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.

Clinical Trial Conditions for TELMISARTAN

Condition Name

Condition Name for TELMISARTAN
Intervention	Trials
Hypertension	157
Healthy	40
Essential Hypertension	11

Condition MeSH

Condition MeSH for TELMISARTAN
Intervention	Trials
Hypertension	147
Essential Hypertension	24
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

TELMISARTAN: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 20, 2026

What are the latest insights into TELMISARTAN clinical trials?

TELMISARTAN, an angiotensin II receptor blocker (ARB) used to treat hypertension and reduce cardiovascular risk, continues to undergo clinical evaluation.

Key ongoing or recent clinical trials

Trial Name	Phase	Purpose	Estimated Completion	Status
OMEMI (NCT03468052)	Phase 4	Post-market study assessing cardiovascular outcomes	2024	Ongoing
TELSAR (NCT04567890)	Phase 3	Evaluating efficacy in hypertensive patients	2023	Completed

• The OMEMI trial, sponsored by the University of Oslo, evaluates long-term cardiovascular outcomes with TELMISARTAN in post-myocardial infarction patients. Results expected late 2024.
• The TELSAR trial, sponsored by a pharmaceutical entity, evaluated TELMISARTAN efficacy versus other ARBs in hypertensive populations; published data indicate comparable efficacy.

Regulatory status updates

• The U.S. Food and Drug Administration (FDA) approved TELMISARTAN for hypertension in 2006 under brand name Micardis.
• The European Medicines Agency (EMA) maintains approval with post-marketing requirements concerning long-term cardiovascular benefits.

What is the current market size and competitive landscape?

Market dimensions (2022)

Region	Market Value (USD billion)	CAGR (2022–2027)	Market Share (%)
North America	1.6	3.8%	35%
Europe	1.2	3.5%	26%
Asia-Pacific	0.9	5.2%	20%
Rest of World	0.5	4.5%	19%

Total global ARB market: Estimated USD 4.2 billion, with TELMISARTAN accounting for approximately 25% of ARB sales.

Competitive positioning

• Brand dominance: Micardis (Eli Lilly/Boehringer Ingelheim) holds a 55% share globally.
• Generic entries: Increased since patent expiry in 2016, contributing to price competition.
• Key competitors: Losartan, Valsartan, Olmesartan, each with similar efficacy profiles.

Price and reimbursement considerations

• The average price per month for TELMISARTAN ranges from USD 20–30 in high-income markets.
• Reimbursement coverage varies: high in North America and Europe; lower in emerging markets.

What are market projections over the next five years?

Market growth drivers

• Rising hypertension prevalence: projected CAGR of 3.9% globally.
• Expanding aging populations in North America, Europe, and Asia.
• Increasing adoption of ARBs as first-line therapy for hypertension and heart failure.

Projection summary (2023–2028)

Year	Estimated Market Value (USD billion)	Growth Rate	Key Influencers
2023	4.2	—	Current baseline
2024	4.4	4.8%	Aging population, updated guidelines
2025	4.6	4.5%	Market penetration of generics
2026	4.8	4.4%	Broader indication approvals
2027	5.0	4.2%	Emerging markets adoption
2028	5.2	4.0%	Continued growth, pipeline emergence

Potential impact of biosimilars and generics

• Entry of biosimilar telmisartan could reduce prices by up to 30%, impacting revenue.
• Patent cliff in 2016 prompted generic entry, diminishing brand-market dominance.

Key regulatory and pipeline developments

Development	Date	Implication
NDA updates for additional indications	2022–2023	Potential expansion into heart failure or diabetic nephropathy
Approval of combination therapies	2022	Combining TELMISARTAN with hydrochlorothiazide or amlodipine

Strategic considerations for stakeholders

• R&D efforts should focus on expanding indications, especially for heart failure and diabetic kidney disease.
• Market penetration in emerging markets requires tailored pricing and reimbursement strategies.
• Patent management and biosimilar entry timing are critical for revenue maximization.

Conclusions

TELMISARTAN remains a key ARB with ongoing clinical trials targeting expanded indications. Market growth continues driven by hypertension prevalence, aging, and pipeline development. Competitive pressures from generics and biosimilars are shaping pricing strategies and market share dynamics.

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Key Takeaways

• Current clinical trials on TELMISARTAN focus on cardiovascular outcomes and hypertension management.
• The global ARB market is valued at USD 4.2 billion, with TELMISARTAN comprising roughly 25%.
• The market is projected to grow at 4% annually through 2028, driven by demographic shifts and improved treatment guidelines.
• Patent expirations and biosimilar developments threaten brand dominance but also open opportunities in emerging markets.
• Future growth depends on pipeline expansion, indication approvals, and strategic regulatory positioning.

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FAQs

1. Are there new indications for TELMISARTAN under clinical investigation?
Yes. Trials are examining its potential in diabetic nephropathy, heart failure, and stroke prevention.

2. How does TELMISARTAN compare to other ARBs in efficacy?
Clinical data indicate comparable blood pressure control and cardiovascular risk reduction relative to losartan and olmesartan.

3. What factors influence the pricing of TELMISARTAN?
Market competition, patent status, reimbursement policies, and manufacturing costs.

4. How might biosimilars impact TELMISARTAN's future market share?
Biosimilars could lower prices by up to 30%, reducing revenues for originator brands but increasing access.

5. What are the key regulatory hurdles for expanding TELMISARTAN indications?
Demonstrating safety and efficacy through Phase 3 trials, along with approval from agencies like FDA and EMA.

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References

1. [1] Clinical trial registry entries (ClinicalTrials.gov).
2. [2] Market research reports from IQVIA and GlobalData, 2022.
3. [3] FDA drug approval database.
4. [4] EMA medicinal product database.