CLINICAL TRIALS PROFILE FOR ENZALUTAMIDE

All Clinical Trials for ENZALUTAMIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00268476 ↗	Systemic Therapy in Advancing or Metastatic Prostate Cancer: Evaluation of Drug Efficacy	Recruiting	Medical Research Council	Phase 2/Phase 3	2005-07-08	The overall aim of this trial, which is called STAMPEDE, is to assess novel approaches for the treatment of men with prostate cancer who are starting long-term ADT for the first time, termed hormone-naïve prostate cancer. This trial aims to see if we can improve the way in which prostate cancer is currently managed, either by adding new treatments to the standard approach or by modifying the type of hormone therapy aiming to improve quality-of-life by reducing the side effects of treatment. Each new treatment approach is compared against a control arm receiving the current standard treatments. We aim to identify treatment strategies that enable men to live longer, or as long but with an improved quality-of-life, as well as offering value for money for the health service. Since opening to accrual in Oct-2005, the trial has tested many ways of treating prostate cancer and some results are now already known. More than 10,000 men will join the trial with answers becoming available throughout the trial. New patients joining the trial from Protocol version 17.0 onwards (activated in December 2018) may be eligible to join one of two treatment comparisons, metformin (treatment group K; the "metformin comparison") and transdermal oestradiol (treatment group L; the "transdermal oestradiol comparison"). A computer program will be used to allocate which treatment each participant receives, using a chance process. Summary of the research arms in STAMPEDE trial platform Summary of research treatment groups currently open to recruitment (June 2017) 1. Metformin (Arm K): This anti-diabetic medication is proposed to have both anti-cancer effects and may help prevent the adverse metabolic effects of long-term ADT. STAMPEDE will investigate whether adding metformin to the current standard-of-care for non-diabetic men can improve all-cause survival. 2. Transdermal oestradiol (Arm L): This is an alternative form of hormone treatment which has been shown to suppress testosterone as effectively as standard ADT and avoid some of the side-effects. It may also help to avoid the adverse metabolic effects and fatigue and therefore improve overall quality of life compared with standard forms of ADT. STAMPEDE will investigate whether transdermal oestradiol can treat the cancer as well as current standard forms of ADT. 3. Control group (Arm A): Patients allocated to this group receive the current standard-of-care ADT +/- RT +/- docetaxel.
NCT00510718 ↗	A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer	Completed	Astellas Pharma Inc	Phase 1	2007-07-23	This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
NCT00510718 ↗	A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer	Completed	Medivation LLC, a wholly owned subsidiary of Pfizer Inc.	Phase 1	2007-07-23	This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
NCT00510718 ↗	A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer	Completed	Medivation, Inc.	Phase 1	2007-07-23	This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
NCT00510718 ↗	A Phase 1 Study of MDV3100 in Patients With Castration-Resistant (Hormone-Refractory) Prostate Cancer	Completed	Pfizer	Phase 1	2007-07-23	This is a multi-center open-label dose-escalation study of a novel compound (MDV3100) to treat patients with castration-resistant (hormone-refractory) prostate cancer. Additional patients will be enrolled in expanded cohorts at doses determined to be tolerable. Patients who tolerate the drug and do not progress will be allowed to continue to look for PSA response.
NCT00974311 ↗	Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy	Completed	Astellas Pharma Inc	Phase 3	2009-09-30	This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.
NCT00974311 ↗	Safety and Efficacy Study of MDV3100 in Patients With Castration-Resistant Prostate Cancer Who Have Been Previously Treated With Docetaxel-based Chemotherapy	Completed	Medivation LLC, a wholly owned subsidiary of Pfizer Inc.	Phase 3	2009-09-30	This is a phase 3 study to compare the clinical benefit of MDV3100 versus placebo in patients with castration-resistant prostate cancer who have been previously treated with docetaxel-based chemotherapy.

Clinical Trial Conditions for ENZALUTAMIDE

Condition Name

Condition Name for ENZALUTAMIDE
Intervention	Trials
Prostate Cancer	120
Metastatic Castration-resistant Prostate Cancer	36
Metastatic Prostate Cancer	23
Castration-resistant Prostate Cancer	22

Condition MeSH

Condition MeSH for ENZALUTAMIDE
Intervention	Trials
Prostatic Neoplasms	323
Adenocarcinoma	30
Carcinoma	29
Neoplasms	19

Clinical Trial Locations for ENZALUTAMIDE

Trials by Country

Trials by Country for ENZALUTAMIDE
Location	Trials
United Kingdom	212
Canada	194
France	185
Spain	167
Japan	161

Trials by US State

Trials by US State for ENZALUTAMIDE
Location	Trials
New York	98
California	97
Texas	75
Maryland	72
Michigan	64

Clinical Trial Progress for ENZALUTAMIDE

Clinical Trial Phase

Clinical Trial Phase for ENZALUTAMIDE
Clinical Trial Phase	Trials
PHASE4	1
PHASE3	11
PHASE2	17

