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.
NCT04176081 ↗	Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer	Not yet recruiting	Bayer	Phase 2	2021-09-01	Prostate cancer (PCa) is the most frequently diagnosed cancer in men and second leading cause of cancer-related death. Men with PCa have a wide range of possible outcomes if the cancer has not spread and is classified as Intermediate-Risk PCa (IR-PCa). The standard treatment for IR-PCa is radiation therapy (RT) with or without hormone therapy which can result in cure in some men. In other men, the cancer can come back or spread to other areas of the body. Treatment response in men with IR-PCa is highly variable. This uncertainty has led to significant under- and over-treatment. This study aims to find out if the addition of intensive treatment (hormonal therapy: darolutamide + degarelix) to standard treatment for PCa will work better than standard treatment alone. To do this, some participants will receive hormone therapy and others will not. All participants will receive RT. Currently, it is difficult to identify men who may require more intensive therapy. Current methods, such as using prostate specific antigen (PSA) alone, may not give the doctor enough information about who requires more intensive treatment. The researchers conducting this study believe that a particular arrangement of cancer cells [called intraductal carcinoma (IDC)] and the presence of a genetic marker called SChLAP1 can be used to identify people who would benefit from more intensive therapy. Hormonal therapy such as with drugs called darolutamide (new drug for PCa) and Degarelix, reduce androgens (male hormones, such as testosterone) or block their effect on the cells. PCa cells require androgens to grow and divide, so removal of androgens may be effective in preventing the return of cancer following radiation therapy. Although darolutamide has been studied in about 1000 men with PCa and seems promising and well tolerated it is considered an experimental drug, therefore it can only be used in a research study such as this one. Degarelix has been approved by Health Canada to treat PCa. This is a phase 2, open label, randomized, controlled study and will be conducted across sites in Canada. To qualify, men must have IR-PCa and have both SChLAP1 and IDC present or both absent. Participants will be randomized to receive RT with hormone therapy or RT only. The study treatment period is 6 months for the RT + hormone therapy group. RT will take about 1-2 weeks. All participants will be followed for 5 years with multiple visits to assess safety and treatment effects.

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
Carcinoma	2
Urogenital Diseases	2

Clinical Trial Locations for NUBEQA

Trials by Country

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

Trials by US State

Trials by US State for NUBEQA
Location	Trials
California	5
Michigan	4
Illinois	3
Washington	3
South Carolina	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

Clinical Trials Update, Market Analysis, and Projection for Nubeqa (Darolutamide)

Last updated: October 30, 2025

---

Introduction

Nubeqa (darolutamide) is an oral androgen receptor inhibitor developed by Bayer Pharmaceuticals for the treatment of non-metastatic castration-resistant prostate cancer (nmCRPC). Approved by the U.S. Food and Drug Administration (FDA) in July 2019, Nubeqa has emerged as a pivotal option aligned with the evolving landscape of prostate cancer therapeutics. As the global oncology market continues to expand, understanding the clinical development trajectory, market dynamics, and future growth prospects of Nubeqa is critical for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

---

Clinical Trials Update

Key Clinical Trials and Outcomes

The landmark trial supporting Nubeqa's approval was the ARAMIS (Androgen Receptor Antagonist in Metastatic and Nonmetastatic Castration-Resistant Prostate Cancer) study, a Phase III, randomized, double-blind, placebo-controlled trial. Enrolling 1,509 men with nmCRPC, the trial demonstrated a significant improvement in metastasis-free survival (MFS) for patients treated with Nubeqa.

• Results:
  • Median MFS: 40.4 months for Nubeqa versus 18.4 months for placebo (Hazard Ratio [HR] = 0.41; P<0.001).
  • The trial also indicated a favorable safety profile, with manageable adverse effects primarily consisting of fatigue, dizziness, and hypertension.

Following this, Bayer launched several ongoing or planned trials:

• ARASENS (Androgen Receptor Antagonist Study in Edwards with Nasal Cell Carcinoma):
  A Phase III trial evaluating Nubeqa combined with androgen deprivation therapy (ADT) in metastatic hormone-sensitive prostate cancer (mHSPC). Results expected to inform broader indications beyond nonmetastatic settings.

• Combination Studies:
  Trials assessing Nubeqa in combination with other agents like pembrolizumab in metastatic castration-resistant prostate cancer (mCRPC) are underway, aiming to enhance efficacy and overcome resistance mechanisms.

Recent Developments

In 2022, Bayer announced the initiation of Phase III trials investigating Nubeqa in earlier stages of prostate cancer, including high-risk localized disease, which could further extend its label and market share, contingent upon positive outcomes.

Regulatory Milestones

• FDA Approval (2019): Primary indication for nmCRPC.
• EMA Approval: Secured in Europe, expanding access across key markets.
• Health Technology Assessments: Several countries’ payers have begun incorporating Nubeqa into prostate cancer treatment algorithms, often with reimbursement secured based on cost-effectiveness analyses.

---

Market Analysis

Current Market Landscape

Prostate cancer remains the second most common cancer worldwide, with approximately 1.4 million new cases annually [1]. The treatment paradigm has shifted towards targeting advanced stages with potent androgen receptor inhibitors, including enzalutamide, apalutamide, and now Nubeqa.

