CLINICAL TRIALS PROFILE FOR FLUTAMIDE

All Clinical Trials for FLUTAMIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00001266 ↗	A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma	Completed	National Cancer Institute (NCI)	Phase 2	1990-10-01	One current hypothesis as to what limits duration of initial hormone response is the rapid emergence of hormone resistant prostate carcinoma cells. Suramin has shown effectiveness as a treatment for hormonally refractory prostate carcinoma. Survival was less in patients with high rather than low circulating androgen levels. Thus, suramin might slow the emergence of hormone refractory tumor cells while combined androgen ablation may maximize the effectiveness of suramin. In this trial, we will pilot this concept.
NCT00001521 ↗	Three Drug Combination Therapy Versus Conventional Treatment of Children With Congenital Adrenal Hyperplasia	Active, not recruiting	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	1995-06-08	This study was developed to determine if a combination of four drugs (flutamide, testolactone, reduced hydrocortisone dose, and fludrocortisone) can normalize growth in children with congenital adrenal hyperplasia. The study will take 60 children, boys and girls and divide them into 2 groups based on the medications given. Group one will receive the new four- drug combination. Group two will receive the standard treatment for congenital adrenal hyperplasia (hydrocortisone and fludrocortisone). The boys in group one will take the medication until the age of 14 at which time they will stop taking the four drug combination and begin receiving the standard treatment for congenital adrenal hyperplasia. Girls in group one will take the four drug combination until the age of 13, at which time they will stop and begin receiving the standard treatment for congenital adrenal hyperplasia plus flutamide. Flutamide will be given to the girls until six months after their first menstrual period. All of the children will be followed until they reach their final adult height. The effectiveness of the treatment will be determined by measuring the patient's adult height, body mass index, and bone density. ...
NCT00002597 ↗	Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer	Completed	National Cancer Institute (NCI)	Phase 3	1994-10-01	RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.
NCT00002597 ↗	Radiation Therapy With or Without Antiandrogen Therapy in Treating Patients With Stage I or Stage II Prostate Cancer	Completed	Radiation Therapy Oncology Group	Phase 3	1994-10-01	RATIONALE: Radiation therapy (RT) uses high-energy x-rays to damage tumor cells. Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using flutamide, goserelin, and leuprolide may fight prostate cancer by reducing the production of androgens. It is not yet known which regimen of antiandrogen therapy is most effective for prostate cancer. PURPOSE: Randomized phase III trial to study the effectiveness of radiation therapy with or without antiandrogen therapy in treating patients who have stage I or stage II prostate cancer.

Clinical Trial Conditions for FLUTAMIDE

Condition Name

Condition Name for FLUTAMIDE
Intervention	Trials
Prostate Cancer	43
Polycystic Ovary Syndrome	6
Prostatic Neoplasms	4
Prostate Adenocarcinoma	4

Condition MeSH

Condition MeSH for FLUTAMIDE
Intervention	Trials
Prostatic Neoplasms	54
Polycystic Ovary Syndrome	7
Adenocarcinoma	7
Syndrome	3

Clinical Trial Locations for FLUTAMIDE

Trials by Country

Trials by Country for FLUTAMIDE
Location	Trials
United States	564
Canada	60
Japan	17
Australia	6
France	4

Trials by US State

Trials by US State for FLUTAMIDE
Location	Trials
Maryland	19
Illinois	18
Texas	17
California	17
Ohio	16

Clinical Trial Progress for FLUTAMIDE

Clinical Trial Phase

Clinical Trial Phase for FLUTAMIDE
Clinical Trial Phase	Trials
PHASE2	2
Phase 4	5
Phase 3	29

Clinical Trial Status

Clinical Trial Status for FLUTAMIDE
Clinical Trial Phase	Trials
Completed	42
Active, not recruiting	9
Terminated	7

Clinical Trial Sponsors for FLUTAMIDE

Sponsor Name

Sponsor Name for FLUTAMIDE
Sponsor	Trials
National Cancer Institute (NCI)	35
Radiation Therapy Oncology Group	12
NRG Oncology	9

Sponsor Type

Sponsor Type for FLUTAMIDE
Sponsor	Trials
Other	102
NIH	42
Industry	17

Flutamide: Clinical Trials Update, Market Analysis and 5-Year Projection

Last updated: April 27, 2026

What is flutamide and where is it used?

Flutamide (CAS 240-22-6) is a nonsteroidal androgen receptor (AR) antagonist used in advanced prostate cancer, typically in combination with gonadotropin-releasing hormone (GnRH) therapy to achieve androgen deprivation. It is also used in other androgen-driven conditions in some markets, but the dominant commercial use remains prostate cancer.

What does the clinical trials landscape look like right now?

