Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats neurofibromatosis type 1 (NF1). Sold as Koselugo. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 2 applications for Selumetinib Sulfate (sold as Koselugo), first approved Apr 10, 2020, with 3 new uses approved and 0 published complete response letters.
First approved: Apr 10, 2020
Applications: 2
New uses approved: 3
Complete response letters: 0
Medicare spending, 2025: $23.3M
Orphan exclusivity until: Nov 19, 2032
First approved in the EU: Jun 17, 2021
First approved in Japan: Sep 26, 2022
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 30 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
Koselugo, new ingredientDrugs with a new active ingredient indicated for the treatment of plexiform neurofibroma in patients with neurofibromatosis type 1. · Alexion Pharma GK · Sep 26, 2022
Clinical Trials
10 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Astrazeneca