Revuforj

(Revumenib)

ApprovedSmall molecule

Revuforj is a small molecule that works as a Menin Inhibitor; Menin/histone-Lysine N-Methyltransferase MLL Inhibitor.[2] It is being used across 12 indications, with its most advanced program in Approved.[1]

Revuforj is one of 174 small molecule programs targeting Leukemia. It is currently in Approved.

Indications

Total Trials

Active Trials

173

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

LeukemiaRecruiting

Adult Acute Myeloid LeukemiaApproved

MyelofibrosisNot yet recruiting

Acute Myeloid LeukemiaRecruiting

Refractory Acute Myeloid LeukemiaRecruiting

Leukemia, Myeloid, AcuteNot yet recruiting

Relapsed Adult AMLNot yet recruiting

BlinatumomabNot yet recruiting

Acute Myeloid Leukemia, AdultRecruiting

RevumenibRecruiting

LeukemiaPhase 2

Recruiting

Adult Acute Myeloid LeukemiaApproved

Approved

MyelofibrosisPreclinical

Not yet recruiting

Acute Myeloid LeukemiaPhase 3

Recruiting

Refractory Acute Myeloid LeukemiaPhase 1

Recruiting

Leukemia, Myeloid, AcutePhase 2

Not yet recruiting

Relapsed Adult AMLPhase 2

Not yet recruiting

BlinatumomabPhase 1

Not yet recruiting

Acute Myeloid Leukemia, AdultPhase 3

Recruiting

RevumenibPhase 1

Recruiting

Showing 10 of 12 indications

Competition

Competitive Landscape

235 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Novantrone

Pfizer

Phase 3

34 2

Fludara

Sanofi

Phase 3

18 3

Revuforj

SSyndax Pharmaceuticals

Approved

4 4

Cerubidine

HHikma Pharmaceuticals LLC

Phase 3

42 5

Vanflyta

Daiichi Sankyo

Phase 3

16 6

Vepesid

AAvyxa

Phase 3

52 7

Neupogen

EEastern Cooperative Oncology Group

Phase 3

30 8

Cellcept

Roche

Phase 3

11 9

Cytoxan

BBaxter Healthcare Corporation

Busulfex

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q1 2027

Phase 1Active, not recruiting

Acute Myeloid Leukemias

NCT06226571

Phase 1Recruiting

Acute Myeloid Leukemia

NCT06222580

Q4 2027

PreclinicalRecruiting

Acute Myeloid Leukemia

NCT04065399

Phase 2Active, not recruiting

Acute Leukemia of Ambiguous Lineage

NCT05761171

Phase 1Recruiting

Acute Myeloid Leukemia

NCT05886049

Q1 2028

Phase 1Recruiting

Revumenib

NCT06313437

Clinical

Trials by Indication[1]

Acute Myeloid Leukemia4 trials

SNDX-5613 and Gilteritinib for the Treatment of Relapsed or Refractory FLT3-Mutated Acute Myeloid Leukemia and Concurrent MLL-Rearrangement or NPM1 Mutation

Recruiting·UUma Borate·Phase 1·NCT06222580·30 enrolled

A Phase 1/2, Open-label, Dose-Escalation and Dose-Expansion Cohort Study of SNDX-5613 in Patients With Relapsed/Refractory Leukemias, Including Those Harboring an MLL/KMT2A Gene Rearrangement or Nucleophosmin 1 (NPM1) Mutation

Recruiting·SSyndax Pharmaceuticals·Preclinical·NCT04065399·447 enrolled

A Multi-Site Break Through Cancer Trial: Phase II Study Investigating Dual Inhibition of BCL2 and Menin in AML MRD Using the Combination of Venetoclax and Revumenib

Recruiting·MM.D. Anderson Cancer Center·Preclinical·NCT06284486·8 enrolled

Show 1 more trial

A Phase 1b Study of Menin Inhibitor SNDX-5613 in Combination With Daunorubicin and Cytarabine in Newly Diagnosed Patients With Acute Myeloid Leukemia and NPM1 Mutated/FLT3 Wildtype or MLL/KMT2A Rearranged or NUP98 Alterations Disease

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05886049·38 enrolled

Acute Leukemia3 trials

A Study of Revumenib in Combination With Chemotherapy in Participants With R/R Acute Leukemia

Completed·SSyndax Pharmaceuticals·Phase 1·NCT05326516·30 enrolled

Study of Radiolabeled Revumenib in Adults With Acute Leukemia

Completed·SSyndax Pharmaceuticals·Phase 1·NCT05406817·9 enrolled

A Phase I Study of SNDX 5613 (Revumenib) as Post-Transplant Maintenance After Allogeneic Hematopoietic Cell Transplant in Patients With KMT2A-Rearranged or NPM1-Mutated Acute Leukemia

Recruiting·CCity of Hope Medical Center·Phase 1·NCT06575296·27 enrolled

Revumenib2 trials

Expanded Access Program for Revumenib

No longer available·SSyndax Pharmaceuticals··NCT05918913

Revumenib in Combination With 7+3 + Midostaurin in AML

Recruiting·RRichard Stone, MD·Phase 1·NCT06313437·22 enrolled

Leukemia2 trials

A Phase II Study of the Menin Inhibitor Revumenib in Leukemia Associated With Upregulation of HOX Genes

Recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT06229912·40 enrolled

A Phase 1/2 Study of the Menin Inhibitor Revumenib With the CELMod Mezigdomide in Relapsed/Refractory KMT2A-rearanged, NPM1-mutant, and NUP98-rearranged Acute Leukemias

Recruiting·MMemorial Sloan Kettering Cancer Center·Preclinical·NCT07356154·52 enrolled

Refractory Acute Myeloid Leukemia2 trials

A Phase 1 Study of Revumenib, Azacitidine, and Venetoclax in Pediatric and Young Adult Patients With Refractory or Relapsed Acute Myeloid Leukemia

Recruiting·SSt. Jude Children's Research Hospital·Phase 1·NCT06177067·24 enrolled

A Master Protocol for Biomarker-Based Treatment of AML (The Beat AML Trial)

Recruiting·BBeat AML, LLC·Preclinical·NCT03013998·3,000 enrolled

10 more indications

Acute Myeloid Leukemias2 trials

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed AML With an NPM1 Mutation

Recruiting·SSyndax Pharmaceuticals·Phase 3·NCT07211958·468 enrolled

A Phase 1, Open-label, Dose-escalation, and Dose-expansion Study to Evaluate Safety, Tolerability, and Clinical Activity of Revumenib in Combination With Intensive Chemotherapy in Participants With Newly Diagnosed Acute Myeloid Leukemias Harboring Alterations in Lysine-specific Methyltransferase 2A (KMT2A/MLL), Nucleophosmin 1 (NPM1), and Nucleoporin 98 (NUP98) Genes

Active, not recruiting·SSyndax Pharmaceuticals·Phase 1·NCT06226571·96 enrolled

Acute Leukemia of Ambiguous Lineage2 trials

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)

Not yet recruiting·SSWOG Cancer Research Network·Phase 2·NCT07636564·90 enrolled

A Phase 2 Study of SNDX-5613 in Combination With Chemotherapy for Patients With Relapsed or Refractory KMT2A-Rearranged Infant Leukemia

Active, not recruiting·CChildren's Oncology Group·Phase 2·NCT05761171·78 enrolled

Pediatric Acute Leukemia1 trial

A Phase Ia/Ib Trial of Revumenib Combined With Cytarabine, Daunorubicin, and Gemtuzumab Ozogamicin (GO) in Frontline and Relapsed /Refractory Pediatric Acute Leukemia Patients

Withdrawn·MM.D. Anderson Cancer Center·Phase 1·NCT07052994

Leukemia Acute Myeloid1 trial

Revumenib, Azacitidine, and VENetoclax in Newly Diagnosed KMT2A-Rearranged AML

Not yet recruiting·UUNC Lineberger Comprehensive Cancer Center·Phase 2·NCT07605949·88 enrolled

Acute Myeloid Leukemia, Adult1 trial

Randomized Study to Assess Revumenib in Combination With Azacitidine + Venetoclax in Adult Patients With Newly Diagnosed NPM1-mutated or KMT2A-rearranged AML Ineligible for Intensive Chemotherapy

Recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 3·NCT06652438·448 enrolled

Blinatumomab1 trial

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

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT07283640·20 enrolled

Myelofibrosis1 trial

Phase Ib/II Study Of Revumenib As Monotherapy Or In Combination With Jak Inhibitors In Patients With Myelofibrosis

Not yet recruiting·JJohn Mascarenhas·Preclinical·NCT07734077·32 enrolled

Leukemia, Myeloid, Acute1 trial

T2023-004 Phase 2 Trial of Revumenib (SNDX-5613) in Combination With FLA Chemotherapy for Children With Relapsed or Refractory NUP98-rearranged Acute Myeloid Leukemia

Not yet recruiting·TTherapeutic Advances in Childhood Leukemia Consortium·Phase 2·NCT07686107·24 enrolled

Colorectal Cancer1 trial

A Phase 1/2 Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SNDX-5613 in Patients With Colorectal Cancer and Other Solid Tumors

Terminated·SSyndax Pharmaceuticals·Preclinical·NCT05731947·41 enrolled

Relapsed Adult AML1 trial

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)

Not yet recruiting·CCenter for International Blood and Marrow Transplant Research·Phase 2·NCT07563010·146 enrolled

Regulatory

FDA Approval Timeline[4]

Nov 15, 2024

REVUFORJ

NDA NDA218944

Sources

References

[1]
ClinicalTrials.gov — 25 trial records for Revumenib. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Revumenib compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Revumenib. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA218944). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Revuforj. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Syndax Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Menin Inhibitor; Menin/histone-Lysine N-Methyltransferase MLL Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: SSyndax Pharmaceuticals

Patent Landscape[5]

Patent Cliff

Jun 8, 2037

Earliest patent expiration — generic entry possible after this date

Patent #Expires

11479557Jun 8, 2037

10683302Jun 8, 2037

12564590Dec 18, 2042

Revuforj

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q1 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Acute Myeloid Leukemia4 trials

Acute Leukemia3 trials

Revumenib2 trials

Leukemia2 trials

Refractory Acute Myeloid Leukemia2 trials

Acute Myeloid Leukemias2 trials

Acute Leukemia of Ambiguous Lineage2 trials

Pediatric Acute Leukemia1 trial

Leukemia Acute Myeloid1 trial

Acute Myeloid Leukemia, Adult1 trial

Blinatumomab1 trial

Myelofibrosis1 trial

Leukemia, Myeloid, Acute1 trial

Colorectal Cancer1 trial

Relapsed Adult AML1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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