Mirdametinib

Overview

PD-0325901 has been used in trials studying the treatment and basic science of Melanoma, Solid Tumour, Solid Tumors, Advanced Cancer, and Breast Neoplasms, among others.

Indication

No indication information available.

Associated Conditions

No associated conditions information available.

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Testing the Effectiveness of the Anti-cancer Drug, Mirdametinib, in Treating Relapsed, Refractory Chronic Lymphocytic Leukemia	2025/07/14	NCT07061951	Not Applicable	Not yet recruiting	National Cancer Institute (NCI)
Effect of Hepatic Impairment on the Pharmacokinetics of Mirdametinib	2025/05/30	NCT06997276	Phase 1	Recruiting	SpringWorks Therapeutics, Inc.
Combination Therapy (Mirdametinib and Sirolimus) for RAS Mutated Relapsed Refractory Multiple Myeloma	2025/03/14	NCT06876142	Phase 1	Recruiting	National Cancer Institute (NCI)
A Study of Mirdametinib in Combination With Palbociclib in People With Liposarcoma	2025/02/25	NCT06843967	Phase 1	Recruiting	Memorial Sloan Kettering Cancer Center
A Window of Opportunity Trial of Mirdametinib Plus Vorinostat for NF1 Associated, H3K27 Trimethylation Deficient Malignant Peripheral Nerve Sheath Tumor [MPNST]	2024/11/18	NCT06693284	Early Phase 1	Recruiting	University of Minnesota
Phase 1/2 Study of Mirdametinib + Vinblastine for Newly Diagnosed/Previously Untreated PLGG + Activation of MAPK	2024/10/30	NCT06666348	Phase 1	Not yet recruiting	C17 Council
Mirdametinib Monotherapy in Adults With Neurofibromatosis 1 (NF1) and Cutaneous Neurofibromas (cNF).	2023/12/06	NCT06159166	Phase 1	Recruiting	Johns Hopkins University
Mirdametinib in Histiocytic Disorders	2023/12/01	NCT06153173	Phase 2	Recruiting	Children's Hospital Medical Center, Cincinnati
A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations	2023/08/09	NCT05983159	Phase 2	Recruiting	Murdoch Childrens Research Institute
Clinical Trial Evaluating the Safety and Efficacy of Chemoimmunotherapy Plus Short Course of Mek Inhibitor in First Line of Treatment of Metastatic Non Squamous Non Small Cell Lung Adenocarcinoma With PDL1 < 50 %.	2023/07/10	NCT05937906	Phase 1	Recruiting	Centre Georges Francois Leclerc

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
No FDA approvals found for this drug.

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

Related News

BrightSpring's Onco360 Pharmacy Selected as National Partner for Three New Cancer and Rare Disease Therapies

a month ago

BrightSpring Health Services announced that its specialty pharmacy Onco360 has been selected as the national pharmacy partner for three newly approved therapies targeting advanced cancers and rare genetic disorders.

Merck KGaA to Acquire SpringWorks Therapeutics in $3.9 Billion Deal for Rare Disease Portfolio

3 months ago

German pharmaceutical giant Merck KGaA has agreed to acquire Connecticut-based SpringWorks Therapeutics for $3.9 billion, paying $47 per share in cash, representing a 26% premium over SpringWorks' unaffected 20-day average price.

SpringWorks Anticipates CHMP Opinion on Nirogacestat for Desmoid Tumors in Q2 2025

3 months ago

SpringWorks Therapeutics expects the European Medicines Agency's CHMP to issue an opinion on nirogacestat for adult desmoid tumors in Q2 2025, potentially expanding access beyond its current FDA approval.

SpringWorks' Gomekli Approval Showcases New Model for Rescuing Shelved Rare Disease Drugs

5 months ago

• SpringWorks Therapeutics recently secured FDA approval for Gomekli (mirdametinib), a drug once abandoned by Pfizer, providing the first treatment option for adults with neurofibromatosis type 1. • The Children's Tumor Foundation played a crucial role in rescuing the drug from Pfizer's intellectual property vault, demonstrating how patient advocacy groups can bridge the gap between academia and industry for rare disease treatments. • Experts estimate that approximately 30 more potential treatments for neurofibromatosis alone may be sitting idle in pharmaceutical companies' portfolios, highlighting a significant opportunity to replicate this model across rare diseases.

SpringWorks Therapeutics Anticipates Key Milestones for OGSIVEO and Mirdametinib in 2025

6 months ago

• SpringWorks Therapeutics projects OGSIVEO revenue to reach $61.5 million for Q4 and aims for EU regulatory approval in mid-2025, starting with Germany. • The company anticipates FDA approval for mirdametinib in NF1-associated plexiform neurofibromas by February 28, 2025, with EU approval and launch also planned for 2025. • Initial data from a Phase 2 trial of nirogacestat (OGSIVEO) in ovarian granulosa cell tumors is expected in the first half of 2025. • SpringWorks will continue advancing its oncology pipeline, including trials for SW-682 in Hippo-mutant solid tumors and plans to file an IND for SW-3431 by the end of 2025.

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