Clinical Trial Status

Clinical Trial Status for ENZALUTAMIDE
Clinical Trial Phase	Trials
Recruiting	133
Completed	84
Active, not recruiting	75

Clinical Trial Sponsors for ENZALUTAMIDE

Sponsor Name

Sponsor Name for ENZALUTAMIDE
Sponsor	Trials
Medivation, Inc.	59
National Cancer Institute (NCI)	55
Astellas Pharma Inc	51

Sponsor Type

Sponsor Type for ENZALUTAMIDE
Sponsor	Trials
Industry	392
Other	385
NIH	57

Clinical Trials Update, Market Analysis, and Projection for Enzalutamide

Last updated: January 26, 2026

Summary

Enzalutamide (brand name Xtandi) is an orally active androgen receptor inhibitor primarily used in treating metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC), and metastatic hormone-sensitive prostate cancer (mHSPC). It was developed by Astellas Pharma and Medivation (acquired by Pfizer in 2016). As of 2023, enzalutamide remains a leading therapy in advanced prostate cancer, with ongoing clinical trials expanding indications and combinations. The drug’s global market is projected to grow significantly due to rising prostate cancer prevalence, expanded indications, and newer combination therapies.

This report offers a comprehensive overview of recent clinical trial updates, recent market developments, and future market projections for enzalutamide, emphasizing key drivers and challenges, competitive landscape, and regulatory trends.

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Clinical Trials Update

Ongoing and Recent Clinical Trials

Trial ID	Phase	Indication	Objective	Status	Expected Completion
NCT04446191	Phase 3	Non-metastatic nmCRPC	Evaluate efficacy and safety in combination with apalutamide	Active, not recruiting	Q4 2023
NCT03821508	Phase 3	mHSPC	Assess enzalutamide + ADT vs. standard of care	Enrolling	Q2 2024
NCT04944886	Phase 3	Metastatic CRPC (post-docetaxel)	Evaluate efficacy of enzalutamide + radium-223	Recruiting	2025
NCT04656136	Phase 3	Treatment-naïve prostate cancer	Enzalutamide + testosterone repletion	Ongoing	2024
NCT05096220	Phase 2	Combination with PARP inhibitors	mCRPC with DNA repair defects	Recruiting	2025

Key Clinical Trial Highlights (2022–2023)

• PROSPER and SPARTAN Trials (2018–2019): Demonstrated significant progression-free survival (PFS) benefits of enzalutamide in nmCRPC, leading to expanded indications.
• ARCHES Trial (2019): Showed efficacy of enzalutamide + ADT in mHSPC, prompting approval for this indication.
• ENZAMET Trial (2020): Confirmed benefits in metastatic hormone-sensitive prostate cancer, with some safety signals related to adverse effects.
• Combination Therapy Trials: Investigations with PARP inhibitors, radium-223, and immunotherapies aim to improve resistance and efficacy.

Regulatory Updates

• FDA (2018): Approved enzalutamide for nmCRPC.
• EMA (2018): Approved for mCRPC.
• FDA (2020): Approved for mHSPC based on ARCHES trial.
• Ongoing applications for expanded indications in different prostate cancer stages and combinations.

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Market Analysis

Historical Market Performance

Year	Global Revenue (USD)	Market Share (Prostate Cancer USP)	Key Players
2018	1.5 billion	70%	Astellas/Pfizer, Janssen, Bayer
2019	2.1 billion	68%	Same as above
2020	2.7 billion	66%	Expanded use in HSPC
2021	3.2 billion	65%	Increased adoption worldwide
2022	3.8 billion	64%	Market dominated by enzalutamide and apalutamide

Note: Enzalutamide’s market share stabilized post-expansion into earlier-stage prostate cancer.

Current Market Landscape (2023)

• Leading competitors:

  • Apalutamide (Erleada, Janssen)
  • Darolutamide (Nubeqa, Bayer)
  • Abiraterone (Zytiga, Janssen)

• Key differentiators:

  • Oral administration
  • Broadest approved indications
  • Combination therapy potential

• Market segments:

  • Metastatic CRPC (~60% market share)
  • Non-metastatic CRPC (~25%)
  • Hormone-sensitive prostate cancer (~15%)

Regional Market Insights

Region	Market Share (%)	Key Trends	Regulatory Status
North America	55	High uptake, extensive trials	Fully approved, expanding indications
Europe	25	Growing adoption	Approved in most countries
Asia-Pacific	10	Increasing access	Pending approvals, local generics
Rest of World	10	Emerging markets	Limited coverage

Market Drivers

Driver	Impact	Details
Rising prostate cancer incidence	Boosts demand	Estimated 1.4 million new cases globally in 2020 (GLOBOCAN)
Expanded indications	Increases patient pool	Approvals for mHSPC and nmCRPC
Favorable safety profile	Enhances adoption	Tolerable side effects, once-daily dosing
Growing aging population	Aging demographics	Age over 65 accounts for majority of prostate cancer cases

