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drugsProductApproved2018🇪🇺🇬🇧🇯🇵🇨🇳🇦🇺

Apalutamide

An AR blocker approved for prostate cancer that has spread and for high-risk disease before it shows on scans.

SPARTAN (nmCRPC, OS benefit) and TITAN (mHSPC, OS HR 0.65). Rash and hypothyroidism are distinctive.

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Apalutamide
PubChem
Modality
Small-molecule AR antagonist
Mechanism
Second-generation AR antagonist with lower CNS penetration than enzalutamide.
Brand / code
Erleada
Medicare
Part D (self-administered)

Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026).

Commercial insurance
covered with prior authorisation

Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. Non-metastatic castration-resistant or metastatic castration-sensitive disease per the label.

Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.

Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.

NICE recommendedNICE TA740 · 2021SMC: accepted
Appraised for
With ADT for hormone-sensitive metastatic prostate cancer
Notes
High-risk non-metastatic CRPC: TA741 (2021).
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA740 · SMC advice: apalutamide. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2018Non-metastatic CRPC (SPARTAN)
US2019mHSPC (TITAN)

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
108 studies29 recruiting72 Phase 229 Phase 3
Search “Apalutamide” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Apalutamide
intervention: Apalutamide
Open on ClinicalTrials.gov →

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Latest papers

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Literature trend145 papers in the last 12 months+26% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Apalutamide" OR ABSTRACT:"Apalutamide" OR TITLE:"Erleada" OR ABSTRACT:"Erleada") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Apalutamide, not a curated reading list.

Connected

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