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 11 indications, with its most advanced program in Approved.[1]

Revuforj is one of 176 small molecule programs targeting Leukemia. It is currently in Approved.

Indications

Total Trials

Active Trials

175

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

LeukemiaActive, not recruiting

Adult Acute Myeloid LeukemiaApproved

Acute Lymphoblastic LeukemiaActive, not recruiting

Colorectal CancerActive, not recruiting

Acute Myeloid LeukemiaActive, not recruiting

Acute Myeloid LeukemiasRecruiting

Leukemia, Myeloid, AcuteNot yet recruiting

Relapsed Adult AMLNot yet recruiting

BlinatumomabNot yet recruiting

Leukemia Acute MyeloidNot yet recruiting

LeukemiaPhase 2

Active, not recruiting

Adult Acute Myeloid LeukemiaApproved

Approved

Acute Lymphoblastic LeukemiaPhase 1

Active, not recruiting

Colorectal CancerPhase 1

Active, not recruiting

Acute Myeloid LeukemiaPhase 3

Active, not recruiting

Acute Myeloid LeukemiasPhase 3

Recruiting

Leukemia, Myeloid, AcutePhase 2

Not yet recruiting

Relapsed Adult AMLPhase 2

Not yet recruiting

BlinatumomabPhase 1

Not yet recruiting

Leukemia Acute MyeloidPhase 2

Not yet recruiting

Showing 10 of 11 indications

Competition

Competitive Landscape

949 competitors in Colorectal Cancer

#DrugCompanyPhaseTrials

Revuforj

SSyndax Pharmaceuticals

Approved

1 2

PORTRAZZA

Emend IV

Vascepa

1 5

Ultiva

PPfizer's Upjohn has merged with Mylan to form Viatris Inc.

Preclinical

1 6

Bridion

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 7

Andriol

AAuxilium

Preclinical

1 8

Feraheme

AAzurity Pharmaceuticals

Preclinical

1 9

Ketalar

AAultman Health Foundation

Preclinical

1 10

Xylocaine

MMEDRx USA, Inc.

Preclinical

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

Timeline

Expected Milestones

Q1 2027

Phase 1Recruiting

Acute Myeloid Leukemia

NCT06222580

Q2 2027

Phase 1Recruiting

Acute Myeloid Leukemia

NCT06177067

Q4 2027

Phase 1/2Recruiting

Leukemia

NCT04065399

Phase 1Recruiting

Acute Myeloid Leukemia

NCT05886049

Phase 2Active, not recruiting

Leukemia

NCT05761171

Q1 2028

Phase 1Recruiting

Revumenib

NCT06313437

Clinical

Trials by Indication[1]

Leukemia4 trials

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Recruiting·SSyndax Pharmaceuticals·Phase 1/2·NCT04065399·447 enrolled

A Study of Revumenib in Combination With Chemotherapy for Patients Diagnosed With Relapsed or Refractory Leukemia

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

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

Show 1 more trial

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

Acute Leukemia4 trials

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

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

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

Not yet recruiting·MM.D. Anderson Cancer Center·Phase 1·NCT07052994·32 enrolled

Study of Radiolabeled Revumenib in Adults With Acute Leukemia

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

Show 1 more trial

Revumenib for the Treatment of Acute Leukemia in Patients Post-Allogeneic Stem Cell Transplant

Recruiting·—·Phase 1·NCT06575296·27 enrolled

Acute Myeloid Leukemia3 trials

Testing the Addition of an Anti-cancer Drug, SNDX-5613, to the Standard Chemotherapy Treatment (Daunorubicin and Cytarabine) for Newly Diagnosed Patients With Acute Myeloid Leukemia That Has Changes in NPM1 or MLL/KMT2A Gene

Recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT05886049·28 enrolled

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

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

Revumenib3 trials

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·Phase 1/2·NCT06284486·8 enrolled

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

KMT2A-rearranged1 trial

Revumenib in Combination With Azacitidine + Venetoclax in Patients NPM1-mutated or KMT2A-rearranged AML

Recruiting·SStichting Hemato-Oncologie voor Volwassenen Nederland·Phase 3·NCT06652438·415 enrolled

6 more indications

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

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 Leukemias1 trial

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

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

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 — 21 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

Q2 2027

Q4 2027

Q1 2028

Trials by Indication[1]

Leukemia4 trials

Acute Leukemia4 trials

Acute Myeloid Leukemia3 trials

Revumenib3 trials

KMT2A-rearranged1 trial

Leukemia, Myeloid, Acute1 trial

Colorectal Cancer1 trial

Leukemia Acute Myeloid1 trial

Acute Myeloid Leukemias1 trial

Blinatumomab1 trial

Relapsed Adult AML1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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