A complete, up-to-date global clinical-trials inventory with status and readouts requires a live registry pull (e.g., ClinicalTrials.gov and other national registries). No such registry data is available in the input provided here. Under this constraint, no “current trials update” can be produced without risking factual gaps.

What can be stated from non-trial evidence?

• Flutamide is an established therapy with long-standing clinical use; new development programs are typically incremental (formulations, combinations, sequencing, and label expansions) rather than new mechanism-of-action candidates.
• Current market behavior for established oncology agents usually reflects: (1) patent/market exclusivity structure in each geography, (2) generic penetration, and (3) guideline positioning versus newer AR pathway inhibitors (abiraterone, enzalutamide, darolutamide).

No additional trial-specific claims are provided.

---

What is the market structure for flutamide?

How flutamide is positioned commercially

Flutamide is a mature small-molecule oncology drug. In most markets, supply is dominated by generics, which typically compress prices and reduce incremental revenue opportunities for new entrants unless they offer:

• differentiated formulations,
• supply guarantees,
• or geography where generic adoption lags.

Competitive set

In prostate cancer, AR-targeted competition is intense. Flutamide competes (directly or indirectly through standard-of-care sequencing) with:

• AR pathway inhibitors: abiraterone acetate, enzalutamide, darolutamide
• other hormonal approaches: GnRH analogs and antagonists, chemotherapy in later lines

Price and volume drivers

The primary commercial drivers for flutamide are:

• generic pricing and tender behavior by hospital systems,
• uptake of newer AR agents that may displace older AR antagonists in current treatment algorithms,
• patient access and reimbursement, which is often budget-driven for off-patent oncology drugs.

---

What is the patent and exclusivity context?

No patent-expiry, exclusivity, or ownership data is provided in the input. Without such data, a defensible patent cliff and payer-label linkage analysis cannot be constructed.

---

5-year market projection: what is the baseline and directionality?

A credible 5-year projection requires baseline revenue, unit volume, prescribing rates, current market size by geography, and assumptions about generic penetration and displacement by newer AR agents. None of those numerical inputs are available.

Under the constraint that only complete and accurate responses are allowed, no numeric forecast (CAGR, TAM, or year-by-year sales) is produced.

Directionality that follows from the product lifecycle (non-numeric)

• Revenue growth is typically low or negative for mature, off-patent oncology agents once generic competition saturates.
• Volume can remain stable in some geographies where entrenched prescribing and reimbursement support continued use.
• Value erosion is usually the bigger factor than volume contraction, driven by competitive generics and treatment shifts toward newer AR agents.

---

Business implications for R&D and investment decisions

Even without numeric forecasts, market logic for flutamide is consistent:

• If development targets a new competitive clinical claim, the bar is high because the AR inhibitor class has moved forward.
• If development targets formulation or access, the business case depends on supply-chain differentiation and payer acceptance in budget-constrained formularies.
• If development targets combination/sequence, value depends on demonstrating advantage in endpoints that matter to oncology practice and reimbursement.

---

Key Takeaways

• Flutamide is a mature AR antagonist used primarily in advanced prostate cancer, with commercial dynamics dominated by generic competition.
• A fully accurate “clinical trials update” with current statuses and readouts cannot be provided without a live registry dataset.
• A numeric market size and 5-year projection cannot be produced without baseline market figures and geography-specific adoption assumptions.
• Near-term business outcomes for flutamide products are likely driven more by pricing and access than by incremental clinical novelty.

---

FAQs

1) Is flutamide still prescribed for prostate cancer?

Yes. Flutamide remains in use in prostate cancer treatment pathways, though many markets shift earlier prescribing toward newer AR agents where access permits.

2) What tends to affect flutamide pricing most?

Generic tendering, hospital formularies, and payer reimbursement policies. Off-patent status typically leads to price pressure.

3) Does flutamide face direct competition from newer prostate cancer drugs?

Yes. Newer AR pathway inhibitors and other hormonal regimens compete through treatment sequencing and guideline preference.

4) What kind of new flutamide development can pass a commercial hurdle?

Programs that add measurable differentiation versus generics (formulation, access model, or clinically meaningful combination/sequence evidence) are the most plausible.

5) Can a precise 5-year forecast be produced without registry and market baseline inputs?

No. Numeric projections require current market baseline and geography-specific adoption and competitive displacement assumptions.

---

References

[1] U.S. National Library of Medicine. ClinicalTrials.gov. (database). https://clinicaltrials.gov/
[2] European Medicines Agency. Flutamide-related information in European regulatory databases. https://www.ema.europa.eu/
[3] FDA. Drug labels and product information for flutamide (where applicable). https://www.accessdata.fda.gov/