CLINICAL TRIALS PROFILE FOR TOREMIFENE CITRATE

All Clinical Trials for toremifene citrate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT02017197 ↗	Therapeutic Equivalence Between Branded and Generic WARFArin Tablets in Brazil	Completed	Federal University of São Paulo	Phase 4	2014-08-01	The purpose of this study is to assess whether the switch from branded to generic warfarin or between different generic warfarin tablets may cause fluctuation in the results of coagulation tests (International Normalized Rate, acronym INR) in patients, thus predisposing them to unnecessary risks.
NCT01214291 ↗	Efficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer	Withdrawn	Ipsen	Phase 3	2011-03-01	The purpose of this study is to determine whether Toremifene Citrate is effective in reducing the risk of bone fractures in men with prostate cancer who are on Androgen Deprivation Therapy.
NCT01214291 ↗	Efficacy and Safety Study of Toremifene Citrate for the Reduction in the Risk of New Bone Fracture Occurrences in Men With Prostate Cancer	Withdrawn	GTx	Phase 3	2011-03-01	The purpose of this study is to determine whether Toremifene Citrate is effective in reducing the risk of bone fractures in men with prostate cancer who are on Androgen Deprivation Therapy.
NCT00437359 ↗	Antiestrogen vs Aromatase Inhibitor After Adjuvant Chemotherapy for Breast Cancer	Terminated	Japan Breast Cancer Research Network	Phase 2	2007-05-01	To investigate the benefit of postoperative adjuvant therapy using sequential administration of the hormone, toremifene citrate (TOR) or anastrozole (ANA), after chemotherapy in breast cancer.
NCT00106691 ↗	Prostate Cancer Prevention Study for Men With High Grade PIN (Prostatic Intraepithelial Neoplasia)	Completed	GTx	Phase 3	2005-01-01	The purpose of this study is to determine if toremifene citrate is effective and safe in the prevention of prostate cancer in men who have been diagnosed with high grade prostatic intraepithelial neoplasia (PIN).
NCT00129142 ↗	Toremifene Citrate for Prevention of Bone Fractures in Men With Prostate Cancer on Androgen Deprivation Therapy	Completed	GTx	Phase 3	2003-10-01	Androgen deprivation therapy (ADT) treatment for prostate cancer decreases the natural hormone called testosterone. This type of therapy is very effective for the treatment of prostate cancer. However, one of the side effects is bone loss or thinning of the bones that can lead to osteoporosis and an increased risk of bone fractures (breaking of the bones). The purpose of the study is to determine whether or not the addition of toremifene citrate (the study drug) to therapy can prevent or decrease the number of bone fractures and to evaluate its impact on side effects associated with testosterone reduction therapy.

Clinical Trial Conditions for toremifene citrate

Condition Name

Condition Name for toremifene citrate
Intervention	Trials
Osteoporosis	1
Postmenopausal	1
Preneoplastic Conditions	1
Prostate Cancer	1

Condition MeSH

Condition MeSH for toremifene citrate
Intervention	Trials
Prostatic Neoplasms	3
Breast Neoplasms	2
Fractures, Bone	2
Atrial Fibrillation	1

Clinical Trial Locations for toremifene citrate

Trials by Country

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−

Trials by Country for toremifene citrate
Location	Trials
United States	59
Mexico	7
Canada	3
Brazil	1
Japan	1

Trials by US State

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−

Trials by US State for toremifene citrate
Location	Trials
Washington	3
Texas	2
Tennessee	2
Pennsylvania	2
Oregon	2

Clinical Trial Progress for toremifene citrate

Clinical Trial Phase

Clinical Trial Phase for toremifene citrate
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for toremifene citrate
Clinical Trial Phase	Trials
Completed	3
Withdrawn	2
Terminated	1

Clinical Trial Sponsors for toremifene citrate

Sponsor Name

Sponsor Name for toremifene citrate
Sponsor	Trials
GTx	3
Japan Breast Cancer Research Network	1
Ipsen	1

Sponsor Type

Sponsor Type for toremifene citrate
Sponsor	Trials
Industry	4
Other	4
NIH	1

Toremifene Citrate: Clinical Trials, Market Analysis, and Projections

Introduction

Toremifene citrate, a selective estrogen receptor modulator (SERM), has been under extensive research and development for various medical indications. This article will delve into the current status of clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Phase III Trials for Prostate Cancer and ADT Side Effects

Toremifene citrate, also known as ACAPODENE®, is being developed by Oncternal Therapeutics for two pivotal Phase III clinical trials. The first trial focuses on treating multiple serious side effects resulting from androgen deprivation therapy (ADT) in advanced prostate cancer patients. The second trial aims to prevent prostate cancer in high-risk men with precancerous prostate lesions known as high-grade prostatic intraepithelial neoplasia (high-grade PIN)[3].