• Market Position:
  Nubeqa competes chiefly with apalutamide (Janssen) and enzalutamide (Pfizer). According to IQVIA data, in 2022, Nubeqa captured approximately 15-20% of the nmCRPC market, with increasing uptake driven by its favorable safety profile and marginal benefits in head-to-head comparisons.

• Pricing and Reimbursement:
  Pricing strategies position Nubeqa at premium levels, with annual treatment costs ranging from $40,000 to $50,000. Favorable reimbursement policies in major markets have facilitated rapid adoption.

Growth Drivers

• Expanding Indications:
  Positive Phase III data for mHSPC and early-stage disease could propel Nubeqa into broader markets, doubling its addressable population.

• Market Penetration:
  Growing awareness and clinical guidelines endorsing Nubeqa could accelerate adoption. The inclusion in NCCN guidelines in 2020 sparked increased prescribing.

• Competitive Advantages:
  Nubeqa’s low blood-brain barrier penetration results in fewer CNS side effects, positioning it as a safer alternative for some patients.

Challenges and Competitive Landscape

• Market Competition:
  Enzalutamide and apalutamide are well-established, with extensive clinical data. Bayer’s challenge lies in demonstrating superiority or clear differentiated benefits.

• Cost and Access Barriers:
  High costs and reimbursement hurdles may limit broader utilization in emerging markets.

• Patent Life and Biosimilar Entry:
  Patent expiry timelines remain uncertain but could impact future pricing strategies.

---

Market Projection

Short-term Outlook (2023–2025)

The global prostate cancer therapeutics market is projected to grow at a CAGR of approximately 8-10%, reaching over $10 billion by 2025. Nubeqa is anticipated to secure a significant portion, driven by its approval for nmCRPC and the initiation of further trials.

• Revenue Estimates:
  Assuming a conservative market share increase to 30-35% in the nmCRPC segment by 2025, Nubeqa could generate revenue exceeding $1 billion annually globally.

• Geographic Expansion:
  Expansion into Asian and Latin American markets, supported by pricing adjustments and strategic partnerships, is expected to augment sales.

Long-term Projection (2025–2030)

• Indication Expansion:
  If ongoing trials demonstrate efficacy in HSPC and localized prostate cancer, Nubeqa’s market could expand twofold or more.

• Combination Therapies:
  The integration into combination regimens may open lucrative segments, especially if trials show improved survival outcomes.

• Market Share Stability:
  Given the established efficacy of competitors and potential patent expirations, Nubeqa’s market share may plateau unless differentiated through clinical advantages or cost-effective access strategies.

Overall, Nubeqa’s market trajectory remains optimistic, contingent upon successful trial outcomes, competitive positioning, and regulatory approvals of broader indications.

---

Conclusion and Key Takeaways

Nubeqa (darolutamide) has established itself as a credible option for nonmetastatic castration-resistant prostate cancer, supported by robust Phase III trial data demonstrating superior metastasis-free survival. The company's ongoing clinical development activities suggest potential for a broader therapeutic footprint across various prostate cancer stages.

Market dynamics favor continued growth, with a projected CAGR of 8-10% over the next five years, potentially exceeding $1 billion in annual revenues by 2025. However, Bayer’s success will depend on effective expansion into new indications, competitive differentiation, and strategic pricing.

Key Takeaways:

• Robust Clinical Evidence: Nubeqa’s ARAMIS trial cemented its role in nmCRPC, with ongoing trials promising future therapeutic expansions.
• Market Penetration: Despite stiff competition, Nubeqa’s favorable safety profile enhances its adoption prospects.
• Regulatory and Indication Expansion: Positive outcomes from ongoing Phase III trials could significantly broaden its market.
• Pricing Strategies: Maintaining competitive pricing, coupled with reimbursement gains, will be vital for sustained growth.
• Future Challenges: Patent expirations, biosimilar threats, and market rivalry necessitate strategic innovation and clinical differentiation.

Understanding Nubeqa’s clinical development trajectory and market evolution positions stakeholders to make informed decisions amid a rapidly transforming prostate cancer treatment landscape.

---

FAQs

1. What distinguishes Nubeqa from other androgen receptor inhibitors?
Nubeqa exhibits unique pharmacokinetics, including minimal blood-brain barrier penetration, reducing CNS-related side effects compared to peers like enzalutamide and apalutamide.

2. What are the primary indications approved for Nubeqa?
Currently, Nubeqa is approved for nonmetastatic castration-resistant prostate cancer (nmCRPC). Ongoing trials aim to expand its indications to metastatic settings and early-stage disease.

3. How does Nubeqa’s efficacy compare to competitors?
Clinical trials demonstrate comparable efficacy in prolonging metastasis-free survival. Its safety profile may offer advantages, but direct head-to-head trials are limited.

4. What is the outlook for Nubeqa’s market share?
With continued clinical success and indication expansion, Nubeqa is poised to increase its market share, especially if it gains approval for metastatic and earlier stages of prostate cancer.

5. What are the challenges faced by Nubeqa in its growth trajectory?
Key challenges include intensifying competition, patent expirations, reimbursement hurdles, and ensuring clinical differentiation through ongoing trials.

---

Sources
[1] International Agency for Research on Cancer (IARC). Global Cancer Statistics 2020.
[2] Bayer Pharmaceuticals. Nubeqa (darolutamide) clinical trial filings and updates.
[3] IQVIA. Oncology Market Data 2022.
[4] National Comprehensive Cancer Network. Prostate Cancer Guidelines.