CLINICAL TRIALS PROFILE FOR AVODART

All Clinical Trials for AVODART

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00161421 ↗	Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone	Completed	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Phase 2	2005-03-01	The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.
NCT00161421 ↗	Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone	Completed	GlaxoSmithKline	Phase 2	2005-03-01	The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.
NCT00161421 ↗	Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone	Completed	National Institutes of Health (NIH)	Phase 2	2005-03-01	The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.
NCT00161421 ↗	Oral Androgens in Man-3 (ORAL T-3) Pharmacokinetics of Oral Testosterone	Completed	University of Washington	Phase 2	2005-03-01	The purpose of this study is to test the how the body absorbs and processes new forms of oral testosterone. Information gained during the study may help develop better forms of testosterone therapy in the future. We will be administering three drugs. Dutasteride is FDA approved to treat prostate enlargement. Lupron is approved for treatment of prostate cancer. Testosterone is approved for treatment of testicular insufficiency. They are being used in this study for "off-label" research purposes. This study will allow us to find out the effect of food on two formulations of testosterone taken by mouth, and the relative effect of food on testosterone absorption. Information from this study may be useful in treatment of men with low testosterone levels and the development of a male hormonal contraceptive.
NCT00244309 ↗	Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer	Completed	GlaxoSmithKline	Phase 3	2005-11-01	The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or another drug named dutasteride (Avodart), or a combination of these two drugs is effective in improving urinary symptoms and decreasing the rate of intermittent self-catheterization after prostate brachytherapy.
NCT00244309 ↗	Study of Tamsulosin and/or Dutasteride to Relieve Urinary Symptoms After Brachytherapy for Localized Prostate Cancer	Completed	Case Comprehensive Cancer Center	Phase 3	2005-11-01	The purpose of this study is to determine whether a drug named tamsulosin (Flomax), or another drug named dutasteride (Avodart), or a combination of these two drugs is effective in improving urinary symptoms and decreasing the rate of intermittent self-catheterization after prostate brachytherapy.
NCT00303446 ↗	Dutasteride to Treat Spinal and Bulbar Muscular Atrophy (SBMA)	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2006-03-01	This study will determine if the drug dutasteride can improve weakness, mobility, functioning, nerve function, and quality of life in patients with spinal and bulbar muscular atrophy (SBMA). Patients with this inherited disease have an abnormal androgen receptor protein. The male hormones testosterone and dihydrotestosterone (DHT) bind to this abnormal receptor, causing damage to nerve cells that innervate muscle and leading to weakness. Dutasteride decreases DHT production. Lowering DHT levels may decrease the harmful effects of DHT to the nerves and improve strength in people with SBMA. Males 18 years of age and older with SBMA who have neurological symptoms and can walk 100 feet (with or without assistive devices) may be eligible for this study. Candidates are screened with a blood test and a review of their medical records and genetic studies. Participants undergo the following procedures: - Blood and urine tests, history and physical examination, assessment of muscle strength - Quality-of-life questionnaire - Tests to assess functional abilities, such walking up steps, keeping the head up while lying down, and other measures - Nerve conduction study and motor unit number estimation to assess nerve damage. A probe placed on the skin delivers small electrical impulses and wires taped to the skin record the impulses. - Quantitative muscle testing to measure strength. The subject pushes and pulls levers attached to a gauge. Strength is recorded by a computer. - Medication. Participants are divided into two groups. One group is given the study drug, dutasteride; the other receives a placebo (sugar pill). All participants take their assigned medication once a day for 24 months. - Follow-up evaluations. Every 6 months for 2 years, participants return to NIH to repeat the tests described above to determine the effects of the dutasteride. Nerve and quantitative muscle testing is not done at the 6- and 18-month visits. - In addition to their follow-up appointments here at the NIH every 6 months, participants will also have blood tests and a physical examination performed after 3, 9, 15 and 21 months of treatment by the patient's local physician.

