CLINICAL TRIALS PROFILE FOR TRELSTAR

All Clinical Trials for Trelstar

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01467882 ↗	Efficacy, Safety, and Pharmacokinetics (PK) of Triptorelin 6-month Formulation in Patients With Central Precocious Puberty	Completed	Debiopharm International SA	Phase 3	2012-04-01	The study will investigate the efficacy, safety and pharmacokinetics of triptorelin 22.5 mg 6-month formulation in 44 patients suffering from central precocious puberty. The total study duration per patient will be 12 months (48 weeks).
NCT02090114 ↗	RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)	Recruiting	National Cancer Institute (NCI)	Phase 2	2014-06-01	Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide, abiraterone or castration-only therapy in men with metastatic CRPC who previously progressed on one of these forms of therapy. The study will enroll four cohorts of patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A; n=30); men with metastatic CRPC who have progressed on abiraterone acetate (Cohort B; n=30); men with metastatic CRPC who have progressed on first line castration-only therapy (Cohort C; n=30); men with metastatic CRPC with inactivating somatic or germline mutations in ≥2 of the genes TP53, PTEN, or RB1 (Cohort D; n=20).
NCT02090114 ↗	RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)	Recruiting	Sidney Kimmel Comprehensive Cancer Center	Phase 2	2014-06-01	Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide, abiraterone or castration-only therapy in men with metastatic CRPC who previously progressed on one of these forms of therapy. The study will enroll four cohorts of patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A; n=30); men with metastatic CRPC who have progressed on abiraterone acetate (Cohort B; n=30); men with metastatic CRPC who have progressed on first line castration-only therapy (Cohort C; n=30); men with metastatic CRPC with inactivating somatic or germline mutations in ≥2 of the genes TP53, PTEN, or RB1 (Cohort D; n=20).
NCT02090114 ↗	RE-sensitizing With Supraphysiologic Testosterone to Overcome REsistance (The RESTORE Study)	Recruiting	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Phase 2	2014-06-01	Single-arm, single site, open label study of the effects of parenteral testosterone followed by enzalutamide, abiraterone or castration-only therapy in men with metastatic CRPC who previously progressed on one of these forms of therapy. The study will enroll four cohorts of patients: men with metastatic CRPC who have progressed on enzalutamide (Cohort A; n=30); men with metastatic CRPC who have progressed on abiraterone acetate (Cohort B; n=30); men with metastatic CRPC who have progressed on first line castration-only therapy (Cohort C; n=30); men with metastatic CRPC with inactivating somatic or germline mutations in ≥2 of the genes TP53, PTEN, or RB1 (Cohort D; n=20).

Clinical Trial Conditions for Trelstar

Condition Name

Condition Name for Trelstar
Intervention	Trials
Prostate Cancer	6
Castration Resistant Metastatic Prostate Cancer	2
Prostate Adenocarcinoma	2
Stage IIA Prostate Cancer	1

Condition MeSH

Condition MeSH for Trelstar
Intervention	Trials
Prostatic Neoplasms	10
Adenocarcinoma	2
Puberty, Precocious	1

Clinical Trial Locations for Trelstar

Trials by Country

Trials by Country for Trelstar
Location	Trials
United States	45
Canada	5
Mexico	1
Chile	1

Trials by US State

Trials by US State for Trelstar
Location	Trials
California	6
Maryland	5
New Jersey	3
District of Columbia	3
Pennsylvania	2

Clinical Trial Progress for Trelstar

Clinical Trial Phase

Clinical Trial Phase for Trelstar
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	1
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Trelstar
Clinical Trial Phase	Trials
Recruiting	4
Active, not recruiting	2
Terminated	2

Clinical Trial Sponsors for Trelstar

Sponsor Name

Sponsor Name for Trelstar
Sponsor	Trials
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	5
United States Department of Defense	3
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for Trelstar
Sponsor	Trials
Other	13
Industry	5
NIH	3

TRELSTAR: Clinical Trials, Market Analysis, and Projections

Introduction

TRELSTAR, a brand name for the drug triptorelin pamoate, is a gonadotropin-releasing hormone (GnRH) agonist used primarily in the palliative treatment of advanced prostate cancer. Here, we will delve into the clinical trials, market analysis, and future projections for TRELSTAR.

Clinical Trials Overview

Study Design and Objectives

TRELSTAR has been evaluated in several clinical trials to assess its efficacy and safety in patients with advanced prostate cancer.

• 3.75 mg Formulation: A 9-month, multicenter, parallel-group, double-blind, randomized, controlled clinical trial compared TRELSTAR 3.75 mg to leuprolide acetate in patients with advanced (stage C/D) prostate cancer. The primary efficacy endpoints included the achievement of castration by Day 29 and maintenance of castration from Day 57 through Day 253[1][3][5].

