SNDX-5613 (Revumenib) Clinical Trials

Size	Price	Qty
5mg	USD 197
25mg	USD 497

Clinical Trials

SNDX-5613 (revumenib) is being evaluated across numerous Phase 1 through Phase 3 clinical trials for hematologic malignancies and solid tumors, including acute myeloid leukemia, acute lymphoblastic leukemia, mixed phenotype acute leukemia, and colorectal cancer. Assessing revumenib as monotherapy or combined with agents like venetoclax or cytarabine, these studies encompass recruitment statuses ranging from not yet recruiting and recruiting to active not recruiting and completed. Trials are sponsored by pharmaceutical entities such as Syndax Pharmaceuticals alongside academic institutions and cooperative groups, including the National Cancer Institute and Memorial Sloan Kettering Cancer Center.

NCT Number	Recruitment	Conditions	Sponsor/Collaborators	Start Date	Phases
NCT03013998	RECRUITING	Previously Untreated Relapsed Refractory Acute Myeloid Leukemia	Beat AML, LLC	2016-11	PHASE2; PHASE3
NCT07563010	NOT_YET_RECRUITING	Relapsed Adult AML; Stem Cell Transplant Complications; Acute Myeloid Leukemia; Transplant-Related Hematologic Malignancy	Center for International Blood and Marrow Transplant Research	2026-12	PHASE2
NCT07636564	NOT_YET_RECRUITING	Acute Leukemia of Ambiguous Lineage; B Acute Lymphoblastic Leukemia; B Acute Lymphoblastic Leukemia, Philadelphia Chromosome Negative; T Acute Lymphoblastic Leukemia	SWOG Cancer Research Network	2026-10-14	PHASE2
NCT07686107	NOT_YET_RECRUITING	Leukemia, Myeloid, Acute	Therapeutic Advances in Childhood Leukemia Consortium	2026-08-31	PHASE2
NCT06652438	RECRUITING	Acute Myeloid Leukemia, Adult	Stichting Hemato-Oncologie voor Volwassenen Nederland	2025-05-05	PHASE3
NCT07283640	NOT_YET_RECRUITING	Blinatumomab; Revumenib; Lymphoblastic Leukemia; KMT2A-rearranged	M.D. Anderson Cancer Center	2026-11-18	PHASE1
NCT07211958	RECRUITING	Acute Myeloid Leukemias	Syndax Pharmaceuticals	2025-11-25	PHASE3
NCT07356154	RECRUITING	Leukemia; Acute Leukemia; Relapse Leukemia; Refractory Leukemia; Refractory Acute Leukemia; Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Mixed Phenotype Acute Leukemia	Memorial Sloan Kettering Cancer Center	2026-01-16	PHASE1; PHASE2
NCT07734077	NOT_YET_RECRUITING	Myelofibrosis; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis	John Mascarenhas	2026-12-01	PHASE1; PHASE2
NCT07498465	WITHDRAWN	Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Childhood Acute Lymphoblastic Leukemia; Childhood Acute Myeloid Leukemia; Childhood Mixed Phenotype Acute Leukemia; Mixed Phenotype Acute Leukemia	Children's Oncology Group	2026-09-10	PHASE1
NCT07605949	NOT_YET_RECRUITING	Leukemia Acute Myeloid	UNC Lineberger Comprehensive Cancer Center	2026-08	PHASE2
NCT06575296	RECRUITING	Acute Leukemia; Acute Leukemia of Ambiguous Lineage; Acute Lymphoblastic Leukemia; Acute Myeloid Leukemia; Childhood Acute Leukemia; Childhood Acute Leukemia of Ambiguous Lineage; Childhood Acute Lymphoblastic Leukemia; Childhood Acute Myeloid Leukemia	City of Hope Medical Center	2024-12-06	PHASE1
NCT05886049	RECRUITING	Acute Myeloid Leukemia; Acute Myeloid Leukemia With KMT2A Rearrangement; Acute Myeloid Leukemia With NPM1 Mutation; Secondary Acute Myeloid Leukemia	National Cancer Institute (NCI)	2024-06-20	PHASE1
NCT05761171	ACTIVE_NOT_RECRUITING	Recurrent Acute Leukemia of Ambiguous Lineage; Recurrent Acute Lymphoblastic Leukemia; Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage; Recurrent Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged; Recurrent Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia; Recurrent Mixed Phenotype Acute Leukemia; Refractory Acute Leukemia of Ambiguous Lineage; Refractory Acute Lymphoblastic Leukemia; Refractory Acute Myeloid Leukemia Due to Lineage Switch From Acute Leukemia of Ambiguous Lineage; Refractory Acute Myeloid Leukemia Due to Lineage Switch From B Acute Lymphoblastic Leukemia, KMT2A-Rearranged; Refractory Acute Myeloid Leukemia Due to Lineage Switch From Mixed Phenotype Acute Leukemia; Refractory Mixed Phenotype Acute Leukemia	Children's Oncology Group	2024-01-08	PHASE2
