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.

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
Hyperlipidemias	11
Diabetes Mellitus	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

Telmisartan Clinical Trials Update, Market Analysis, and Projection

Last updated: April 24, 2026

What is telmisartan and where is it used commercially?

Telmisartan is an angiotensin II receptor blocker (ARB) indicated for the treatment of hypertension and, in many markets, for reduction of cardiovascular risk in selected patient populations (label wording varies by jurisdiction). It is widely marketed globally under brand names including Micardis (Boehringer Ingelheim) and generics.

Key commercial reality: telmisartan is an established, off-patent product in most major geographies. Market dynamics are driven primarily by generic penetration, price compression, channel contracting, and ongoing physician demand in hypertension and cardiovascular risk management.

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What do recent clinical developments focus on?

Telmisartan’s clinical pipeline activity is mostly concentrated in:

• Combination regimens (telmisartan with complementary antihypertensives or metabolic modifiers)
• Real-world effectiveness and safety studies in hypertension or cardio-metabolic cohorts
• Formulation and bioequivalence work for generics and line extensions
• Studies exploring renal and cardiovascular endpoints in specific subgroups

Clinical trial volume pattern: In public registries, telmisartan appears repeatedly as an active comparator or background therapy in trials evaluating add-on treatments, rather than as the sole investigational drug.

Regulatory and lifecycle note: Because telmisartan is already approved, most newer studies are not seeking primary approval for a new molecular entity. They typically support label refinement, new combinations, safety/efficacy characterization in specific populations, or generic entry.

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Where are clinical trials concentrated geographically and by trial type?

Across registries and publications, telmisartan studies cluster in:

• India, China, Latin America, and Eastern Europe (high volume of investigator-initiated hypertension cohorts and bioequivalence)
• Western Europe and North America for post-marketing safety, comparative effectiveness, and guideline-aligned outcomes cohorts

Trial-type mix

• Bioequivalence / formulation: generics and combination generics
• Interventional add-on: telmisartan plus another therapy versus telmisartan alone or standard-of-care comparators
• Observational: adherence, BP control outcomes, persistence, and tolerability

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What is the current market size and how is it changing?

Telmisartan sits in the global ARB class, where demand is durable due to chronic use, but the commercial growth profile is constrained by mature competitive dynamics.

Market drivers

• Persistent incidence of hypertension and rising treated prevalence
• Generic erosion that caps price growth
• Ongoing physician preference for ARBs in patients intolerant to ACE inhibitors
• Shift toward fixed-dose combinations (FDCs) and simplified titration regimens

Market headwinds

• Price compression from generics and multi-source competition
• Manufacturing and regulatory execution pressures for generics
• Intensifying payer and procurement controls, especially in hospital and tender-driven markets

Practical market structure

• Retail and reimbursed outpatient segments dominate
• In tender markets (public systems), branded products typically lose share after generic launch waves

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What is the competitive landscape for telmisartan?

Competition is led by:

• Branded originator history (Micardis and line extensions)
• Multiple generic manufacturers across major supply regions
• Combination products (telmisartan plus thiazide/thiazide-like diuretics and other add-ons)

Brand versus generic: market share is primarily a function of formulary positioning, contracted pricing, and FDC availability rather than clinical differentiation, given telmisartan’s established evidence base.

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What is the projection for telmisartan through 2030?

A credible projection for telmisartan must reflect mature-drug economics:

• Volume growth: steady, driven by hypertension prevalence and treated patient numbers
• Value growth: slower, dominated by price erosion offsetting volume gains
• Share dynamics: gradual shift toward combinations and lower-cost multi-source supply

Projection direction (high-level)

• Global units: expected to grow at a low-to-mid single-digit rate over the remainder of the decade, depending on access expansion and population growth.
• Global sales value: expected to grow at a lower rate than units due to ongoing price compression and tender-based procurement.
• Formulation mix: increasing share of fixed-dose combinations containing telmisartan.

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How do fixed-dose combinations change telmisartan’s outlook?

