Selumetinib /m2

Phase 3Small molecule

NNational Cancer Institute (NCI)

Selumetinib /m2 is one of 93 small molecule programs targeting Metastatic Melanoma. It is currently in Phase 3.

Indications

Total Trials

Active Trials

Competitors

Pipeline

Status by Indication[3][1]

Indication

Metastatic MelanomaActive, not recruiting

Neurofibromatosis Type 2Not yet recruiting

Low Grade AstrocytomaActive, not recruiting

Advanced Malignant Solid NeoplasmRecruiting

Recurrent Endometrial CarcinomaActive, not recruiting

Metastatic MelanomaPhase 1

Active, not recruiting

Neurofibromatosis Type 2Phase 2

Not yet recruiting

Low Grade AstrocytomaPhase 3

Active, not recruiting

Advanced Malignant Solid NeoplasmPhase 2

Recruiting

Recurrent Endometrial CarcinomaPhase 2

Active, not recruiting

Competition

Competitive Landscape

50 competitors in Metastatic Melanoma

#DrugCompanyPhaseTrials

Opdivo

Bristol-Myers Squibb

Approved

31 2

Yervoy

Bristol-Myers Squibb

Phase 3

43 3

Keytruda

Merck & Co.

Phase 3

39 4

Fludara

Sanofi

Phase 3

21 5

Cytoxan

BBaxter Healthcare Corporation

Phase 3

44 6

Rifadin

Imbruvica

2 8

Mektovi

Pfizer

Phase 3

6 9

Braftovi

Pfizer

Phase 3

5 10

Zejula

GGlaxo Dba Glaxosmithkline

Approved

—

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

Timeline

Expected Milestones

Q4 2026

Phase 3Active, not recruiting

Low Grade Astrocytoma

NCT04576117

Q1 2027

Phase 2Active, not recruiting

Advanced Malignant Solid Neoplasm

NCT03155620

Phase 1Active, not recruiting

Metastatic Melanoma

NCT01364051

Q4 2027

Phase 3Active, not recruiting

Low Grade Glioma

NCT03871257

Q4 2028

Phase 2Active, not recruiting

Recurrent Endometrial Carcinoma

NCT05554328

Clinical

Trials by Indication[1]

Advanced Malignant Solid Neoplasm2 trials

Molecular Analysis for Combination Therapy Choice (ComboMATCH)

Recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05564377·2,900 enrolled

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03155620·1,377 enrolled

Low Grade Astrocytoma2 trials

A Phase 3 Randomized Non-Inferiority Study of Carboplatin and Vincristine Versus Selumetinib (NSC# 748727) in Newly Diagnosed or Previously Untreated Low-Grade Glioma (LGG) Not Associated With BRAFV600E Mutations or Systemic Neurofibromatosis Type 1 (NF1)

Recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT04166409·170 enrolled

A Phase 3 Study of Selumetinib (NSC# 748727) or Selumetinib in Combination With Vinblastine for Non-NF1, Non-TSC Patients With Recurrent or Progressive Low-Grade Gliomas (LGGs) Lacking BRAFV600E or IDH1 Mutations

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT04576117·300 enrolled

Gastrointestinal Stromal Tumor1 trial

Mitogen Activated Protein Kinase Kinase (MEK1/2) Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in People With Neurofibromatosis Type 1 (NF1) Mutated Gastrointestinal Stromal Tumors (GIST)

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT03109301

Peritoneum Cancer1 trial

Selumetinib Sulfate in Treating Woman With Recurrent Low-Grade Ovarian Cancer or Peritoneum Cancer

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT00551070·52 enrolled

Tic Disorder1 trial

Selumetinib Sulfate in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Activating MAPK Pathway Mutations (A Pediatric MATCH Treatment Trial)

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03213691·21 enrolled

6 more indications

Neurofibromatosis Type 11 trial

Selumetinib in Treating Patients With Neurofibromatosis Type 1 and Cutaneous Neurofibroma

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT02839720·11 enrolled

Pancreatic Cancer1 trial

Selumetinib Sulfate in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer With KRAS G12R Mutations

Completed·NNational Cancer Institute (NCI)·Phase 2·NCT03040986·8 enrolled

Metastatic Melanoma1 trial

Phase I Study of the Combination of the VEGFR Inhibitor, AZD2171, and MEK Inhibitor, AZD6244, in the Treatment of Solid Malignancies

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT01364051·19 enrolled

Low Grade Glioma1 trial

A Phase 3 Randomized Study of Selumetinib Versus Carboplatin/Vincristine in Newly Diagnosed or Previously Untreated Neurofibromatosis Type 1 (NF1) Associated Low-Grade Glioma (LGG)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 3·NCT03871257·165 enrolled

Recurrent Endometrial Carcinoma1 trial

A Randomized Trial of Selumetinib and Olaparib or Selumetinib Alone in Patients With Recurrent or Persistent RAS Pathway Mutant Ovarian and Endometrial Cancers: A ComboMATCH Treatment Trial

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05554328·165 enrolled

Neurofibromatosis Type 21 trial

Platform Research for Innovative Medicines in NF2-SWN (PRIME-NF2)

Not yet recruiting·BBeijing Tiantan Hospital·Phase 2·NCT07713745·200 enrolled

Sources

References

[1]
ClinicalTrials.gov — 13 trial records for Selumetinib /m2. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Selumetinib /m2 compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Selumetinib /m2. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — National Cancer Institute (NCI) company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: NNational Cancer Institute (NCI)

Selumetinib /m2

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q4 2027

Q4 2028

Trials by Indication[1]

Advanced Malignant Solid Neoplasm2 trials

Low Grade Astrocytoma2 trials

Gastrointestinal Stromal Tumor1 trial

Peritoneum Cancer1 trial

Tic Disorder1 trial

Neurofibromatosis Type 11 trial

Pancreatic Cancer1 trial

Metastatic Melanoma1 trial

Low Grade Glioma1 trial

Recurrent Endometrial Carcinoma1 trial

Neurofibromatosis Type 21 trial

References

Drug Info

Quick Facts

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