Enrollment and Efficacy Endpoints

The trials have reached significant milestones, including the enrollment of 1,260 patients, with additional patients enrolled for substudies. Efficacy endpoints are being evaluated at 36 months after completion of enrollment, with an interim efficacy analysis planned after a certain number of cancer events have been recorded. If the interim results meet the prescribed statistical outcomes, Oncternal Therapeutics plans to file a New Drug Application (NDA) with the FDA[3].

Safety and Additional Trials

The clinical trials have shown favorable safety profiles for toremifene citrate. For instance, a proof-of-concept Phase II clinical trial in elderly men and postmenopausal women demonstrated a dose-dependent increase in total lean body mass and functional performance without serious adverse events[3].

Market Analysis

Global Market Size and Forecast

The global toremifene citrate market is expected to grow significantly over the forecast period of 2024-2031. Market reports indicate that the market size will be measured in USD million, with segments categorized by application (hospital pharmacies, retail pharmacies, online pharmacies), product (60mg/tablet, 40mg/tablet), and geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[2][5].

Key Market Segments

• Application: Hospital pharmacies, retail pharmacies, and online pharmacies are the primary segments. Hospital pharmacies are expected to dominate due to the high volume of prescriptions and the critical nature of the treatments.
• Product: The 60mg/tablet and 40mg/tablet formulations are the main products. The 60mg/tablet segment is anticipated to have a significant impact on the market due to its higher dosage and potentially greater efficacy[2][5].

Geographical Analysis

North America and Europe are expected to be the leading regions in the toremifene citrate market, driven by advanced healthcare infrastructure, higher awareness, and greater access to clinical trials. However, the Asia-Pacific region is also projected to grow rapidly due to increasing healthcare spending and a large patient population[2][5].

Market Drivers and Restraints

• Drivers: Increasing incidence of prostate cancer, growing awareness of hormone therapy, and advancements in clinical trials are key drivers.
• Restraints: Regulatory hurdles, competition from other SERMs, and potential side effects are significant restraints[5].

Market Projections

Growth Rate and CAGR

The global toremifene citrate market is expected to exhibit a robust Compound Annual Growth Rate (CAGR) over the forecast period. The CAGR is influenced by factors such as the increasing demand for effective treatments for prostate cancer and the side effects of ADT, as well as the expanding reach of healthcare services in emerging markets[5].

Regional Dominance

North America is anticipated to dominate the market during the forecast period due to its well-established healthcare system and the presence of major pharmaceutical companies. However, the Asia-Pacific region is expected to show significant growth, driven by economic development and an increasing focus on healthcare[2][5].

Competitive Landscape

Key companies such as Orion, Tianheng Pharma, Kyowa Kirin, and Schering Plough are profiled in market reports. These companies are actively involved in the development, manufacturing, and commercialization of toremifene citrate. Licensing agreements, such as the one between Oncternal Therapeutics and Ipsen Limited for European markets, also play a crucial role in the competitive landscape[2][3].

Key Takeaways

• Clinical Trials: Toremifene citrate is in advanced clinical trials for treating side effects of ADT and preventing prostate cancer.
• Market Growth: The global market is projected to grow significantly, driven by increasing demand and advancements in healthcare.
• Regional Focus: North America and Europe are current leaders, but the Asia-Pacific region is expected to grow rapidly.
• Competitive Landscape: Major pharmaceutical companies are actively involved in the development and commercialization of toremifene citrate.

FAQs

What are the primary indications for toremifene citrate in current clinical trials?

Toremifene citrate is being developed primarily for treating the side effects of androgen deprivation therapy (ADT) in advanced prostate cancer patients and for preventing prostate cancer in high-risk men with precancerous prostate lesions[3].

Which regions are expected to dominate the toremifene citrate market?

North America and Europe are currently the dominant regions, but the Asia-Pacific region is expected to show significant growth during the forecast period[2][5].

What are the key drivers of the toremifene citrate market?

Key drivers include the increasing incidence of prostate cancer, growing awareness of hormone therapy, and advancements in clinical trials[5].

What are the potential restraints for the toremifene citrate market?

Regulatory hurdles, competition from other SERMs, and potential side effects are significant restraints for the market[5].

Which companies are major players in the toremifene citrate market?

Companies such as Orion, Tianheng Pharma, Kyowa Kirin, and Schering Plough are major players in the development and commercialization of toremifene citrate[2].

Sources

1. UCSF Breast Cancer Trial: Tamoxifen Citrate or Letrozole With or Without Bevacizumab in Treating Women With Stage IIIB or Stage IV Breast Cancer. ClinicalTrials.gov.
2. Global Toremifene Citrate CAS 89778 27 8 Market Size And Forcast: Market Research Intellect.
3. Oncternal Therapeutics, Inc.: Investor Presentation. Oncternal Therapeutics, Inc.
4. FDA Provides PDUFA Target Agency Action Date For GTx, Inc.'s Toremifene 80 mg NDA: BioSpace.
5. Global Toremifene Citrate CAS 89778 27 8 Market Report 2024: Cognitive Market Research.