CLINICAL TRIALS PROFILE FOR MACITENTAN; TADALAFIL

All Clinical Trials for Macitentan; Tadalafil

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02558231 ↗	The Efficacy and Safety of Initial Triple Versus Initial Dual Oral Combination Therapy in Patients With Newly Diagnosed Pulmonary Arterial Hypertension	Completed	Actelion	Phase 3	2016-05-01	The objective of this clinical trial is to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.
NCT02968901 ↗	Clinical Study Evaluating the Effects of First-line Oral cOmbination theraPy of maciTentan and tadalafIl in Patients With Newly Diagnosed pulMonary Arterial Hypertension (OPTIMA)	Terminated	Actelion	Phase 4	2015-09-01	The purpose of the study is to document the effect of first line dual oral combination therapy with macitentan 10mg and tadalafil 40mg on pulmonary vascular resistance (PVR) in treatment-naïve patients with newly diagnosed pulmonary arterial hypertension (PAH).
NCT03215966 ↗	A Study to Compare the Macitentan-tadalafil Fixed Dose Combination Tablet Relative to the Concomitant Administration of the Reference Tablets of Macitentan and Tadalafil in Healthy Subjects	Completed	Actelion	Phase 1	2017-08-07	The primary objective of this study is to demonstrate that macitentan and tadalafil administered as a fixed combination is bioequivalent to both compounds given as separate tablets given at the same doses as in the fixed combination (i.e. whether the amounts of macitentan and tadalfil which reach the blood are comparable).
NCT03904693 ↗	Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)	Recruiting	Almac Clinical Technologies	Phase 3	2019-07-29	Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcomes. Reducing the pill/tablet count and frequency has a major impact on patients' adherence to therapies and therefore the observed clinical outcomes. One way to simplify treatment is to use fixed-dose combination (FDC) products that combine multiple treatments targeting different pathways into a single tablet. This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.
NCT03904693 ↗	Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)	Recruiting	Covance	Phase 3	2019-07-29	Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcomes. Reducing the pill/tablet count and frequency has a major impact on patients' adherence to therapies and therefore the observed clinical outcomes. One way to simplify treatment is to use fixed-dose combination (FDC) products that combine multiple treatments targeting different pathways into a single tablet. This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.
NCT03904693 ↗	Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH)	Recruiting	Frontier Science Foundation	Phase 3	2019-07-29	Combination therapy in pulmonary arterial hypertension (PAH) has been the subject of active investigation for more than a decade, with the benefit of targeting different pathways known to be involved in the pathogenesis of the disease. Adherence to prescribed therapy has an impact on clinical outcomes. Reducing the pill/tablet count and frequency has a major impact on patients' adherence to therapies and therefore the observed clinical outcomes. One way to simplify treatment is to use fixed-dose combination (FDC) products that combine multiple treatments targeting different pathways into a single tablet. This study aims to demonstrate that the FDC of macitentan and tadalafil is more effective than therapy with 10 mg of macitentan alone or 40 mg of tadalafil alone. This phase 3 study will evaluate the efficacy and safety at 16 weeks of an FDC (macitentan 10 mg and tadalafil 40 mg) against these two PAH-approved therapies given as monotherapy to further confirm the added value of the FDC.

Clinical Trial Conditions for Macitentan; Tadalafil

Condition Name

Condition Name for Macitentan; Tadalafil
Intervention	Trials
Healthy	4
Pulmonary Arterial Hypertension	2
Healthy Subjects	1
Pulmonary Arterial Hypertension (PAH) (WHO Group 1 PH)	1

Condition MeSH

Condition MeSH for Macitentan; Tadalafil
Intervention	Trials
Pulmonary Arterial Hypertension	3
Hypertension	3
Familial Primary Pulmonary Hypertension	3

Clinical Trial Locations for Macitentan; Tadalafil

Trials by Country

Trials by Country for Macitentan; Tadalafil
Location	Trials
United States	38
Canada	7
Germany	3
Belgium	3
Australia	2

Trials by US State

Trials by US State for Macitentan; Tadalafil
Location	Trials
Arizona	3
Texas	2
Pennsylvania	2
Ohio	2
Michigan	2

Clinical Trial Progress for Macitentan; Tadalafil

Clinical Trial Phase

Clinical Trial Phase for Macitentan; Tadalafil
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 1	5

Clinical Trial Status

Clinical Trial Status for Macitentan; Tadalafil
Clinical Trial Phase	Trials
Completed	5
Recruiting	2
Terminated	1

Clinical Trial Sponsors for Macitentan; Tadalafil

Sponsor Name

Sponsor Name for Macitentan; Tadalafil
Sponsor	Trials
Actelion	6
Janssen Research & Development, LLC	2
Almac Clinical Technologies	1

Sponsor Type

Sponsor Type for Macitentan; Tadalafil
Sponsor	Trials
Industry	9
Other	3

Macitentan and Tadalafil: Clinical Trials, Market Analysis, and Projections

Introduction to Macitentan and Tadalafil

Macitentan and tadalafil are two medications that have been at the forefront of treating pulmonary hypertension, a rare and life-threatening condition characterized by elevated blood pressure in the pulmonary circulation. Here, we will delve into the latest clinical trials, market analysis, and projections for these drugs.

Clinical Trials Update

MACiTEPH Study

The Phase 3 MACiTEPH study, conducted by Janssen Pharmaceutical Companies, aimed to evaluate the efficacy and safety of macitentan 75 mg in patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH). However, the study was halted due to futility, as recommended by the independent data monitoring committee following a pre-planned interim analysis. No new safety signals were observed, and this decision does not impact other commercialized pulmonary hypertension medicines[1].

