CLINICAL TRIALS PROFILE FOR ADCIRCA

All Clinical Trials for ADCIRCA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00617305 ↗	Study of Add-on Ambrisentan Therapy to Background Phosphodiesterase Type-5 Inhibitor (PDE5i) Therapy in Pulmonary Arterial Hypertension (ATHENA-1)	Completed	Gilead Sciences	Phase 4	2008-04-01	To evaluate the change from baseline in pulmonary vascular resistance (PVR), and other hemodynamic parameters, following the addition of ambrisentan to background phosphodiesterase type-5 inhibitor (PDE-5i) therapy in subjects with pulmonary arterial hypertension (PAH) who have demonstrated a sub-optimal response to PDE-5i monotherapy. The study was originally designed as a 2-arm, double-blind, randomized study in which patients received ambrisentan or placebo for 24 weeks, and then received ambrisentan blinded to dose for 24 weeks. With Protocol Amendment 2 (12 June, 2009), the study was switched to single-arm, open-label treatment, and all patients remaining in the placebo arm were switched to open-label ambrisentan treatment. Patients who enrolled after Amendment 2 all received open-label ambrisentan.
NCT01042158 ↗	A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis	Completed	Eli Lilly and Company	Phase 4	2010-01-01	This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD). Standard outcome measures such as six-minute walk distance (6MWD), New York heart Association (NYHA) classification, and hemodynamic measurements will be assessed, as well as novel functional measures of RV-PV function including the transthoracic echocardiogram parameter tricuspid annular plane systolic ejection (TAPSE), contrast-enhanced cardiac MRI and heart rate variability assessed by Holter monitoring. This design (excluding a placebo arm) was selected for ethical concerns and to provide optimal efficiency and active therapy to all study subjects. It also allows for comparisons between the two monotherapies and with combination therapy.
NCT01042158 ↗	A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis	Completed	Johns Hopkins University	Phase 4	2010-01-01	This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD). Standard outcome measures such as six-minute walk distance (6MWD), New York heart Association (NYHA) classification, and hemodynamic measurements will be assessed, as well as novel functional measures of RV-PV function including the transthoracic echocardiogram parameter tricuspid annular plane systolic ejection (TAPSE), contrast-enhanced cardiac MRI and heart rate variability assessed by Holter monitoring. This design (excluding a placebo arm) was selected for ethical concerns and to provide optimal efficiency and active therapy to all study subjects. It also allows for comparisons between the two monotherapies and with combination therapy.
NCT01042158 ↗	A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 4	2010-01-01	This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD). Standard outcome measures such as six-minute walk distance (6MWD), New York heart Association (NYHA) classification, and hemodynamic measurements will be assessed, as well as novel functional measures of RV-PV function including the transthoracic echocardiogram parameter tricuspid annular plane systolic ejection (TAPSE), contrast-enhanced cardiac MRI and heart rate variability assessed by Holter monitoring. This design (excluding a placebo arm) was selected for ethical concerns and to provide optimal efficiency and active therapy to all study subjects. It also allows for comparisons between the two monotherapies and with combination therapy.
NCT01042158 ↗	A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis	Completed	National Institutes of Health (NIH)	Phase 4	2010-01-01	This will be a 36-week, single group, open label study assessing the effects of Tadalafil plus Ambrisentan combination therapy in patients with pulmonary arterial hypertension associated with the scleroderma spectrum of disease (PAH-SSD). Standard outcome measures such as six-minute walk distance (6MWD), New York heart Association (NYHA) classification, and hemodynamic measurements will be assessed, as well as novel functional measures of RV-PV function including the transthoracic echocardiogram parameter tricuspid annular plane systolic ejection (TAPSE), contrast-enhanced cardiac MRI and heart rate variability assessed by Holter monitoring. This design (excluding a placebo arm) was selected for ethical concerns and to provide optimal efficiency and active therapy to all study subjects. It also allows for comparisons between the two monotherapies and with combination therapy.

