CLINICAL TRIALS PROFILE FOR TELMISARTAN

505(b)(2) Clinical Trials for telmisartan

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT02262572 ↗	Relative Bioavailability of Telmisartan and HCTZ in Two Experimental Formulations Compared to the Standard Formulation Telmisartan and HCTZ in Healthy Female and Male Subjects	Completed	Boehringer Ingelheim	Phase 1	2003-04-01	Study to assess the comparative pharmacokinetics of telmisartan/HCTZ in two new formulations based on sodium salt compared to the present commercial formulation (MicardisPlus®)

All Clinical Trials for telmisartan

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00034840 ↗	Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose	Completed	Bayer	Phase 4	2001-10-01	The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
NCT00034840 ↗	Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose	Completed	GlaxoSmithKline	Phase 4	2001-10-01	The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
NCT00034840 ↗	Telmisartan vs. Valsartan in Patients With Mild to Moderate Hypertension Following a Missed Dose	Completed	Boehringer Ingelheim	Phase 4	2001-10-01	The primary objectives are to demonstrate that MICARDIS® (telmisartan) is statistically superior to Diovan® (valsartan) in reducing diastolic blood pressure (DBP) following a missed dose at the end of a 6 to 8-week treatment period as measured by the 24-hour ABPM mean and to demonstrate that MICARDIS® is statistically superior to Diovan® in reducing DBP during the last 6-hours of the 24-hour dosing interval as measured by ABPM following a dose of active study medication at the end of a 6 to 8-week treatment period.
NCT00067977 ↗	HALT Progression of Polycystic Kidney Disease Study B	Completed	Boehringer Ingelheim	Phase 3	2006-01-01	The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR >60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years. Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.
NCT00067977 ↗	HALT Progression of Polycystic Kidney Disease Study B	Completed	Merck Sharp & Dohme Corp.	Phase 3	2006-01-01	The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR >60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years. Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.
NCT00067977 ↗	HALT Progression of Polycystic Kidney Disease Study B	Completed	Polycystic Kidney Disease Foundation	Phase 3	2006-01-01	The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR >60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years. Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.
NCT00067977 ↗	HALT Progression of Polycystic Kidney Disease Study B	Completed	University of Pittsburgh	Phase 3	2006-01-01	The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the progression of cystic disease and on the decline in renal function in autosomal dominant kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical trials targeting different levels of kidney function: 1) early disease defined by GFR >60 mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73 m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the first three years. Participants enrolled in Study B will be followed for five-to-eight years, with the average length of follow-up being six and a half years. Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.

Clinical Trial Conditions for telmisartan

Condition Name

Condition Name for telmisartan
Intervention	Trials
Hypertension	157
Healthy	40
Essential Hypertension	11
Hyperlipidemia	9

Condition MeSH

Condition MeSH for telmisartan
Intervention	Trials
Hypertension	147
Essential Hypertension	24
Diabetes Mellitus	11
Hyperlipidemias	11

Clinical Trial Locations for telmisartan

Trials by Country

Trials by Country for telmisartan
Location	Trials
United States	395
Korea, Republic of	95
Canada	77
Australia	26
Spain	23

Trials by US State

Trials by US State for telmisartan
Location	Trials
California	19
Georgia	16
Florida	16
Ohio	15
Texas	15

Clinical Trial Progress for telmisartan

Clinical Trial Phase

Clinical Trial Phase for telmisartan
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	2
PHASE2	1

Clinical Trial Status

Clinical Trial Status for telmisartan
Clinical Trial Phase	Trials
Completed	219
RECRUITING	22
Unknown status	16

Clinical Trial Sponsors for telmisartan

Sponsor Name

Sponsor Name for telmisartan
Sponsor	Trials
Boehringer Ingelheim	134
Chong Kun Dang Pharmaceutical	19
Yuhan Corporation	13

Sponsor Type

Sponsor Type for telmisartan
Sponsor	Trials
Industry	220
Other	142
NIH	9

Clinical Trials Update, Market Analysis, and Projection for Telmisartan

Last updated: October 28, 2025

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Introduction

Telmisartan, an angiotensin II receptor blocker (ARB), is primarily prescribed for the management of hypertension and cardiovascular risk reduction. Since its FDA approval in 1999, the drug has experienced significant market penetration and numerous ongoing investigations aimed at expanding its indications. This report provides an in-depth analysis of recent clinical trials, current market dynamics, and projected growth trajectories for Telmisartan.

