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Gomekli

mirdametinib · Capsule

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information.

Overview

Brand name
Gomekli
Generic name
mirdametinib
Dosage form
Capsule
Route
Oral
Marketing category
NDA · NDA
Labeler
SpringWorks Therapeutics, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
3
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Mirdametinib 1 mg/1 — —
Mirdametinib 2 mg/1 — —

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule
Route of administration
Oral
Presentations
5

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Kinase Inhibitor [EPC] EPC All 89 members
Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA] MoA 3 members — no class page
Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [MoA] MoA 3 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
219389
Application type
NDA · New Drug Application
Approval date
February 11, 2025
Sponsor
SPRINGWORKS
Products on application
2
Submissions recorded
1
Products approved under application 219389.
Product Trade name Form Strength Ingredient Status TE Flags
219389-001 GOMEKLI CAPSULE MIRDAMETINIB Prescription — RLD
219389-002 GOMEKLI CAPSULE MIRDAMETINIB Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
11806321 February 17, 2041 001 No U-4130 February 14, 2025
11453641 February 17, 2041 001 No U-4130 February 14, 2025
12263146 February 17, 2041 001 No U-4130 April 3, 2025
12275688 February 17, 2041 001 No U-4130 April 17, 2025
12037306 February 17, 2041 001 No U-4130 February 14, 2025
12295925 February 17, 2041 001 No U-4590 May 15, 2025
12011424 February 17, 2041 001 No U-4595 February 14, 2025
11819487 February 17, 2041 001 No U-4590 February 14, 2025
11066358 February 17, 2041 001 Yes February 14, 2025
11084780 February 17, 2041 001 Yes February 14, 2025
11806321 February 17, 2041 002 No U-4130 February 14, 2025
11453641 February 17, 2041 002 No U-4130 February 14, 2025
12263146 February 17, 2041 002 No U-4130 April 3, 2025
12275688 February 17, 2041 002 No U-4130 April 17, 2025
12037306 February 17, 2041 002 No U-4130 February 14, 2025
12295925 February 17, 2041 002 No U-4590 May 15, 2025
11819487 February 17, 2041 002 No U-4590 February 14, 2025
11084780 February 17, 2041 002 Yes February 14, 2025
11066358 February 17, 2041 002 Yes February 14, 2025
11883375 March 16, 2043 001 No U-4130 February 14, 2025
11839595 March 16, 2043 001 No U-4130 February 14, 2025
12257215 March 16, 2043 001 No U-4130 April 3, 2025
12220390 March 16, 2043 001 No U-4130 February 14, 2025
12324791 March 16, 2043 001 No U-4591 June 16, 2025
11883375 March 16, 2043 002 No U-4130 February 14, 2025
11839595 March 16, 2043 002 No U-4130 February 14, 2025
12257215 March 16, 2043 002 No U-4130 April 3, 2025
12220390 March 16, 2043 002 No U-4130 February 14, 2025
12324791 March 16, 2043 002 No U-4591 June 16, 2025
11806322 April 9, 2043 001 No U-4130 February 14, 2025
11806322 April 9, 2043 002 No U-4130 February 14, 2025
12661330 February 5, 2044 001 No U-4130 July 2, 2026
12661330 February 5, 2044 002 No U-4130 July 2, 2026
12383517 March 15, 2044 001 No U-4130 August 20, 2025
12029711 March 15, 2044 001 No U-4130 February 14, 2025
12383517 March 15, 2044 002 No U-4130 August 20, 2025
12029711 March 15, 2044 002 No U-4130 February 14, 2025
12390430 October 10, 2044 001 No U-4130 August 20, 2025
12390430 October 10, 2044 002 No U-4130 August 20, 2025
Regulatory exclusivity periods.
Code Expires Product
NCE February 11, 2030 001
NCE February 11, 2030 002
ODE-488 February 11, 2032 001
ODE-488 February 11, 2032 002

Approval history

Source: Drugs@FDA
Most recent submissions on application 219389.
Type No. Action Status Date Review
Original application 1 Type 3 - New Dosage Form Approved February 11, 2025 Priority

Review documents

  • 0 · Original application · March 24, 2025
  • 0 · Original application · February 14, 2025
  • 0 · Original application · February 12, 2025

Adverse event reports

Source: openFDA FAERS
0
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
82448-130-42 82448-130 SpringWorks Therapeutics, Inc. 42 CAPSULE in 1 BOTTLE (82448-130-42) February 11, 2025
82448-260-42 82448-260 SpringWorks Therapeutics, Inc. 42 CAPSULE in 1 BOTTLE (82448-260-42) February 11, 2025
82448-260-84 82448-260 SpringWorks Therapeutics, Inc. 84 CAPSULE in 1 BOTTLE (82448-260-84) February 11, 2025
82448-130 82448-130 SpringWorks Therapeutics, Inc. — February 11, 2025
82448-260 82448-260 SpringWorks Therapeutics, Inc. — February 11, 2025

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity

Generated September 25, 2026 · 10 sections on this page.