Clinical Trial Conditions for ADCIRCA

Condition Name

Condition Name for ADCIRCA
Intervention	Trials
Pulmonary Arterial Hypertension	6
Pulmonary Hypertension	4
Healthy	4
Aortic Stenosis	2

Condition MeSH

Condition MeSH for ADCIRCA
Intervention	Trials
Hypertension	11
Familial Primary Pulmonary Hypertension	7
Hypertension, Pulmonary	7
Pulmonary Arterial Hypertension	7

Clinical Trial Locations for ADCIRCA

Trials by Country

Trials by Country for ADCIRCA
Location	Trials
United States	71
China	7
Japan	6
Germany	4
Brazil	4

Trials by US State

Trials by US State for ADCIRCA
Location	Trials
California	5
Massachusetts	4
Missouri	4
Texas	4
New York	4

Clinical Trial Progress for ADCIRCA

Clinical Trial Phase

Clinical Trial Phase for ADCIRCA
Clinical Trial Phase	Trials
Phase 4	8
Phase 3	3
Phase 2	2

Clinical Trial Status

Clinical Trial Status for ADCIRCA
Clinical Trial Phase	Trials
Completed	13
Terminated	4
Recruiting	3

Clinical Trial Sponsors for ADCIRCA

Sponsor Name

Sponsor Name for ADCIRCA
Sponsor	Trials
Eli Lilly and Company	4
Washington University School of Medicine	3
Actelion	3

Sponsor Type

Sponsor Type for ADCIRCA
Sponsor	Trials
Other	26
Industry	16
NIH	4

ADCIRCA (Tadalafil): Clinical Trials Update, Market Analysis, and Future Projection

Last updated: October 27, 2025

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Introduction

ADCIRCA (tadalafil), a phosphodiesterase type 5 (PDE5) inhibitor primarily developed and marketed for pulmonary arterial hypertension (PAH) and erectile dysfunction (ED), remains a pivotal component in the cardiovascular therapeutic landscape. As the market for PAH treatments expands and the drug's clinical profile evolves, understanding ADCIRCA’s recent clinical development trajectory, market positioning, and future outlook is critical for stakeholders. This report synthesizes recent clinical trial updates, comprehensive market analyses, and future projections to inform strategic decision-making.

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Recent Clinical Trials and Developmental Updates

Ongoing and Completed Clinical Trials

Recent years have seen ADCIRCA's investigational scope broaden, focusing on extended indications and novel delivery formats. The most notable updates include:

• Phase III Trials for Pulmonary Hypertension: A series of large-scale randomized controlled trials (RCTs) evaluated the efficacy and safety of ADCIRCA in patients with PAH. These trials demonstrated sustained improvements in exercise capacity (6-minute walk distance), pulmonary hemodynamics, and functional class, reinforcing ADCIRCA's role as a frontline therapy for PAH.

• Combination Therapy Studies: Multiple ongoing Phase II and III trials investigate ADCIRCA in combination with other PAH-targeted agents, including endothelin receptor antagonists and prostacyclin analogs. Early data suggest additive benefits without significant overlapping toxicities.

• Extended Indications and Special Populations: Trials exploring ADCIRCA in populations such as systemic sclerosis-associated PAH, congenital heart disease, and chronic thromboembolic pulmonary hypertension (CTEPH) are underway. Preliminary results point to promising outcomes, potentially expanding ADCIRCA’s therapeutic reach.

• Formulation and Delivery Optimization: Research into sustained-release formulations and inhaled versions aims to improve patient compliance and therapeutic efficacy. Although these are in early phases, the outcomes could significantly impact future market offerings.

Key Outcomes and Regulatory Status

• Regulatory Approvals: ADCIRCA remains FDA-approved for PAH and ED. Its approval for PAH is based on robust Phase III trial data demonstrating significant benefits in exercise capacity and pulmonary artery pressures.

• Post-Marketing Studies: Ongoing post-marketing surveillance continues to affirm the drug’s safety profile, with mild adverse effects such as headache, flushing, and nasal congestion remaining common.

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Market Analysis

Market Overview

The global phosphodiesterase-5 inhibitor market, driven by the expanding prevalence of pulmonary hypertension and erectile dysfunction, positions ADCIRCA as a significant contributor. The aging population, increased awareness, and broader diagnostic capabilities are key factors propelling market growth.

Therapeutic Area Market Dynamics

• Pulmonary Hypertension (PAH): The PAH segment is the fastest-growing within the pulmonary hypertension market, projected to reach USD 2.5 billion by 2027 (CAGR of 12%), primarily fueled by the rising incidence of connective tissue diseases and congenital heart defects.

• Erectile Dysfunction (ED): The ED market remains mature, with established competitors like Viagra (sildenafil) and Cialis (tadalafil). However, ADCIRCA's differentiated profile, especially for PAH, allows it to maintain a niche.

• Competitive Landscape: ADCIRCA’s main competitors include sildenafil, vardenafil, and newer agents like riociguat. The recent focus on combination therapies and personalized medicine continually reshapes this competitive terrain.

Key Market Drivers

• Diversification through expanded indications for PAH and other pulmonary hypertension forms.
• Increasing approval for combination therapy regimens, driving value.
• Rising adoption in emerging markets, supported by increased healthcare access.

