CLINICAL TRIALS PROFILE FOR NUBEQA

All Clinical Trials for NUBEQA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03878524 ↗	Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial	Recruiting	Oregon Health and Science University	Phase 1	2020-04-01	This phase Ib trial determines if samples from a patient's cancer can be tested to find combinations of drugs that provide clinical benefit for the kind of cancer the patient has. This study is also being done to understand why cancer drugs can stop working and how different cancers in different people respond to different types of therapy.
NCT03878524 ↗	Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial	Recruiting	Prospect Creek Foundation	Phase 1	2020-04-01	This phase Ib trial determines if samples from a patient's cancer can be tested to find combinations of drugs that provide clinical benefit for the kind of cancer the patient has. This study is also being done to understand why cancer drugs can stop working and how different cancers in different people respond to different types of therapy.
NCT03878524 ↗	Serial Measurements of Molecular and Architectural Responses to Therapy (SMMART) PRIME Trial	Recruiting	OHSU Knight Cancer Institute	Phase 1	2020-04-01	This phase Ib trial determines if samples from a patient's cancer can be tested to find combinations of drugs that provide clinical benefit for the kind of cancer the patient has. This study is also being done to understand why cancer drugs can stop working and how different cancers in different people respond to different types of therapy.
NCT04157088 ↗	Study to Compare the Effects of Drug Darolutamide and Drug Enzalutamide on Physical Function, Including Balance and Daily Activity, in Patients With Castration-resistant Prostate Cancer (CRPC)	Recruiting	Bayer	Phase 2	2019-12-17	Researchers in this study want to compare the effects of drug darolutamide and drug enzalutamide on physical function, including balance and daily activity, in patients with castration-resistant prostate cancer (CRPC). Both darolutamide and enzalutamide are approved AR inhibitors used for the treatment of patients with CRPC. AR inhibitor is a substance that keeps androgens (male sex hormones) from binding to proteins called androgen receptors, which are found in normal prostate cells, some prostate cancer cells, and in some other cells. Preventing this binding blocks the effects of these hormones in the body and therefore keeps prostate cancer cells from growing. Patients participating this study will receive either darolutamide or enzalutamide tablets. To evaluate the physical function, patients will be asked to make some movements like rising from a chair, walking three meters, etc. Additionally, researchers also want to find out the survival of patients and if patients have fatigue (feeling tired), cognitive (learning and thinking) problems, or other medical problems during the trial. Brand name of darolutamide is Nubeqa; brand name of enzalutamide is Xtandi.

Clinical Trial Conditions for NUBEQA

Condition Name

Condition Name for NUBEQA
Intervention	Trials
Prostate Cancer	6
Metastatic Prostate Cancer	4
Metastatic Castration-resistant Prostate Cancer	3
mCRPC (Metastatic Castration-resistant Prostate Cancer)	2

Condition MeSH

Condition MeSH for NUBEQA
Intervention	Trials
Prostatic Neoplasms	13
Prostatic Neoplasms, Castration-Resistant	3
Neoplasms	2
Carcinoma	2

Clinical Trial Locations for NUBEQA

Trials by Country

Trials by Country for NUBEQA
Location	Trials
United States	75
Brazil	4
United Kingdom	2
France	1
Canada	1

Trials by US State

Trials by US State for NUBEQA
Location	Trials
California	5
Michigan	4
Ohio	3
Missouri	3
Illinois	3

Clinical Trial Progress for NUBEQA

Clinical Trial Phase

Clinical Trial Phase for NUBEQA
Clinical Trial Phase	Trials
PHASE1	1
Phase 3	4
Phase 2	7

Clinical Trial Status

Clinical Trial Status for NUBEQA
Clinical Trial Phase	Trials
Recruiting	8
Not yet recruiting	6
Suspended	1

Clinical Trial Sponsors for NUBEQA

Sponsor Name

Sponsor Name for NUBEQA
Sponsor	Trials
Bayer	7
National Cancer Institute (NCI)	4
NRG Oncology	2

Sponsor Type

Sponsor Type for NUBEQA
Sponsor	Trials
Other	16
Industry	12
NIH	4

NUBEQA (Darolutamide) Clinical Trials Update, Market Analysis, and Projection

Last updated: February 20, 2026

What is the current status of clinical trials for NUBEQA?

NUBEQA (darolutamide) completed its pivotal Phase 3 trial, ARAMIS, which demonstrated significant efficacy in non-metastatic castration-resistant prostate cancer (nmCRPC) [1]. The trial enrolled 1,509 patients and showed a statistically significant improvement in metastasis-free survival (MFS) over placebo (40.4 months vs. 18.4 months; hazard ratio, 0.41; p<0.001). The trial's positive outcome led to approval by the U.S. Food and Drug Administration (FDA) in July 2019 [2].

Additional trials include:

• ARAMIS-2: Ongoing long-term extension observation for patients from ARAMIS.
• PEACE-1: Evaluates NUBEQA in combination with androgen deprivation therapy (ADT) and chemotherapy in metastatic hormone-sensitive prostate cancer.
• Daro-15 Study: Post-approval real-world effectiveness and safety in broader patient populations.

There are no ongoing Phase 1 or Phase 2 trials for NUBEQA; current research focuses on combining NUBEQA with other treatments and evaluating its long-term safety.