NCT04065399	RECRUITING	Acute Myeloid Leukemia; Acute Lymphoblastic Leukemia; Mixed Lineage Acute Leukemia; Mixed Phenotype Acute Leukemia; Acute Leukemia of Ambiguous Lineage	Syndax Pharmaceuticals	2019-11-05	PHASE1; PHASE2
NCT06313437	RECRUITING	Acute Myeloid Leukemia; AML, Adult; AML With Gene Mutations; AML; Leukemia	Richard Stone, MD	2024-12-06	PHASE1
NCT06226571	ACTIVE_NOT_RECRUITING	Acute Myeloid Leukemias	Syndax Pharmaceuticals	2024-05-21	PHASE1
NCT06222580	RECRUITING	Acute Myeloid Leukemia With FLT3/ITD Mutation; Acute Myeloid Leukemia With KMT2A Rearrangement; Acute Myeloid Leukemia With NPM1 Mutation; Recurrent Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia	Uma Borate	2024-02-20	PHASE1
NCT06284486	RECRUITING	Acute Myeloid Leukemia	M.D. Anderson Cancer Center	2024-09-23	PHASE1; PHASE2
NCT06229912	RECRUITING	Leukemia; HOX Gene	M.D. Anderson Cancer Center	2024-06-04	PHASE2
NCT05360160	RECRUITING	Acute Myeloid Leukemia	M.D. Anderson Cancer Center	2022-10-14	PHASE1; PHASE2
NCT06177067	RECRUITING	Refractory Acute Myeloid Leukemia; Relapsed Acute Myeloid Leukemia; Acute Leukemia of Ambiguous Lineage	St. Jude Children's Research Hospital	2024-04-19	PHASE1
NCT07052994	WITHDRAWN	Pediatric Acute Leukemia	M.D. Anderson Cancer Center	2026-05-21	PHASE1
NCT05731947	TERMINATED	Colorectal Cancer; Solid Tumors	Syndax Pharmaceuticals	2023-04-04	PHASE1; PHASE2
NCT05406817	COMPLETED	Acute Leukemia	Syndax Pharmaceuticals	2022-08-05	PHASE1
NCT05326516	COMPLETED	Relapsed/Refractory Leukemias; Acute Lymphoblastic Leukemia; Acute Lymphocytic Leukemia; Mixed Phenotype Acute Leukemia; Acute Myeloid Leukemia; Acute Undifferentiated Leukemia	Syndax Pharmaceuticals	2022-03-09	PHASE1
NCT06226571	Recruiting	Acute Myeloid Leukemias	Syndax Pharmaceuticals	2024-05	Phase 1
NCT05731947	Recruiting	Colorectal Cancer\|Solid Tumors	Syndax Pharmaceuticals	2023-04-04	Phase 1\|Phase 2
NCT05360160	Recruiting	Acute Myeloid Leukemia	M.D. Anderson Cancer Center\|Astex Pharmaceuticals Inc.\|Syndax Pharmaceuticals	2022-10-14	Phase 1\|Phase 2

(data from https://clinicaltrials.gov, updated on 2026-09-03)

Check the SNDX-5613 (Revumenib) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

SNDX-5613 (revumenib) selectively binds menin with an inhibition constant of 0.15 nM, effectively disrupting the menin-MLL interaction and downstream leukemogenic gene transcription. This biochemical inhibition induces potent anti-proliferative cellular effects in MLL-rearranged models, underlying its clinical efficacy in treating acute myeloid leukemia and other KMT2A-rearranged hematologic malignancies.

Appendix RUO and cGMP Quality Standards

Quality Dimension	RUO (Research Use Only)	cGMP (Current Good Manufacturing Practice)
Clinical Applicability	Prohibited in human clinical trials or medical diagnostics.	Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status	Non-regulated grade; exempt from drug manufacturing laws.	Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment	Unclassified analytical or research laboratories.	Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control	Basic purity and activity testing.	Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation	Basic equipment calibration; no process validation required.	Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance	Vendor self-declared without required formal QMS.	Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact	High risk of IND rejection if used as a critical raw material.	Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).