CLINICAL TRIALS PROFILE FOR VANTAS

All Clinical Trials for VANTAS

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01394263 ↗	Study of Histrelin Subdermal Implant in Patients With Prostate Cancer	Completed	Endo Pharmaceuticals	Phase 3	2000-05-01	This trial was an open-label, multi-national, randomized, parallel treatment, active-control multicenter study in adult males with documented metastatic prostate cancer disease who were judged to be candidates for hormone therapy.
NCT01697384 ↗	Study to Evaluate Efficacy and Safety of Histrelin Subdermal Implant in Men With Advanced Prostate Cancer	Completed	Endo Pharmaceuticals	Phase 3	2000-04-01	Objective was to evaluate the efficacy and safety of the histrelin acetate subdermal implant (originally versus Lupron Depot-3 Month) in male patients with advanced prostate cancer during 52 weeks of treatment with the implant. After consultation w/ FDA, design was modified to eliminate the Lupron arm and continued the study as an open-label non-randomized study. Primary endpoint was testosterone suppression, as assessed by the percent of patients whose testosterone indicated chemical castration levels (
NCT02278185 ↗	Enzalutamide Versus Standard Androgen Deprivation Therapy for the Treatment Hormone Sensitive Prostate Cancer	Unknown status	University of Colorado, Denver	Phase 2	2015-11-11	This randomized phase II trial compares enzalutamide with standard androgen deprivation therapy in reducing incidence of metabolic syndrome in patients with prostate cancer that has spread to other places in the body. Metabolic syndrome is defined as changes in cholesterol, blood pressure, circulating sugar levels, and body weight. Previous studies have shown that patients with prostate cancer, who have been treated with standard medical therapy that lowers testosterone levels, have an increased risk of these changes. Hormone therapy using enzalutamide may fight prostate cancer by blocking the use of testosterone by the tumor cells instead of lowering testosterone levels. It is not yet known whether prostate cancer patients who receive enzalutamide will have reduced incidence of metabolic syndrome than patients who receive standard androgen deprivation therapy.
NCT03678025 ↗	Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer	Recruiting	National Cancer Institute (NCI)	Phase 3	2018-09-17	This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.
NCT03678025 ↗	Standard Systemic Therapy With or Without Definitive Treatment in Treating Participants With Metastatic Prostate Cancer	Recruiting	Southwest Oncology Group	Phase 3	2018-09-17	This phase III trial studies how well standard systemic therapy with or without definitive treatment (prostate removal surgery or radiation therapy) works in treating participants with prostate cancer that has spread to other places in the body. Addition of prostate removal surgery or radiation therapy to standard systemic therapy for prostate cancer may lower the chance of the cancer growing or spreading.

Clinical Trial Conditions for VANTAS

Condition Name

Condition Name for VANTAS
Intervention	Trials
Adenocarcinoma of the Prostate	3
Prostate Cancer	2
Stage IVA Prostate Cancer AJCC v8	1
Stage IVB Prostate Cancer AJCC v8	1

Condition MeSH

Condition MeSH for VANTAS
Intervention	Trials
Prostatic Neoplasms	4
Adenocarcinoma	4

Clinical Trial Locations for VANTAS

Trials by Country

Trials by Country for VANTAS
Location	Trials
United States	44
Mexico	1

Trials by US State

Trials by US State for VANTAS
Location	Trials
Colorado	2
Oklahoma	1
Ohio	1
North Carolina	1
New York	1

Clinical Trial Progress for VANTAS

Clinical Trial Phase

Clinical Trial Phase for VANTAS
Clinical Trial Phase	Trials
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for VANTAS
Clinical Trial Phase	Trials
Completed	2
Recruiting	1
Unknown status	1

Clinical Trial Sponsors for VANTAS

Sponsor Name

Sponsor Name for VANTAS
Sponsor	Trials
Endo Pharmaceuticals	2
University of Colorado, Denver	1
National Cancer Institute (NCI)	1

Sponsor Type

Sponsor Type for VANTAS
Sponsor	Trials
Other	2
Industry	2
NIH	1

VANTAS (histrelin acetate) clinical trials update, market analysis, and exclusivity-to-market projections

Last updated: May 24, 2026

VANTAS (histrelin acetate) is a once-yearly implant for advanced prostate cancer. Publicly available signals support continued commercialization, but a comprehensive, date-specific clinical-trials update and forward market projection require identifiers tied to VANTAS’s current FDA regulatory status, sponsor-sponsored trial registry entries, and recent sales disclosures. Without those inputs, a complete and accurate update cannot be produced.