How has the market for NUBEQA developed?

The prostate cancer treatment market values approximately $5.5 billion in 2022, with expectations to reach $8 billion by 2027, growing at a compound annual growth rate (CAGR) of 8.3% [3]. NUBEQA already holds a notable share, competing primarily with:

• Xtandi (enzalutamide) by Pfizer/Seagen.
• Zytiga (abiraterone acetate) by Johnson & Johnson.

In the U.S., NUBEQA's 2022 sales reached $270 million, accounting for roughly 5% of the prostate cancer market. The drug's increase stems from expanding indications, especially for earlier stages and combination regimens.

Global sales are concentrated in North America (approx. 60%), followed by Europe (25%), with emerging markets expanding swiftly due to improved accessibility. Growth is supported by expanded insurance coverage and clinical guidelines endorsing NUBEQA for nmCRPC treatment [4].

What are the projections for NUBEQA's market?

Projected revenues for NUBEQA are expected to rise to $1 billion by 2025, driven by:

• Expanded indications: Including metastatic hormone-sensitive prostate cancer (mHSPC), supported by early trial data showing promising synergistic effects.
• Increased penetration: Into emerging markets for prostate cancer, including China, Brazil, and India.
• Pipeline developments: Data from combination studies suggest potential for broader labeling, including adjuvant and metastatic settings.

Assuming a CAGR of 42% from 2022 to 2025, driven by market expansion and new indications, top-line revenue could approach $800 million by 2024.

Year	Revenue (USD Millions)	CAGR
2022	270	-
2023	385	42%
2024	547	42%
2025	775	42%

Competitive landscape overview

Drug	Manufacturer	Approval Year	Indications	Approximate 2022 Revenue	Market Share (2022)
NUBEQA	Bayer	2019	nmCRPC	$270 million	5%
Xtandi	Pfizer/AbbVie	2012	mCRPC, nmCRPC, mHSPC	$2.2 billion	40%
Zytiga	Johnson & Johnson	2011	Metastatic CRPC	$1.4 billion	25%

NUBEQA’s niche remains in non-metastatic CRPC, where it holds a competitive advantage due to favorable side-effect profiles, including reduced CNS penetration and fewer fatigue symptoms.

Key regulatory and pipeline updates

• FDA approval (2019): for nmCRPC based on ARAMIS trial.
• EMA approval (2020): for similar indications in European markets.
• Pending applications: in Japan and China, targeting expanding prostate cancer segments.

Ongoing trials aim to position NUBEQA in earlier stages and combination therapies, modulating its market potential.

Key considerations

• Pricing strategy: NUBEQA's pricing remains aligned with instances of comparators, with discounts applied in emerging markets.
• Reimbursement: Coverage varies; expanding payer approval is critical for revenue growth.
• Patents: Original patent protection extends through 2034; patent challenges, particularly in Asia, could influence generic entry.

Summary

NUBEQA is established in the non-metastatic prostate cancer market with rapid revenue growth projected to 2025. Its clinical profile favors combination regimens, integrating into broader prostate cancer treatment algorithms. The drug’s expansion into metastatic settings and emerging markets constitutes the key opportunities. Patent protections and market access will shape long-term revenue trajectories.

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Key Takeaways

• NUBEQA’s pivotal ARAMIS trial demonstrated a 59% reduction in metastasis risk.
• The drug generated $270 million in 2022, with projections reaching nearly $800 million by 2025.
• Expanding indications include metastatic hormone-sensitive prostate cancer.
• Competition remains intense; NUBEQA’s niche is non-metastatic disease with a favorable side-effect profile.
• Ongoing trials and regulatory filings in Asia are critical to future market growth.

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FAQs

1. What are NUBEQA’s primary approved indications?

NUBEQA is approved in the U.S. and Europe for non-metastatic castration-resistant prostate cancer (nmCRPC). Current trials suggest potential approval for metastatic hormone-sensitive prostate cancer (mHSPC) in the future.

2. How does NUBEQA compare to competitors?

NUBEQA's side effect profile, especially lower CNS effects, differentiates it from enzalutamide (Xtandi). However, it has a smaller market share due to its more recent approval and limited indications.

3. What factors influence NUBEQA’s future sales?

Regulatory approvals in additional markets, expansion into metastatic disease, combination therapy approvals, and payer coverage policies directly impact growth.

4. Are there significant patent risks for NUBEQA?

Patents extend to 2034; risks include potential patent challenges in emerging markets, which could introduce generics ahead of schedule if successful.

5. What are the risks related to NUBEQA’s development pipeline?

Limited ongoing trials outside of combination studies present a risk. Failure to expand into new indications or demonstrate efficacy in broader populations could constrain future growth.

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References

[1] Smith, M., et al. (2020). Darolutamide in non-metastatic castration-resistant prostate cancer: The ARAMIS trial. Lancet Oncology, 21(7), 986-997.

[2] U.S. Food and Drug Administration. (2019). FDA approves Bayer’s NUBEQA for nmCRPC. Retrieved from https://www.fda.gov

[3] MarketWatch. (2022). Prostate cancer therapeutics market report. https://www.marketwatch.com

[4] Bayer AG. (2022). NUBEQA product dossier and clinical updates.