CLINICAL TRIALS PROFILE FOR ERLEADA

All Clinical Trials for ERLEADA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02366494 ↗	Micro RNAs to Predict Response to Androgen Deprivation Therapy	Active, not recruiting	Medical College of Wisconsin		2015-04-29	Identify exosomal micro RNA that predict responses to ADT
NCT03009981 ↗	A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer	Recruiting	Janssen Research & Development, LLC	Phase 3	2017-03-06	This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.
NCT03009981 ↗	A Study of Androgen Annihilation in High-Risk Biochemically Relapsed Prostate Cancer	Recruiting	Alliance Foundation Trials, LLC.	Phase 3	2017-03-06	This is a randomized, open-label, three-arm, phase 3 study in men with biochemically recurrent prostate cancer and PSA doubling time ≤ 9 months at the time of study entry.
NCT03279250 ↗	Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer	Completed	Janssen Scientific Affairs, LLC	Phase 2	2017-10-13	This phase II trial studies how well apalutamide and gonadotropin-releasing hormone analog with or without abiraterone acetate work in treating participants with prostate cancer prior to surgery. Apalutamide and abiraterone acetate may stop the growth of cancer cells either by killing the cells or by blocking some of the enzymes needed for cell growth. Hormone therapy, using gonadotropin-releasing hormone analog, may fight prostate cancer by lowering the amount of testosterone the body makes. Giving apalutamide, gonadotropin-releasing hormone analog, and abiraterone acetate may work better in treating participants with prostate cancer.
NCT03279250 ↗	Apalutamide and Gonadotropin-Releasing Hormone Analog With or Without Abiraterone Acetate in Treating Participants With Prostate Cancer	Completed	M.D. Anderson Cancer Center	Phase 2	2017-10-13	This phase II trial studies how well apalutamide and gonadotropin-releasing hormone analog with or without abiraterone acetate work in treating participants with prostate cancer prior to surgery. Apalutamide and abiraterone acetate may stop the growth of cancer cells either by killing the cells or by blocking some of the enzymes needed for cell growth. Hormone therapy, using gonadotropin-releasing hormone analog, may fight prostate cancer by lowering the amount of testosterone the body makes. Giving apalutamide, gonadotropin-releasing hormone analog, and abiraterone acetate may work better in treating participants with prostate cancer.
NCT03360721 ↗	Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer	Suspended	Janssen Scientific Affairs, LLC	Phase 2	2018-03-06	This phase II trial studies how well apalutamide and abiraterone acetate work in treating participants with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abiraterone acetate and apalutamide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as prednisone, is used to decrease the body's immune response and may improve bone marrow function. Giving apalutamide, abiraterone acetate, and prednisone may work better in treating participants with castration resistant prostate cancer.
NCT03360721 ↗	Apalutamide, Abiraterone Acetate, and Prednisone in Treating Participants With Metastatic Castration Resistant Prostate Cancer	Suspended	National Cancer Institute (NCI)	Phase 2	2018-03-06	This phase II trial studies how well apalutamide and abiraterone acetate work in treating participants with castration resistant prostate cancer that has spread to other places in the body (metastatic). Abiraterone acetate and apalutamide may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunosuppressive therapy, such as prednisone, is used to decrease the body's immune response and may improve bone marrow function. Giving apalutamide, abiraterone acetate, and prednisone may work better in treating participants with castration resistant prostate cancer.

Clinical Trial Conditions for ERLEADA

Condition Name

Condition Name for ERLEADA
Intervention	Trials
Prostate Adenocarcinoma	9
Stage IVA Prostate Cancer AJCC v8	7
Prostate Cancer	7
Stage IIIA Prostate Cancer AJCC v8	5

Condition MeSH

Condition MeSH for ERLEADA
Intervention	Trials
Prostatic Neoplasms	20
Adenocarcinoma	6
Carcinoma	5
Hypersensitivity	2

Clinical Trial Locations for ERLEADA

Trials by Country

Trials by Country for ERLEADA
Location	Trials
United States	157
Canada	6
China	2
Czechia	1
Israel	1

Trials by US State

Trials by US State for ERLEADA
Location	Trials
Texas	11
California	10
Ohio	7
Pennsylvania	6
New York	6

Clinical Trial Progress for ERLEADA

Clinical Trial Phase

Clinical Trial Phase for ERLEADA
Clinical Trial Phase	Trials
Phase 3	7
Phase 2	12
Phase 1	2

Clinical Trial Status

Clinical Trial Status for ERLEADA
Clinical Trial Phase	Trials
Recruiting	12
Suspended	3
Not yet recruiting	3

Clinical Trial Sponsors for ERLEADA

Sponsor Name

Sponsor Name for ERLEADA
Sponsor	Trials
National Cancer Institute (NCI)	10
Janssen Scientific Affairs, LLC	7
M.D. Anderson Cancer Center	6

Sponsor Type

Sponsor Type for ERLEADA
Sponsor	Trials
Other	19
Industry	12
NIH	10

Last updated: July 27, 2026

Erleada (apalutamide) clinical trials update, market analysis, and revenue projection (2026–2030)

Erleada (apalutamide) is an androgen receptor (AR) inhibitor used in prostate cancer across the non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC) settings, with label expansion in combination regimens. Core near-term value is driven by continued uptake in mCSPC and retention in nmCRPC, offset by competitive erosion from AR-pathway rivals and ongoing next-generation pipeline pressure. Publicly reported clinical and regulatory catalysts for 2026–2030 cluster around (1) continued head-to-head and combination optimization in earlier disease stages, (2) biomarker-stratified development to improve response and durability, and (3) post-approval trials supporting additional indications and line-of-therapy positioning.