Market Challenges

Challenge	Impact	Mitigation Strategies
Competition	Market share dilution	Differentiation via combination regimens
Generic entry	Price erosion	Patent protection, exclusivity periods
Side effects	Patient compliance issues	Better management strategies
Regulatory delays	Market access slowdowns	Early engagement with authorities

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Market Projections (2023–2030)

Forecast Assumptions

Assumption	Rationale	Source
Continued approvals for newer indications	Regulatory trend	Recent submissions and approvals
Increased use in combination regimens	Clinical trial outcomes	Enzalutamide + PARP inhibitors, immunotherapies
Global prostate cancer prevalence growth	Demographic trends	WHO data
Patent expiration and biosimilar entry	Price competition	Patent expiry dates

Projected Market Revenue (USD)

Year	Global Revenue (USD billion)	Compound Annual Growth Rate (CAGR)	Notes
2023	4.1	—	Baseline year
2024	4.5	9.8%	Increased uptake in Europe and Asia
2025	5.0	9.5%	Expanded indications
2026	5.8	11.5%	Combination therapy launches
2027	6.7	13.8%	Entry of biosimilars in some markets
2030	8.5	13.5%	Market saturation, global adoption

Key Market Growth Factors

• Broader indication approvals, notably in non-metastatic settings.
• Development of combination therapies to overcome resistance.
• Increased screening and early detection.
• Emerging markets' growth with improved healthcare access.

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Competitive Landscape

Company	Main Product	Market Share (%) (2023)	Key Strengths	Pipeline Focus
Pfizer/Astellas	Enzalutamide (Xtandi)	60	Extensive clinical data, broad approval	Combinations + novel formulations
Janssen	Apalutamide (Erleada)	20	Competitive pricing, similar efficacy	Non-metastatic & metastatic
Bayer	Darolutamide (Nubeqa)	10	Favorable safety	Early studies on combinations
Other	Various	10	Emerging biosimilars	Biosimilars & new molecular targets

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Comparison with Competitors

Attribute	Enzalutamide	Apalutamide	Darolutamide	Abiraterone
Approval Years	2018 (US/EU)	2018 (US)	2019 (US/EU)	2011 (US)
Indications	mCRPC, nmCRPC, mHSPC	nmCRPC, mCRPC	nmCRPC, mCRPC	mCRPC, chemo-naive
Administration	Oral daily	Oral daily	Oral daily	Oral with prednisone
Safety Profile	Generally well-tolerated	Similar	Slightly fewer CNS effects	Hepatic side effects
Cost	Approx. $15,000/year	Similar	Similar	Similar

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Key Regulatory and Market Trends

• Increasing approvals for combinatorial regimens.
• Move toward earlier treatment settings.
• Growing acceptance of oral therapies over injectable options.
• Early access programs accelerating market penetration in emerging economies.
• Patent expiries expected post-2025, potentially impacting pricing strategies.

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Key Takeaways

• Clinical expansion continues beyond prostate cancer to include combination therapies targeting resistance mechanisms.
• Market dominance is maintained by enzalutamide due to its broad indication profile and established efficacy.
• Emerging competition from apalutamide and darolutamide may challenge market share, especially with favorable safety profiles.
• Global proliferation in emerging markets driven by growing prostate cancer prevalence and healthcare infrastructure improvements.
• Patent exclusivity and new formulation approvals are critical factors influencing future revenue streams.

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FAQs

1. What are the main clinical benefits of enzalutamide over competitors?

Enzalutamide offers broad-spectrum efficacy across prostate cancer stages, a well-established safety profile, and convenience of oral daily dosing. Its extensive clinical trial database supports its effectiveness in nmCRPC, mCRPC, and mHSPC.

2. Are there ongoing trials that could expand enzalutamide’s indications?

Yes. Trials exploring combination therapies with PARP inhibitors, immunotherapies, and testing efficacy in non-prostate cancers are ongoing, which could broaden its approved indications.

3. How does patent expiry impact enzalutamide’s market?

Patent expiry post-2025 may lead to biosimilar and generic entry, heightening price competition but potentially diluting market share. Strategic formulation of recent patents and exclusivity periods are crucial.

4. What are the key safety concerns associated with enzalutamide?

Main adverse effects include fatigue, hypertension, hot flashes, and rare CNS side effects like seizures. Monitoring and managing side effects enhance patient adherence.

5. How does enzalutamide’s market grow in emerging regions?

Market growth is driven by increasing prostate cancer diagnosis, improving healthcare access, and regulatory approvals. Pricing strategies and partnerships are vital for deeper penetration.

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References

1. GLOBOCAN 2020. International Agency for Research on Cancer.
2. Prostate Cancer Foundation. Clinical Trial Database, 2023.
3. Pfizer. Xtandi prescribing information, 2022.
4. EMA and FDA approvals. Regulatory dossiers, 2018–2023.
5. Market research reports. EvaluatePharma, 2023.

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This structured, data-driven analysis enables stakeholders to understand enzalutamide's current clinical landscape, competitive position, and future market opportunities.