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Clinical Trials Update

Recent and Ongoing Studies

Over the past 24 months, clinical research on Telmisartan has concentrated on its cardio-renal protective effects, off-label indications, and combination therapy efficacy. Notable clinical trial identifiers include NCT03386291 and NCT04511672, both focusing on additional benefits of Telmisartan in conditions such as metabolic syndrome and diabetic nephropathy.

• Meta-analyses and Post-Hoc Reviews:
  Recent systematic reviews have reaffirmed Telmisartan's role in reducing blood pressure and providing endothelial protection comparable to other ARBs, with a favorable safety profile[^1].

• Cardiovascular and Renal Outcomes:
  Studies such as the ONTARGET trial (2008) laid the groundwork for its cardio-renal benefits. Currently, researchers are exploring Telmisartan’s potential in preventing progression of chronic kidney disease (CKD) in diabetic populations, with ongoing studies assessing long-term outcomes[^2].

• Novel Indications:
  Several trials are assessing Telmisartan's potential in treating non-traditional conditions. For instance, NCT03963412 investigates its use in preventing cognitive decline among high-risk hypertensive patients, emphasizing its vasoprotective qualities[^3].

Latest Results and Regulatory Landscape

While no new approvals have been granted recently, regulators in certain jurisdictions are considering expanding indications to include prevention of CKD progression, based on accumulating evidence from observational studies and ongoing randomized controlled trials.

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Market Analysis

Current Market Composition

The global antihypertensive drugs market, valued at approximately USD 37.4 billion in 2021, features ARBs like Telmisartan as a substantial segment due to their favorable side effect profile and efficacy[^4].

• Key Players:
  Major pharmaceutical companies such as Boehringer Ingelheim (original manufacturer), Mylan, and Teva dominate the generic Telmisartan market. Patent expirations in the late 2010s facilitated generic proliferation, resulting in increased accessibility.

• Geographic Distribution:
  North America accounts for the largest share, driven by high prevalence of hypertension and robust healthcare infrastructure. Emerging economies in Asia-Pacific exhibit rapid growth potential, propelled by expanding healthcare expenditure and regulatory approvals[^5].

Market Drivers

• Growing Hypertension Prevalence:
  An estimated 1.28 billion adults worldwide suffer from hypertension, a primary target for Telmisartan therapy[^6].

• Expanded Indications:
  Evidence supporting Telmisartan’s role in metabolic syndrome and CKD management broadens its usage, fostering growth beyond traditional hypertension control.

• Patient Preference:
  Once-daily dosing and minimal side effects bolster patient adherence, favorable for market demand.

Market Challenges

• Competitive Landscape:
  The ARB segment is highly competitive, with Losartan, Valsartan, and Irbesartan offering alternative options. Additionally, ACE inhibitors and calcium channel blockers also vie for market share.

• Patent and Pricing Dynamics:
  Patent expirations and generic availability pressure pricing, potentially limiting margins.

• Regulatory Hurdles:
  Uncertainty over label expansions requires substantive clinical evidence, which entails time and investment.

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Market Projection (2023–2030)

Growth Forecast

Analysts project a compounded annual growth rate (CAGR) of approximately 4.8% for the global Telmisartan market, driven by increasing hypertension prevalence, expanding indications, and rising acceptance in emerging economies[^7].

• 2023 Valuation:
  The market is estimated to reach USD 2.6 billion, with generic versions accounting for nearly 85% of sales.

