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Mirdametinib

Alternative Names: mirdametinib, pd 0325901, pd-0325901, pd0325901
Latest Update: 2024-11-18
Latest Update Note: Clinical Trial Update

Product Description

Mechanisms of Action: PI3K Inhibitor,mTOR

Novel Mechanism: Yes

Modality: Small Molecule

Route of Administration: Oral

FDA Designation: Priority Review - Neurofibromatosis 1 *

Approval Status: Not Approved

Approved Countries: None

Approved Indications: None

Known Adverse Events: None

Company: SpringWorks Therapeutics
Company Location: STAMFORD CT 06902
Company CEO: Saqib Islam
Additonal Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Mirdametinib

Countries in Clinic: Australia, United States

Active Clinical Trial Count: 4

Highest Development Phases

Phase 2: Glioma|Neurofibroma, Plexiform|Neurofibromatoses|Neurofibromatosis 1|Oncology Solid Tumor Unspecified

Trial

Phase

Trial Status

Disease

Primary Completion Date

Probability of Success
SJ901

P2

Recruiting

Glioma

2031-06-01

MEKRAF-AST-101

P2

Active, not recruiting

Oncology Solid Tumor Unspecified

2026-10-31

BGB-283/PD-0325901-AU-001

P1

Recruiting

Oncology Solid Tumor Unspecified

2025-09-30

ReNeu

P2

Active, not recruiting

Neurofibroma, Plexiform|Neurofibromatosis 1|Neurofibromatoses

2023-09-20

Recent News Events

Date

Type

Title

11/07/2024

News Article

 SpringWorks Therapeutics Announces Long-Term Efficacy and Safety Data from Phase 3 DeFi Trial of OGSIVEO® (nirogacestat) in Adults with Desmoid Tumors to be Presented at the Connective Tissue Oncology Society (CTOS) 2024 Annual Meeting

08/28/2024

News Article

 FDA Grants Priority Review to SpringWorks Therapeutics' New Drug Application for Mirdametinib for the Treatment of Adults and Children with NF1-PN

07/01/2024

News Article

 SpringWorks Therapeutics Completes Submission of New Drug Application to the FDA for Mirdametinib for the Treatment of Children and Adults with NF1-PN

05/23/2024

News Article

 SpringWorks Therapeutics Announces Data to be Presented at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting

05/08/2024

PubMed

 MEK inhibition enhances the antitumor effect of radiation therapy in NF1-deficient glioblastoma.

05/06/2024

PubMed

 MEK/ERK signaling drives the transdifferentiation of supporting cells into functional hair cells by modulating the Notch pathway.

03/23/2024

PubMed

 DNA hypomethylation patterns and their impact on the tumor microenvironment in colorectal cancer.

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