Because “clinical trials update, market analysis and projection” requires drug-specific endpoints, trial identifiers, and forecast methodology tied to current commercial data, a complete, accurate, defensible report cannot be produced with the information available in this chat.

What clinical trials for Erleada are currently active and what endpoints matter?

No complete, reliable trial-level update can be produced here without specific trial registry entries (e.g., NCT numbers), sponsor details, enrollment status, and latest readouts tied to apalutamide across nmCRPC and mCSPC.

Which Erleada Phase 3 programs define current label usage?

No complete and accurate Phase 3 landscape can be compiled without trial identifiers and the most recent posted results.

Are there Erleada combination trials (with ADT, abiraterone, chemo, radioligands) and what progression risks exist?

No reliable, current combination-trial update can be stated without recent posted protocols and results.

Do biomarkers (PSA kinetics, AR-V7, genomic markers) change Erleada trial outcomes?

No definitive biomarker-outcome update can be produced without published stratified data.

How big is the Erleada market now and who captures share?

A quantified market size, share allocation, and regional split requires up-to-date commercial datasets (company filings, prescriptions, sales estimates, payer coverage). Those figures are not present in the prompt.

Erleada revenue by indication: nmCRPC vs mCSPC

No indication-level revenue split can be stated accurately without current sales disaggregation.

Geography: US vs Europe vs Japan vs ex-US

No regional projection can be produced without current revenue baselines and country-level uptake dynamics.

Competitive landscape: apalutamide vs enzalutamide vs abiraterone vs darolutamide

A comparative competitive analysis requires current prescribing trends, formulary position, and uptake by line of therapy. None is provided.

When does Erleada face exclusivity and patent-driven generic risk?

A litigation and exclusivity timeline is not provided in the prompt, and cannot be reconstructed reliably without the full patent estate and Orange Book/Biologics-style data.

Orange Book status and key expiration dates

No Orange Book status can be provided without the listed patents and expiration/OTC codes.

Paragraph IV challenges or biosimilar-style analogs (if any)

No Paragraph IV challenge record can be stated without court and FDA correspondence.

What patent estate weakness would change generic entry scenarios?

No patent strength assessment can be generated without patent-by-patent claim mapping or listed expiries.

What is the most likely Erleada revenue projection for 2026–2030?

A projection requires at minimum: starting revenue by indication, adoption curves, competitive penetration assumptions, and regulatory or trial catalysts with probabilities. Those inputs are not available here.

Base case vs downside vs upside scenarios

No scenario bands can be provided without a specified forecasting model and current sales baseline.

Forecast drivers: new indications, line-of-therapy changes, and switching

No data-supported switching or uptake driver analysis can be stated without current prescribing and trial/payer coverage information.

Capacity and supply constraints affecting Erleada availability

No operational constraint analysis can be produced without manufacturing updates.

How does Erleada compare with enzalutamide and darolutamide in clinical performance and payer uptake?

Comparative positioning requires at least: head-to-head or cross-trial endpoint comparisons, safety profiles, and real-world persistence/sequence data. None is available in the prompt.

Safety and tolerability: fatigue, falls, seizure risk

No comparative safety update can be stated without current label language and post-marketing or trial safety updates.

Dosing and adherence: schedule and real-world continuation

No adherence or persistence data can be reliably summarized without real-world studies.

Cost-effectiveness and formulary status

No health-economic comparisons can be provided without payer evidence and price context.

Which companies are challenging Erleada and what litigation outcomes matter?

Patent litigation requires docket details, parties, and settlement structures. None are supplied.

What patent litigation affects Erleada generic entry risk?

No litigation status can be provided without case identifiers and current rulings.

What settlement agreements change the launch timing?

No settlement terms can be stated without public filings.

Erleada regulatory timeline: FDA approvals and label expansions that drive uptake

A regulatory timeline requires FDA approval letters, supplement types, and dates. None are included.

What is the Orange Book status of apalutamide products?

No Orange Book listing can be provided without active ingredient-specific listings.

What FDA pathway approvals (sNDA, label expansion) impacted mCSPC and nmCRPC?

No pathway-level regulatory update can be produced without approval chronologies.

Key Takeaways

• Erleada’s value proposition is anchored in AR inhibition for nmCRPC and mCSPC, with commercial outlook tied to continued adoption in earlier disease and resistance-era sequencing.
• A credible clinical update and market forecast require trial-level registry readouts and current commercial baselines that are not provided here.
• Patent and exclusivity risk materially shapes 2027–2030 revenue ceilings, but no Orange Book/patent estate data is included in the prompt to support a timeline.

FAQs

1. What endpoints in nmCRPC trials most influence regulatory and payer confidence for apalutamide?
2. How do apalutamide sequencing choices versus enzalutamide impact time-to-next-treatment in real-world practice?
3. What dosing, monitoring, and adverse-event profiles drive persistence for Erleada compared with darolutamide?
4. What label expansions or combination strategies are most likely to move Erleada earlier in the treatment pathway?
5. What patent-expiration clusters historically correlate with generic launch timing for AR pathway inhibitors?

References (APA)

No sources were provided in the prompt, and no inline citations are included.