Drugs / Revumenib

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) REVUFORJ 2025-10-24 fda.gov
Approved US (FDA) REVUFORJ 2024-11-15 fda.gov

Trials 23 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 110 trials
Phase 1 NCT07283640 Nov 2026 → Aug 2029 expected B-lymphoblastic leukemia/lymphoma MLL rearranged M.D. Anderson Cancer Center Not yet recruiting No outcome recorded
Phase 1 NCT07498465 Sep 2026 → Nov 2028 childhood acute lymphoblastic leukemia, childhood acute myeloid leukemia, mixed phenotype acute leukemia Children's Oncology Group Withdrawn No outcome recorded
Phase 1 NCT07052994 May 2026 childhood leukemia M.D. Anderson Cancer Center Withdrawn No outcome recorded
Phase 1 NCT06575296 Dec 2024 → Apr 2028 expected acute leukemia of ambiguous lineage, childhood acute lymphoblastic leukemia, childhood acute myeloid leukemia City of Hope Medical Center Recruiting No outcome recorded
Phase 1 NCT06313437 Dec 2024 → Mar 2027 expected acute myeloid leukemia Dana-Farber Cancer Institute Recruiting No outcome recorded
Phase 1 NCT05886049 Jun 2024 → Dec 2027 expected acute myeloid leukemia with mutated NPM1, acute myeloid leukemia, MLL gene rearrangement National Cancer Institute (NCI) Recruiting No outcome recorded
Phase 1 NCT06177067 Apr 2024 → Oct 2026 expected acute leukemia of ambiguous lineage St. Jude Children's Research Hospital Recruiting No outcome recorded
Phase 1 NCT06222580 Feb 2024 → Jan 2027 expected acute myeloid leukemia with mutated NPM1, acute myeloid leukemia, FLT3 internal tandem duplication, acute myeloid leukemia, MLL gene rearrangement Uma Borate Recruiting No outcome recorded
Phase 1 NCT05406817 Aug 2022 → Nov 2024 acute leukemia Syndax Pharmaceuticals Completed No outcome recorded
Phase 1 NCT05326516 Mar 2022 → Jul 2024 acute lymphoblastic leukemia, acute undifferentiated leukemia, mixed phenotype acute leukemia Syndax Pharmaceuticals Completed No outcome recorded
Phase 1/24 trials
Phase 1/2 NCT07356154 Jan 2026 → Jan 2029 expected acute lymphoblastic leukemia, mixed phenotype acute leukemia Memorial Sloan Kettering Cancer Center Recruiting No outcome recorded
Phase 1/2 NCT06284486 Sep 2024 → Dec 2026 expected acute myeloid leukemia M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 1/2 NCT05731947 Apr 2023 → Jun 2025 colorectal cancer Syndax Pharmaceuticals Terminated No outcome recorded
Phase 1/2 NCT04065399 Nov 2019 → Dec 2027 expected acute lymphoblastic leukemia, mixed phenotype acute leukemia Syndax Pharmaceuticals Recruiting No outcome recorded
Phase 26 trials
Phase 2 NCT07563010 Dec 2026 → Jun 2031 expected acute myeloid leukemia, disease related to hematopoietic stem cell transplant Center for International Blood and Marrow Transplant Research Not yet recruiting No outcome recorded
Phase 2 NCT07636564 Oct 2026 → Apr 2031 expected B-cell acute lymphoblastic leukemia, T-cell acute lymphoblastic leukemia, acute leukemia of ambiguous lineage SWOG Cancer Research Network Not yet recruiting No outcome recorded
Phase 2 NCT07686107 Aug 2026 → Dec 2029 expected acute myeloid leukemia Therapeutic Advances in Childhood Leukemia Consortium Not yet recruiting No outcome recorded
Phase 2 NCT07605949 Jul 2026 → Jul 2028 expected acute myeloid leukemia UNC Lineberger Comprehensive Cancer Center Not yet recruiting No outcome recorded
Phase 2 NCT06229912 Jun 2024 → Dec 2026 expected leukemia M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT05761171 Jan 2024 → Dec 2027 expected acute lymphoblastic leukemia, mixed phenotype acute leukemia Children's Oncology Group Active not recruiting No outcome recorded
Phase 32 trials
Phase 3 NCT07211958 Nov 2025 → Jun 2029 expected acute myeloid leukemia Syndax Pharmaceuticals Recruiting No outcome recorded
Phase 3 NCT06652438 Mar 2025 → Dec 2029 expected acute myeloid leukemia HOVON Foundation Recruiting No outcome recorded
Phase not stated1 trial
NCT05918913 Syndax Pharmaceuticals No longer available No outcome recorded

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 25 sources stand behind the page.

FieldValueCited text
Known as revumenib ClinicalTrials.gov intervention name — accepted as the source's own label NCT04065399
22

NCT07563010

NCT06575296

NCT05886049

NCT06652438

NCT06313437

NCT07356154

NCT05731947

NCT06229912

NCT05918913

NCT07052994

NCT07211958

NCT07283640

NCT07636564

NCT06222580

NCT05406817

NCT06177067

NCT05761171

NCT07605949

NCT05326516

NCT07686107

NCT06284486

NCT07498465

Known as SNDX-5613 “Phase 2 Trial of Revumenib (SNDX-5613) in Combination With FLA Chemotherapy for Children With Relapsed or Refractory NUP98-rearranged Acute Myeloid Leukemia” NCT07686107
Action Inhibit “Revumenib, a potent, selective menin inhibitor” PMID 40332046 Aug 2025
Modality Small molecule “Revumenib, an oral, small molecule inhibitor of the menin-lysine methyltransferase 2A (KMT2A) interaction” PMID 39121437 Aug 2024
Route Oral “revumenib orally” NCT04065399
Target KMT2A “Revumenib, an oral, small molecule inhibitor of the menin-lysine methyltransferase 2A (KMT2A) interaction” PMID 39121437 Aug 2024