OnCo
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Enzalutamide

The most widely used androgen-receptor blocker, approved across every stage of advanced prostate cancer, including rising PSA after surgery.

AFFIRM and PREVAIL (mCRPC), PROSPER (nmCRPC), ARCHES and ENZAMET (mHSPC, OS benefit), EMBARK (high-risk BCR, 2023). Partner in TALAPRO-2 (talazoparib) and MEVPRO trials (mevrometostat). Fatigue, falls, and cognitive effects are the main toxicities.

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Enzalutamide
PubChem
Modality
Small-molecule AR antagonist
Mechanism
Second-generation AR antagonist blocking ligand binding, nuclear translocation, and DNA binding.
Brand / code
Xtandi
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). Xtandi was selected for Medicare price negotiation in January 2025; the negotiated price takes effect 1 January 2027.

Commercial insurance
step therapy common

Covered with prior authorisation; several PBMs require a trial of generic abiraterone first in metastatic castration-resistant disease unless abiraterone is contraindicated.

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) · CMS: Medicare Drug Price Negotiation Program. Not medical or financial advice; verify with your plan.

NICE recommendedNICE TA316 · 2014SMC: accepted
Appraised for
Metastatic castration-resistant prostate cancer after docetaxel
Notes
Before chemotherapy: TA377 (2016). Hormone-sensitive metastatic disease: TA712 (2021). Non-metastatic CRPC: TA580 (2019).
NHS England
Routinely funded for the appraised indication (or via managed access)

Sources: NICE TA316 · SMC advice: enzalutamide. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2012mCRPC after docetaxel (pre-chemo 2014)
US2018Non-metastatic CRPC
US2019mHSPC (ARCHES)
US2023High-risk biochemical recurrence (EMBARK)

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
288 studies28 recruiting74 Phase 227 Phase 3
Search “Enzalutamide” 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
Enzalutamide
intervention: Enzalutamide
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend460 papers in the last 12 months+29% vs prior 12How this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Enzalutamide" OR ABSTRACT:"Enzalutamide" OR TITLE:"Xtandi" OR ABSTRACT:"Xtandi") 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 Enzalutamide, not a curated reading list.

Connected

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