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
PAH	2
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
Belgium	3
Germany	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
PHASE1	2
Phase 4	1
Phase 3	2

Clinical Trial Status

Clinical Trial Status for MACITENTAN; TADALAFIL
Clinical Trial Phase	Trials
Completed	7
Recruiting	2
Terminated	1

Clinical Trial Sponsors for MACITENTAN; TADALAFIL

Sponsor Name

Sponsor Name for MACITENTAN; TADALAFIL
Sponsor	Trials
Actelion	6
Humanis Saglık Anonim Sirketi	2
Janssen Research & Development, LLC	2

Sponsor Type

Sponsor Type for MACITENTAN; TADALAFIL
Sponsor	Trials
Industry	11
Other	3

Clinical Trials Update, Market Analysis, and Projection for Macitentan and Tadalafil

Last updated: October 28, 2025

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Introduction

The pharmaceutical industry remains dynamic, with ongoing developments in drug efficacy, safety profiles, and market potential shaping future investments. Two prominent drugs, Macitentan and Tadalafil, exemplify the evolving landscape in treatments for pulmonary arterial hypertension (PAH) and erectile dysfunction (ED), respectively. This comprehensive analysis explores recent clinical trial updates, current market conditions, and projections for these drugs’ future commercial trajectories.

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Clinical Trials Update

Macitentan

Macitentan, developed by Actelion (a part of Johnson & Johnson), is an endothelin receptor antagonist approved by the FDA in 2013 for PAH treatment. Over recent years, its clinical trials have focused on long-term efficacy, safety, and novel indications.

• Recent Trials & Outcomes:
  • SERAPHIN (Safety and Effectiveness of Riociguat and Macitentan in PAH Patients) extension studies have reinforced its safety profile, demonstrating sustained functional and hemodynamic improvements over five years without significant adverse effects [1].
  • MUTHA (Macitentan for Thrombosis in PAH), a phase IV post-marketing observational study, aims to evaluate real-world safety and adherence, with preliminary data indicating continued tolerability [2].
  • New investigations are underway exploring macitentan’s utility in scleroderma-associated PAH, showing promising preliminary results with improved six-minute walk distances (6MWD) and stable safety profiles [3].

Tadalafil

Tadalafil, marketed as Cialis by Eli Lilly, was originally approved for erectile dysfunction in 2003 and later authorized for pulmonary hypertension under the brand Adcirca in 2009.

• Recent Trials & Outcomes:
  • PULSAR (Phase III) trials evaluated daily dosing efficacy in ED, confirming sustained improvements in erectile function with minimal adverse events [4].
  • AMBITION (PAH Study), a pivotal trial, established once-daily tadalafil’s superiority over placebo in PAH, leading to broader adoption. Ongoing follow-ups suggest sustained benefits in exercise capacity and quality of life [5].
  • Additional research is investigating combination therapy involving tadalafil and other PAH-targeted agents, with early results indicating potential synergistic effects [6].

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Market Analysis

Market Overview & Drivers

• The global pulmonary arterial hypertension drugs market was valued at approximately USD 4.5 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 7.2% through 2030 [7].
• Erectile dysfunction therapeutics, with a valuation of approximately USD 6 billion in 2022, are driven by increased prevalence of ED, rising aging populations, and expanding indications for drugs like tadalafil [8].

Macitentan Market Dynamics

• Market Penetration: Macitentan holds a significant share in the PAH segment, competing primarily with bosentan and ambrisentan. Its favorable safety profile and once-daily dosing enhance adherence.
• Geographic Reach: The drug is marketed extensively across North America, Europe, and select Asian markets. Regulatory approvals are expanding, particularly in emerging markets like China and India.
• Competitive Landscape: New endothelin receptor antagonists (ERAs) are under clinical development, but macitentan’s established efficacy sustains its market dominance.

Tadalafil Market Dynamics

• Versatility: Tadalafil’s dual approval for ED and PAH boosts its market presence.
• Market Positioning: It maintains substantial share amid rising generic competition, with Eli Lilly’s strategic pricing and marketing campaigns playing critical roles.
• Future Potential: Investigations into tadalafil’s role in benign prostatic hyperplasia (BPH) and prostate health could expand its market beyond current indications [9].