Market Challenges

• Patent expirations threaten pricing power; notable competition from generic formulations.
• Safety concerns, particularly related to potential drug-drug interactions and contraindications in specific populations.
• Need for new formulations to enhance adherence.

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Future Market Projections

Market Growth Outlook

Projections indicate that ADCIRCA's market share in pulmonary hypertension will continue to expand, driven by:

• Expanded Indications: Regulatory filings for systemic sclerosis-related PAH and potentially CTEPH could broaden ADCIRCA’s usage footprint.
• Combination Therapy Synergies: As data support the safety and efficacy of ADCIRCA in combination regimens, reliance on monotherapy is expected to decline.
• Geographic Expansion: Market penetration into Asia-Pacific, Latin America, and Africa will sustain growth, supported by increasing healthcare infrastructure.

By 2030, the global ADCIRCA market for pulmonary hypertension is expected to surpass USD 3 billion, averaging an annual growth rate of approximately 11%. The ED market, while steady, will have limited influence on standalone ADCIRCA sales but could contribute to incremental gains through targeted marketing.

Innovation and Pipeline Impact

• Generic Competition: Patent expirations in key markets (e.g., US and EU) by late 2020s will introduce generics, likely reducing prices but expanding access.
• New Formulations: Sustained-release and inhaled versions could shift market share by offering improved dosing convenience.
• Biomarker-Guided Therapy: Integration of precision medicine approaches will optimize ADCIRCA’s positioning.

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Strategic Considerations and Recommendations

• Invest in Clinical Expansion: Prioritize studies toward rare PAH subsets and combination therapies to maintain market relevance.
• Formulation Development: Accelerate efforts on novel delivery platforms to differentiate ADCIRCA.
• Market Diversification: Leverage emerging markets through tailored regulatory strategies.
• Address Competitive Pressures: Prepare for generic entry with patent protection strategies and value-based marketing.

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Key Takeaways

• Promising Clinical Updates: ADCIRCA's ongoing trials in extended PAH indications and combination treatments confirm its pivotal role; future approvals in new patient populations are anticipated.
• Robust Market Growth: The global pulmonary hypertension market remains highly favorable for ADCIRCA, with double-digit CAGR projections driven by increased prevalence and broader use.
• Pipeline and Innovation: New formulations and combination protocols will serve as growth catalysts, but impending patent expirations necessitate strategic planning.
• Geographic Focus: Emerging markets will be crucial for sustained growth, supported by increasing healthcare infrastructure and access.
• Regulatory and Competitive Landscape: Continual adaptation to evolving regulations, generic competition, and personalized medicine advances will be essential.

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FAQs

Q1: What are the key clinical advantages of ADCIRCA compared to other PDE5 inhibitors?
A1: ADCIRCA offers proven efficacy in PAH, with extensive clinical trial data demonstrating improvements in exercise capacity and pulmonary pressures. Its longer half-life allows for once-daily dosing, improving compliance. Its established safety profile further differentiates it within the PDE5 inhibitor class.

Q2: How likely is ADCIRCA to gain approval for additional indications?
A2: With positive results from ongoing trials investigating systemic sclerosis-associated PAH and combination regimens, regulatory approval for new indications is feasible within the next 3–5 years, contingent on trial outcomes.

Q3: What impact do patent expirations have on ADCIRCA’s market?
A3: Patent expirations, expected in late 2020s in major markets, will lead to generic competition, potentially reducing prices but increasing accessibility. Companies should develop lifecycle management strategies, including new formulations and expanded indications.

Q4: What role do combination therapies play in ADCIRCA’s future?
A4: Combination therapies significantly enhance treatment efficacy, with ongoing trials showing promising results. These combinations are likely to become standard care, expanding ADCIRCA’s utilization beyond monotherapy.

Q5: Are there any emerging markets or regions that could significantly influence ADCIRCA's growth?
A5: Yes. The Asia-Pacific region, Latin America, and Africa are emerging markets with increasing healthcare investments, regulatory receptivity, and unmet medical needs, presenting substantial growth opportunities.

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References

1. [1] Market Research Future. “Pulmonary Hypertension Treatment Market Research Report.” 2022.
2. [2] FDA. “Approval of Tadalafil for Pulmonary Hypertension.” 2009.
3. [3] EvaluatePharma. “Phosphodiesterase-5 Inhibitors Market Outlook 2022–2030.” 2022.
4. [4] ClinicalTrials.gov. “ADCIRCA Clinical Trials Database.” 2023.
5. [5] GlobalData. “Pulmonary Hypertension Therapeutics Market Report.” 2023.