Clinical Trial Conditions for AVODART

Condition Name

Condition Name for AVODART
Intervention	Trials
Prostate Cancer	11
Prostatic Hyperplasia	6
Benign Prostatic Hyperplasia	5
Alcoholism	4

Condition MeSH

Condition MeSH for AVODART
Intervention	Trials
Prostatic Neoplasms	13
Prostatic Hyperplasia	12
Hyperplasia	10
Alcoholism	5

Clinical Trial Locations for AVODART

Trials by Country

Trials by Country for AVODART
Location	Trials
United States	56
Germany	10
Korea, Republic of	6
United Kingdom	6
Canada	5

Trials by US State

Trials by US State for AVODART
Location	Trials
Washington	7
Massachusetts	6
Connecticut	6
Illinois	3
Indiana	2

Clinical Trial Progress for AVODART

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for AVODART
Clinical Trial Phase	Trials
Completed	29
Not yet recruiting	2
Unknown status	2

Clinical Trial Sponsors for AVODART

Sponsor Name

Sponsor Name for AVODART
Sponsor	Trials
GlaxoSmithKline	17
University of Washington	5
UConn Health	5

Sponsor Type

Sponsor Type for AVODART
Sponsor	Trials
Other	36
Industry	21
NIH	12

AVODART (dutasteride) Clinical Trials Update, Market Analysis, and Exclusivity-Based Forecasts

Last updated: July 28, 2026

Avodart (dutasteride) is an established 5α-reductase inhibitor for benign prostatic hyperplasia (BPH). Published clinical evidence is mature, and ongoing development is best characterized as post-approval lifecycle work. Commercial demand is driven by U.S. and ex-U.S. BPH treatment penetration, payer adoption of generics, and access channel mix. Patent and exclusivity headwinds for branded Avodart are largely settled in most major markets because generic dutasteride is marketed. The forward outlook hinges on guideline adherence, switching economics, and residual brand share where branded pricing can persist.

What clinical trials updates exist for Avodart (dutasteride) in BPH?

Short answer: Publicly available development for Avodart is not dominated by late-stage, NDA-enabling phase 3 readouts in the way it would be for a new entrant. Most “updates” in the public record take the form of post-marketing studies, registry analyses, mechanistic work around 5α-reductase inhibition, and secondary endpoints (LUTS progression, prostate volume, PSA dynamics) rather than fresh pivotal trials for new indications.

Which trial questions does Avodart’s current evidence base still cover?

• Long-term BPH/LUTS outcomes linked to 5α-reductase inhibition, including symptom progression and acute urinary retention (AUR) risk.
• Biochemical monitoring relationships: PSA reduction magnitude and implications for prostate cancer risk stratification (contextual, not an indication expansion in standard product labeling).
• Comparisons of dutasteride-containing regimens versus placebo or alternative BPH drug classes in older studies.

What is the current practical status of “new” clinical development?

• No recurring pattern of large, brand-defining phase 3 programs for new Avodart indications is visible in the standard late-stage pipeline layer typically associated with major regulatory milestones.
• Development activity is more likely to be lifecycle: new formulations, real-world evidence, subpopulation analyses, adherence and persistence studies, and post-authorization safety monitoring.

How does this affect near-term competitive and regulatory strategy?

• For a branded forecast, the absence of a new, late-stage readout means growth is less about label expansion and more about market access, contracting, and switching resistance.
• For investors or licensors, the primary “trial risk” is not clinical failure in late-stage pivotal programs. It is commercial substitutability against generic dutasteride.

What is the market landscape for Avodart (dutasteride) for BPH?

Short answer: Avodart competes in a BPH/LUTS drug category that is heavily genericized and payer-driven. The active ingredient dutasteride is widely available as generics, which compresses branded pricing power and limits market share expansion for Avodart unless payers support brand-specific contracts, or prescribers remain anchored by dosing familiarity and patient history.

Core competitive set in BPH/LUTS

• Other 5α-reductase inhibitors: finasteride (often even more entrenched generically in many regions).
• Alpha-1 blockers: tamsulosin and others, with generic availability.
• Combination therapy strategies: dutasteride + an alpha blocker, typically as co-prescribing or branded fixed-dose products depending on country.
• Newer agents in urology pipelines tend to shift attention more than they displace entrenched generic categories in the near term.

Pricing and channel dynamics that matter

• Brand share vs generic volume: branded Avodart demand is typically maintenance-based, not acquisition-driven.
• Formulary access: BPH drugs are frequently subject to tiering and step therapy. Generic dutasteride generally sits on a lower tier.
• Contracting and rebates: branded performance depends on pharmacy benefit manager (PBM) contracting strength and how aggressively formularies prefer generics.

Where demand is most resilient for Avodart?

• Patients stabilized on dutasteride who prefer to avoid changes.
• Urologist prescribing habits where a “known response” to dutasteride is valued in the context of symptom trajectory and prostate volume reduction.
• Settings where formularies preserve historical brand coverage, at least temporarily, due to negotiated rates and medical management patterns.

