive myelosuppression were observed. kmecahanoh (trbnhlouvy )	Positive	30 Jan 2024
				ziftomenib+SOC (ziftomenib and 7+3)
NCT04067336 (KOMET-001, SOHO2023)	Phase 1/2	Acute myeloid leukemia with mutated NPM1 FLT3 \| IDH1/2 \| NPM1	29	Ziftomenib 600mg	bpfwjvpnxf(aiqicywnii) = developed in 1 of 29 patients, detected at C4D28; the patient maintained stable disease through cycle 7 wiglbkswkn (aeatnjnryk ) View more	Positive	01 Sep 2023

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