• 2030 Outlook:
  The market is expected to surpass USD 4.1 billion, with a significant share attributed to clinical trials supporting new therapeutic uses and regulatory approvals.

Key Regional Trends

• North America:
  Continues as the largest consumer, with emerging growth in personalized medicine approaches that leverage Telmisartan’s pharmacogenomic profile.

• Asia-Pacific:
  Exhibits the fastest growth rate, supported by increased hypertension awareness and evolving healthcare infrastructure.

• Europe:
  Steady expansion, contingent on approval extensions and ongoing clinical research.

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Implications for Stakeholders

• Pharmaceutical Companies:
  Investment in clinical trials targeting expanded indications may yield substantial market share gains.

• Regulatory Bodies:
  Encouraged to facilitate approval processes for label expansions, provided that robust clinical evidence is supplied.

• Healthcare Providers:
  Continuing education on new evidence for Telmisartan’s broader therapeutic role can inform optimal prescribing practices.

• Investors:
  Focus on companies with active pipelines or clinical programs extending Telmisartan's use, especially in cardio-renal and metabolic disease domains.

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Key Takeaways

• Clinical Landscape:
  Recent studies underscore Telmisartan’s potential beyond hypertension, particularly in CKD and metabolic syndrome, with ongoing trials pivotal in expanding its indications.

• Market Dynamics:
  Widespread generic availability has lowered prices, increasing access but intensifying price competition within a highly saturated ARB market.

• Growth Opportunities:
  Expanding clinical evidence could catalyze label extensions, especially in emerging markets, thereby fueling future growth.

• Challenges:
  Competitive pressure, regulatory hurdles, and the need for conclusive evidence for new indications remain critical obstacles.

• Strategic Focus:
  Stakeholders investing in Telmisartan should monitor ongoing trials, emerging guidelines, and regional regulatory developments to capitalize on emerging opportunities.

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FAQs

1. What are the main current indications for Telmisartan?
   Telmisartan is primarily indicated for hypertension and cardiovascular risk reduction. Recent research suggests potential in preventing CKD progression and metabolic syndrome.

2. Are there any recent changes in the regulatory status of Telmisartan?
   No recent major regulatory approvals; however, discussions continue about expanding indications based on ongoing clinical evidence.

3. How does Telmisartan compare to other ARBs in the market?
   Similar in efficacy to other ARBs with a favorable safety profile; its unique partial PPAR-gamma modulating properties may confer additional metabolic benefits.

4. What are the prospects for innovative formulations or combination therapies involving Telmisartan?
   Likely positive, with combination products (e.g., Telmisartan with policies targeting resistant hypertension) gaining traction, especially in personalized medicine approaches.

5. What are the key factors influencing Telmisartan’s future market growth?
   Clinical trial outcomes, regulatory approvals for expanded indications, regional healthcare policies, and competitive pricing dynamics.

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References

[1] Liu, Y., et al. (2020). "Meta-Analysis of Telmisartan Efficacy in Blood Pressure Control." Journal of Hypertension, 38(7), 1140-1148.
[2] National Clinical Trial Registry. (2022). Ongoing Studies in Diabetic Nephropathy. NCT04511672.
[3] ClinicalTrials.gov. (2019). Telmisartan and Cognitive Decline Prevention. NCT03963412.
[4] GlobalData. (2022). "Antihypertensive Drugs Market Report."
[5] IQVIA. (2022). "Emerging Markets Growth Analysis."
[6] World Health Organization. (2021). "Hypertension Fact Sheet."
[7] MarketWatch. (2023). "Telmisartan Market Size and Forecast."

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In Summary:
Telmisartan stands as a cornerstone ARB with evolving clinical applications. While current market saturation and competitive pressures limit short-term growth, ongoing research and potential regulatory expansions position it for a promising long-term trajectory, especially with emerging evidence supporting expanded indications. Stakeholders should prioritize clinical trial monitoring and regional regulatory landscapes to maximize opportunities in this dynamic market.