• 11.25 mg Formulation: Another 9-month trial compared TRELSTAR 11.25 mg (given every 12 weeks) to TRELSTAR 3.75 mg (given every 28 days). The primary efficacy endpoints were similar to the 3.75 mg trial[1][5].

• 22.5 mg Formulation: A non-comparative trial evaluated patients receiving TRELSTAR 22.5 mg every 24 weeks for a total of two doses. The primary efficacy endpoints included achievement of castration by Day 29 and maintenance of castration from Day 57 through Day 337[1][5].

Efficacy Outcomes

The clinical trials demonstrated high efficacy of TRELSTAR in achieving and maintaining medical castration.

• By Day 29, 91.2% to 97.7% of patients achieved medical castration (testosterone levels < 50 ng/dL).
• By the end of the studies, 93.3% to 96.2% of patients remained in medical castration[5].

Adverse Reactions

Common adverse reactions associated with TRELSTAR include hot flushes, skeletal pain, impotence, headache, and in some formulations, edema in legs, leg pain, erectile dysfunction, and testicular atrophy. Local reactions at the injection site and allergic reactions may also occur[1][3].

Market Analysis

Current Market Size and Growth

The global triptorelin market, which includes TRELSTAR, was valued at approximately US$ 955.50 million in 2023. This market is projected to grow at a Compound Annual Growth Rate (CAGR) of 5% from 2023 to 2033, reaching US$ 1,556.41 million by 2033[2][4].

Drivers of Market Growth

Several factors are driving the growth of the triptorelin market:

• Increasing Prevalence of Endocrine Disorders: Conditions such as endometriosis, prostate cancer, and central precocious puberty are becoming more prevalent, increasing the demand for triptorelin.
• Awareness and Treatment Choices: Increased awareness about available treatment options and the expanding number of hospitals and pharmacies are contributing to market growth.
• Government Initiatives: Government efforts to raise awareness about endocrine disorders are also fueling market expansion[2].

Market Challenges

Despite the growth, the market faces some challenges:

• High Cost of Therapy: The high cost of triptorelin therapy is a significant barrier to market growth.
• Adverse Effects: The negative effects associated with triptorelin use, such as hot flushes and skeletal pain, can limit market growth[2].

Geographical Distribution

North America holds the largest market share for triptorelin, including TRELSTAR. The market is also expanding in other regions due to strategic partnerships and inorganic expansion tactics by pharmaceutical manufacturers[2].

Market Projections

Future Applications

Research and development are ongoing to explore the potential future use of triptorelin in various therapeutic indications, including breast cancer and HIV. These developments are expected to further drive market growth[2].

Technological Advancements

Advancements in technology are expected to lower production costs, enhance the drug's efficacy and safety, and improve marketing and distribution strategies. This could lead to increased market adoption and expansion[2].

Competitive Landscape

Key competitors in the triptorelin market are expanding their product portfolios through inorganic expansion techniques. For example, Debiopharm Group's agreement with Allergan and Amneal Pharmaceuticals' partnership with Orion Corporation are significant moves to enhance market presence[2].

Key Takeaways

• Clinical Efficacy: TRELSTAR has demonstrated high efficacy in achieving and maintaining medical castration in patients with advanced prostate cancer.
• Market Growth: The global triptorelin market is projected to grow at a CAGR of 5% from 2023 to 2033, driven by increasing prevalence of endocrine disorders and government initiatives.
• Challenges: High costs and adverse effects are significant challenges to market growth.
• Future Applications: Ongoing research and technological advancements are expected to expand the market further.

FAQs

What is TRELSTAR used for?

TRELSTAR is used for the palliative treatment of advanced prostate cancer. It is a GnRH agonist that helps reduce testosterone levels, which can slow the growth of prostate cancer cells[3].

How effective is TRELSTAR in achieving medical castration?

TRELSTAR has been shown to achieve medical castration in 91.2% to 97.7% of patients by Day 29, with 93.3% to 96.2% maintaining castration by the end of the studies[5].

What are the common adverse reactions associated with TRELSTAR?

Common adverse reactions include hot flushes, skeletal pain, impotence, headache, and in some formulations, edema in legs, leg pain, erectile dysfunction, and testicular atrophy[1][3].

What is the projected market size of the triptorelin market by 2033?

The global triptorelin market is projected to reach US$ 1,556.41 million by 2033, growing at a CAGR of 5% from 2023 to 2033[2][4].

Which region holds the largest market share for triptorelin?

North America holds the largest market share for triptorelin, including TRELSTAR[2].

Sources

1. Trelstar - Efficacy. Trelstar.com.
2. Triptorelin Market Size, Growth, Trends & Forecast 2033. Future Market Insights.
3. Trelstar - Drug Information from Guideline Central. Guideline Central.
4. TRELSTAR Drug Patent Profile. DrugPatentWatch.
5. Trelstar: Dosage, side effects, alternatives, and more. Medical News Today.