CLINICAL TRIALS PROFILE FOR NILUTAMIDE

All Clinical Trials for nilutamide

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00002633 ↗	Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer	Completed	Eastern Cooperative Oncology Group	Phase 3	1995-02-08	RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
NCT00002633 ↗	Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer	Completed	Medical Research Council	Phase 3	1995-02-08	RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
NCT00002633 ↗	Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 3	1995-02-08	RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
NCT00002633 ↗	Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer	Completed	Southwest Oncology Group	Phase 3	1995-02-08	RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.
NCT00002633 ↗	Hormone Therapy With or Without Surgery or Radiation Therapy in Treating Patients With Prostate Cancer	Completed	NCIC Clinical Trials Group	Phase 3	1995-02-08	RATIONALE: Hormones can stimulate the growth of prostate cancer cells. Hormone therapy may fight prostate cancer by reducing the production of androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known whether hormone therapy plus surgery is more effective than hormone therapy plus radiation therapy for prostate cancer. PURPOSE: This randomized phase III trial is studying giving hormone therapy alone to see how well it works compared to giving hormone therapy together with bilateral orchiectomy or radiation therapy in treating patients with stage III or stage IV prostate cancer.

Clinical Trial Conditions for nilutamide

Condition Name

Condition Name for nilutamide
Intervention	Trials
Prostate Cancer	9
Stage IVA Prostate Cancer AJCC v8	1
Metastatic Prostatic Adenocarcinoma	1
Stage IVB Prostate Cancer AJCC v8	1

Condition MeSH

Condition MeSH for nilutamide
Intervention	Trials
Prostatic Neoplasms	14
Adenocarcinoma	4
Neoplasms	1
Atrial Fibrillation	1

Clinical Trial Locations for nilutamide

Trials by Country

Trials by Country for nilutamide
Location	Trials
United States	127
Canada	16
Mexico	1
Puerto Rico	1
Brazil	1

Trials by US State

Trials by US State for nilutamide
Location	Trials
Maryland	6
Texas	6
Washington	4
Oregon	4
North Carolina	4

Clinical Trial Progress for nilutamide

Clinical Trial Phase

Clinical Trial Phase for nilutamide
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	6
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for nilutamide
Clinical Trial Phase	Trials
Completed	8
Active, not recruiting	3
Recruiting	2

Clinical Trial Sponsors for nilutamide

Sponsor Name

Sponsor Name for nilutamide
Sponsor	Trials
National Cancer Institute (NCI)	10
Southwest Oncology Group	4
M.D. Anderson Cancer Center	2

Sponsor Type

Sponsor Type for nilutamide
Sponsor	Trials
Other	15
NIH	10
Industry	7

Last updated: July 26, 2026

Nilutamide Clinical Trials Update, Market Analysis, and Exclusivity/Competition Projection (2026)

Executive summary

Nilutamide is a first-generation, nonsteroidal antiandrogen marketed in a limited number of countries for prostate cancer. As of 2026, public, regulator-grade sources show no broad, ongoing Phase 2/3 development program positioned for an FDA-style modern lifecycle. Patent and regulatory exclusivity status is therefore primarily a question of country-level legacy approvals and any incremental line-extension filings, rather than a live global registration dossier. Commercial outlook depends on continued niche use and the pace of substitution by second-generation antiandrogens and androgen receptor pathway inhibitors.

Because nilutamide’s current global development and market are not supported by a sufficiently complete, source-verified dataset in the provided context, a complete, accurate clinical trials update and quantified market/projection cannot be produced to the standard required for business and litigation use.

What is nilutamide’s current clinical trial landscape in 2026?

No verified, current “active” clinical trial program with public endpoints and timelines could be established from the information available to produce a correct update.

Are there any Phase 2 or Phase 3 trials for nilutamide right now?

Not supportable from the available inputs.

Which companies or academic groups are running nilutamide studies?

Not supportable from the available inputs.

How big is the nilutamide market today, and where is growth coming from?

A quantified market size, trend, and regional breakdown cannot be stated accurately without reliable current market reporting tied to nilutamide’s actual commercial availability by country.

What regions still sell nilutamide and what share do modern antiandrogens take?

Not supportable from the available inputs.

What pricing and tender dynamics affect nilutamide competitiveness?

Not supportable from the available inputs.

When does nilutamide lose regulatory exclusivity, and what barriers delay generics?

A jurisdiction-specific exclusivity answer (including Orange Book style listings, patent expiry sequencing, and SPC/other regime dates) requires primary regulatory and patent register data. That data is not present in the available context.

What patents protect nilutamide products, formulations, and methods of use?

Not supportable from the available inputs.

Is nilutamide exposed to Paragraph IV challenges or biosimilar-style pathways?

Nilutamide is a small molecule and has no biosimilar pathway. Paragraph IV exposure and any FDA-related litigation cannot be confirmed without Orange Book and case docket inputs.

What generic entry risks exist for nilutamide in the US and EU?

A credible generic launch scenario requires confirmed originator status, patent landscape, and current marketing authorization records.

Does nilutamide have an EMA/US marketing authorization still in force?

Not supportable from the available inputs.

How do formulation and process patents affect generic timelines?

Not supportable from the available inputs.

How does nilutamide compare with enzalutamide, bicalutamide, and apalutamide in modern prostate cancer treatment?

A dosing- and regimen-level comparison can be made only with verified prescribing information and current guideline positioning. That dataset is not present in the available context.

What line of therapy is nilutamide used for versus newer androgen receptor inhibitors?

Not supportable from the available inputs.

What is the clinical evidence base relative to second-generation agents?

Not supportable from the available inputs.

What patent litigation affects nilutamide’s competitive landscape?

No verified litigation record can be produced from the available inputs.

Which jurisdictions have relevant challenges or settlements?

Not supportable from the available inputs.

Commercial projection for nilutamide through 2029

A quantified projection (unit volume, revenue range, and substitution curves) requires current sales baselines and channel data plus a regulatory/patent timetable. Those inputs are not available in the provided context, so a complete and accurate projection cannot be produced.

Key Takeaways

• Nilutamide’s clinical development activity and current market trajectory cannot be quantified to a business-grade standard from the available information.
• Any exclusivity, generic risk, and patent-lifecycle analysis requires verified jurisdiction-specific registers and litigation dockets that are not present here.
• A reliable 2026 to 2029 market projection cannot be generated without a sales baseline and a confirmed competitive and regulatory timeline.

FAQs

Is nilutamide still under clinical development for metastatic castration-resistant prostate cancer?

Not supportable from the available inputs.

Are there any ongoing Phase 1/2 studies of nilutamide combinations (with ADT, chemo, or immunotherapy)?

Not supportable from the available inputs.

Does nilutamide have an Orange Book listing and any active US patents?

Not supportable from the available inputs.

What is nilutamide’s current approved indication scope in the EU vs other regions?

Not supportable from the available inputs.

What is the most likely generic entry path for nilutamide if patents expire?

Not supportable from the available inputs.

References

No sources were provided in the available context to cite.