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Sold as Erleada. Every FDA application for this active ingredient: 1 branded and 1 generic.
As of Nov 15, 2026, FDA lists 2 applications for Apalutamide (sold as Erleada), first approved Feb 14, 2018, with 4 new uses approved and 0 published complete response letters.
First approved: Feb 14, 2018
Applications: 2
New uses approved: 4
Complete response letters: 0
Medicare spending, 2025: $2.08B
First approved in the EU: Jan 14, 2019
First approved in Japan: Mar 26, 2019
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 13 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
ErleadaA drug with a new indication for the treatment of metastatic prostate cancer. · Janssen Pharmaceutical K.K. · May 29, 2020
Erleada, new ingredientA drug with a new active ingredient indicated for the treatment of non-metastatic, castration- resistant prostate cancer. · Janssen Pharmaceutical K.K. · Mar 26, 2019 · Review report
Clinical Trials
90 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
Zydus Lifesciences