When does Avodart lose exclusivity, and how does that shape generic entry risk?

Short answer: In most major markets, the branded exclusivity posture for dutasteride has already been diluted by generic entry. The incremental near-term generic entry risk for “Avodart brand” is therefore less about fresh Paragraph IV style events and more about continued penetration and further switch activity as contracts and price differentials evolve.

U.S. exclusivity and generic dynamics (conceptual timeline)

• Once formulation, method, and regulatory exclusivities expire and patents are no longer enforceable, generics compete through price and contracting.
• Even where some patents remain in force for specific claims (formulation or use), generic substitutions for the base active ingredient often still proceed if they can design around or if relevant patents are not asserted or are invalidated.

What does this mean for a forward forecast?

• Branded volume growth is unlikely to be structurally supported by exclusivity.
• A brand forecast should assume a “decline-to-flat” trajectory in mature geographies driven by ongoing brand-to-generic switching, with possible temporary stabilization due to contract cycles.

How does Avodart compare with finasteride and alpha blockers in BPH treatment?

Short answer: Dutasteride (Avodart) typically provides stronger androgen pathway suppression than finasteride, with common clinical framing around greater DHT suppression and the impact on prostate volume and symptom endpoints. Alpha blockers act faster symptomatically, while 5α-reductase inhibitors are slower but can reduce progression risk.

Practical comparative positioning

• Symptom relief: alpha blockers usually offer faster LUTS improvement.
• Disease modification signals: 5α-reductase inhibitors are associated with reduced progression measures in long-term evidence, especially for larger prostate volumes.
• Combination therapy rationale: adding an alpha blocker to a 5α-reductase inhibitor targets both symptom relief and progression risk.

Commercial implication

• In generic-dominant categories, comparative efficacy matters less than contracting. When both products are generic, formulary and copay design drives utilization.
• Where combination therapy is used, uptake depends on whether a payer treats it as a preferred pathway or an optional second-line.

What patents protect Avodart (dutasteride), and how strong is the patent estate?

Short answer: A complete, claim-level patent estate map is required for litigation-grade conclusions; without that curated dataset, only a high-level business framing can be supported. For mature drugs like Avodart with widespread generic dutasteride, the practical reality for market modeling is that core active-ingredient coverage is already outcompeted, leaving mostly incremental lifecycle claims (formulation, specific methods of use, or manufacturing) as the typical residual enforcement footprint.

How to model “patent strength” for Avodart brand forecasting

• Assume reduced ability to block generic dutasteride entry based on widespread market availability.
• Model residual patent value as influencing substitution speed rather than preventing substitution.
• Tie forecast sensitivity to contract timing and prescribing inertia, not to headline exclusivity.

Formulation and method-of-use: why it rarely changes the market

• Even when some secondary patents exist, generics can often compete with the base product unless specific claim scope blocks common generic manufacturing or labeling.
• Patent litigation, if any residual remains, usually affects brand share at the margins rather than stopping generic competition in an already mature class.

What is the Orange Book status of Avodart, and what does it imply for generic competition?

Short answer: Avodart’s active ingredient dutasteride is a long-established molecule with marketed generics in the U.S., implying that Orange Book listings for branded reference product no longer provide enforceable exclusivity that meaningfully restricts generic availability at scale.

How Orange Book status typically translates into commercial outcomes

• When Orange Book barriers are weak or expired, generics enter and gain volume quickly after approval.
• Any remaining listed patents, if present, usually shift outcomes to:
  • design-around strategies,
  • labeling carve-outs,
  • or litigation/settlement arrangements.

What patent litigation affects Avodart or dutasteride generics?

Short answer: For a mature active ingredient with widespread generic availability, litigation impacts most often appear as short-term pricing and market share perturbations rather than long duration barriers to generic supply.

How to incorporate litigation risk into forecasts

• Use litigation only as an event driver for quarter-to-quarter share, not as a structural driver for multi-year brand market size, unless the case involves a still-enforceable barrier to generic supply or requires product redesign.
• For Avodart, the commercial model generally assumes that the generic competitor set remains available.

How are settlements and licensing deals likely to influence Avodart revenue?

Short answer: In an already genericized market, settlements and licensing deals, where they exist historically, typically determine timing of generic uptake rather than sustaining long-term brand dominance.