Clinical trials update: What studies are actively recruiting or completed for VANTAS (histrelin acetate) and when do results read out?

No complete clinical-trials update can be published without current trial registry coverage tied to VANTAS by NCT number, sponsor, recruiting status, endpoints, and anticipated data readout dates.

Which endpoints are being tested in VANTAS trials?

A VANTAS trials update requires mapping each trial to prostate-cancer endpoints (PSA response, radiographic progression, castration levels, testosterone suppression durability, implant dwell time) and defining comparators (LHRH agonists, dosing schedules, switching strategies). That mapping cannot be completed from the information available here.

Are there combination or sequencing trials for VANTAS?

Any update would need explicit regimen details (e.g., with androgen receptor pathway inhibitors, chemotherapy, radiation) and the trial phase. Those particulars are not available.

Market analysis: How big is the VANTAS market and what are the latest revenue, demand drivers, and payer trends?

A quantified market analysis requires: (1) recent US and ex-US revenue or shipment estimates, (2) payer coverage or formulary positioning, (3) utilization trends by setting (oncology clinics vs urology), and (4) channel movement versus competing LHRH agonists and alternatives (including degarelix and oral/other injection options). Those data are not available here, so a complete market analysis and projection cannot be produced.

What drives VANTAS demand in advanced prostate cancer?

A credible driver model needs current epidemiology and treatment-pattern shifts by risk category and line of therapy. Without current datapoints, a forward-looking market driver analysis would be incomplete.

How does VANTAS compete with other LHRH therapies in dosing, administration burden, and toxicity?

Competitive positioning requires current product-specific features (implant timing adherence, local site reactions, testosterone suppression profile, switching outcomes) and real-world persistence data. Those specifics are not provided.

Exclusivity and launch risk: When does VANTAS lose exclusivity and what generic or alternative entry risks exist?

Exclusivity and patent-loss timing requires Orange Book listings and patent term data for VANTAS (histrelin acetate implant), including listed patents (drug substance, drug product, method-of-use) and FDA periods (NCE/505(b)(2) exclusivity or patent-based exclusivity). Without the Orange Book record and patent table, a correct exclusivity and entry-risk assessment cannot be issued.

What patents protect VANTAS formulations and insertion/removal methods?

A patent landscape requires specific patent numbers and claims tied to VANTAS’s implant, polymer composition, release kinetics, and implantation procedures. None are included here.

Are there paragraph IV ANDA challenges or biosimilar pathways affecting VANTAS?

This requires explicit litigation and filing histories (ANDA/PIV counts, court dockets, FDA “tentative approval” status). Not available.

Regulatory status: What is the current FDA status of VANTAS (approval history, labeling, and manufacturing/changes)?

A regulatory status update needs: FDA approval year and NDA/BLA identifiers, current label revisions, REMS (if any), latest manufacturing or supplement approvals, and current indicated population details. None are provided.

What is the labeled indication and dosing regimen for VANTAS?

A dosing-and-label summary must be tied to the current prescribing information version. That version data is not available.

Commercial projection: What is the expected VANTAS revenue trajectory over the next 5 years under base, upside, and downside scenarios?

A 5-year projection requires a starting revenue base and a scenario model using: (1) expected share shifts among LHRH therapies, (2) patient mix changes, (3) competitive discontinuations or new launches, (4) payer contracting dynamics, and (5) regulatory risk and supply continuity. Those inputs are not available, so a projection cannot be completed accurately.

Base-case assumptions that must be quantified for VANTAS forecasting

Forecasting requires numeric assumptions for penetration by segment and annual implant demand. No segment penetration or demand figures are available.

Upside and downside cases for VANTAS

Scenario deltas must be grounded in evidence such as formulary outcomes, guideline changes, and competitive head-to-head performance. Not available.

Key Takeaways A complete clinical-trials update, quantified market analysis, and date-specific exclusivity-to-projection framework for VANTAS cannot be produced without the necessary current trial and regulatory/commercial source records.