Telmisartan’s commercial durability improves when it is packaged into FDCs because:

• Prescribers target faster BP control with fewer pills
• Payers often prefer FDCs after clinical protocol alignment
• Generics can more easily differentiate on price and procurement convenience even when API is the same

Typical FDC patterns in market practice

• Telmisartan + hydrochlorothiazide (HCTZ)
• Telmisartan + amlodipine (in some markets where approved and available)
• Other regional combinations depending on local regulatory approvals

The long-term mix shift toward combinations supports stability in telmisartan demand even as monotherapy pricing declines.

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What should investors and R&D leaders watch next?

For a mature ARB, “signal” comes less from breakthrough efficacy and more from commercial and regulatory execution:

Evidence to track in public records

• Ongoing trials targeting specific patient subgroups (renal impairment, high cardiovascular risk, post-event populations)
• Comparative trials evaluating BP control endpoints and tolerability of combination regimens
• Studies supporting new FDC entrants and their market authorization

Commercial indicators

• Generic pricing trajectories in major procurement markets
• Formulary adoption rates for telmisartan-containing FDCs
• Supply chain stability and regulatory inspection outcomes affecting manufacturing capacity

Competitive pressure points

• Entry timing and scale of generic manufacturers in China, India, and EU tender systems
• Manufacturer consolidation and capacity additions that affect price competition
• Patent landscape management for brand line extensions (where any remain)

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Clinical trials update: what does the evidence base already show?

Telmisartan is supported by large-scale outcomes data from its established clinical dossier, including cardiovascular risk reduction findings in high-risk populations. The modern trial landscape tends to “extend the use,” study subgroups, or compare combination strategies rather than re-proving first principles.

Core scientific positioning

• ARB mechanism: angiotensin II receptor blockade (AT1)
• BP reduction efficacy across diverse patient groups
• Tolerability profile consistent with ARB class expectations

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Key takeaways

• Telmisartan is a mature, off-patent ARB with clinical research activity dominated by combinations, subgroup refinement, real-world evidence, and generic/formulation work rather than new molecular approvals.
• Market growth is primarily volume-led, with value constrained by sustained generic price compression and tender-driven procurement.
• Fixed-dose combinations containing telmisartan are the main pathway to maintain unit demand and support relative value stability.
• Projections through 2030 point to steady global volume growth, slower value growth, and increasing mix toward FDCs.

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FAQs

1) Is telmisartan still the subject of new clinical development?

Yes, but most new activity is concentrated in combination regimens, post-authorization studies, bioequivalence/formulation efforts, and real-world effectiveness cohorts, often with telmisartan used as background therapy.

2) What most affects telmisartan’s market performance today?

Generic pricing, formulary access, and the shift toward fixed-dose combinations that improve prescription convenience and BP control strategy.

3) How should market projections treat value versus volume?

Model them separately: volume tracks prevalence and treatment rates; value is capped by price erosion, especially in tender and reimbursed procurement systems.

4) Where are clinical trials most concentrated?

Trials and studies with telmisartan frequently concentrate in high patient-volume and high generic research markets, with additional real-world and comparative studies in regulated markets.

5) What is the main R&D opportunity for telmisartan going forward?

Regulatory and commercial differentiation through FDCs, subgroup-specific evidence, and formulation improvements that reduce pill burden and support payer adoption.

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References (APA)

[1] U.S. National Library of Medicine. (n.d.). ClinicalTrials.gov. https://clinicaltrials.gov
[2] World Health Organization. (n.d.). WHO Global Health Observatory (GHO) data: Hypertension. https://www.who.int/data/gho
[3] European Medicines Agency. (n.d.). EPAR: Micardis (telmisartan). https://www.ema.europa.eu
[4] FDA. (n.d.). Drug approvals and labeling for telmisartan-containing products. https://www.fda.gov
[5] NICE. (n.d.). Hypertension in adults: diagnosis and management (clinical guidance). https://www.nice.org.uk