Commercial modeling approach

• Treat any settlement effects as a schedule-shifting factor for switching rates.
• Forecast brand revenue using:
  • declining patient pool (switching),
  • residual protected subsegments (contract coverage),
  • and price compression.

What formulations are protected for Avodart, and what are generic substitution barriers?

Short answer: Brand formulation patents, if any, generally do not stop generic dutasteride tablets from entering unless the claimed features are necessary to generic bioavailability or manufacturing in a way that forces higher-cost redesign.

Typical substitution barriers in mature 5α-reductase inhibitor products

• Bioequivalence and formulation stability.
• Differences in dissolution profile and excipients, if claimed.
• Labeling restrictions tied to method-of-use claims, if any.

Commercial implication

• Generic substitution barriers, when they exist, affect speed and sometimes pharmacy confidence but rarely prevent long-term commoditization for a widely established oral tablet therapy.

Market projection for Avodart (dutasteride): base case, downside, and upside drivers

Short answer: The base case is ongoing branded share compression as generic dutasteride remains the low-cost default. Upside scenarios require temporary brand resilience from contracting or patient inertia; downside scenarios reflect acceleration in switch behavior through formulary tightening and enhanced PBM incentives for generics.

What determines the slope of brand decline?

1. Formulary positioning: tier placement and prior authorization for branded versus generic.
2. PBM rebate engineering: how actively branded Avodart is used to manage net pricing.
3. Prescriber inertia: patient persistence on dutasteride regimens once stabilized.
4. Combination therapy patterns: switching from monotherapy to combination regimens can either preserve or erode Avodart depending on how those combinations are covered.

Revenue modeling framework (practical)

• Start with addressable BPH LUTS treated population growth (modest over time).
• Apply class-level share constants for 5α-reductase inhibitors versus alpha blockers.
• Apply brand share decline due to generic penetration.
• Apply net price trend based on contracting intensity.

Projection drivers that override clinical updates

• No late-stage pivotal readouts are needed to change utilization in a generic market.
• Clinical updates influence switching only if they create clear, guideline-level preference shifts. In established BPH categories, guideline nuance changes utilization slowly.

Geographical outlook: where Avodart brand performance is likely strongest

Short answer: Brand performance is typically best in markets with:

• slower generic uptake due to policy or enforcement variability,
• sustained pricing support,
• and entrenched prescribing patterns.

High-level regional dynamics to consider

• U.S.: generics dominate; branded survival depends on contracting and rebates rather than exclusivity.
• EU/UK: similar commoditization patterns with country-specific uptake pacing.
• Emerging markets: brand may persist longer where generic penetration is slower or distribution networks remain brand-leaning.

Key Takeaways

• Avodart’s development profile is mature; “clinical trial updates” are mostly lifecycle and evidence reinforcement rather than new pivotal phase breakthroughs.
• Market outcomes are driven primarily by generic dutasteride competition, PBM/formulary contracting, and switching economics.
• Patent/exclusivity barriers that would have structurally protected the brand in the past are largely overtaken in major markets, shifting forecast focus from legal timelines to commercial execution.
• Future brand performance is most sensitive to net price and formulary placement, not new clinical signals.

FAQs

1) Is Avodart still prescribed in the U.S. despite generic dutasteride?
Yes. Brand prescribing persists in stabilized patients and where contracting maintains some access, but generic substitution is the main utilization driver.

2) Do new BPH guidelines change the outlook for dutasteride brands like Avodart?
Guideline updates can shift class preference, but in a commoditized class the strongest impact comes through payer policy and formulary design.

3) What is the main commercial risk to Avodart revenue over the next 2–3 years?
Accelerated brand-to-generic switching driven by formulary tightening, rebate changes, and pharmacy benefit design.

4) Are there any late-stage clinical trials that could extend Avodart’s exclusivity narrative?
In the public record of late-stage pipeline activity, no clear pattern of new NDA-enabling phase 3 programs is evident that would materially change exclusivity assumptions.

5) How do combination therapies affect Avodart market share?
Combination pathway coverage can either preserve 5α-reductase inhibitor use (if dutasteride combinations are preferred on formularies) or accelerate substitution away from branded Avodart if generic combinations win net pricing.

References

1. FDA. Approved Drug Products: Avodart (dutasteride) Drug Label and Regulatory Information. U.S. Food and Drug Administration.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (dutasteride; Avodart reference product). U.S. Food and Drug Administration.
3. EMA. Avodart (dutasteride) Product Information. European Medicines Agency.