Mirdametinib (PD-0325901) oral capsule or dispersible tablet

Phase 2

SpringWorks Therapeutics, Inc. (SWTX)

Phase 2

Development Phase

Upcoming Catalysts

Historical Events

Regulatory Approvals

No Catalysts Found

No catalyst events have been recorded for this drug yet.

Competitive Landscape

0 competitors in Plexiform Neurofibroma

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Drug Information

Target Indication

Plexiform Neurofibroma

Clinical Trial

NCT03962543

Last updated: 12/4/2025

Patent & Exclusivity

No patent data available. Pre-approval drugs may not have Orange Book listings.

Source: FDA Orange Book

Regulatory Approvals

EMA7/17/2025

Ezmekly

Ezmekly as monotherapy is indicated for the treatment of symptomatic, inoperable plexiform neurofibromas (PN) in paediatric and adult patients with neurofibromatosis type 1 (NF1) aged 2 years and above.

OrphanConditional

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Drug Science

Mechanism of action & safety profile

Developer

SWTX

SpringWorks Therapeutics, Inc.

Biotechnology•North America•NASDAQ

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