Revumenib History and Updates

67 events · 2019 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

2
FDA Approvals
0
Label Revisions
65
Trial Milestones
0
Pivotal Publications
Revumenib — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications20202021202220232024202520262027202820292030203120322033Trial: NCT07052994 2027-12-01 → 2032-12-31 (primary completion)Trial: NCT07563010 2026-12-31 → 2031-06-30 (primary completion)Trial: NCT07636564 2026-10-14 → 2031-04-16 (primary completion)Trial: NCT07498465 2026-09-10 → 2028-11-12 (primary completion)Trial: NCT07605949 2026-07-31 → 2028-07-31 (primary completion)Trial: NCT07283640 2026-05-18 → 2029-08-31 (primary completion)Trial: NCT07356154 2026-01-16 → 2029-01-16 (primary completion)Trial: NCT07211958 2025-11-25 → 2029-06-30 (primary completion)Trial: NCT06652438 2025-03-31 → 2029-12-13 (primary completion)Trial: NCT06575296 2024-12-06 → 2028-04-29 (primary completion)Trial: NCT06313437 2024-12-06 → 2027-03-02 (primary completion)Trial: NCT06284486 2024-09-23 → 2026-12-30 (primary completion)Trial: NCT05886049 2024-06-20 → 2027-12-31 (primary completion)Trial: NCT06229912 2024-06-04 → 2026-12-01 (primary completion)Trial: NCT06177067 2024-04-19 → 2026-10-31 (primary completion)Trial: NCT06222580 2024-02-20 → 2027-01-31 (primary completion)Trial: NCT05761171 2024-01-08 → 2027-12-31 (primary completion)Trial: NCT05731947 2023-04-04 → 2025-06-30 (primary completion)Trial: NCT05406817 2022-08-05 → 2024-11-18 (primary completion)Trial: NCT05326516 2022-03-09 → 2024-07-29 (primary completion)Trial: NCT04065399 2019-11-05 → 2027-12-15 (primary completion)FDA approval — 2024-11-15 FDA approved Revuforj (revumenib) (NDA 218944) Sponsor: SYNDAX. Class: Type 1 - New Molecular Entity.FDA approval (supplemental) — 2025-10-24 FDA approved supplemental application for Revuforj (revumenib) — Efficacy (NDA 218944 S-3) Sponsor: SYNDAX. Class: Efficacy.today (2026-06-12)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-12Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Revumenib since 2019, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (1)

2025

Upcoming & expected milestones

Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07498465
A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Ac
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT07636564
Testing Blinatumomab With or Without Revumenib in Patients With B-cell Acute Lymphoblastic Leukemia With a Genetic Change Requiring More Tre
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06177067
Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
Primary completion· ClinicalTrials.gov
Phase 1/Phase 2 primary completion: NCT06284486
A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06222580
SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07052994
A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and Relapsed /Refractor
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05886049
A Phase 1b Study of Menin Inhibitor SNDX- 5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloi
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT05761171
A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07498465
A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant in Children With Ac
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT07211958
Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07283640
A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT07636564
Testing Blinatumomab With or Without Revumenib in Patients With B-cell Acute Lymphoblastic Leukemia With a Genetic Change Requiring More Tre
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07052994
A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and Relapsed /Refractor

Past events

2026
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07052994
A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and Relapsed /Refractor
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07283640
A Phase IB Trial of Subcutaneous Blinatumomab in Combination With Revumenib for Patients With KMT2A-rearranged Acute Lymphoblastic Leukemia
2025
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT07211958
Study of Revumenib in Combination With Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia (AML) With a NPM1 Mutation
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06652438
Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML
2024
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06575296
Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant
Trial started· ClinicalTrials.gov
Phase 1/Phase 2 trial started: NCT06284486
A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05886049
Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagn
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT06229912
A Phase II Study of the Menin Inhibitor Revumenib in Leukemia Associated With Upregulation of HOX Genes
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06177067
Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06222580
SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT05761171
A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia
2023
2022
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05326516
A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia
2019

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.