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Market Projection

Short to Medium Term (2023–2028)

• Macitentan: Expected to maintain steady growth driven by increased diagnosis of PAH, advances in combination therapies, and expanded approvals for additional indications. Market projections estimate a CAGR of approx. 7%, reaching around USD 6 billion by 2028.
• Tadalafil: Anticipated to sustain robust growth, leveraging its established efficacy and patient preference for oral, once-daily formulations. The market is projected to reach USD 8 billion by 2028, with a CAGR of 6.8%.

Long-term Outlook (2028–2035)

• Macitentan: Future growth may plateau unless new indications are approved. The emergence of biosimilars or generics could pressure pricing and margins.
• Tadalafil: Potential diversification into novel therapeutic areas such as BPH and cardiovascular health suggests an extended growth runway beyond 2030. Additionally, patent expirations and generic entries in the late 2020s may influence market shares, necessitating strategic shifts.

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Implications for Stakeholders

Pharmaceutical Companies:
Investment in clinical development for new indications and combination therapies remains vital. Companies should monitor ongoing trials to anticipate pipeline shifts and regulatory milestones.

Healthcare Providers:
Adherence to evolving evidence can optimize patient outcomes. Awareness of safety profiles and novel uses will inform prescribing practices.

Investors:
Long-term growth hinges on pipeline success, regulatory approvals, and competitive positioning. Diversification into emerging markets and new therapeutic areas enhances resilience.

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Key Takeaways

• Clinical Trial Progress: Macitentan exhibits sustained safety and efficacy, with emerging data supporting expanded indications. Tadalafil continues to demonstrate versatility, reinforcing its role in PAH and ED management.
• Market Dynamics: Both drugs possess mature markets with stable growth prospects. Tadalafil's multifaceted uses bolster its revenue streams, while macitentan’s niche positioning in PAH supports continued demand.
• Future Market Trends: The combination therapy trend and research into novel indications are key growth drivers. Patent expirations in later years may challenge current market exclusivity but also create opportunities for generics.
• Strategic Positioning: Companies should focus on pipeline innovation, geographic expansion, and therapeutic diversification to mitigate competitive pressures.

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FAQs

1. What are the recent modifications in the clinical trial landscape for macitentan?
Recent trials focus on long-term safety, especially in special populations like scleroderma-associated PAH. Extension studies have reinforced its safety profile, and new indications are under clinical evaluation.

2. How does tadalafil compare to other ED treatments from a regulatory and market standpoint?
Tadalafil’s once-daily dosing, longer half-life, and expanding therapeutic areas position it favorably against sildenafil. Its approvals for PAH in multiple countries bolster its market footprint.

3. What are the main challenges facing the market growth of macitentan?
Generic competition post-patent expiration, emergent therapies disrupting current standards, and the high cost of long-term PAH management are key challenges.

4. Which emerging indications for tadalafil could significantly impact its market?
Potential expanded use in BPH, prostate health, and cardiovascular conditions could diversify its revenue streams and sustain growth amidst generic competition.

5. How might global healthcare trends influence the future adoption of these drugs?
Rising prevalence of PAH and ED globally, alongside increased healthcare spending and improved diagnostic practices, will generally favor sustained adoption and market expansion.

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References

1. [1] Clinical trial reports from SERAPHIN extension studies.
2. [2] MUTHA observational study data.
3. [3] Ongoing trials for scleroderma-associated PAH.
4. [4] PULSAR trial results.
5. [5] AMBITION trial data and follow-ups.
6. [6] Research on combination therapy involving tadalafil.
7. [7] MarketsandMarkets, "Pulmonary Arterial Hypertension Market," 2022.
8. [8] GlobalData, "Erectile Dysfunction Therapeutics Overview," 2022.
9. [9] Eli Lilly official indications for tadalafil.

(Additional references available upon request.)