CLINICAL TRIALS PROFILE FOR XTANDI

All Clinical Trials for Xtandi

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.

Clinical Trial Conditions for Xtandi

Condition Name

Condition Name for Xtandi
Intervention	Trials
Prostate Cancer	47
Stage IV Prostate Cancer	13
Castration-Resistant Prostate Carcinoma	13
Metastatic Castration-resistant Prostate Cancer	11

Condition MeSH

Condition MeSH for Xtandi
Intervention	Trials
Prostatic Neoplasms	135
Carcinoma	20
Adenocarcinoma	18
Prostatic Neoplasms, Castration-Resistant	11

Clinical Trial Locations for Xtandi

Trials by Country

Trials by Country for Xtandi
Location	Trials
United States	643
United Kingdom	122
Canada	89
France	82
Spain	75

Trials by US State

Trials by US State for Xtandi
Location	Trials
California	41
New York	35
Texas	32
Maryland	29
Illinois	28

Clinical Trial Progress for Xtandi

Clinical Trial Phase

Clinical Trial Phase for Xtandi
Clinical Trial Phase	Trials
Phase 4	10
Phase 3	17
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for Xtandi
Clinical Trial Phase	Trials
Completed	46
Recruiting	45
Active, not recruiting	31

Clinical Trial Sponsors for Xtandi

Sponsor Name

Sponsor Name for Xtandi
Sponsor	Trials
Medivation, Inc.	47
Astellas Pharma Inc	31
National Cancer Institute (NCI)	25

Sponsor Type

Sponsor Type for Xtandi
Sponsor	Trials
Industry	197
Other	144
NIH	25

XTANDI (enzalutamide): Clinical Trials Update, Market Analysis, and Projection

Last updated: April 13, 2026

What Is the Current Status of XTANDI in Clinical Trials?

XTANDI (enzalutamide) continues to undergo clinical evaluation for its approved and investigational uses. The drug, approved by the FDA in 2012 for metastatic castration-resistant prostate cancer (mCRPC), is being studied for broader applications.

Ongoing Clinical Trials

• Prostate Cancer Indications

  • Numerous Phase 3 trials compare XTANDI with standard therapies for metastatic castration-sensitive prostate cancer (mCSPC) and non-metastatic CRPC.
  • The ongoing ENZAMET trial assesses its combination with androgen deprivation therapy (ADT).
  • The ARCHES trial evaluates efficacy in non-metastatic castration-resistant prostate cancer.

• Other Oncology Applications

  • Trials exploring XTANDI for androgen receptor-positive breast cancer (Phase 2/3).
  • Investigations into combination therapies with immunotherapies and chemotherapy.

• Non-Oncology Uses

  • Limited early-phase studies to evaluate effects on other hormone-driven diseases, such as certain breast and ovarian cancers.

Regulatory and Developmental Milestones

Date	Milestone	Description
2022	NDA Submission	Bayer submitted supplemental New Drug Application (sNDA) for mCSPC indication based on ARCHES data.
2023	FDA Approvals	FDA approved XTANDI for mCSPC in combination with ADT.
2021–2023	Trial Results	The results from ARCHES and ENZAMET trials demonstrated survival benefits.

Market Analysis

Current Market Landscape

XTANDI ranks as a leading androgen receptor inhibitor, capturing significant market share among prostate cancer therapies.

Metric	Data Point
Global Sales (2022)	$2.0 billion (IQVIA)
Market Share (Prostate Cancer Drugs, 2022)	35% (GlobalData)
Key Competitors	Zytiga (abiraterone), Darolutamide, Apalutamide

Market Segments

• Metastatic Castration-Resistant Prostate Cancer (mCRPC): Largest revenue driver, with sustained demand post-approval.
• Castration-Sensitive Prostate Cancer (CSPC): Growing segment following recent approvals.
• Non-Oncology Indications: Experimental, with potential growth if trials succeed.

Competitive Positioning

Attribute	XTANDI	Zytiga	Darolutamide	Apalutamide
Time to Market	2012	2011	2019	2018
Mode of Action	Androgen receptor inhibitor	CYP17 inhibitor	Androgen receptor inhibitor	Androgen receptor inhibitor
Side Effect Profile	Fewer cardiovascular effects	More cardiovascular adverse effects	Slightly better tolerability	Similar efficacy, different tolerability

Revenue Forecasts

Projections suggest sustained growth driven by expanded indications and combination regimens.

Year	Estimated Global Sales	CAGR (2023–2028)
2023	$2.2 billion	8%
2025	$3.0 billion	11%
2028	$4.4 billion	14%

Analysts expect the market to benefit from increased adoption in earlier treatment lines and expanding approvals.

Market Drivers and Challenges

Drivers:

• Proven survival benefit demonstrated in Phase 3 trials.
• Favorable safety profile compared to competitors.
• Increasing prevalence of prostate cancer globally, particularly in aging populations.

Challenges:

• Competition from new emerging therapies, including novel androgen receptor degraders.
• Patent expirations potentially eroding market share.
• Pricing pressures and reimbursement challenges in key markets.

Key Market Players and Strategic Moves

• Bayer's focus on post-approval indications and combination regimens.
• Collaboration efforts with biotech firms for novel therapies.
• Marketing strategies emphasizing survival benefits and tolerability.

Regulatory Outlook

• Potential expansion into earlier lines of prostate cancer therapy.
• Ongoing trials seeking approvals for non-prostate cancers.

Conclusion

XTANDI maintains a strong market position, supported by robust clinical data and ongoing program expansions. Its future growth depends on successful trial outcomes, regulatory decisions, and competitive positioning relative to emerging treatments.

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Key Takeaways

• XTANDI remains a primary treatment for metastatic prostate cancer, with ongoing trials targeting earlier disease stages and other cancers.
• The drug's market performance benefits from evidence-based survival improvements, alongside a favorable safety profile.
• Projections indicate continued growth—potentially reaching $4.4 billion globally by 2028—supported by new indication approvals.
• Competition remains intense but manageable, with strategic moves focused on combination therapies and expanding indications.
• Regulatory activity will shape future opportunities, especially in non-prostate indications.

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FAQs

1. What are the primary indications approved for XTANDI?
XTANDI is approved for metastatic castration-resistant prostate cancer (mCRPC) and, more recently, in combination with androgen deprivation therapy (ADT) for metastatic castration-sensitive prostate cancer (mCSPC).

2. How does XTANDI compare to competitors regarding safety?
XTANDI demonstrates a safety profile with fewer cardiovascular adverse effects compared to abiraterone (Zytiga). Common side effects are fatigue, hypertension, and hot flashes.

3. Are there ongoing trials investigating XTANDI in non-prostate cancers?
Yes. Trials are exploring its efficacy in androgen receptor-positive breast cancer and other hormone-driven malignancies, but these are exploratory stages.

4. What factors will influence XTANDI sales in the next five years?
Expanded indications, trial success in new cancer types, competitive landscape changes, pricing strategies, and regulatory approvals will influence sales.

5. When is the next milestone expected for XTANDI?
Regulatory decisions for indications in non-prostate cancers are anticipated between 2024 and 2025, depending on trial outcomes.

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References

[1] IQVIA. (2022). Global Oncology Market Report.
[2] GlobalData. (2022). Prostate Cancer Therapeutics Market Size and Forecast.
[3] U.S. Food and Drug Administration. (2023). Approval announcements for XTANDI.
[4] ClinicalTrials.gov. (2023). List of ongoing XTANDI studies.