UNISUS Study

The ongoing Phase 3 UNISUS study is designed to establish the superiority of a 75 mg dose of macitentan over the currently available 10 mg dose in patients with pulmonary arterial hypertension (PAH). This study is continuing as planned and aims to compare the efficacy, safety, and tolerability of the higher dose in a broad patient population[1][5].

A DUE Study

The Phase 3 A DUE study has shown promising results for the investigational single tablet combination therapy of macitentan 10 mg and tadalafil 40 mg. This combination therapy significantly improved pulmonary hemodynamics compared to monotherapy in patients with PAH. The study demonstrated a reduction of 29% in pulmonary vascular resistance compared to macitentan alone and a 28% reduction compared to tadalafil alone[3][4].

Market Analysis

Market Drivers

The market for macitentan tablets is driven by several factors:

• Higher disposable income levels have increased accessibility to advanced medical treatments.
• Government initiatives and funding for rare disease research have boosted demand for targeted therapies like macitentan.
• The expansion of distribution channels has made macitentan tablets more accessible to patients globally[2].

Market Restraints

Despite the positive drivers, there are several restraints:

• The high cost of macitentan tablets and lack of reimbursement in some regions limit demand.
• Stringent regulatory requirements can delay product launches in certain areas.
• Limited patient awareness and acceptance also hinder widespread adoption[2].

Market Opportunities

Several opportunities are emerging:

• Expanding healthcare infrastructure in emerging markets is enhancing the penetration of macitentan tablets.
• Collaborations between pharmaceutical companies and research institutes are driving innovations.
• Strategic pricing and reimbursement policies are expected to boost the adoption of macitentan tablets[2].

Market Projections

Market Size and Growth

The macitentan tablets market is expected to grow significantly over the next few years, driven by increasing demand for targeted therapies in pulmonary hypertension. Higher disposable incomes and government support for rare disease research are key factors contributing to this growth[2].

Competitive Landscape

The competitive landscape is characterized by a few key players, including Janssen Pharmaceutical Companies. The market is highly competitive, with companies focusing on product innovation, strategic partnerships, and regulatory approvals to gain market share. The approval of the single tablet combination therapy of macitentan and tadalafil, known as Yuvanci®, by the European Commission is a significant development in this space[4].

Product Development and Innovation

Ongoing research and development efforts are crucial for the growth of the macitentan market. The Phase 3 A DUE study's positive results and the ongoing UNISUS study are examples of these efforts. Innovations such as the single tablet combination therapy are expected to improve patient outcomes and compliance, further driving market growth[3][5].

Impact on Pulmonary Hypertension Treatment

Single Tablet Combination Therapy

The approval of Yuvanci®, the single tablet combination therapy of macitentan and tadalafil, represents a significant advancement in the treatment of PAH. This therapy offers a convenient and effective option for patients, reducing the complexity of managing multiple medications.

"These results, along with the consistent efficacy across different patient subgroups in the study are encouraging. This single tablet combination therapy represents an important new treatment option for many people living with PAH, who, until now, had no single tablet option available," said Professor Ekkehard Grunig, MD, Professor of Internal Medicine, Heidelberg University[4].

Patient Outcomes

The improved pulmonary hemodynamics and reduced pulmonary vascular resistance observed in clinical trials translate to better patient outcomes. These advancements are critical in managing a condition that can lead to right heart failure and death if not properly treated.

Key Takeaways

• The MACiTEPH study was halted due to futility, but other studies like UNISUS and A DUE continue to show promising results.
• The market for macitentan tablets is driven by higher disposable incomes, government initiatives, and expanding distribution channels.
• High costs and limited patient awareness are significant market restraints.
• The single tablet combination therapy of macitentan and tadalafil has been approved and offers a new treatment option for PAH patients.
• Ongoing research and development are crucial for market growth and improving patient outcomes.

FAQs

What is the current status of the MACiTEPH study?

The MACiTEPH study was stopped due to futility following a pre-planned interim analysis, as recommended by the independent data monitoring committee[1].

What are the key findings of the A DUE study?

The A DUE study showed that the single tablet combination therapy of macitentan 10 mg and tadalafil 40 mg significantly improved pulmonary hemodynamics compared to monotherapy in PAH patients[3][4].

What is the UNISUS study evaluating?

The UNISUS study is evaluating the superiority of a 75 mg dose of macitentan over the currently available 10 mg dose in patients with PAH[1][5].

What are the market drivers for macitentan tablets?

The market drivers include higher disposable income levels, government initiatives for rare disease research, and the expansion of distribution channels[2].

What is the significance of the single tablet combination therapy of macitentan and tadalafil?

The single tablet combination therapy, approved as Yuvanci®, offers a convenient and effective treatment option for PAH patients, reducing the complexity of managing multiple medications and improving patient outcomes[4].

Sources

1. Janssen Pharmaceutical Companies of Johnson & Johnson. "Janssen Announces Update to Phase 3 MACiTEPH Study Evaluating Macitentan 75 mg in Patients with Chronic Thromboembolic Pulmonary Hypertension (CTEPH)." September 6, 2023.
2. 360iResearch. "Macitentan Tablets Market Size & Share 2025-2030."
3. Janssen Pharmaceutical Companies of Johnson & Johnson. "Late-Breaking Phase 3 A DUE Data Show Investigational Single Tablet Combination Therapy of Macitentan and Tadalafil Significantly Improves Pulmonary Hemodynamics Versus Monotherapy in Patients with Pulmonary Arterial Hypertension (PAH)." March 6, 2023.
4. Innovative Medicine at Janssen. "European Commission approves Yuvanci® (Single Tablet Combination Therapy of Macitentan and Tadalafil) for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)." September 30, 2024.
5. Janssen Science. "OPSUMIT - Macitentan 75 mg in Treatment of Pulmonary Hypertension."